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Клеточная терапия и трансплантация
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Introduction

Over recent years, scientometric criteria have been increasingly used, in order to evaluate the effectiveness of scientific institutions, enabling us to present the fact-based characteristics of the institutions, and their impact on development of world science, if used in correct manner. To some degree, such an evaluation is important for monitoring the quality of both individual and team work, as well as efficient use of resources allocated for research.

Similarly, scientometric methods are increasingly used to answer the questions of preferential financial support for certain areas of research, and discern the priority products and technologies, as well as to resolve problems with research staff recruitment [1].

Current science management is largely focused on accountability. Therefore, quantitative evaluation of research activities sufficiently adds to qualitative assessments of research (i.e., peer reviewing of projects and articles). Hence, bibliometric evaluation with its measurements of research output and citation impact seems to be a quite important quantitative approach [2].

The Strategy for the Development of Medical Science is one of the key documents that determines the development trends of medical science in Russia. According to it, the main goal is to create high-tech innovative products ensuring the improvement of public health based on the transfer of innovative technologies to practical healthcare. To achieve this goal, it was necessary to arrange a network of leading centers for the prioritized areas [3].

To arrange such a system and provide methodological support of research projects for the leading institutions, a Decree №125 was issued by the Ministry of Healthcare of Russian Federation (March 21, 2017) entitled: "On arranging measures for establishment of network of National Research and Practical Medical Centers". Its implementation started by creating a network of National Medical Research Centers (NMRCs) on the basis of specialized research institutions subordinated to the Ministry of Healthcare of the Russian Federation that are leaders in the top areas of medical science. At the same time, the educational priorities in medical research were assigned to specialized research centers, but not to appropriate educational institutions (e.g., medical universities), being in controbersy with global trends in the basic science development. Thus, a network of 22 NMRCs was arranged [4, 5], involving the four research centers that conduct research in the field of oncology and hematology.

Hence, along with the National Research Center for Hematology, this study also included other major Russian centers active in clinical and experimental hematology, i.e., N. N. Blokhin National Medical Research Center of Oncology, Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, N. N. Petrov National Medical Research Center of Oncology, and Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation which is a part the St. Petersburg I. Pavlov Medical University.

Among the scientific indices of the institutions that are widely used in the reports, there is a clear bias towards quantitative characteristics, such as total number of articles, the number of articles indexed in the Web of Science (WoS) and Scopus international databases, total impact factor of the journals in which the articles were published, etc. At the same time, the indices characterizing quality of published works (citation scores) and, indirectly, the reputation of the institution (Hirsch index of the organization) are practically not used. Nevertheless, the Hirsch index is most difficult to manipulate by researchers and management staff at the institutions, and, therefore, it can be more objective when comparing scientific reputation characteristics [6].

The aim of our work was to perform a scientometric evaluation of these organizations, relying primarily on their quality indicators and impact of the research results. Moreover, our task was to determine the position of R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation (R. Gorbacheva Institute), a large university research center which is not an autonomous legal entity, and which was not put on the list of NMRCs with special support for research activities.

Materials and methods

Our study included five major institutions active in Hematology/Oncology over last 3 years (2016-2018), i.e., N. N. Petrov National Medical Research Center of Oncology (St. Petersburg), National Medical Research Center of Hematology (Moscow), N. Blokhin National Medical Research Center of Oncology (Moscow), Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (Moscow), and Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation at the I. Pavlov First St. Petersburg State Medical Unibersity.

For the convenience of this study, we concentrated precisely on the qualitative and reputation indices of the work of organizations for the period of 2016 to 2018. WoS and Scopus databases were used as a data source, which allowed filtering publications in journals that did not receive worldwide recognition. Publications marked "articles" were taken into account. This is especially important, since a Department of Hematology at the Pavlov University was also included into the study, and so without the filtering, publications by students and postgraduates occupied at the University, in general, could give a distorted characteristic of publications from the local researchers [7]. The list of publications was limited to keywords defining the field of research (Table 1), thus allowing to filter out most of the publications, first of all, by other branches of the I. Pavlov St. Petersburg Medical University that were not related to the specific area of Hematology/Oncology/Transplantation. Hence, the analysis was limited by the scientific publications from R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, and the I. Pavlov University Department of Hematology, Transfusiology and Transplantation.

Khrustalev-tab01.jpg

To evaluate the research activities of major haematological centers in Russia, we have calculated the widely used scientometric indicators, e.g., the citation index, which can be calculated for publications and also for organizations and individual researchers or research teams.

However, these commonly used indices have a significant drawback, i.e., they vary greatly for different areas, which can lead to distortions and inaccurate data. There are various approaches to the allocation of scientific fields for calculating the weighted average indicators in each of them.

Hence, to normalize indicators in the WoS system, classification is used based on the topics of the journals included in indexing. But this approach has a number of significant drawbacks, the main one of which is the inadequate processing of publications in interdisciplinary journals and other journals with a wide coverage. Therefore, more accurate, it seems the selection of areas based on individual publications, and not on the level of entire journals [1].

To perform the statistical evaluation, we used MS Excel software for plotting the diagrams. The ScVal database concerning the specialized St. Petersburg and Moscow centers were kindly provided by Dr. Mark A. Akoev (Laboratory of Scientometry, B. Yeltsin Ural Federal University, Yekaterinburg, Russia).

Results

Common scientometry

Comparison of the characteristics of organizations was done by the number of articles and citations for the period 2016-2018, and by the Hirsch index, calculated on the basis of their publications. The results are presented in Table 2 (according to WoS data) and in Table 3 (according to Scopus data).

Table 2. Common scientometric indices of the four major NMRCs active in Hematology/Oncology, and Raisa Gorbacheva Memorial Research Institute, according to the Web of Science data

Khrustalev-tab02.jpg

N. N. Blokhin National Medical Research Center of Oncology is a leader by the number of WoS-indexed publications (2798 papers). However, the average number of citations per publication proved to be the highest for N. N. Petrov NMRC of Oncology (7.8). For N.N. Blokhin NMRC of Oncology, this figure is almost the same as for R. Gorbacheva Memorial Research Institute, i.e. (6.98 and 6.5, respectively). At the same time, National Research Center for Hematology, ranking second in the number of publications, is significantly behind other surveyed institutions in terms of citation, with average citation number only 1.5 per an article. The same conclusions can be drawn by evaluating Hirsch index of these institutions (Table 3, Fig. 1). The N. Blokhin National Medical Research Center of Oncology (22), N. Petrov National Medical Research Center of Oncology (17) and R. Gorbacheva Memorial Research Institute (10) are in the top three for this index, and the National Research Center for Hematology has a lower Hirsch index level (5). Thus, on the basis of WoS-derived data, the N. N. Blokhin National Medical Research Center of Oncology is the leader in publishing activity in Oncology/Hematology among the studied organizations, and R. Gorbacheva Memorial Research Institute holds a middle position among the research centers working in this field.

Similar results are obtained when evaluating the publications of these institutions according to Scopus data. Here, the same three leading organizations are determined by the Hirsch index, and R. Gorbacheva Memorial Research Institute proved to be a leader in the number of publications referred in Scopus (890 publications over three years).

Table 3. Common scientometric indices of four NMRCs and R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation,according to the Scopus data

Khrustalev-tab03.jpg

Khrustalev-fig01.jpg

Figure 1. Hirsch Index of the four Russian NMRCs (see Table 3), and the R. Gorbacheva Institute (I. Pavlov University), as based on Scopus data

SciVal approach

A more profound study on the contribution of these organizations was done using the Elsevier SciVal online platform, which is based on the Scopus database, thus allowing monitoring and analysis of international scientific research using visualization tools and modern metrics for citations, economic and social efficiency. Each scientific topic in the Scopus database is a collection of documents united by a common research interest, grouped together in a SciVal cluster, as based on analysis of direct citations in the lists of document links (a document can have only one topic). While indexing, the newly published documents are added to the relevant topics, as based on the lists of appropriate links. Thus, the clusters reflect a narrow scientific direction, characterized by a set of keywords (e.g., in oncology/hematology), as well as the relationship between authors and cross-citations. As for 2017, 91726 clusters were allocated in SciVal [8]. The SciVal platform provides access to research results from more than 14.000 research institutions from 230 countries. Such wide service coverage allows us to evaluate and compare the research results of similar scientific organizations around the world.

The assessment was done according to the following indicators:
1. Scientific Products (Scholarly Output) – the total number of published research results. SO is an indicator that determines the productivity of scientific work. The following publications are included: journal article; chapter or article in the book; books (monographs, textbooks and reference books); software; report. Excludes: patents, dissertations.
2. The share of publications in the cluster (Publication share, %). A comparison of research results was carried out according to the metrics of the TC.307 cluster, which can be described by the following keywords: Hematopoietic Stem Cell Transplantation; Graft vs Host Disease; Transplants.
3. Field-Weighted Citation Impact is a science-normalized citation rate [9]. Calculated by SciVal, this indicator is equal to the ratio of the number of links received by researchers' publications to the average number of links received by all other similar publications indexed in the Scopus database.

The Field-Weighted Citation Impact of 1.00 indicates that publications cited on average for similar publications issued worldwide.

Field-Weighted Citation Impact higher than 1.00 indicates that publications were cited more often than might be expected based on global average for similar publications. For example, a score of 1.44 means that the results were cited 44% more often than expected.

Field-Weighted Citation Impact less than 1.00 indicates that publications were cited less than would be expected based on the world average for similar publications. For example, a rating of 0.85 means 15% less cited than the world average.

Similar publications are publications in the Scopus database that have the same year of publication, type of publication, and discipline.

Field-Weighted Citation Impact refers to citations received in the year of publication plus the next 3 years.

This indicator is useful for evaluating publications regardless of their differences in size, disciplinary profile, age and type of publication, as well as for assessing the level of citation of a researcher.

Khrustalev-fig02.jpg

Figure. 2. Distribution of publications of R. Gorbacheva Memorial
Research Institute of Pediatric Oncology, Hematology and
Transplantation (Pavlov University) by the SciVal topic clusters (TCs)

Abscissa, number of publications; Ordinate shows the publication share which is the 5-year publication output of the given institution divided by the publication output from the institution ranked #1 worldwide within a particular competency. Publication clusters mean the groups of highly cited publications and the current publications that cite them. Area of the circles reflects the field-weighted citation impact.

The analysis of scientific publications has shown that the performance of R. Gorbacheva Memorial Research Institute in different topic clusters (TC), according to SciVal data, does not correlate with the number of the articles published in the specified TCs. The highest share among high-ranked world publications for R. Gorbacheva Memorial Research Institute corresponds to the TC. 307 (HSCT and adjacent areas), followed by TC.1326 (multilayer films, microparticles), whereas the total number of publications is highest in TC.307 followed by TC.134 (leukemia research), as seen from Table 4 and Fig. 2. On the other hand, we see a correlation between the share among world publications and field-weighted citation impact, thus suggesting that the papers from R. Gorbacheva Memorial Research Institute in TC.307 and TC.1326 are highly shared among the world publications, and also have high field-weighted citation impact. In general, the indices of scientific works from R. Gorbacheva Memorial Research Institute based on SciVal data are at comparable level with the bulk of world publications in the selected topic clusters (TCs).







Table 4. Number of publications by the R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation (Pavlov University) in different topic clusters (TC) according to SciVal data

Khrustalev-tab04.jpg

Discussion

At the present time, there is no unified solution for a comprehensive model of science, or a list of scientific topics (and their relative value). Therefore, in order to assess the scientific significance of an institution, it is necessary to rely both on metrics obtained from various sources and on the results of expert evaluation.

The comparative assessment method we used is based on the clustering of the SCOPUS citation network. Firstly, this allows a more accurate assessment of the development within narrow range of studies for the organizations performing a wide-range research. Secondly, modern scientific trends consider interdisciplinary basis for many new achievements in research. Taking into account the fact that all clusters have a dynamic nature, it does not allow a general description of the work of a distinct organization, even in a specified field. Comparing efficiency of institutions by the metrics of only one cluster of items does not characterize the work of the organization as a whole, but only allows us to describe the degree of development of research in a single narrow area. Therefore, these results do not allow conclusions about the work of specific organizations, but the results will be useful to consider when choosing institutions developing similar scientific projects.

Conclusion

1. Over the past three years, according to Scopus and WoS, there has been an increase in the number of publications in the field of hematology in the major specialized Russian scientific institutions coordinated into a network of National Medical Research Centers (NMRCs), thus indicating advancements and growing relevance of this clinical topic.

2. The use of widespread scientometric indicators, such as numbers of publications, citation, and the Hirsch index, does not allow an unambiguous conclusion about the leadership of scientific organizations, even those conducting research in one narrow area.

3. The efficiency of research in Hematology and related fields at the Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, a part of St. Petersburg State Medical University, may not be lower, and, sometimes, even higher than in specialized research centers, as evidenced by the number of cited works in international databases.

4. A study of publication activity using the SciVal system showed that the research-funding bodies may consider R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation (at the Pavlov University) a perspective university platform for research in relevant areas of Hematology/Oncology, along with existing specialized scientific institutions.

Acknowledgement

The authors would like to thank Mark A. Akoev (Scientific Laboratory "Laboratory of Scientometry", The B. Yeltsin Ural Federal University, Yekaterinburg, Russia) for his help in selecting materials.

No conflicts of interest reported.

References

  1. Ruiz-Castillo J, Waltman L. Field-normalized citation impact indicators using algorithmically constructed classification systems of science. Journal of Informetrics. 2015;9(1):102-117.
  2. Bornmann L, Wohlrabe K. Normalisation of citation impact in economics. Scientometrics. 2019;120(2):841-884.
  3. Demina MA. Legal regulation of scientific and innovative activities of medical organizations. Actual Problems of Russian Law. 2018; 11 (96):116-123 (In Russian). DOI: 10.17803/1994-1471.2018.96.11.116-123.
  4. Decree of the Ministry of Health of Russia (March 21, 2017, N 125) "On the organization of work on the formation of a network of national scientific and practical medical centers." URL: https://rulaws.ru/acts/Prikaz-Minzdrava-Rossii-ot-11.09.2017-N-622/(In Russian).
  5. Decree of the Ministry of Health of Russia (September 11, 2017, N 622) "On the network of national medical research centers. URL: https://rulaws.ru/acts/Prikaz-Minzdrava-Rossii-ot-11.09.2017-N-622/ (Accessed: 19.10.2019) (In Russian).
  6. Pavlou C, Elkind E. Manipulating citation indices in a social context. Proc Intern Joint Conference on Autonomous Agents and Multiagent Systems (AAMAS). 2016: 32-40.
  7. Khrustalev MB, Tishkov AV, Maksimova AA, Turbina NY. Comparing research performance of national medical research centers and medical universities in Russia according to scientific indicators. University Management: Practice and Analysis. 2019; 23(3):108-118 (In Russian).
  8. Klavans R, Boyack KW. Research portfolio analysis and topic prominence. Journal of Informetrics. 2017;11(4):1158-1174.
  9. Akoev MA, Markusova VA, Moskaleva OV, Pislyakov VV. Guidelines for scientometry: indicators of the development of science and technology. Publishing House of the Ural University: Yekaterinburg, 2014 (In Russian).
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Introduction

Over recent years, scientometric criteria have been increasingly used, in order to evaluate the effectiveness of scientific institutions, enabling us to present the fact-based characteristics of the institutions, and their impact on development of world science, if used in correct manner. To some degree, such an evaluation is important for monitoring the quality of both individual and team work, as well as efficient use of resources allocated for research.

Similarly, scientometric methods are increasingly used to answer the questions of preferential financial support for certain areas of research, and discern the priority products and technologies, as well as to resolve problems with research staff recruitment [1].

Current science management is largely focused on accountability. Therefore, quantitative evaluation of research activities sufficiently adds to qualitative assessments of research (i.e., peer reviewing of projects and articles). Hence, bibliometric evaluation with its measurements of research output and citation impact seems to be a quite important quantitative approach [2].

The Strategy for the Development of Medical Science is one of the key documents that determines the development trends of medical science in Russia. According to it, the main goal is to create high-tech innovative products ensuring the improvement of public health based on the transfer of innovative technologies to practical healthcare. To achieve this goal, it was necessary to arrange a network of leading centers for the prioritized areas [3].

To arrange such a system and provide methodological support of research projects for the leading institutions, a Decree №125 was issued by the Ministry of Healthcare of Russian Federation (March 21, 2017) entitled: "On arranging measures for establishment of network of National Research and Practical Medical Centers". Its implementation started by creating a network of National Medical Research Centers (NMRCs) on the basis of specialized research institutions subordinated to the Ministry of Healthcare of the Russian Federation that are leaders in the top areas of medical science. At the same time, the educational priorities in medical research were assigned to specialized research centers, but not to appropriate educational institutions (e.g., medical universities), being in controbersy with global trends in the basic science development. Thus, a network of 22 NMRCs was arranged [4, 5], involving the four research centers that conduct research in the field of oncology and hematology.

Hence, along with the National Research Center for Hematology, this study also included other major Russian centers active in clinical and experimental hematology, i.e., N. N. Blokhin National Medical Research Center of Oncology, Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, N. N. Petrov National Medical Research Center of Oncology, and Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation which is a part the St. Petersburg I. Pavlov Medical University.

Among the scientific indices of the institutions that are widely used in the reports, there is a clear bias towards quantitative characteristics, such as total number of articles, the number of articles indexed in the Web of Science (WoS) and Scopus international databases, total impact factor of the journals in which the articles were published, etc. At the same time, the indices characterizing quality of published works (citation scores) and, indirectly, the reputation of the institution (Hirsch index of the organization) are practically not used. Nevertheless, the Hirsch index is most difficult to manipulate by researchers and management staff at the institutions, and, therefore, it can be more objective when comparing scientific reputation characteristics [6].

The aim of our work was to perform a scientometric evaluation of these organizations, relying primarily on their quality indicators and impact of the research results. Moreover, our task was to determine the position of R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation (R. Gorbacheva Institute), a large university research center which is not an autonomous legal entity, and which was not put on the list of NMRCs with special support for research activities.

Materials and methods

Our study included five major institutions active in Hematology/Oncology over last 3 years (2016-2018), i.e., N. N. Petrov National Medical Research Center of Oncology (St. Petersburg), National Medical Research Center of Hematology (Moscow), N. Blokhin National Medical Research Center of Oncology (Moscow), Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (Moscow), and Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation at the I. Pavlov First St. Petersburg State Medical Unibersity.

For the convenience of this study, we concentrated precisely on the qualitative and reputation indices of the work of organizations for the period of 2016 to 2018. WoS and Scopus databases were used as a data source, which allowed filtering publications in journals that did not receive worldwide recognition. Publications marked "articles" were taken into account. This is especially important, since a Department of Hematology at the Pavlov University was also included into the study, and so without the filtering, publications by students and postgraduates occupied at the University, in general, could give a distorted characteristic of publications from the local researchers [7]. The list of publications was limited to keywords defining the field of research (Table 1), thus allowing to filter out most of the publications, first of all, by other branches of the I. Pavlov St. Petersburg Medical University that were not related to the specific area of Hematology/Oncology/Transplantation. Hence, the analysis was limited by the scientific publications from R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, and the I. Pavlov University Department of Hematology, Transfusiology and Transplantation.

Khrustalev-tab01.jpg

To evaluate the research activities of major haematological centers in Russia, we have calculated the widely used scientometric indicators, e.g., the citation index, which can be calculated for publications and also for organizations and individual researchers or research teams.

However, these commonly used indices have a significant drawback, i.e., they vary greatly for different areas, which can lead to distortions and inaccurate data. There are various approaches to the allocation of scientific fields for calculating the weighted average indicators in each of them.

Hence, to normalize indicators in the WoS system, classification is used based on the topics of the journals included in indexing. But this approach has a number of significant drawbacks, the main one of which is the inadequate processing of publications in interdisciplinary journals and other journals with a wide coverage. Therefore, more accurate, it seems the selection of areas based on individual publications, and not on the level of entire journals [1].

To perform the statistical evaluation, we used MS Excel software for plotting the diagrams. The ScVal database concerning the specialized St. Petersburg and Moscow centers were kindly provided by Dr. Mark A. Akoev (Laboratory of Scientometry, B. Yeltsin Ural Federal University, Yekaterinburg, Russia).

Results

Common scientometry

Comparison of the characteristics of organizations was done by the number of articles and citations for the period 2016-2018, and by the Hirsch index, calculated on the basis of their publications. The results are presented in Table 2 (according to WoS data) and in Table 3 (according to Scopus data).

Table 2. Common scientometric indices of the four major NMRCs active in Hematology/Oncology, and Raisa Gorbacheva Memorial Research Institute, according to the Web of Science data

Khrustalev-tab02.jpg

N. N. Blokhin National Medical Research Center of Oncology is a leader by the number of WoS-indexed publications (2798 papers). However, the average number of citations per publication proved to be the highest for N. N. Petrov NMRC of Oncology (7.8). For N.N. Blokhin NMRC of Oncology, this figure is almost the same as for R. Gorbacheva Memorial Research Institute, i.e. (6.98 and 6.5, respectively). At the same time, National Research Center for Hematology, ranking second in the number of publications, is significantly behind other surveyed institutions in terms of citation, with average citation number only 1.5 per an article. The same conclusions can be drawn by evaluating Hirsch index of these institutions (Table 3, Fig. 1). The N. Blokhin National Medical Research Center of Oncology (22), N. Petrov National Medical Research Center of Oncology (17) and R. Gorbacheva Memorial Research Institute (10) are in the top three for this index, and the National Research Center for Hematology has a lower Hirsch index level (5). Thus, on the basis of WoS-derived data, the N. N. Blokhin National Medical Research Center of Oncology is the leader in publishing activity in Oncology/Hematology among the studied organizations, and R. Gorbacheva Memorial Research Institute holds a middle position among the research centers working in this field.

Similar results are obtained when evaluating the publications of these institutions according to Scopus data. Here, the same three leading organizations are determined by the Hirsch index, and R. Gorbacheva Memorial Research Institute proved to be a leader in the number of publications referred in Scopus (890 publications over three years).

Table 3. Common scientometric indices of four NMRCs and R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation,according to the Scopus data

Khrustalev-tab03.jpg

Khrustalev-fig01.jpg

Figure 1. Hirsch Index of the four Russian NMRCs (see Table 3), and the R. Gorbacheva Institute (I. Pavlov University), as based on Scopus data

SciVal approach

A more profound study on the contribution of these organizations was done using the Elsevier SciVal online platform, which is based on the Scopus database, thus allowing monitoring and analysis of international scientific research using visualization tools and modern metrics for citations, economic and social efficiency. Each scientific topic in the Scopus database is a collection of documents united by a common research interest, grouped together in a SciVal cluster, as based on analysis of direct citations in the lists of document links (a document can have only one topic). While indexing, the newly published documents are added to the relevant topics, as based on the lists of appropriate links. Thus, the clusters reflect a narrow scientific direction, characterized by a set of keywords (e.g., in oncology/hematology), as well as the relationship between authors and cross-citations. As for 2017, 91726 clusters were allocated in SciVal [8]. The SciVal platform provides access to research results from more than 14.000 research institutions from 230 countries. Such wide service coverage allows us to evaluate and compare the research results of similar scientific organizations around the world.

The assessment was done according to the following indicators:
1. Scientific Products (Scholarly Output) – the total number of published research results. SO is an indicator that determines the productivity of scientific work. The following publications are included: journal article; chapter or article in the book; books (monographs, textbooks and reference books); software; report. Excludes: patents, dissertations.
2. The share of publications in the cluster (Publication share, %). A comparison of research results was carried out according to the metrics of the TC.307 cluster, which can be described by the following keywords: Hematopoietic Stem Cell Transplantation; Graft vs Host Disease; Transplants.
3. Field-Weighted Citation Impact is a science-normalized citation rate [9]. Calculated by SciVal, this indicator is equal to the ratio of the number of links received by researchers' publications to the average number of links received by all other similar publications indexed in the Scopus database.

The Field-Weighted Citation Impact of 1.00 indicates that publications cited on average for similar publications issued worldwide.

Field-Weighted Citation Impact higher than 1.00 indicates that publications were cited more often than might be expected based on global average for similar publications. For example, a score of 1.44 means that the results were cited 44% more often than expected.

Field-Weighted Citation Impact less than 1.00 indicates that publications were cited less than would be expected based on the world average for similar publications. For example, a rating of 0.85 means 15% less cited than the world average.

Similar publications are publications in the Scopus database that have the same year of publication, type of publication, and discipline.

Field-Weighted Citation Impact refers to citations received in the year of publication plus the next 3 years.

This indicator is useful for evaluating publications regardless of their differences in size, disciplinary profile, age and type of publication, as well as for assessing the level of citation of a researcher.

Khrustalev-fig02.jpg

Figure. 2. Distribution of publications of R. Gorbacheva Memorial
Research Institute of Pediatric Oncology, Hematology and
Transplantation (Pavlov University) by the SciVal topic clusters (TCs)

Abscissa, number of publications; Ordinate shows the publication share which is the 5-year publication output of the given institution divided by the publication output from the institution ranked #1 worldwide within a particular competency. Publication clusters mean the groups of highly cited publications and the current publications that cite them. Area of the circles reflects the field-weighted citation impact.

The analysis of scientific publications has shown that the performance of R. Gorbacheva Memorial Research Institute in different topic clusters (TC), according to SciVal data, does not correlate with the number of the articles published in the specified TCs. The highest share among high-ranked world publications for R. Gorbacheva Memorial Research Institute corresponds to the TC. 307 (HSCT and adjacent areas), followed by TC.1326 (multilayer films, microparticles), whereas the total number of publications is highest in TC.307 followed by TC.134 (leukemia research), as seen from Table 4 and Fig. 2. On the other hand, we see a correlation between the share among world publications and field-weighted citation impact, thus suggesting that the papers from R. Gorbacheva Memorial Research Institute in TC.307 and TC.1326 are highly shared among the world publications, and also have high field-weighted citation impact. In general, the indices of scientific works from R. Gorbacheva Memorial Research Institute based on SciVal data are at comparable level with the bulk of world publications in the selected topic clusters (TCs).







Table 4. Number of publications by the R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation (Pavlov University) in different topic clusters (TC) according to SciVal data

Khrustalev-tab04.jpg

Discussion

At the present time, there is no unified solution for a comprehensive model of science, or a list of scientific topics (and their relative value). Therefore, in order to assess the scientific significance of an institution, it is necessary to rely both on metrics obtained from various sources and on the results of expert evaluation.

The comparative assessment method we used is based on the clustering of the SCOPUS citation network. Firstly, this allows a more accurate assessment of the development within narrow range of studies for the organizations performing a wide-range research. Secondly, modern scientific trends consider interdisciplinary basis for many new achievements in research. Taking into account the fact that all clusters have a dynamic nature, it does not allow a general description of the work of a distinct organization, even in a specified field. Comparing efficiency of institutions by the metrics of only one cluster of items does not characterize the work of the organization as a whole, but only allows us to describe the degree of development of research in a single narrow area. Therefore, these results do not allow conclusions about the work of specific organizations, but the results will be useful to consider when choosing institutions developing similar scientific projects.

Conclusion

1. Over the past three years, according to Scopus and WoS, there has been an increase in the number of publications in the field of hematology in the major specialized Russian scientific institutions coordinated into a network of National Medical Research Centers (NMRCs), thus indicating advancements and growing relevance of this clinical topic.

2. The use of widespread scientometric indicators, such as numbers of publications, citation, and the Hirsch index, does not allow an unambiguous conclusion about the leadership of scientific organizations, even those conducting research in one narrow area.

3. The efficiency of research in Hematology and related fields at the Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, a part of St. Petersburg State Medical University, may not be lower, and, sometimes, even higher than in specialized research centers, as evidenced by the number of cited works in international databases.

4. A study of publication activity using the SciVal system showed that the research-funding bodies may consider R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation (at the Pavlov University) a perspective university platform for research in relevant areas of Hematology/Oncology, along with existing specialized scientific institutions.

Acknowledgement

The authors would like to thank Mark A. Akoev (Scientific Laboratory "Laboratory of Scientometry", The B. Yeltsin Ural Federal University, Yekaterinburg, Russia) for his help in selecting materials.

No conflicts of interest reported.

References

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Хрусталев, Артем В. Тишков, Наталья Ю. Турбина, Анна А. Максимова</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(139) "

Максим Б. Хрусталев, Артем В. Тишков, Наталья Ю. Турбина, Анна А. Максимова

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_RU"]=> array(36) { ["ID"]=> string(2) "26" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(22) "Организации" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "26" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24364" ["VALUE"]=> array(2) { ["TEXT"]=> string(220) "<p>Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(208) "

Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24365" ["VALUE"]=> array(2) { ["TEXT"]=> string(4452) "<p style="text-align: justify;">Цель работы – дать наукометрическую характеристику основных российских организаций, проводящих исследования в области онкологии и гематологии, опираясь, прежде всего, на показатели качества и влияния результатов научных исследований, оценить их позиции в тематических научных кластерах по данным международных баз цитирования.</p> <h3>Материалы и методы</h3> <p style="text-align: justify;">Проведено сравнение наукометрических показателей (количество публикаций, цитируемость, индекс Хирша организации) пяти организаций, проводящих исследования в области онкологии и гематологии: четыре НМИЦ и НИИ детской онкологии, гематологии и трансплантологии им. Р. Горбачевой (НИИДОГиТ) в составе Первого Санкт-Петербургского государственного медицинского университета им. И. Павлова. Оценена также продуктивность научной работы НИИДОГиТ, количество публикаций в соответствующих научных тематических кластерах (ТК), средневзвешенное цитирование по данным SciVal и доля среди мировых публикаций. Перечень публикаций был ограничен ключевыми словами, определяющими область исследований этих организаций.</p> <h3>Результаты</h3> <p style="text-align: justify;">Анализ научных публикаций выявил, что показатели научной работы НИИДОГиТ, не входящего в сеть национальных медицинских исследовательских центров, находятся на лидирующих позициях, лишь немного уступая показателям центров онкологии имени Н. Н. Петрова и им. Н. Н. Блохина. Показатели научной работы НИИДОГиТ на основании данных SciVal находятся на уровне по сравнению с показателями мировых публикаций в выбранных ТК.</p> <h3>Выводы</h3> <p style="text-align: justify;">Результативность научных исследований, которая косвенно отражается в количестве высокоцитируемых публикаций в образовательном учреждении оказывается на уровне не ниже, а иногда и выше, чем в специализированных научных учреждениях. Изучение публикационной активности с помощью системы SciVal показало, что спонсирующие организации могут рассматривать НИИДОГиТ им. Р. М. Горбачевой, как перспективную площадку для проведения исследований в соответствующих областях наравне с существующими специализированными научными учреждениями.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Гематология, онкология, национальные медицинские исследовательские центры, медицинский университет, наукометрические показатели, анализ цитирования, библиометрия.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(4294) "

Цель работы – дать наукометрическую характеристику основных российских организаций, проводящих исследования в области онкологии и гематологии, опираясь, прежде всего, на показатели качества и влияния результатов научных исследований, оценить их позиции в тематических научных кластерах по данным международных баз цитирования.

Материалы и методы

Проведено сравнение наукометрических показателей (количество публикаций, цитируемость, индекс Хирша организации) пяти организаций, проводящих исследования в области онкологии и гематологии: четыре НМИЦ и НИИ детской онкологии, гематологии и трансплантологии им. Р. Горбачевой (НИИДОГиТ) в составе Первого Санкт-Петербургского государственного медицинского университета им. И. Павлова. Оценена также продуктивность научной работы НИИДОГиТ, количество публикаций в соответствующих научных тематических кластерах (ТК), средневзвешенное цитирование по данным SciVal и доля среди мировых публикаций. Перечень публикаций был ограничен ключевыми словами, определяющими область исследований этих организаций.

Результаты

Анализ научных публикаций выявил, что показатели научной работы НИИДОГиТ, не входящего в сеть национальных медицинских исследовательских центров, находятся на лидирующих позициях, лишь немного уступая показателям центров онкологии имени Н. Н. Петрова и им. Н. Н. Блохина. Показатели научной работы НИИДОГиТ на основании данных SciVal находятся на уровне по сравнению с показателями мировых публикаций в выбранных ТК.

Выводы

Результативность научных исследований, которая косвенно отражается в количестве высокоцитируемых публикаций в образовательном учреждении оказывается на уровне не ниже, а иногда и выше, чем в специализированных научных учреждениях. Изучение публикационной активности с помощью системы SciVal показало, что спонсирующие организации могут рассматривать НИИДОГиТ им. Р. М. Горбачевой, как перспективную площадку для проведения исследований в соответствующих областях наравне с существующими специализированными научными учреждениями.

Ключевые слова

Гематология, онкология, национальные медицинские исследовательские центры, медицинский университет, наукометрические показатели, анализ цитирования, библиометрия.

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Maksim B. Khrustalev, Artem V. Tishkov, Natalia Yu. Turbina, Anna A. Maksimova

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The list of publications was limited to keywords defining the field of research of these organizations.</p> <h3>Results</h3> <p style="text-align: justify;">Comparative evaluation of research publication activity in oncohematology has shown the leading position of R. Gorbacheva Institute, as a part of I. Pavlov St. Petersburg State Medical University, which was not included into the NMRCs network. Its rating was only slightly lower than the indices of N. Petrov National Medical Research Center of Oncology and N. Blokhin National Medical Research Center of Oncology. The overall indices of the citation impact based on SciVal analytic platform assessed for R. Gorbacheva Institute are at a level compared to the figures for world publications in the selected topic clusters.</p> <h3>Conclusion</h3> <p style="text-align: justify;">Efficiency of clinical research at an educational institution, evaluated as the number of highly cited publications proved to be not lower, but sometimes even higher than in specialized research institutions working in the field. Appropriate publishing activity evaluated by the SciVal system showed that the funding authorities providing research financiation should recognize R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation at the Pavlov University as a perspective university-based platform for research in relevant areas, along with existing specialized scientific institutions.</p> <h2>Keywords</h2> <p style="text-align: justify;">Hematology, oncology, national medical research centers, medical university, scientometric indexes, bibliometry, citation analysis. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2753) "

The aim of this survey was to perform scientometric evaluation of the major Russian institutions conducting research in the field of oncology and hematology, relying primarily on the common quality indicators and impact of the research results, to аssess their position in the scientific topic clusters (TC) according to international citation databases.

Materials and methods

A comparison was made between five organizations conducting research in the field of oncology and hematology, i.e., four National Medical Research Centers (NMRCs), and Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation (R. Gorbacheva Institute) which is a part of I. Pavlov St. Petersburg State Medical University, using the following scientometric indices: citation, collective Hirsch index, as well as the productivity of research determined as relative share of publications in the scientific TC, as well as Field-weighted Citation Impact, using the SciVal platform. The list of publications was limited to keywords defining the field of research of these organizations.

Results

Comparative evaluation of research publication activity in oncohematology has shown the leading position of R. Gorbacheva Institute, as a part of I. Pavlov St. Petersburg State Medical University, which was not included into the NMRCs network. Its rating was only slightly lower than the indices of N. Petrov National Medical Research Center of Oncology and N. Blokhin National Medical Research Center of Oncology. The overall indices of the citation impact based on SciVal analytic platform assessed for R. Gorbacheva Institute are at a level compared to the figures for world publications in the selected topic clusters.

Conclusion

Efficiency of clinical research at an educational institution, evaluated as the number of highly cited publications proved to be not lower, but sometimes even higher than in specialized research institutions working in the field. Appropriate publishing activity evaluated by the SciVal system showed that the funding authorities providing research financiation should recognize R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation at the Pavlov University as a perspective university-based platform for research in relevant areas, along with existing specialized scientific institutions.

Keywords

Hematology, oncology, national medical research centers, medical university, scientometric indexes, bibliometry, citation analysis.

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Khrustalev, Artem V. Tishkov, Natalia Yu. Turbina, Anna A. Maksimova</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(85) "

Maksim B. Khrustalev, Artem V. Tishkov, Natalia Yu. Turbina, Anna A. Maksimova

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Maksim B. Khrustalev, Artem V. Tishkov, Natalia Yu. Turbina, Anna A. Maksimova

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The aim of this survey was to perform scientometric evaluation of the major Russian institutions conducting research in the field of oncology and hematology, relying primarily on the common quality indicators and impact of the research results, to аssess their position in the scientific topic clusters (TC) according to international citation databases.

Materials and methods

A comparison was made between five organizations conducting research in the field of oncology and hematology, i.e., four National Medical Research Centers (NMRCs), and Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation (R. Gorbacheva Institute) which is a part of I. Pavlov St. Petersburg State Medical University, using the following scientometric indices: citation, collective Hirsch index, as well as the productivity of research determined as relative share of publications in the scientific TC, as well as Field-weighted Citation Impact, using the SciVal platform. The list of publications was limited to keywords defining the field of research of these organizations.

Results

Comparative evaluation of research publication activity in oncohematology has shown the leading position of R. Gorbacheva Institute, as a part of I. Pavlov St. Petersburg State Medical University, which was not included into the NMRCs network. Its rating was only slightly lower than the indices of N. Petrov National Medical Research Center of Oncology and N. Blokhin National Medical Research Center of Oncology. The overall indices of the citation impact based on SciVal analytic platform assessed for R. Gorbacheva Institute are at a level compared to the figures for world publications in the selected topic clusters.

Conclusion

Efficiency of clinical research at an educational institution, evaluated as the number of highly cited publications proved to be not lower, but sometimes even higher than in specialized research institutions working in the field. Appropriate publishing activity evaluated by the SciVal system showed that the funding authorities providing research financiation should recognize R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation at the Pavlov University as a perspective university-based platform for research in relevant areas, along with existing specialized scientific institutions.

Keywords

Hematology, oncology, national medical research centers, medical university, scientometric indexes, bibliometry, citation analysis.

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(21) "Description / Summary" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(2753) "

The aim of this survey was to perform scientometric evaluation of the major Russian institutions conducting research in the field of oncology and hematology, relying primarily on the common quality indicators and impact of the research results, to аssess their position in the scientific topic clusters (TC) according to international citation databases.

Materials and methods

A comparison was made between five organizations conducting research in the field of oncology and hematology, i.e., four National Medical Research Centers (NMRCs), and Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation (R. Gorbacheva Institute) which is a part of I. Pavlov St. Petersburg State Medical University, using the following scientometric indices: citation, collective Hirsch index, as well as the productivity of research determined as relative share of publications in the scientific TC, as well as Field-weighted Citation Impact, using the SciVal platform. The list of publications was limited to keywords defining the field of research of these organizations.

Results

Comparative evaluation of research publication activity in oncohematology has shown the leading position of R. Gorbacheva Institute, as a part of I. Pavlov St. Petersburg State Medical University, which was not included into the NMRCs network. Its rating was only slightly lower than the indices of N. Petrov National Medical Research Center of Oncology and N. Blokhin National Medical Research Center of Oncology. The overall indices of the citation impact based on SciVal analytic platform assessed for R. Gorbacheva Institute are at a level compared to the figures for world publications in the selected topic clusters.

Conclusion

Efficiency of clinical research at an educational institution, evaluated as the number of highly cited publications proved to be not lower, but sometimes even higher than in specialized research institutions working in the field. Appropriate publishing activity evaluated by the SciVal system showed that the funding authorities providing research financiation should recognize R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation at the Pavlov University as a perspective university-based platform for research in relevant areas, along with existing specialized scientific institutions.

Keywords

Hematology, oncology, national medical research centers, medical university, scientometric indexes, bibliometry, citation analysis.

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Максим Б. Хрусталев, Артем В. Тишков, Наталья Ю. Турбина, Анна А. Максимова

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Максим Б. Хрусталев, Артем В. Тишков, Наталья Ю. Турбина, Анна А. Максимова

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Khrustalev" ["LINK_ELEMENT_VALUE"]=> bool(false) } ["SUMMARY_RU"]=> array(37) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24365" ["VALUE"]=> array(2) { ["TEXT"]=> string(4452) "<p style="text-align: justify;">Цель работы – дать наукометрическую характеристику основных российских организаций, проводящих исследования в области онкологии и гематологии, опираясь, прежде всего, на показатели качества и влияния результатов научных исследований, оценить их позиции в тематических научных кластерах по данным международных баз цитирования.</p> <h3>Материалы и методы</h3> <p style="text-align: justify;">Проведено сравнение наукометрических показателей (количество публикаций, цитируемость, индекс Хирша организации) пяти организаций, проводящих исследования в области онкологии и гематологии: четыре НМИЦ и НИИ детской онкологии, гематологии и трансплантологии им. Р. Горбачевой (НИИДОГиТ) в составе Первого Санкт-Петербургского государственного медицинского университета им. И. Павлова. Оценена также продуктивность научной работы НИИДОГиТ, количество публикаций в соответствующих научных тематических кластерах (ТК), средневзвешенное цитирование по данным SciVal и доля среди мировых публикаций. Перечень публикаций был ограничен ключевыми словами, определяющими область исследований этих организаций.</p> <h3>Результаты</h3> <p style="text-align: justify;">Анализ научных публикаций выявил, что показатели научной работы НИИДОГиТ, не входящего в сеть национальных медицинских исследовательских центров, находятся на лидирующих позициях, лишь немного уступая показателям центров онкологии имени Н. Н. Петрова и им. Н. Н. Блохина. Показатели научной работы НИИДОГиТ на основании данных SciVal находятся на уровне по сравнению с показателями мировых публикаций в выбранных ТК.</p> <h3>Выводы</h3> <p style="text-align: justify;">Результативность научных исследований, которая косвенно отражается в количестве высокоцитируемых публикаций в образовательном учреждении оказывается на уровне не ниже, а иногда и выше, чем в специализированных научных учреждениях. Изучение публикационной активности с помощью системы SciVal показало, что спонсирующие организации могут рассматривать НИИДОГиТ им. Р. М. Горбачевой, как перспективную площадку для проведения исследований в соответствующих областях наравне с существующими специализированными научными учреждениями.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Гематология, онкология, национальные медицинские исследовательские центры, медицинский университет, наукометрические показатели, анализ цитирования, библиометрия.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(4294) "

Цель работы – дать наукометрическую характеристику основных российских организаций, проводящих исследования в области онкологии и гематологии, опираясь, прежде всего, на показатели качества и влияния результатов научных исследований, оценить их позиции в тематических научных кластерах по данным международных баз цитирования.

Материалы и методы

Проведено сравнение наукометрических показателей (количество публикаций, цитируемость, индекс Хирша организации) пяти организаций, проводящих исследования в области онкологии и гематологии: четыре НМИЦ и НИИ детской онкологии, гематологии и трансплантологии им. Р. Горбачевой (НИИДОГиТ) в составе Первого Санкт-Петербургского государственного медицинского университета им. И. Павлова. Оценена также продуктивность научной работы НИИДОГиТ, количество публикаций в соответствующих научных тематических кластерах (ТК), средневзвешенное цитирование по данным SciVal и доля среди мировых публикаций. Перечень публикаций был ограничен ключевыми словами, определяющими область исследований этих организаций.

Результаты

Анализ научных публикаций выявил, что показатели научной работы НИИДОГиТ, не входящего в сеть национальных медицинских исследовательских центров, находятся на лидирующих позициях, лишь немного уступая показателям центров онкологии имени Н. Н. Петрова и им. Н. Н. Блохина. Показатели научной работы НИИДОГиТ на основании данных SciVal находятся на уровне по сравнению с показателями мировых публикаций в выбранных ТК.

Выводы

Результативность научных исследований, которая косвенно отражается в количестве высокоцитируемых публикаций в образовательном учреждении оказывается на уровне не ниже, а иногда и выше, чем в специализированных научных учреждениях. Изучение публикационной активности с помощью системы SciVal показало, что спонсирующие организации могут рассматривать НИИДОГиТ им. Р. М. Горбачевой, как перспективную площадку для проведения исследований в соответствующих областях наравне с существующими специализированными научными учреждениями.

Ключевые слова

Гематология, онкология, национальные медицинские исследовательские центры, медицинский университет, наукометрические показатели, анализ цитирования, библиометрия.

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Цель работы – дать наукометрическую характеристику основных российских организаций, проводящих исследования в области онкологии и гематологии, опираясь, прежде всего, на показатели качества и влияния результатов научных исследований, оценить их позиции в тематических научных кластерах по данным международных баз цитирования.

Материалы и методы

Проведено сравнение наукометрических показателей (количество публикаций, цитируемость, индекс Хирша организации) пяти организаций, проводящих исследования в области онкологии и гематологии: четыре НМИЦ и НИИ детской онкологии, гематологии и трансплантологии им. Р. Горбачевой (НИИДОГиТ) в составе Первого Санкт-Петербургского государственного медицинского университета им. И. Павлова. Оценена также продуктивность научной работы НИИДОГиТ, количество публикаций в соответствующих научных тематических кластерах (ТК), средневзвешенное цитирование по данным SciVal и доля среди мировых публикаций. Перечень публикаций был ограничен ключевыми словами, определяющими область исследований этих организаций.

Результаты

Анализ научных публикаций выявил, что показатели научной работы НИИДОГиТ, не входящего в сеть национальных медицинских исследовательских центров, находятся на лидирующих позициях, лишь немного уступая показателям центров онкологии имени Н. Н. Петрова и им. Н. Н. Блохина. Показатели научной работы НИИДОГиТ на основании данных SciVal находятся на уровне по сравнению с показателями мировых публикаций в выбранных ТК.

Выводы

Результативность научных исследований, которая косвенно отражается в количестве высокоцитируемых публикаций в образовательном учреждении оказывается на уровне не ниже, а иногда и выше, чем в специализированных научных учреждениях. Изучение публикационной активности с помощью системы SciVal показало, что спонсирующие организации могут рассматривать НИИДОГиТ им. Р. М. Горбачевой, как перспективную площадку для проведения исследований в соответствующих областях наравне с существующими специализированными научными учреждениями.

Ключевые слова

Гематология, онкология, национальные медицинские исследовательские центры, медицинский университет, наукометрические показатели, анализ цитирования, библиометрия.

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Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия

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Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия

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Introduction

Alexander Friedenstein is considered the founder of the mesenchymal stem cell concept. He described fibroblasts like clonogenic cells, forming colonies, named by him CFU-F. The MSCs are multi-potential, and differentiate into osteoblasts, chondrocytes and adipocytes [1] and support hematopoiesis. Alexander Friedenstein himself refers to Alexander Maximov, who first described stromal-hematopoietic interrelationship, hypothesizing that committed hematopoietic precursors descend from the hematopoietic stem cells, due to local impacts generated by marrow stroma, leading to hematopoietic differentiation [2, 3]. These fibroblast like clonogenic cells have been named by Caplan mesenchymal stem cells [4]. These CFU-F have been shown to be negative for the markers CD34, CD45, CD14, MHCII and positive for the markers CD90, CD105, MHCI an CD73. These cells can be induced and differentiated to adipocytes, documented by staining of lipid vacuols with sudan red, into osteoblasts, which can be documented by staining of calcium deposits with silver nitrate and into chondroblasts, documented by staining of proteoglycanes with alcian blue. These precursors can be propagated millionfold in liquid culture [5, 6, 7].

MSCs are immunoprivileged cells and possess immunomodulatory properties, modulating all populations of the innate and adaptive immune system [8]. MSC decrease proliferation cytotoxicity and interferon-γ production by NK cells, diminish proliferation of B cells and their differentiation to plasma cells. They decrease proliferation and CTL formation as well as interferon gamma production of T-Cells, increase regulatory T-Cells and decrease differentiation, maturation and activation of dendritic cells [8]. MHC suppress T-cell proliferation and TH1 specific cytokine secretion [9].

There has been an immense interest in clinical application of MSCs for several reasons:
1. There is no need for complicated donor search. MSC can be given beyond the MHC barrier. That leads to easy availability.
2. One donation provides cells for many treatments, which makes this approach inexpensive.
3. No major side effects have been reported from MSC infusion. MSC treatment is considered to be safe.

The mechanism of action of MSC has been explored in several preclinical systems, like acute kidney injury, where MSC therapy augments expression of anti-apoptotic BCL-2 and inhibits that of pro-inflammatory genes, like eNOS. It inhibits expression of pro-inflammatory genes (IL1-beta, TNF-alpha, IFN-gamma) and it increases the expression of anti-inflammatory IL-10 [10, 11, 12]. MSC therapy has been further explored in models for radiation injury, where it rescued mice after supralethal irradiation [13]. In this model MSC treatment leads to an increased expression of genes related to detoxification, cell metabolism, cell motility, anti- inflammation and anti-apoptosis, as well as a decreased expression of genes associated with toxification, inflammation and apoptosis [13]. Based on several studies in kidney, heart, radioprotection and graft-versus-host disease, it could be shown that MSCs are anti-inflammatory, anti-apoptotic, angiogenic and mitogenic [14, 15, 16].

The first area of MSC therapy was acute graft-versus-host disease, where Katharina Le Blanc could show effectiveness in steroid resistant acute graft-versus-host disease in a proof of concept study [17], followed by a multi-center European study including 55 patients, leading to complete response in 30 patients and to some improvement in 9, which lead to lower transplant related mortality in responding patients [18]. The company Osiris Therapeutics carried out a phase 3 trial in adults and children with GvHD, in which only the subset of children showed a significant response to MSCs [19, 20]. Osiris did not obtain licenses for MSC treatment of GvHD in the United States and Europe, following the study. Health Canada gave a notice of compliance with conditions (hightened post-market surveillance), but so far no approval. In Japan, MSCs can be marketed (Tem-cell) for acute graft-versus-host disease [21]. In Europe a new attempt in steroide resistant GvHD treatment with standardized MSC from several donors, is carried out in a multi-center study. The preliminary reports appear very promising [22].

210 studies are listed as completed under clinicaltrials.gov. Major entities include are as follows: rheumatic arthritis/osteoarthrtis (n=12); amyotrophic lateral sclerosis (n=9); graft-versus-host disease (n=8); multiple sclerosis (n=7); diabetes (n=7); Crohn’s disease (n=6); myocardial infarction (n=5); spinal cord injury (n=4).

The general overview of all these studies, reveals some activity, but not enough for licensing in all countries, in steroid resistant GvHD, some activity in Crohn’s disease, where several randomized studies could show that a reduction of steroid dose is possible, following MSC treatment [23, 24]. Encouraging findings in spinal cord injury, where improved sensory and bladder function were noted, but no improvement in motor function and the treatment was proven to be safe [25]. In Amyotrophic-Lateral-Sklerosis (ALS), a disease with very few treatment options, several studies showed slower progression of disease in the treated group, but larger studies are needed [26, 27].

There are several encouraging studies in MS, a large randomized study has been initiated by Andrea Uccelli and several European groups [28].

In Lupus several studies showed improved disease activity, but a large-scale validation is needed [29, 30]. The results of the studies in Diabetes mellitus are less encouraging, even though there has been some improvement in DMT1 [31, 32]. Results in arthritis show inconsistent results and in heart disease large randomized studies showed no long-term benefit [33-37].

The field of MSC is under attack from two directions. Several studies have shown that the phenotype of MSC in vitro does not reflect cell identity and function. Stromal cells from bone marrow, muscle, peritoneum and cord blood have been isolated and the gene expression profiles clearly separated by origin of cells and MSCs from different sources have radically different, differentiation properties [38], leading to the editorial "Clear up the Stem Cell mess", by Sipp Douglas et al. [39]. He states that the confusion about mesenchyme stem cells is making it easier for people to sell unproven treatments. The problem lies in the name mesenchymal stem cell. Caplan, who coined the term mesenchymal stem cell, recommended the more correct term of "Medicinal Signaling Cells". Other investigators use the term Mesenchymal Stroma Cell, which might suffice to get these cells out of the hyped stem cell theater.

The excellent sales argument for MSC – no complicated donor search, one donation for many treatments and the safety of the infusion, led to an explosion of unapproved stem cell treatments in USA, Australia and Japan, with direct to consumer marketing. In 2016 there were 351 US companies selling putative stem cell treatments, mostly MSCs, directly to the consumer [39].To dispel the MSC myth one should stop bunching multiple cell types, under one catch-all phrase. Clinical trial registries, as well as editors and reviewers should be more critical. One should watch for well designed and well described clinical studies in regenerative medicine. Regulators should stop commercial clinics from selling unproven treatments whenever possible. Physicians should discourage their patients from receiving unproven stem cell therapies. Overall one should keep in mind, not to pour out the baby with the bath water: it will take more time to firmly establish MSC treatment in Regenerative Medicine.

Acknowledgement

Thanks to Andrea Zander for her assistance in the preparation of the manuscript.

Conflict of interest

None reported.

References

  1. Friedenstein AJ, Chailakhyan RK, Latsinik NV, Panasyuk AF, Keiliss-Borok IV. (). Stromal cells responsible for trabsferring the microenvironment of the hemopoietic tissues. Cloning in vitro and retransplantation in vivo. Transplantation. 1974; 17:331-340.
  2. Maximov AA. Über experimentelle Erzeugung von Knochenmarksgewebe. Anat Anz. 1906; 28: 24-38.
  3. Afanasyev BV, Elstner E, Zander AR. A. Friedenstein, founder of the mesenchymal stem cell concept. Cell Ther Transplant. 2009; 1(3): 35-38.
  4. Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991; 9:641-650.
  5. Porcellini A. Regenerative medicine: a review. Rev Bras Hematol Hemoter. 2009;31 (Suppl. 2). 31:63-66. DOI:10.1590/S1516-84842009000800017.
  6. Bunnell BA, Flaat M, Gagliardi C, Patel B, Ripoll C. Adipose-derived stem cells: Isolation, expansion and differentiation. Methods. Methods in Stem Cell Res. 2008; 45(2):115-120.
  7. Lange C, Schroeder J, Stute N, Lioznov MV, Zander AR. High-potential human mesenchymal stem cells. Stem Cells Dev. 2005;14(1):70-80.
  8. Nauta AJ, Fibbe WE. Immunomodulatory properties of mesenchymal stromal cells. Blood. 2007;110:3499-3506.
  9. Fang L, Lange C, Engel M, Zander A, Fehse B. Sensitive balance of suppressing and activating effects of mesenchymal stem cells on T-cell proliferation. Transplantation. 2006;82(10):1370-1373.
  10. Tögel F, Westenfelder C. Treatment of acute kidney injury with allogeneic mesenchymal stem cells: preclinical and initial clinical data. In: Regenerative Nephrology (Ed. M. Goligorsky), Elsevier, 2011. pp. 315-339.
  11. Tögel F, Westenfelder C. Mesenchymal stem cells: a new therapeutic tool for AKI. Nat Rev Nephrol. 2010; 6(3):179-183, DOI: 10.1038/nrneph.2009.229.
  12. Tögel F, Westenfelder C. The role of multipotent marrow stromal cells (MSCs) in tissue regeneration. Organogenesis.2011; 7(2):96-100, DOI: 10.4161/org.7.2.15781.
  13. Lange C, Brunswig-Spickenheie B, Cappallo-Obermann H, Eggert K, Gehling UM, Rudolph C, Schlegelberger B, Cornils K, Zustin J, Spiess AN, Zander AR. PLos One. 2011;6(1):e14486. Doi: 10.1089/scd.2009.0494.
  14. Krause K, Fehse B, Jaquet K, Lange C, Kyriazis K, Boczor S, Zander A, Kuck K. Analysis of progenitor cell mobilization and erythropoietin plasma levels in patients with acute myocardial infarction. Exp Clin Cardiol. 2005;10(2):104-107.
  15. Wang S, Qu X, Zhao RS. Clinical applications of mesenchymal stem cells. J Hematol Oncol. 2012. 5:19. DOI:10.1186/1756-8722-5-19.
  16. Zander AR, Lange C, Westenfelder C. Mesenchymal stromal cells: main factor or helper in regenerative medicine? Kidney Int. 2011; 1(3 Suppl):74-76.
  17. Le Blanc K, Rasmussen I, Sundberg B, Gotherstorm C, Hassan M, Uzunel M et al. Treatment of severe acute graft-versus-host-disease with third-party haploidentical mesenchymal stem cells. Lancet. 200;363:1439-1441.
  18. Le Blanc K, Frassoni F, Ball L, Locatelli F, Roelofs H, Lewis I, Lanino E, Sundberg B, Bernardo ME, Remberger M, Dini G, Egeler M, Bacigalupo A, Fibbe W, Ringden O et al. Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet. 2008; 371,1579-1586.
  19. Martin PJ, Uberti JP, Soiffer RJ, Klingermann H, Waller EK, Daly AS, Herrmann RP, Kebriaei P. Prochymal improves response rates in patients with steroid-refractory, acute GvHD: results of a randomized, placebo-controlled, multicenter Phase III trial in GvHD. Biol Blood Marrow Transplant. 2010;16: S169-S170.
  20. Kurtzberg J, Prasad V, Grimley M, Horn B, Carpenter P, Jacobsohn D, Prochop S. Allogeneic human mesenchymal stem cell therapy (Prochymal®) as a rescue agent for severe treatment resistant GVHD in pediatric patients. Biol. Blood Marrow Transplant. 2010; 16: S169.
  21. Hara A, Sato D, Sahara Y. New governmental regulatory system for stem cell-based therapies in Japan. Ther Innov Regul Sci. 2014; 48:681-688.
  22. Bader P. Effective treatment of steroid and therapy-refractory acute graft-versus-host disease with a novel mesenchymal stromal cell product (MSC-FFM). Bone Marrow Transplant. 2018; 53:852-862.
  23. Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M , Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A ,Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn’s disease: a phase 3 randomized, double-blind controlled trial. Lancet 2016; 388:1281-1290.
  24. Panes J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S;ADMIRE CD Study Group Collaborators. Long-term efficacy and safety of stem cell therapy (Cx601) for complex perianal fistulas in patients with Crohn’s disease. Gastroenterology. 2018; 154: 1334-1342 e4.
  25. Cofano F, Boido M, Monticelli M, Zenga F, Ducati A, Vercelli A, Garbossa D. Mesenchymal stem cells for spinal cord injury: current options. Int J Mol Sci. 2019; 20(11). pii: E2698.
  26. Gugliandolo A, Bramanti P, Mazzon E. Mesenchymal stem cells: a potential therapeutic approach for amyotriphic lateral sclerosis. Stem Cells Int. 2019; 2019:3675627.
  27. Oh KW, Noh MY, Kwon MS, Kim HY, Oh SI, Park J, Kim HJ, Ki CS, Kim SH. Repeated intrathecal mesenchymal stem cells for amyotrophic lateral sclerosis. Ann Neurol. 2018;84(3):361-373.
  28. Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, Muraro PA, Oliveri RS, Radue EW, Sellner J, Soelberg Sorensen P, Sormani MP, Wuerfel JT, Battaglia MA, Freedman MS; MESEMS study group. Mesenchymal stem cells for multiple sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for therapy of multiple sclerosis“. Trials. 2019, May 9; 20(1):263. DOI 10.1186/s13063-019-3346-z.
  29. Deng D, Zhang P, Guo Y, Lim TO. A randomized double-blind placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis“. Ann Rheum Dis. 2017;76(8):1436-1439.
  30. Cras A. Update on mesenchymal stem cell-based therapy in lupus and scleroderma. Arthritis Res Ther. 2015 Nov. 3; 17:301.
  31. Zang L, Hao H, Liu J, Li Y, Han W, Mu Y. Mesenchymal stem cell therapy in type 2 diabetes mellitus. Diabetol Metab Syndr. 2017 May 15;9:36.
  32. Moreira A, Kahlenberg S, Hornsby P. Therapeutic potential of mesenchymal stem cells for diabetes. J Mol Endocrinol. 2017; 59(3):R109-R120.
  33. Liu L, Wong CW, Han M, Farhoodi HP, Liu G, Liu Y, Liao W, Zhao W. Meta-analysis of preclinical studies of mesenchymal stromal cells to treat rheumatoid arthritis. EBioMedicine. 2019 Sep; 47: 563-577. DOI: 10.1016/j.ebiom.2019.08.073.
  34. Fan Yang, Yang Li. Effects of mesenchymal stem cells in autoimmune arthritis. Eur Med J. 2018 ;3 (4):130-137.
  35. Steinhoff G, Nesteruk J, Wolfien M, Große J, Ruch U, Vasudevan P, Müller P. Stem cells and heart disease – Brake or accelerator? Adv Drug Deliv Rev. 2017;120:2-24. DOI: 10.1016/j.addr.2017.10.007.
  36. Lalu MM, Mazzarello S, Zlepnig J, Dong YY, Montroy J, McIntyre L, Devereaux PJ, Stewart DJ. Safety and efficacy of adult stem cell therapy for acute myocardial infarction and ischemic heart failure (SafeCell Heart): a systematic review and meta-analysis. Stem Cells Transl Med; 7(12): 857-866.
  37. Blau HM, Daley GQ. Stem cells in the treatment of disease. New Engl J Med. 2019; 308:1748-1760. DOI: 10.1056/NEJMra1716145.
  38. Sacchetti B, Funari A, Remoli C, Giannicola G, Kogler G, Liedtke S, Cossu G, Serafini M, Sampaolesi M, Tagliafico E, Tenedini E, Saggio I, Robey PG, Riminucci M, Bianco P. No identical mesenchymal stem cells at different times and sites: human committed progenitors of distinct origin and differentiation potential are incorporated as adventitial cells in microvessels. Stem Cell Rep. 2016; 6(6): 897-913.
  39. Sipp D, Robey PG, Turner L. Clear up this stem-cell mess. Nature. 2018; 561(7724): 455-457.
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Introduction

Alexander Friedenstein is considered the founder of the mesenchymal stem cell concept. He described fibroblasts like clonogenic cells, forming colonies, named by him CFU-F. The MSCs are multi-potential, and differentiate into osteoblasts, chondrocytes and adipocytes [1] and support hematopoiesis. Alexander Friedenstein himself refers to Alexander Maximov, who first described stromal-hematopoietic interrelationship, hypothesizing that committed hematopoietic precursors descend from the hematopoietic stem cells, due to local impacts generated by marrow stroma, leading to hematopoietic differentiation [2, 3]. These fibroblast like clonogenic cells have been named by Caplan mesenchymal stem cells [4]. These CFU-F have been shown to be negative for the markers CD34, CD45, CD14, MHCII and positive for the markers CD90, CD105, MHCI an CD73. These cells can be induced and differentiated to adipocytes, documented by staining of lipid vacuols with sudan red, into osteoblasts, which can be documented by staining of calcium deposits with silver nitrate and into chondroblasts, documented by staining of proteoglycanes with alcian blue. These precursors can be propagated millionfold in liquid culture [5, 6, 7].

MSCs are immunoprivileged cells and possess immunomodulatory properties, modulating all populations of the innate and adaptive immune system [8]. MSC decrease proliferation cytotoxicity and interferon-γ production by NK cells, diminish proliferation of B cells and their differentiation to plasma cells. They decrease proliferation and CTL formation as well as interferon gamma production of T-Cells, increase regulatory T-Cells and decrease differentiation, maturation and activation of dendritic cells [8]. MHC suppress T-cell proliferation and TH1 specific cytokine secretion [9].

There has been an immense interest in clinical application of MSCs for several reasons:
1. There is no need for complicated donor search. MSC can be given beyond the MHC barrier. That leads to easy availability.
2. One donation provides cells for many treatments, which makes this approach inexpensive.
3. No major side effects have been reported from MSC infusion. MSC treatment is considered to be safe.

The mechanism of action of MSC has been explored in several preclinical systems, like acute kidney injury, where MSC therapy augments expression of anti-apoptotic BCL-2 and inhibits that of pro-inflammatory genes, like eNOS. It inhibits expression of pro-inflammatory genes (IL1-beta, TNF-alpha, IFN-gamma) and it increases the expression of anti-inflammatory IL-10 [10, 11, 12]. MSC therapy has been further explored in models for radiation injury, where it rescued mice after supralethal irradiation [13]. In this model MSC treatment leads to an increased expression of genes related to detoxification, cell metabolism, cell motility, anti- inflammation and anti-apoptosis, as well as a decreased expression of genes associated with toxification, inflammation and apoptosis [13]. Based on several studies in kidney, heart, radioprotection and graft-versus-host disease, it could be shown that MSCs are anti-inflammatory, anti-apoptotic, angiogenic and mitogenic [14, 15, 16].

The first area of MSC therapy was acute graft-versus-host disease, where Katharina Le Blanc could show effectiveness in steroid resistant acute graft-versus-host disease in a proof of concept study [17], followed by a multi-center European study including 55 patients, leading to complete response in 30 patients and to some improvement in 9, which lead to lower transplant related mortality in responding patients [18]. The company Osiris Therapeutics carried out a phase 3 trial in adults and children with GvHD, in which only the subset of children showed a significant response to MSCs [19, 20]. Osiris did not obtain licenses for MSC treatment of GvHD in the United States and Europe, following the study. Health Canada gave a notice of compliance with conditions (hightened post-market surveillance), but so far no approval. In Japan, MSCs can be marketed (Tem-cell) for acute graft-versus-host disease [21]. In Europe a new attempt in steroide resistant GvHD treatment with standardized MSC from several donors, is carried out in a multi-center study. The preliminary reports appear very promising [22].

210 studies are listed as completed under clinicaltrials.gov. Major entities include are as follows: rheumatic arthritis/osteoarthrtis (n=12); amyotrophic lateral sclerosis (n=9); graft-versus-host disease (n=8); multiple sclerosis (n=7); diabetes (n=7); Crohn’s disease (n=6); myocardial infarction (n=5); spinal cord injury (n=4).

The general overview of all these studies, reveals some activity, but not enough for licensing in all countries, in steroid resistant GvHD, some activity in Crohn’s disease, where several randomized studies could show that a reduction of steroid dose is possible, following MSC treatment [23, 24]. Encouraging findings in spinal cord injury, where improved sensory and bladder function were noted, but no improvement in motor function and the treatment was proven to be safe [25]. In Amyotrophic-Lateral-Sklerosis (ALS), a disease with very few treatment options, several studies showed slower progression of disease in the treated group, but larger studies are needed [26, 27].

There are several encouraging studies in MS, a large randomized study has been initiated by Andrea Uccelli and several European groups [28].

In Lupus several studies showed improved disease activity, but a large-scale validation is needed [29, 30]. The results of the studies in Diabetes mellitus are less encouraging, even though there has been some improvement in DMT1 [31, 32]. Results in arthritis show inconsistent results and in heart disease large randomized studies showed no long-term benefit [33-37].

The field of MSC is under attack from two directions. Several studies have shown that the phenotype of MSC in vitro does not reflect cell identity and function. Stromal cells from bone marrow, muscle, peritoneum and cord blood have been isolated and the gene expression profiles clearly separated by origin of cells and MSCs from different sources have radically different, differentiation properties [38], leading to the editorial "Clear up the Stem Cell mess", by Sipp Douglas et al. [39]. He states that the confusion about mesenchyme stem cells is making it easier for people to sell unproven treatments. The problem lies in the name mesenchymal stem cell. Caplan, who coined the term mesenchymal stem cell, recommended the more correct term of "Medicinal Signaling Cells". Other investigators use the term Mesenchymal Stroma Cell, which might suffice to get these cells out of the hyped stem cell theater.

The excellent sales argument for MSC – no complicated donor search, one donation for many treatments and the safety of the infusion, led to an explosion of unapproved stem cell treatments in USA, Australia and Japan, with direct to consumer marketing. In 2016 there were 351 US companies selling putative stem cell treatments, mostly MSCs, directly to the consumer [39].To dispel the MSC myth one should stop bunching multiple cell types, under one catch-all phrase. Clinical trial registries, as well as editors and reviewers should be more critical. One should watch for well designed and well described clinical studies in regenerative medicine. Regulators should stop commercial clinics from selling unproven treatments whenever possible. Physicians should discourage their patients from receiving unproven stem cell therapies. Overall one should keep in mind, not to pour out the baby with the bath water: it will take more time to firmly establish MSC treatment in Regenerative Medicine.

Acknowledgement

Thanks to Andrea Zander for her assistance in the preparation of the manuscript.

Conflict of interest

None reported.

References

  1. Friedenstein AJ, Chailakhyan RK, Latsinik NV, Panasyuk AF, Keiliss-Borok IV. (). Stromal cells responsible for trabsferring the microenvironment of the hemopoietic tissues. Cloning in vitro and retransplantation in vivo. Transplantation. 1974; 17:331-340.
  2. Maximov AA. Über experimentelle Erzeugung von Knochenmarksgewebe. Anat Anz. 1906; 28: 24-38.
  3. Afanasyev BV, Elstner E, Zander AR. A. Friedenstein, founder of the mesenchymal stem cell concept. Cell Ther Transplant. 2009; 1(3): 35-38.
  4. Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991; 9:641-650.
  5. Porcellini A. Regenerative medicine: a review. Rev Bras Hematol Hemoter. 2009;31 (Suppl. 2). 31:63-66. DOI:10.1590/S1516-84842009000800017.
  6. Bunnell BA, Flaat M, Gagliardi C, Patel B, Ripoll C. Adipose-derived stem cells: Isolation, expansion and differentiation. Methods. Methods in Stem Cell Res. 2008; 45(2):115-120.
  7. Lange C, Schroeder J, Stute N, Lioznov MV, Zander AR. High-potential human mesenchymal stem cells. Stem Cells Dev. 2005;14(1):70-80.
  8. Nauta AJ, Fibbe WE. Immunomodulatory properties of mesenchymal stromal cells. Blood. 2007;110:3499-3506.
  9. Fang L, Lange C, Engel M, Zander A, Fehse B. Sensitive balance of suppressing and activating effects of mesenchymal stem cells on T-cell proliferation. Transplantation. 2006;82(10):1370-1373.
  10. Tögel F, Westenfelder C. Treatment of acute kidney injury with allogeneic mesenchymal stem cells: preclinical and initial clinical data. In: Regenerative Nephrology (Ed. M. Goligorsky), Elsevier, 2011. pp. 315-339.
  11. Tögel F, Westenfelder C. Mesenchymal stem cells: a new therapeutic tool for AKI. Nat Rev Nephrol. 2010; 6(3):179-183, DOI: 10.1038/nrneph.2009.229.
  12. Tögel F, Westenfelder C. The role of multipotent marrow stromal cells (MSCs) in tissue regeneration. Organogenesis.2011; 7(2):96-100, DOI: 10.4161/org.7.2.15781.
  13. Lange C, Brunswig-Spickenheie B, Cappallo-Obermann H, Eggert K, Gehling UM, Rudolph C, Schlegelberger B, Cornils K, Zustin J, Spiess AN, Zander AR. PLos One. 2011;6(1):e14486. Doi: 10.1089/scd.2009.0494.
  14. Krause K, Fehse B, Jaquet K, Lange C, Kyriazis K, Boczor S, Zander A, Kuck K. Analysis of progenitor cell mobilization and erythropoietin plasma levels in patients with acute myocardial infarction. Exp Clin Cardiol. 2005;10(2):104-107.
  15. Wang S, Qu X, Zhao RS. Clinical applications of mesenchymal stem cells. J Hematol Oncol. 2012. 5:19. DOI:10.1186/1756-8722-5-19.
  16. Zander AR, Lange C, Westenfelder C. Mesenchymal stromal cells: main factor or helper in regenerative medicine? Kidney Int. 2011; 1(3 Suppl):74-76.
  17. Le Blanc K, Rasmussen I, Sundberg B, Gotherstorm C, Hassan M, Uzunel M et al. Treatment of severe acute graft-versus-host-disease with third-party haploidentical mesenchymal stem cells. Lancet. 200;363:1439-1441.
  18. Le Blanc K, Frassoni F, Ball L, Locatelli F, Roelofs H, Lewis I, Lanino E, Sundberg B, Bernardo ME, Remberger M, Dini G, Egeler M, Bacigalupo A, Fibbe W, Ringden O et al. Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet. 2008; 371,1579-1586.
  19. Martin PJ, Uberti JP, Soiffer RJ, Klingermann H, Waller EK, Daly AS, Herrmann RP, Kebriaei P. Prochymal improves response rates in patients with steroid-refractory, acute GvHD: results of a randomized, placebo-controlled, multicenter Phase III trial in GvHD. Biol Blood Marrow Transplant. 2010;16: S169-S170.
  20. Kurtzberg J, Prasad V, Grimley M, Horn B, Carpenter P, Jacobsohn D, Prochop S. Allogeneic human mesenchymal stem cell therapy (Prochymal®) as a rescue agent for severe treatment resistant GVHD in pediatric patients. Biol. Blood Marrow Transplant. 2010; 16: S169.
  21. Hara A, Sato D, Sahara Y. New governmental regulatory system for stem cell-based therapies in Japan. Ther Innov Regul Sci. 2014; 48:681-688.
  22. Bader P. Effective treatment of steroid and therapy-refractory acute graft-versus-host disease with a novel mesenchymal stromal cell product (MSC-FFM). Bone Marrow Transplant. 2018; 53:852-862.
  23. Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M , Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A ,Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn’s disease: a phase 3 randomized, double-blind controlled trial. Lancet 2016; 388:1281-1290.
  24. Panes J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S;ADMIRE CD Study Group Collaborators. Long-term efficacy and safety of stem cell therapy (Cx601) for complex perianal fistulas in patients with Crohn’s disease. Gastroenterology. 2018; 154: 1334-1342 e4.
  25. Cofano F, Boido M, Monticelli M, Zenga F, Ducati A, Vercelli A, Garbossa D. Mesenchymal stem cells for spinal cord injury: current options. Int J Mol Sci. 2019; 20(11). pii: E2698.
  26. Gugliandolo A, Bramanti P, Mazzon E. Mesenchymal stem cells: a potential therapeutic approach for amyotriphic lateral sclerosis. Stem Cells Int. 2019; 2019:3675627.
  27. Oh KW, Noh MY, Kwon MS, Kim HY, Oh SI, Park J, Kim HJ, Ki CS, Kim SH. Repeated intrathecal mesenchymal stem cells for amyotrophic lateral sclerosis. Ann Neurol. 2018;84(3):361-373.
  28. Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, Muraro PA, Oliveri RS, Radue EW, Sellner J, Soelberg Sorensen P, Sormani MP, Wuerfel JT, Battaglia MA, Freedman MS; MESEMS study group. Mesenchymal stem cells for multiple sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for therapy of multiple sclerosis“. Trials. 2019, May 9; 20(1):263. DOI 10.1186/s13063-019-3346-z.
  29. Deng D, Zhang P, Guo Y, Lim TO. A randomized double-blind placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis“. Ann Rheum Dis. 2017;76(8):1436-1439.
  30. Cras A. Update on mesenchymal stem cell-based therapy in lupus and scleroderma. Arthritis Res Ther. 2015 Nov. 3; 17:301.
  31. Zang L, Hao H, Liu J, Li Y, Han W, Mu Y. Mesenchymal stem cell therapy in type 2 diabetes mellitus. Diabetol Metab Syndr. 2017 May 15;9:36.
  32. Moreira A, Kahlenberg S, Hornsby P. Therapeutic potential of mesenchymal stem cells for diabetes. J Mol Endocrinol. 2017; 59(3):R109-R120.
  33. Liu L, Wong CW, Han M, Farhoodi HP, Liu G, Liu Y, Liao W, Zhao W. Meta-analysis of preclinical studies of mesenchymal stromal cells to treat rheumatoid arthritis. EBioMedicine. 2019 Sep; 47: 563-577. DOI: 10.1016/j.ebiom.2019.08.073.
  34. Fan Yang, Yang Li. Effects of mesenchymal stem cells in autoimmune arthritis. Eur Med J. 2018 ;3 (4):130-137.
  35. Steinhoff G, Nesteruk J, Wolfien M, Große J, Ruch U, Vasudevan P, Müller P. Stem cells and heart disease – Brake or accelerator? Adv Drug Deliv Rev. 2017;120:2-24. DOI: 10.1016/j.addr.2017.10.007.
  36. Lalu MM, Mazzarello S, Zlepnig J, Dong YY, Montroy J, McIntyre L, Devereaux PJ, Stewart DJ. Safety and efficacy of adult stem cell therapy for acute myocardial infarction and ischemic heart failure (SafeCell Heart): a systematic review and meta-analysis. Stem Cells Transl Med; 7(12): 857-866.
  37. Blau HM, Daley GQ. Stem cells in the treatment of disease. New Engl J Med. 2019; 308:1748-1760. DOI: 10.1056/NEJMra1716145.
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Гамбургский университет, Гамбург, Германия

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Мезенхимные стромальные клетки (МСК) проявляют противовоспалительные, анти-апоптотические и иммуномодулирующие свойства. Поэтому их исследовали на предмет лечения аутоиммунных и хронических воспалительных заболеваний на протяжении последних двух десятилетий. МСК получили одобрение надзорных органов в нескольких странах на лечение ими острой реакции «трансплантат против хозяина» и болезни Крона. Обещающие результаты получены при их применении для лечения некоторых других болезней, таких, как системная красная волчанка, множественный склероз, амиотрофический боковой склероз и при травмах спинного мозга. При некритичном подходе прямая продажа частными предпринимателями неразрешенных стволовых клеток для лечения вносит беспорядок в область исследований МСК и угрожают внедрению МСК в арсенал медицинских методов. Необходимы еще несколько лет для полной оценки этого нового подхода к лечению по нескольким показаниям.

Ключевые слова

Мезенхимные стромальные клетки, иммунные эффекты, медицинское применение.

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Axel R. Zander

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University of Hamburg, Germany

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Mesenchymal stroma cells (MSCs) have anti-inflammatory, anti-apoptotic and immunomodulating properties, and they have, therefore, been explored in the treatment of autoimmune and chronic inflammatory diseases during the last two decades. MSCs have reached regulatory approval in several countries for the treatment of Acute Graft-versus-Host Disease and for Crohn’s disease. Results in several other diseases like Lupus, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and Spinal cord injury look promising.

Uncritical, direct to consumer sales of unapproved stem cell treatments by private entrepreneurs cloud the field of MSC research and jeopardize the establishment of MSC treatment in the armamentarium of Medicine. Several more years are necessary for a full evaluation of this new treatment modality in several indications.

Keywords

Mesenchymal stromal cells, immune effects, medical applications.

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Axel R. Zander

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Axel R. Zander

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Mesenchymal stroma cells (MSCs) have anti-inflammatory, anti-apoptotic and immunomodulating properties, and they have, therefore, been explored in the treatment of autoimmune and chronic inflammatory diseases during the last two decades. MSCs have reached regulatory approval in several countries for the treatment of Acute Graft-versus-Host Disease and for Crohn’s disease. Results in several other diseases like Lupus, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and Spinal cord injury look promising.

Uncritical, direct to consumer sales of unapproved stem cell treatments by private entrepreneurs cloud the field of MSC research and jeopardize the establishment of MSC treatment in the armamentarium of Medicine. Several more years are necessary for a full evaluation of this new treatment modality in several indications.

Keywords

Mesenchymal stromal cells, immune effects, medical applications.

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Mesenchymal stroma cells (MSCs) have anti-inflammatory, anti-apoptotic and immunomodulating properties, and they have, therefore, been explored in the treatment of autoimmune and chronic inflammatory diseases during the last two decades. MSCs have reached regulatory approval in several countries for the treatment of Acute Graft-versus-Host Disease and for Crohn’s disease. Results in several other diseases like Lupus, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and Spinal cord injury look promising.

Uncritical, direct to consumer sales of unapproved stem cell treatments by private entrepreneurs cloud the field of MSC research and jeopardize the establishment of MSC treatment in the armamentarium of Medicine. Several more years are necessary for a full evaluation of this new treatment modality in several indications.

Keywords

Mesenchymal stromal cells, immune effects, medical applications.

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University of Hamburg, Germany

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University of Hamburg, Germany

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Аксель Р. Цандер

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Аксель Р. Цандер

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Zander" ["LINK_ELEMENT_VALUE"]=> bool(false) } ["SUMMARY_RU"]=> array(37) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24434" ["VALUE"]=> array(2) { ["TEXT"]=> string(2024) "<p style="text-align: justify;">Мезенхимные стромальные клетки (МСК) проявляют противовоспалительные, анти-апоптотические и иммуномодулирующие свойства. Поэтому их исследовали на предмет лечения аутоиммунных и хронических воспалительных заболеваний на протяжении последних двух десятилетий. МСК получили одобрение надзорных органов в нескольких странах на лечение ими острой реакции «трансплантат против хозяина» и болезни Крона. Обещающие результаты получены при их применении для лечения некоторых других болезней, таких, как системная красная волчанка, множественный склероз, амиотрофический боковой склероз и при травмах спинного мозга. При некритичном подходе прямая продажа частными предпринимателями неразрешенных стволовых клеток для лечения вносит беспорядок в область исследований МСК и угрожают внедрению МСК в арсенал медицинских методов. Необходимы еще несколько лет для полной оценки этого нового подхода к лечению по нескольким показаниям.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Мезенхимные стромальные клетки, иммунные эффекты, медицинское применение.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1968) "

Мезенхимные стромальные клетки (МСК) проявляют противовоспалительные, анти-апоптотические и иммуномодулирующие свойства. Поэтому их исследовали на предмет лечения аутоиммунных и хронических воспалительных заболеваний на протяжении последних двух десятилетий. МСК получили одобрение надзорных органов в нескольких странах на лечение ими острой реакции «трансплантат против хозяина» и болезни Крона. Обещающие результаты получены при их применении для лечения некоторых других болезней, таких, как системная красная волчанка, множественный склероз, амиотрофический боковой склероз и при травмах спинного мозга. При некритичном подходе прямая продажа частными предпринимателями неразрешенных стволовых клеток для лечения вносит беспорядок в область исследований МСК и угрожают внедрению МСК в арсенал медицинских методов. Необходимы еще несколько лет для полной оценки этого нового подхода к лечению по нескольким показаниям.

Ключевые слова

Мезенхимные стромальные клетки, иммунные эффекты, медицинское применение.

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(29) "Описание/Резюме" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(1968) "

Мезенхимные стромальные клетки (МСК) проявляют противовоспалительные, анти-апоптотические и иммуномодулирующие свойства. Поэтому их исследовали на предмет лечения аутоиммунных и хронических воспалительных заболеваний на протяжении последних двух десятилетий. МСК получили одобрение надзорных органов в нескольких странах на лечение ими острой реакции «трансплантат против хозяина» и болезни Крона. Обещающие результаты получены при их применении для лечения некоторых других болезней, таких, как системная красная волчанка, множественный склероз, амиотрофический боковой склероз и при травмах спинного мозга. При некритичном подходе прямая продажа частными предпринимателями неразрешенных стволовых клеток для лечения вносит беспорядок в область исследований МСК и угрожают внедрению МСК в арсенал медицинских методов. Необходимы еще несколько лет для полной оценки этого нового подхода к лечению по нескольким показаниям.

Ключевые слова

Мезенхимные стромальные клетки, иммунные эффекты, медицинское применение.

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Гамбургский университет, Гамбург, Германия

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Гамбургский университет, Гамбург, Германия

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Introduction

Treatment of cancer via adoptive transfer of CAR T cells, being proposed over 20 years ago, remained essentially unknown to the broad medical community, largely due to its very limited efficacy observed in clinical trials. CAR T cell-based therapy came into spotlight when complete responses, many of which were long-lasting, had been reported for 50-90% patients with refractory/relapsed acute lymphoblastic leukemia (r/rALL) and B-cell lymphomas [1-7]. This success stemmed from the relatively easy access of CAR T cells to cancer cells, as well as from the broad choice of targetable surface markers present on the surface of malignant B cells. In the case of ALL, these markers include pan-B cell antigens such as CD19, CD20, CD22, etc. Accordingly, normal B cells expressing the same surface markers may also be destroyed by CAR T cells [2, 3, 5]. However, this so-called "on-target off-tumor" activity is well tolerated and can be compensated by immunoglobulin replacement therapy [8]. This may not be the case, however, for most other malignancies, since cancer cells often express surface markers that are shared with normal tissues vital to the patient. Thus, the availability of a specific surface marker is central for any successful anti-cancer CAR T cell therapy, including that for prostate cancer (PCa).

Selecting a CAR target

An ideal target for CAR-based PCa therapy should display the following features: i) strong and homogeneous expression on metastatic PCa cells and limited or absent expression on non-malignant cells, ii) it should be indispensable for the growth of PCa cells, and/or iii) be enriched on the PCa stem cell population. Comprehensive and unbiased profiling of metastatic PCa-specific surfaceome is therefore warranted as this information would be instrumental for the design of highly selective and potent CARs for the therapy of PCa.

Below we summarize the data on the surface antigens having limited expression outside the prostate and PCa lesions. These targets were used for the preclinical and/or clinical development of CAR T cell-based approaches for PCa or are expected to become CAR T cell targets in the nearest future.

PSCA is a small highly glycosylated GPI-anchored protein with apparent molecular weight of ~24 kDa and predicted molecular weight of only ~10 kDa. First described in 1998, this protein has immediately attracted attention as a potential target for anticancer therapy: it was shown to be highly expressed in primary tumors and metastases of over 80% PCa patients [9-11], as well as in up to 60% pancreatic [12, 13] and bladder [14] cancer samples. It should be noted however, that PSCA expression is not restricted to the malignant prostate cells. By profiling human tissues using a PSCA-specific monoclonal antibody 1G8, various levels of PSCA expression were found for normal epithelial (basal, secretory, and neuroendocrine) cells of the prostate, transitional epithelium of the bladder, neuroendocrine cells of the stomach and the colon, as well as for collecting ducts of the kidney [10]. A number of PSCA-specific monoclonal antibodies and humanized variants thereof have been extensively characterized pre-clinically [15, 16], however they never proceeded to advanced clinical stages as monotherapy agents. Notably, 1G8-based PSCA-specific CAR T cells were shown to significantly inhibit growth of PSCA-positive non-small cell lung cancer patient-derived xenografts in mice, which provided the rationale for moving towards a clinical trial of CAR T cells in lung cancer patients (NCT03198052). Furthermore, a "switchable" PSCA-specific GoCAR T cell product (BPX-601, Bellicum Pharmaceuticals) is currently in a Phase1/2 clinical trial for patients with PSCA-positive gastric, pancreatic, and prostate tumors (NCT02744287). Whereas the data for prostate cancer patients are pending, recent analysis of several small cohorts of heavily pre-treated pancreatic patients indicates that BPX-601 infusion combined with a single injection of the small-molecule "switch" has resulted in disease stabilization, which was accompanied by generally moderate and reversible toxicities [17].

Prostate-Specific Membrane Antigen (PSMA) is a type II 100 kDa transmembrane glycoprotein frequently found in both PCa tumors in addition to a limited number of normal human tissues such as prostate epithelium, proximal renal tubules, duodenal, and rectal mucosa [18, 19]. Interestingly, in the LNCaP cell line widely used for PCa research, PSMA expression is partially modulated by steroid hormones [18]. This recapitulates the in vivo situation, as PSMA expression has been reported to be up-regulated in primary PCa tumors and metastases following androgen-deprivation therapy [20]. Nonetheless, different research groups reported the percentage of PSMA-positive prostate tumors to vary from 66 to 100% [19, 21, 22], which is likely attributable to the choice of the PSMA-specific antibody. Interestingly, PSMA is known to mark the neovasculature of various non-prostatic cancers [19, 23]. Several small-molecule inhibitors with high affinity to PSMA and PSMA-specific antibody-drug conjugates have been characterized and are now actively tested for imaging purposes (reviewed in [24]) or as therapeutic agents in Phase 2/3 clinical trials (NCT03042312; NCT02615067; NCT03511664). Excellent safety profile of such PSMA-targeted molecules establishes PSMA as a strong target for CAR T cells in the context of both metastatic PCa lesions and neovasculature of cancers other than PCa (NCT00664196, NCT01140373, NCT03089203).

ErbB2 (Her2/Neu) is a transmembrane protein known as a prominent marker of breast and gastric carcinomas. Low-level ErbB2 overexpression was found in ~20% of PCa tumors, with stronger expression correlating with rapid cancer cell proliferation and tumor recurrence [25]. Multiple ErbB2 ligands currently approved as therapeutics (such as trastuzumab and pertuzumab) make this protein a convenient target for adoptive cellular immunotherapy of PCa. Although infusion of a ErbB2-specific CAR T cell product has been implicated in a death of a clinical trial participant [26], the reason behind such outcome was likely unrelated to "on-target off-tumor" activity which would be consistent with the broad low-level expression of ErbB2 on normal epithelial cells [27], as this was not observed in a later study where a distinct anti-ErbB2 CAR and significantly lower CAR T cell dose were used [28, 29].

EpCAM (CD326) is frequently found on the surface of carcinomas of various origin, including the prostate, where this antigen was reported to be expressed in up to 87% of tumors [30]. This protein is also considered to be a cancer stem cell marker [31], which strengthens the idea of its use as a therapeutic target. Yet, EpCAM is also expressed at the basolateral cell membrane of simple, pseudo-stratified, and transitional epithelia, which raises reasonable safety concerns for EpCAM-specific CAR T cell therapy. Presently, EpCAM-specific CAR T cells are in Phase 1/2 clinical trials for several solid cancers (NCT02729493, NCT02725125, NCT03563326, NCT02915445) including PCa (NCT03013712).

CD133 (Prominin-1) is one of the several controversial markers of cancer stem cells known to be also expressed by normal stem cells and terminally differentiated epithelial cells [32]. In fact, in the context of PCa, CD133 labels only a subset of cancer stem cells [33,34], which may limit the clinical relevance of this protein as a sole CAR target. It must be noted that a recent clinical trial of CD133-specific CAR T cells for the therapy of patients with hepatocellular, pancreatic, and colorectal carcinomas suggested their overall safety and evidence of limited efficacy [35]. This was consistent with a modest pre-clinical in vitro and in vivo activity of these CAR T cells. Not a single complete response was observed among the 23 treated patients most of whom had very bulky lesions and could not be pre-conditioned. Importantly, CD133+ cells were depleted from the tumor bioptates post-treatment and a CD133- tumor escape was observed in one patient. This finding indicates that a two-pronged approach of simultaneously attacking the cancer stem cell population and the tumor cell mass should translate into stronger responses. Therefore, CAR T cells designed to target both CD133 and the surface markers of more differentiated cancer cell types, such as CD133+CEACAM5 or CD133+EGFR, should be more actively explored both pre-clinically and in the clinical setting [36]. So far, no studies of CD133-specific CAR T cells for the therapy of PCa patients have been reported.

Yet another marker of both cancer and hematopoietic stem cells, CD44, is known to be expressed by PCa stem cells [37]. Interestingly, a variant splice form of CD44 known as CD44v6 is not expressed by hematopoietic progenitor cells, and is considered as a favorable target for CAR T cell therapy [38]. CD44v6-retargeted CAR T cells have shown impressive pre-clinical activity in several hematological cancer models [38, 39], but none have so far been specifically evaluated in the context of PCa.

PCTA-1 (Galectin 8) was described as the protein expressed on PCa cells back in 1996 [40], however later it received very little attention as a therapeutic target. Likely this was due to the fact that it was and still is unclear how this protein devoid of the signal sequence is trafficked outside the cell and ultimately reaches the cell surface [41-43] and whether its surface expression is truly restricted to cancer cells (reviewed in [44, 45]). It has recently been demonstrated that patients with metastatic castration-resistant prostate cancer who received Sipuleucel-T produced significantly higher titers of PCTA-1 specific antibodies compared to the control group of patients [46]. This and other observations [47] highlight PCTA-1 as an emerging therapeutic target in PCa.

STEAP1 has been identified as a membrane protein that is overexpressed in metastatic PCa lesions compared to benign prostatic hyperplasia [48]. It was shown to be also expressed, albeit at much lower levels, by normal prostate and urinary bladder cells, however current expression profiling data are indicative of a much broader normal tissue expression of STEAP1 which includes the brain and the lungs [49]. Whether this inconsistency is associated with the specific choice of antibodies used remains to be explored. Nonetheless, recent clinical trial of MSTP2109A, a conjugate of a humanized anti-STEAP1 antibody and MMAE, has provided evidence of its moderate efficacy in the therapy of patients with metastatic castration-resistant prostate cancer (mCRPC), which was accompanied with a significant percentage of treatment-related serious adverse events [50]. Therefore, considering STEAP-1 as a possible target for CAR T cells may not be regarded as straightforward.

Survivin is broadly known as an intracellular anti-apoptotic protein involved in the control of cell proliferation [51]. It is up-regulated in multiple human cancers including PCa [52]. Intriguingly, this protein has recently been shown to be present on the surface of cancer cells [53], thereby lending itself as a prime candidate for Survivin-specific CARs.

MUC1 is expressed by tumors of a fraction of PCa patients. Across different studies, the percentage of MUC1-positive tumors ranges from 17% [54] to 58% [55]. Notably, MUC1 is also expressed by various types of epithelial cells, as well as by hematopoietic cells and activated T cells [56]. This broad expression pattern across multiple normal cell types sets MUC1 as an antigen that appears suboptimal for the target therapy of PCa. Nonetheless, recent efforts from two companies, Minerva Biotechnologies and Poseida Therapeutics, to identify binders that can reliably discriminate between cancer-specific MUC1 species (known as MUC1* or MUC1C) and the full-length MUC1 present on normal cells, have translated into the design of CAR T cells [57] showing robust anti-tumor activity in mouse xenotransplant models [58-60], with a Phase I clinical trial of MUC1*-specific CAR T cells announced for breast cancer patients (NCT04020575).

At the same time, Tn Muc1/sTn Muc1 species predominantly, although not exclusively expressed on the surface of cancerous, rather than normal tissues serve as attractive alternatives to MUC1 for CAR T cell-based therapy [61, 62], with a recently opened early phase clinical trial of TnMuc1-specific CAR T cells in advanced (non-PCa) solid cancer and multiple myeloma patients (NCT04025216). Except for one report [63], expression of these glycopeptide antigens has been extensively explored using a number of mAbs [64-66] (reviewed in [67]) in cancers other than PCa [61, 68]) and warrants further investigation, as the data have been somewhat difficult to reconcile [69].

TAG-72 epitope, established to be a sialyl-Tn O-glycan carbohydrate hapten, has been found in the vast majority of human carcinomas, including PCa. Given its rather restricted expression pattern in normal tissues [70, 71] and favorable safety profile of anti-TAG72 mAbs [72, 73], first-generation TAG-72-specific CAR T cells have been extensively evaluated both pre-clinically [74] and in two early clinical trials [75] for metastatic colorectal cancer, where they proved to be safe and inefficient largely due to the poor persistence afforded by the CAR design and rapid anti-idiotype elimination. Recent study using local delivery of optimized second-generation TAG-72-CART cells in a xenotransplanted ovarian cancer model [76] provides a strong rationale for testing TAG-72 as a promising target for CAR T cells in epithelial carcinomas including PCa.

Integrin αvβ3 is another marker frequently found on PCa cells, as well as on endothelial cells of the tumor vasculature. Expression of this protein is associated with higher risk of metastatic bone lesions [77-79]. Monoclonal αvβ3-specific antibody LM609 and a humanized derivative of LM609 have been characterized in phase I clinical trials which confirmed their safety [80], however no reports of therapeutic activity in the completed phase II clinical trial (NCT00072930) have been posted since 2008, consistent with the complex biology of αvβ3 in cancer [81]. Intriguingly, a recent study reported on the activity of hLM609-derived αvβ3-specific CAR T cells both in vitro and in vivo, in the setting of xenotransplanted human melanoma [82].

CEACAM5 and CEACAM6 are two related proteins expressed at comparable levels on both PCa and normal prostate cells [83]. Variable levels of expression of these proteins have also been reported for normal cells of the lung, pancreas, and intestine. Safety of the cell therapy targeting CEACAM5 was analyzed in several studies and the results were somewhat conflicting. Use of CEACAM5-specific recTCR-T cells was accompanied with serious colitis in all three patients who received the cell products [84]. This was unlike the situation reported for CEACAM5-specific CAR T cells based on the MFE23 scFv, where acute respiratory toxicity was observed [85]. Notably, infusion of CEACAM5-specific CAR T cells based on the alternative antigen recognition modules was not accompanied with critical adverse effects in two more clinical studies [86,87]. So far, CEACAM5-specific CAR T cells have not been tested in PCa patients. As for, CEACAM6-specific CAR T cells, the studies have not yet progressed beyond mouse xenotranplant models, and safety of such CAR T cells in humans is presently unknown [88].

TROP-2 (TACSTD2) is expressed on both benign and malignant prostate lesions [89, 90], yet it is also detectable on the normal epithelial cells of various origin [91]. No clinical trials of TROP-2-specific CAR T cells have so far been approved, however TROP-2-specific antibody-drug conjugates have been tested in patients and numerous adverse effects have been reported [92]. Hence, the safety of TROP-2-targeted CAR T cell therapy is presently questionable.

Finally, two B7-CD28 family members, B7-H3 (CD276) and B7x (VTCN1/B7-H4) have been reported to be overexpressed in a variety of cancers including PCa [93,94] (reviewed in [95, 96]), and are currently the focus of pre-clinical CAR T cell evaluation programs using AML [97], lung [98], breast [99], bile duct [100], bone and brain [101-103] cancer cells as the targets. Importantly, the findings of Phase I/IIa clinical trials of B7-H3-specific monoclonal antibody MGA271 (enoblituzumab) support its favorable safety profile [104], although surface expression of B7-H3 has been demonstrated for several normal cell types such as dendritic cells, as well as in vitro activated T-, NK- and B cells [105]. Accordingly, B7-H3-specific CARs did not display appreciable off-tumor activity in pre-clinical tests, but they may still require structural/affinity optimization to robustly discriminate between different expression levels of this antigen on normal and malignant cells upon transition to human trials. Interestingly, delayed lethal off-tumor toxicity has recently been observed for B7x-specific CAR T cells [106].

Conclusion

None of the abovementioned markers are absolutely specific for PCa or found across PCa lesions in all patients. Furthermore, a fraction of PCa tumors may be expected to be negative for all such markers, and, hence, the feasibility of delivering a targeted CAR therapy would be very low in such cases. Thus, systematic discovery of novel PCa surface markers is highly warranted. Only a handful of studies in this direction have been published to date. For instance, using a combination of proteomic and transcriptomic profiling, Lee and colleagues have identified a number of surface markers enriched in PCa subtypes [107]. Whereas the identification of known PCa markers such as CEACAM5, PSMA, STEAP1, MUC1, and TROP-2 clearly validates this approach, the rest of the high-ranking proteins reported appear to be strongly and broadly expressed in essential tissues, which makes unlikely their potential use as CAR targets.

Analysis of antibodies present in the sera of convalescent cancer patients following immunotherapy who have developed an anticancer immune response may represent an interesting resource of antigen-recognition modules in CAR design. In line with this idea, GuhaThakurta and colleagues have profiled the specificity of antibodies from 25 mCRPC patients who received a dendritic cell-based vaccine sipuleucel-T [46]. Moderate, yet significant increase in antibody titers to PCTA-1 and Galectin-3 among others was observed. The former protein has already been known as a PCa marker, whereas the latter is predominantly secreted, and is a poor candidate for CAR targeting. Nonetheless, in our opinion this approach appears highly promising. In the context of other types of cancer, antibody profiling has identified a number of putative cancer markers including Galectin-1 [108], MYPT1, PSMC5, etc [109]. Importantly, despite the fact that the above proteins lack protein domains that would anchor them at the cell surface, this approach may still be fruitful once substantially more patient samples are analyzed. Of special interest is the recent advance in the technology of single-cell profiling of repertoires of B- and T- cell receptors [110], which may help identify target-receptor pairs, once combined with the proteomics data. Using the above approaches, analysis of samples from more PCa patients may be required to capture novel or subtype-specific PCa markers, or to confidently conclude that no such targets beyond the described ones exist, and that combinations of the known targets should be exploited for CAR design.

Acknowledgements

This work was supported by the Russian Ministry of Education and Science (Agreement # 075-15-2019-1246, unique project identifier RFMEFI60417X0169).

The authors report no conflicts of interests.

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Introduction

Treatment of cancer via adoptive transfer of CAR T cells, being proposed over 20 years ago, remained essentially unknown to the broad medical community, largely due to its very limited efficacy observed in clinical trials. CAR T cell-based therapy came into spotlight when complete responses, many of which were long-lasting, had been reported for 50-90% patients with refractory/relapsed acute lymphoblastic leukemia (r/rALL) and B-cell lymphomas [1-7]. This success stemmed from the relatively easy access of CAR T cells to cancer cells, as well as from the broad choice of targetable surface markers present on the surface of malignant B cells. In the case of ALL, these markers include pan-B cell antigens such as CD19, CD20, CD22, etc. Accordingly, normal B cells expressing the same surface markers may also be destroyed by CAR T cells [2, 3, 5]. However, this so-called "on-target off-tumor" activity is well tolerated and can be compensated by immunoglobulin replacement therapy [8]. This may not be the case, however, for most other malignancies, since cancer cells often express surface markers that are shared with normal tissues vital to the patient. Thus, the availability of a specific surface marker is central for any successful anti-cancer CAR T cell therapy, including that for prostate cancer (PCa).

Selecting a CAR target

An ideal target for CAR-based PCa therapy should display the following features: i) strong and homogeneous expression on metastatic PCa cells and limited or absent expression on non-malignant cells, ii) it should be indispensable for the growth of PCa cells, and/or iii) be enriched on the PCa stem cell population. Comprehensive and unbiased profiling of metastatic PCa-specific surfaceome is therefore warranted as this information would be instrumental for the design of highly selective and potent CARs for the therapy of PCa.

Below we summarize the data on the surface antigens having limited expression outside the prostate and PCa lesions. These targets were used for the preclinical and/or clinical development of CAR T cell-based approaches for PCa or are expected to become CAR T cell targets in the nearest future.

PSCA is a small highly glycosylated GPI-anchored protein with apparent molecular weight of ~24 kDa and predicted molecular weight of only ~10 kDa. First described in 1998, this protein has immediately attracted attention as a potential target for anticancer therapy: it was shown to be highly expressed in primary tumors and metastases of over 80% PCa patients [9-11], as well as in up to 60% pancreatic [12, 13] and bladder [14] cancer samples. It should be noted however, that PSCA expression is not restricted to the malignant prostate cells. By profiling human tissues using a PSCA-specific monoclonal antibody 1G8, various levels of PSCA expression were found for normal epithelial (basal, secretory, and neuroendocrine) cells of the prostate, transitional epithelium of the bladder, neuroendocrine cells of the stomach and the colon, as well as for collecting ducts of the kidney [10]. A number of PSCA-specific monoclonal antibodies and humanized variants thereof have been extensively characterized pre-clinically [15, 16], however they never proceeded to advanced clinical stages as monotherapy agents. Notably, 1G8-based PSCA-specific CAR T cells were shown to significantly inhibit growth of PSCA-positive non-small cell lung cancer patient-derived xenografts in mice, which provided the rationale for moving towards a clinical trial of CAR T cells in lung cancer patients (NCT03198052). Furthermore, a "switchable" PSCA-specific GoCAR T cell product (BPX-601, Bellicum Pharmaceuticals) is currently in a Phase1/2 clinical trial for patients with PSCA-positive gastric, pancreatic, and prostate tumors (NCT02744287). Whereas the data for prostate cancer patients are pending, recent analysis of several small cohorts of heavily pre-treated pancreatic patients indicates that BPX-601 infusion combined with a single injection of the small-molecule "switch" has resulted in disease stabilization, which was accompanied by generally moderate and reversible toxicities [17].

Prostate-Specific Membrane Antigen (PSMA) is a type II 100 kDa transmembrane glycoprotein frequently found in both PCa tumors in addition to a limited number of normal human tissues such as prostate epithelium, proximal renal tubules, duodenal, and rectal mucosa [18, 19]. Interestingly, in the LNCaP cell line widely used for PCa research, PSMA expression is partially modulated by steroid hormones [18]. This recapitulates the in vivo situation, as PSMA expression has been reported to be up-regulated in primary PCa tumors and metastases following androgen-deprivation therapy [20]. Nonetheless, different research groups reported the percentage of PSMA-positive prostate tumors to vary from 66 to 100% [19, 21, 22], which is likely attributable to the choice of the PSMA-specific antibody. Interestingly, PSMA is known to mark the neovasculature of various non-prostatic cancers [19, 23]. Several small-molecule inhibitors with high affinity to PSMA and PSMA-specific antibody-drug conjugates have been characterized and are now actively tested for imaging purposes (reviewed in [24]) or as therapeutic agents in Phase 2/3 clinical trials (NCT03042312; NCT02615067; NCT03511664). Excellent safety profile of such PSMA-targeted molecules establishes PSMA as a strong target for CAR T cells in the context of both metastatic PCa lesions and neovasculature of cancers other than PCa (NCT00664196, NCT01140373, NCT03089203).

ErbB2 (Her2/Neu) is a transmembrane protein known as a prominent marker of breast and gastric carcinomas. Low-level ErbB2 overexpression was found in ~20% of PCa tumors, with stronger expression correlating with rapid cancer cell proliferation and tumor recurrence [25]. Multiple ErbB2 ligands currently approved as therapeutics (such as trastuzumab and pertuzumab) make this protein a convenient target for adoptive cellular immunotherapy of PCa. Although infusion of a ErbB2-specific CAR T cell product has been implicated in a death of a clinical trial participant [26], the reason behind such outcome was likely unrelated to "on-target off-tumor" activity which would be consistent with the broad low-level expression of ErbB2 on normal epithelial cells [27], as this was not observed in a later study where a distinct anti-ErbB2 CAR and significantly lower CAR T cell dose were used [28, 29].

EpCAM (CD326) is frequently found on the surface of carcinomas of various origin, including the prostate, where this antigen was reported to be expressed in up to 87% of tumors [30]. This protein is also considered to be a cancer stem cell marker [31], which strengthens the idea of its use as a therapeutic target. Yet, EpCAM is also expressed at the basolateral cell membrane of simple, pseudo-stratified, and transitional epithelia, which raises reasonable safety concerns for EpCAM-specific CAR T cell therapy. Presently, EpCAM-specific CAR T cells are in Phase 1/2 clinical trials for several solid cancers (NCT02729493, NCT02725125, NCT03563326, NCT02915445) including PCa (NCT03013712).

CD133 (Prominin-1) is one of the several controversial markers of cancer stem cells known to be also expressed by normal stem cells and terminally differentiated epithelial cells [32]. In fact, in the context of PCa, CD133 labels only a subset of cancer stem cells [33,34], which may limit the clinical relevance of this protein as a sole CAR target. It must be noted that a recent clinical trial of CD133-specific CAR T cells for the therapy of patients with hepatocellular, pancreatic, and colorectal carcinomas suggested their overall safety and evidence of limited efficacy [35]. This was consistent with a modest pre-clinical in vitro and in vivo activity of these CAR T cells. Not a single complete response was observed among the 23 treated patients most of whom had very bulky lesions and could not be pre-conditioned. Importantly, CD133+ cells were depleted from the tumor bioptates post-treatment and a CD133- tumor escape was observed in one patient. This finding indicates that a two-pronged approach of simultaneously attacking the cancer stem cell population and the tumor cell mass should translate into stronger responses. Therefore, CAR T cells designed to target both CD133 and the surface markers of more differentiated cancer cell types, such as CD133+CEACAM5 or CD133+EGFR, should be more actively explored both pre-clinically and in the clinical setting [36]. So far, no studies of CD133-specific CAR T cells for the therapy of PCa patients have been reported.

Yet another marker of both cancer and hematopoietic stem cells, CD44, is known to be expressed by PCa stem cells [37]. Interestingly, a variant splice form of CD44 known as CD44v6 is not expressed by hematopoietic progenitor cells, and is considered as a favorable target for CAR T cell therapy [38]. CD44v6-retargeted CAR T cells have shown impressive pre-clinical activity in several hematological cancer models [38, 39], but none have so far been specifically evaluated in the context of PCa.

PCTA-1 (Galectin 8) was described as the protein expressed on PCa cells back in 1996 [40], however later it received very little attention as a therapeutic target. Likely this was due to the fact that it was and still is unclear how this protein devoid of the signal sequence is trafficked outside the cell and ultimately reaches the cell surface [41-43] and whether its surface expression is truly restricted to cancer cells (reviewed in [44, 45]). It has recently been demonstrated that patients with metastatic castration-resistant prostate cancer who received Sipuleucel-T produced significantly higher titers of PCTA-1 specific antibodies compared to the control group of patients [46]. This and other observations [47] highlight PCTA-1 as an emerging therapeutic target in PCa.

STEAP1 has been identified as a membrane protein that is overexpressed in metastatic PCa lesions compared to benign prostatic hyperplasia [48]. It was shown to be also expressed, albeit at much lower levels, by normal prostate and urinary bladder cells, however current expression profiling data are indicative of a much broader normal tissue expression of STEAP1 which includes the brain and the lungs [49]. Whether this inconsistency is associated with the specific choice of antibodies used remains to be explored. Nonetheless, recent clinical trial of MSTP2109A, a conjugate of a humanized anti-STEAP1 antibody and MMAE, has provided evidence of its moderate efficacy in the therapy of patients with metastatic castration-resistant prostate cancer (mCRPC), which was accompanied with a significant percentage of treatment-related serious adverse events [50]. Therefore, considering STEAP-1 as a possible target for CAR T cells may not be regarded as straightforward.

Survivin is broadly known as an intracellular anti-apoptotic protein involved in the control of cell proliferation [51]. It is up-regulated in multiple human cancers including PCa [52]. Intriguingly, this protein has recently been shown to be present on the surface of cancer cells [53], thereby lending itself as a prime candidate for Survivin-specific CARs.

MUC1 is expressed by tumors of a fraction of PCa patients. Across different studies, the percentage of MUC1-positive tumors ranges from 17% [54] to 58% [55]. Notably, MUC1 is also expressed by various types of epithelial cells, as well as by hematopoietic cells and activated T cells [56]. This broad expression pattern across multiple normal cell types sets MUC1 as an antigen that appears suboptimal for the target therapy of PCa. Nonetheless, recent efforts from two companies, Minerva Biotechnologies and Poseida Therapeutics, to identify binders that can reliably discriminate between cancer-specific MUC1 species (known as MUC1* or MUC1C) and the full-length MUC1 present on normal cells, have translated into the design of CAR T cells [57] showing robust anti-tumor activity in mouse xenotransplant models [58-60], with a Phase I clinical trial of MUC1*-specific CAR T cells announced for breast cancer patients (NCT04020575).

At the same time, Tn Muc1/sTn Muc1 species predominantly, although not exclusively expressed on the surface of cancerous, rather than normal tissues serve as attractive alternatives to MUC1 for CAR T cell-based therapy [61, 62], with a recently opened early phase clinical trial of TnMuc1-specific CAR T cells in advanced (non-PCa) solid cancer and multiple myeloma patients (NCT04025216). Except for one report [63], expression of these glycopeptide antigens has been extensively explored using a number of mAbs [64-66] (reviewed in [67]) in cancers other than PCa [61, 68]) and warrants further investigation, as the data have been somewhat difficult to reconcile [69].

TAG-72 epitope, established to be a sialyl-Tn O-glycan carbohydrate hapten, has been found in the vast majority of human carcinomas, including PCa. Given its rather restricted expression pattern in normal tissues [70, 71] and favorable safety profile of anti-TAG72 mAbs [72, 73], first-generation TAG-72-specific CAR T cells have been extensively evaluated both pre-clinically [74] and in two early clinical trials [75] for metastatic colorectal cancer, where they proved to be safe and inefficient largely due to the poor persistence afforded by the CAR design and rapid anti-idiotype elimination. Recent study using local delivery of optimized second-generation TAG-72-CART cells in a xenotransplanted ovarian cancer model [76] provides a strong rationale for testing TAG-72 as a promising target for CAR T cells in epithelial carcinomas including PCa.

Integrin αvβ3 is another marker frequently found on PCa cells, as well as on endothelial cells of the tumor vasculature. Expression of this protein is associated with higher risk of metastatic bone lesions [77-79]. Monoclonal αvβ3-specific antibody LM609 and a humanized derivative of LM609 have been characterized in phase I clinical trials which confirmed their safety [80], however no reports of therapeutic activity in the completed phase II clinical trial (NCT00072930) have been posted since 2008, consistent with the complex biology of αvβ3 in cancer [81]. Intriguingly, a recent study reported on the activity of hLM609-derived αvβ3-specific CAR T cells both in vitro and in vivo, in the setting of xenotransplanted human melanoma [82].

CEACAM5 and CEACAM6 are two related proteins expressed at comparable levels on both PCa and normal prostate cells [83]. Variable levels of expression of these proteins have also been reported for normal cells of the lung, pancreas, and intestine. Safety of the cell therapy targeting CEACAM5 was analyzed in several studies and the results were somewhat conflicting. Use of CEACAM5-specific recTCR-T cells was accompanied with serious colitis in all three patients who received the cell products [84]. This was unlike the situation reported for CEACAM5-specific CAR T cells based on the MFE23 scFv, where acute respiratory toxicity was observed [85]. Notably, infusion of CEACAM5-specific CAR T cells based on the alternative antigen recognition modules was not accompanied with critical adverse effects in two more clinical studies [86,87]. So far, CEACAM5-specific CAR T cells have not been tested in PCa patients. As for, CEACAM6-specific CAR T cells, the studies have not yet progressed beyond mouse xenotranplant models, and safety of such CAR T cells in humans is presently unknown [88].

TROP-2 (TACSTD2) is expressed on both benign and malignant prostate lesions [89, 90], yet it is also detectable on the normal epithelial cells of various origin [91]. No clinical trials of TROP-2-specific CAR T cells have so far been approved, however TROP-2-specific antibody-drug conjugates have been tested in patients and numerous adverse effects have been reported [92]. Hence, the safety of TROP-2-targeted CAR T cell therapy is presently questionable.

Finally, two B7-CD28 family members, B7-H3 (CD276) and B7x (VTCN1/B7-H4) have been reported to be overexpressed in a variety of cancers including PCa [93,94] (reviewed in [95, 96]), and are currently the focus of pre-clinical CAR T cell evaluation programs using AML [97], lung [98], breast [99], bile duct [100], bone and brain [101-103] cancer cells as the targets. Importantly, the findings of Phase I/IIa clinical trials of B7-H3-specific monoclonal antibody MGA271 (enoblituzumab) support its favorable safety profile [104], although surface expression of B7-H3 has been demonstrated for several normal cell types such as dendritic cells, as well as in vitro activated T-, NK- and B cells [105]. Accordingly, B7-H3-specific CARs did not display appreciable off-tumor activity in pre-clinical tests, but they may still require structural/affinity optimization to robustly discriminate between different expression levels of this antigen on normal and malignant cells upon transition to human trials. Interestingly, delayed lethal off-tumor toxicity has recently been observed for B7x-specific CAR T cells [106].

Conclusion

None of the abovementioned markers are absolutely specific for PCa or found across PCa lesions in all patients. Furthermore, a fraction of PCa tumors may be expected to be negative for all such markers, and, hence, the feasibility of delivering a targeted CAR therapy would be very low in such cases. Thus, systematic discovery of novel PCa surface markers is highly warranted. Only a handful of studies in this direction have been published to date. For instance, using a combination of proteomic and transcriptomic profiling, Lee and colleagues have identified a number of surface markers enriched in PCa subtypes [107]. Whereas the identification of known PCa markers such as CEACAM5, PSMA, STEAP1, MUC1, and TROP-2 clearly validates this approach, the rest of the high-ranking proteins reported appear to be strongly and broadly expressed in essential tissues, which makes unlikely their potential use as CAR targets.

Analysis of antibodies present in the sera of convalescent cancer patients following immunotherapy who have developed an anticancer immune response may represent an interesting resource of antigen-recognition modules in CAR design. In line with this idea, GuhaThakurta and colleagues have profiled the specificity of antibodies from 25 mCRPC patients who received a dendritic cell-based vaccine sipuleucel-T [46]. Moderate, yet significant increase in antibody titers to PCTA-1 and Galectin-3 among others was observed. The former protein has already been known as a PCa marker, whereas the latter is predominantly secreted, and is a poor candidate for CAR targeting. Nonetheless, in our opinion this approach appears highly promising. In the context of other types of cancer, antibody profiling has identified a number of putative cancer markers including Galectin-1 [108], MYPT1, PSMC5, etc [109]. Importantly, despite the fact that the above proteins lack protein domains that would anchor them at the cell surface, this approach may still be fruitful once substantially more patient samples are analyzed. Of special interest is the recent advance in the technology of single-cell profiling of repertoires of B- and T- cell receptors [110], which may help identify target-receptor pairs, once combined with the proteomics data. Using the above approaches, analysis of samples from more PCa patients may be required to capture novel or subtype-specific PCa markers, or to confidently conclude that no such targets beyond the described ones exist, and that combinations of the known targets should be exploited for CAR design.

Acknowledgements

This work was supported by the Russian Ministry of Education and Science (Agreement # 075-15-2019-1246, unique project identifier RFMEFI60417X0169).

The authors report no conflicts of interests.

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["ELEMENT_PREVIEW_PICTURE_FILE_ALT"]=> string(2513) "<p style="text-align: justify;">Несмотря на значительный прогресс в области таргетной, химио- и радиотерапии, количество вариантов для пациентов с метастатическим кастрационно-резистентным раком предстательной железы остается невысоким. Большие надежды возлагались на дендритно-клеточные вакцины, в частности на sipuleucel-T, однако не все пациенты отвечают на этот тип терапии. Учитывая впечатляющий успех CAR T-клеток для лечения онкогематологических заболеваний, многие исследовательские группы начали разработку подходов CAR T-клеточной терапии кастрационно-резистентного рака предстательной железы. Из-за этого особенно актуальным стал вопрос об уникальных белках-мишенях рака простаты для CAR Т-клеточной терапии. В идеале такие белки должны отсутствовать на поверхности нормальных клеток, экспрессироваться на всех раковых клетках у всех пациентов и быть незаменимыми для выживания раковой клетки. На практике, однако, ни один из описанных к настоящему моменту поверхностных белков-маркеров рака простаты не отвечает всем указанным требованиям. 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NULL ["~VALUE"]=> array(3) { [0]=> string(4) "1774" [1]=> string(4) "1775" [2]=> string(4) "1776" } ["~DESCRIPTION"]=> array(3) { [0]=> string(0) "" [1]=> string(0) "" [2]=> string(0) "" } ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> string(0) "" } ["AUTHOR_RU"]=> array(36) { ["ID"]=> string(2) "25" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Авторы" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(9) "AUTHOR_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "25" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24475" ["VALUE"]=> array(2) { ["TEXT"]=> string(202) "<p>Сергей В. Кулемзин<sup>1</sup>, Андрей А. Горчаков<sup>1,2</sup>, Александр В. Таранин<sup>1,2</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(154) "

Сергей В. Кулемзин1, Андрей А. Горчаков1,2, Александр В. Таранин1,2

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_RU"]=> array(36) { ["ID"]=> string(2) "26" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(22) "Организации" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "26" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24476" ["VALUE"]=> array(2) { ["TEXT"]=> string(329) "<p><sup>1</sup> Институт молекулярной и клеточной биологии СО РАН, Новосибирск, Россия<br> <sup>2</sup> Новосибирский государственный университет, Новосибирск, Россия</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(287) "

1 Институт молекулярной и клеточной биологии СО РАН, Новосибирск, Россия
2 Новосибирский государственный университет, Новосибирск, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24477" ["VALUE"]=> array(2) { ["TEXT"]=> string(2513) "<p style="text-align: justify;">Несмотря на значительный прогресс в области таргетной, химио- и радиотерапии, количество вариантов для пациентов с метастатическим кастрационно-резистентным раком предстательной железы остается невысоким. Большие надежды возлагались на дендритно-клеточные вакцины, в частности на sipuleucel-T, однако не все пациенты отвечают на этот тип терапии. Учитывая впечатляющий успех CAR T-клеток для лечения онкогематологических заболеваний, многие исследовательские группы начали разработку подходов CAR T-клеточной терапии кастрационно-резистентного рака предстательной железы. Из-за этого особенно актуальным стал вопрос об уникальных белках-мишенях рака простаты для CAR Т-клеточной терапии. В идеале такие белки должны отсутствовать на поверхности нормальных клеток, экспрессироваться на всех раковых клетках у всех пациентов и быть незаменимыми для выживания раковой клетки. На практике, однако, ни один из описанных к настоящему моменту поверхностных белков-маркеров рака простаты не отвечает всем указанным требованиям. В настоящем обзоре рассмотрены основные белки-мишени для CAR T-клеточной терапии рака простаты, обсуждается их безопасность и потенциальная эффективность.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Метастатический рак предстательной железы, иммунотерапия, химерные антигенные рецепторы, CAR T-клетки. </p> " ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2457) "

Несмотря на значительный прогресс в области таргетной, химио- и радиотерапии, количество вариантов для пациентов с метастатическим кастрационно-резистентным раком предстательной железы остается невысоким. Большие надежды возлагались на дендритно-клеточные вакцины, в частности на sipuleucel-T, однако не все пациенты отвечают на этот тип терапии. Учитывая впечатляющий успех CAR T-клеток для лечения онкогематологических заболеваний, многие исследовательские группы начали разработку подходов CAR T-клеточной терапии кастрационно-резистентного рака предстательной железы. Из-за этого особенно актуальным стал вопрос об уникальных белках-мишенях рака простаты для CAR Т-клеточной терапии. В идеале такие белки должны отсутствовать на поверхности нормальных клеток, экспрессироваться на всех раковых клетках у всех пациентов и быть незаменимыми для выживания раковой клетки. На практике, однако, ни один из описанных к настоящему моменту поверхностных белков-маркеров рака простаты не отвечает всем указанным требованиям. В настоящем обзоре рассмотрены основные белки-мишени для CAR T-клеточной терапии рака простаты, обсуждается их безопасность и потенциальная эффективность.

Ключевые слова

Метастатический рак предстательной железы, иммунотерапия, химерные антигенные рецепторы, CAR T-клетки.

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Sergey V. Kulemzin1, Andrey A. Gorchakov1,2, Aleksandr V. Taranin1,2

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1 Institute of Molecular and Cellular Biology, Siberian Branch of the Russian Academy of Sciences, Novosibirsk, Russia
2 Novosibirsk State University, Novosibirsk, Russia

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Despite the progress achieved in target, chemo-, and radiotherapy, treatment options for patients with late-stage metastatic castration-resistant prostate cancer are presently very limited. Use of dendritic cell-based vaccines exemplified by sipuleucel-T appears is rarely curative and is effective in only a fraction of such patients. Given the success of CAR T cell therapy in the field of B cell malignancies, significant efforts have been made to adapt this powerful technology to the problem of metastatic prostate cancer. Availability of unique prostate cancer surface targets for CAR T cells has thereby become a pressing issue in the field of CAR design. Ideally, such targets should be absent from normal cells or tissues, be present on all prostate cancer cells across all patients, and be indispensable for the survival of cancer cells. In reality, however, none of the prostate cancer-associated surface markers described to date are matching such description. Here, we catalogue the list of tested as well as prospective surface antigens to be used as targets for CAR T cell therapy, and discuss the aspects of their safety and potential efficacy.

Keywords

Metastatic prostate cancer, immunotherapy, chimeric antigen receptor, CAR T cells.

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Kulemzin<sup>1</sup>, Andrey A. Gorchakov<sup>1,2</sup>, Aleksandr V. Taranin<sup>1,2</sup> </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(109) "

Sergey V. Kulemzin1, Andrey A. Gorchakov1,2, Aleksandr V. Taranin1,2

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Sergey V. Kulemzin1, Andrey A. Gorchakov1,2, Aleksandr V. Taranin1,2

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Despite the progress achieved in target, chemo-, and radiotherapy, treatment options for patients with late-stage metastatic castration-resistant prostate cancer are presently very limited. Use of dendritic cell-based vaccines exemplified by sipuleucel-T appears is rarely curative and is effective in only a fraction of such patients. Given the success of CAR T cell therapy in the field of B cell malignancies, significant efforts have been made to adapt this powerful technology to the problem of metastatic prostate cancer. Availability of unique prostate cancer surface targets for CAR T cells has thereby become a pressing issue in the field of CAR design. Ideally, such targets should be absent from normal cells or tissues, be present on all prostate cancer cells across all patients, and be indispensable for the survival of cancer cells. In reality, however, none of the prostate cancer-associated surface markers described to date are matching such description. Here, we catalogue the list of tested as well as prospective surface antigens to be used as targets for CAR T cell therapy, and discuss the aspects of their safety and potential efficacy.

Keywords

Metastatic prostate cancer, immunotherapy, chimeric antigen receptor, CAR T cells.

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Despite the progress achieved in target, chemo-, and radiotherapy, treatment options for patients with late-stage metastatic castration-resistant prostate cancer are presently very limited. Use of dendritic cell-based vaccines exemplified by sipuleucel-T appears is rarely curative and is effective in only a fraction of such patients. Given the success of CAR T cell therapy in the field of B cell malignancies, significant efforts have been made to adapt this powerful technology to the problem of metastatic prostate cancer. Availability of unique prostate cancer surface targets for CAR T cells has thereby become a pressing issue in the field of CAR design. Ideally, such targets should be absent from normal cells or tissues, be present on all prostate cancer cells across all patients, and be indispensable for the survival of cancer cells. In reality, however, none of the prostate cancer-associated surface markers described to date are matching such description. Here, we catalogue the list of tested as well as prospective surface antigens to be used as targets for CAR T cell therapy, and discuss the aspects of their safety and potential efficacy.

Keywords

Metastatic prostate cancer, immunotherapy, chimeric antigen receptor, CAR T cells.

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1 Institute of Molecular and Cellular Biology, Siberian Branch of the Russian Academy of Sciences, Novosibirsk, Russia
2 Novosibirsk State University, Novosibirsk, Russia

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1 Institute of Molecular and Cellular Biology, Siberian Branch of the Russian Academy of Sciences, Novosibirsk, Russia
2 Novosibirsk State University, Novosibirsk, Russia

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Сергей В. Кулемзин1, Андрей А. Горчаков1,2, Александр В. Таранин1,2

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Сергей В. Кулемзин1, Андрей А. Горчаков1,2, Александр В. Таранин1,2

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Большие надежды возлагались на дендритно-клеточные вакцины, в частности на sipuleucel-T, однако не все пациенты отвечают на этот тип терапии. Учитывая впечатляющий успех CAR T-клеток для лечения онкогематологических заболеваний, многие исследовательские группы начали разработку подходов CAR T-клеточной терапии кастрационно-резистентного рака предстательной железы. Из-за этого особенно актуальным стал вопрос об уникальных белках-мишенях рака простаты для CAR Т-клеточной терапии. В идеале такие белки должны отсутствовать на поверхности нормальных клеток, экспрессироваться на всех раковых клетках у всех пациентов и быть незаменимыми для выживания раковой клетки. На практике, однако, ни один из описанных к настоящему моменту поверхностных белков-маркеров рака простаты не отвечает всем указанным требованиям. В настоящем обзоре рассмотрены основные белки-мишени для CAR T-клеточной терапии рака простаты, обсуждается их безопасность и потенциальная эффективность.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Метастатический рак предстательной железы, иммунотерапия, химерные антигенные рецепторы, CAR T-клетки. </p> " ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2457) "

Несмотря на значительный прогресс в области таргетной, химио- и радиотерапии, количество вариантов для пациентов с метастатическим кастрационно-резистентным раком предстательной железы остается невысоким. Большие надежды возлагались на дендритно-клеточные вакцины, в частности на sipuleucel-T, однако не все пациенты отвечают на этот тип терапии. Учитывая впечатляющий успех CAR T-клеток для лечения онкогематологических заболеваний, многие исследовательские группы начали разработку подходов CAR T-клеточной терапии кастрационно-резистентного рака предстательной железы. Из-за этого особенно актуальным стал вопрос об уникальных белках-мишенях рака простаты для CAR Т-клеточной терапии. В идеале такие белки должны отсутствовать на поверхности нормальных клеток, экспрессироваться на всех раковых клетках у всех пациентов и быть незаменимыми для выживания раковой клетки. На практике, однако, ни один из описанных к настоящему моменту поверхностных белков-маркеров рака простаты не отвечает всем указанным требованиям. В настоящем обзоре рассмотрены основные белки-мишени для CAR T-клеточной терапии рака простаты, обсуждается их безопасность и потенциальная эффективность.

Ключевые слова

Метастатический рак предстательной железы, иммунотерапия, химерные антигенные рецепторы, CAR T-клетки.

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(29) "Описание/Резюме" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(2457) "

Несмотря на значительный прогресс в области таргетной, химио- и радиотерапии, количество вариантов для пациентов с метастатическим кастрационно-резистентным раком предстательной железы остается невысоким. Большие надежды возлагались на дендритно-клеточные вакцины, в частности на sipuleucel-T, однако не все пациенты отвечают на этот тип терапии. Учитывая впечатляющий успех CAR T-клеток для лечения онкогематологических заболеваний, многие исследовательские группы начали разработку подходов CAR T-клеточной терапии кастрационно-резистентного рака предстательной железы. Из-за этого особенно актуальным стал вопрос об уникальных белках-мишенях рака простаты для CAR Т-клеточной терапии. В идеале такие белки должны отсутствовать на поверхности нормальных клеток, экспрессироваться на всех раковых клетках у всех пациентов и быть незаменимыми для выживания раковой клетки. На практике, однако, ни один из описанных к настоящему моменту поверхностных белков-маркеров рака простаты не отвечает всем указанным требованиям. В настоящем обзоре рассмотрены основные белки-мишени для CAR T-клеточной терапии рака простаты, обсуждается их безопасность и потенциальная эффективность.

Ключевые слова

Метастатический рак предстательной железы, иммунотерапия, химерные антигенные рецепторы, CAR T-клетки.

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1 Институт молекулярной и клеточной биологии СО РАН, Новосибирск, Россия
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Introduction

Discovery and clinical success of ICIs entered a new era in oncology. The 2018 Nobel Prize in Medicine was awarded to James P. Allison and Tasuku Honjo "for their discovery of cancer therapy by inhibition of negative immune regulation". The principal role of immune system in tumor control was understood long ago. Earlier researchers mostly explored the opportunities to activate the immune system by stimulation of effector cells ("pressing gas pedal"). James P. Allison and Tasuku Honjo demonstrated that inhibition of checkpoints ("releasing the brake pedal") may effectively upregulate the immune system.

The ICIs demonstrate substantial efficiency in cHL. Pembrolizumab was approved for the treatment of children with cHL, but the role of other ICIs in pediatrics should only to be elucidated. Despite impressive progress in oncology, the children with refractory or resistant (R-R) cHL still demonstrate suboptimal prognosis if ≥3 lines of therapies have to be used [1]. This group of R-R cHL patients needs new approaches in management, and ICIs are among the most promising candidate drugs. The discovery of CIs introduced principally novel approach to cancer cure. This may convert cancer to one of chronic diseases [2].

The principal feature of immunity is the ability to differ between autoantigens and alloantigens. But the immune system is not ideal and regularly makes mistakes. These errors are often mild and non-significant but sometimes may lead to serious consequences such as oncological, autoimmune or infectious diseases. Studying molecular mechanisms of antigen procession, presentation, co-stimulation and inhibition is crucial for the treatment of patients with tumors.

PD-1 (programmed cell death-1) gene was discovered during the research of cell apoptosis [3]. It took a long journey to understand the function of PD-1 [2]. In terms of physiological role (immune inhibition) the definition of PD-1 is relatively correct, due to fundamental position of apoptosis in tolerance. But, in general, the term PD-1 does not precisely reflect the function of the protein.

Structurally PD-1 is a transmembrane protein and its interaction with ligands (PD-L1 or PD-L2) results in activation of PD-1/PD-L pathway [4, 5]. This effect leads to downregulation of autoreactive T cells and upregulation of T regulatory cells [6]. Development of autoimmune disorders in the model of PD-1 knockout mice proved significance of the pathway for adequate immune regulation [7]. Excessive PD-1 expression due to continuous antigen stimulation results in T-cell exhaustion and tolerance [8]. This mechanism may be realized in tumors.

PD-1 and ligands are expressed constitutive or inducibly on many tissues. PD-1 is expressed on immune cells (T-helpers, cytotoxic T-lymphocytes, natural killers, B cells, monocytes and dendritic cells) [9]. PD-L1 has extensive distribution throughout the body while PD-L2 is only present on macrophages and dendritic cells. PD-L1 can be expressed on non-hematological structures, such as endothelial cells, fibroblasts, mucous, pancreatic islet cells, astrocytes, neurons, trophoblasts, retina, heart, placenta, skeletal muscle, lung and kidney [10, 11]. Presence of PD-1 on endothelial cells may play an important role in the prevention of T cell migration into tissues and establishment of blood-organ immunological barriers [12]. Both PD-1 and PD-L1 are present on T cells, В-cells, macrophages and dendritic cells. These cells possess bimodal opportunity to regulate and to be regulated by the pathway. Some tumors also have PD-L1 on its surface, and it allows them to be "invisible" to immune system [13]. The expression of PD-1 and ligands is controlled by cytokines. For example, interferon 1 and tumor necrosis factor-α stimulate PD-L1 expression. Theoretically, combining these drugs with inducers of PD-1/PD-L1 may improve the efficiency of ICIs.

Nivo and pembro are PD-1 blocking antibodies that have been approved by the U.S. Food and Drug Administration for the treatment of сHL and some solid tumors. They were also registered in Russian Federation for the management of adult patients (nivo and pembro) and children with сHL (pembro). In the majority of сHL patients, ICIs induce durable clinical response. Complete or partial recovery of tumor immune control results in significant attenuation of disease progression. Amplification of 9p24.1 and subsequent overexpression of PD-L1 seems to be the characteristic feature of HL-specific Reed-Sternberg cells [14]. It explains high efficiency of ICIs in cHL. However, most HL patients relapse after treatment with ICIs. Therefore, it is important to improve the results by shifting to combination therapy, incorporation of ICIs earlier in treatment and consolidation with HSCT [15]. We are only in the beginning of CIs era, and appropriate schemes and schedules are only to be discovered. For example, lower dosage of nivolumab could be comparable to standard dosage of 3 mg/kg biweekly [16].

The aim of our work was to assess safety and effectiveness of nivo in childhood R-R cHL.

Patients and methods

Twenty-one children and adolescents with R-R Hodgkin's lymphoma (HL) received nivo-based therapy in Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation, Pavlov First St. Petersburg State Medical University (see Table 1 for patient´s characteristics). Median age was 16 years (9 to 18). Histological forms of HL were as follows: nodular sclerosis was diagnosed in 15 patients (71%); mixed cellularity cHL, 4 cases (19%), lymphocyte-rich cHL, 1 (5%) and nodular lymphocyte predominant Hodgkin's lymphoma, 1 (5%). At the onset of the disease, the early-stage favorable status was diagnosed in 4 patients (19%); early-stage unfavorable or advanced disease was diagnosed in 17 cases (81%). B-symptoms were documented in 12 patients (67%). Bulky disease (>7 cm) and extranodal lesions were registered in 12 (57%) and 14 (67%) children, respectively. The disease was refractory in 9 cases (43%), whereas resistant or multiple relapses occurred in 12 patients (57%).

Table 1. Patient´s characteristics (n=21)

Kozlov-tab01.jpg

Abbreviations: NSCHL (nodular sclerosis classical Hodgkin lymphoma), MCCHL (mixed cellularity classical Hodgkin lymphoma), NLPHL (nodular lymphocyte predominant Hodgkin's lymphoma), LRCHL (lymphocyte-rich classical Hodgkin lymphoma), OEPA/COPDAC (vincristine, etoposide, prednisolone, doxorubicin/cyclophosphamide, vincristine, prednisolone, dacarbazine), RT (radiotherapy), BEACOPP (bleomycin, etoposide, cytarabine, cyclophosphamide, vincristine, prednisolone, procarbazine), GDP (gemcitabine, dexamethasone, cisplatin), ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine), DHAP (dexamethasone, cisplatin, cytarabine), ChVPP (chlorbutine, vinblastine, prednisolone, procarbazine), IEP/ABVD (ifosfamide, etoposide, prednisolone/doxorubicin, bleomycin, vinblastine, dacarbazine), VIGEPP (vinorelbine, gemcitabine, procarbazine, prednisolone), auto-HSCT (autologous hematopoietic stem cell transplantation), GemOx (gemcitabine, oxaliplatin), ICE (ifosfamide, carboplatin, etoposide), OPPA/COPP (vincristine, prednisolone, procarbazine, doxorubicin/cyclophosphamide, vincristine, prednisolone, procarbazine), IEP (ifosfamide, etoposide, prednisolone), IGEV (ifosfamide, gemcitabine, vinorelbine), COPP (cyclophosphamide, vincristine, prednisolone, procarbazine), CEMP (cyclophosphamide, etoposide, mitoxantron, prednisolone), COPP/ABV (cyclophosphamide, vincristine, prednisolone, procarbazine/doxorubicin, bleomycin, vinblastine), BV (brentuximab vedotin), rel (relapse), ref (refractory), mr (multiple relapses), mono/comb (monotherapy/combination therapy), R/R (relapsed/refractory), CR (complete response), PR (partial response), IR (indeterminate response), N/A – not applicable.

Median number of previous therapy lines was 4 (2-7) with radiation therapy in 14 patients (67%), and autologous HSCT in 6 cases (29%). Prior to nivo therapy, 16 children (76%) had progression; 3 (14%), stabilization, and 2 (10%), partial remission according to Lugano criteria [17]. All the patients received nivo in an outpatient setting. Monotherapy was used in 13 (62%) and combination with other drugs in 8 (38%). In 5 children, combination therapy was indicated, based on opinion of attended physician. In 3 cases, other drugs were added after slow clinical response to the first nivo infusions, aiming to achieve faster clinical improvement. Treatment schedule consisted of 3 mg/kg of nivo biweekly in 11 (52%) or 40 mg of nivo biweekly in 10 (48%). Combinations of nivo with following drugs were used: brentuximab vedotin 1.8 mg/kg triweekly (n=4) with median of 5 cycles (4-7), bendamustine 180 mg/m2 triweekly (n=3) with median of 5 cycles (5-7) and gemcitabine 1000 mg/m2 №5 weekly (n=1). Median number of nivo cycles was 9 (2-28). Response to treatment was evaluated by the LYRIC criteria [18]. They represent modified Lugano recommendations, with the addition of indeterminate response (IR). This category describes possible pseudo-progression and allows to continue ICIs hoping for further best response without discontinuation of treatment in the patients with progressive disease according to previous criterial algorithms. After nivo-based treatment, 8 patients (38%) received auto- or allogeneic hematopoietic stem cell transplantation (HSCT). Conditioning regimen in autologous HSCT (n=4) was BeEAM (bendamustine, etoposide, cytarabine and melphalan). Haploidentical donors were employed in two allo-HSCTs, and two matched related siblings were used in two other cases. The conditioning regimen in allogeneic HSCT consisted of bendamustine 360 mg/m2 and Fludarabine 150 mg/m2. Graft-versus-host disease prophylaxis was based on posttransplant cyclophosphamide and calcineurin inhibitors. Radiation therapy was applied to consolidate the effect of nivo in 2 cases (10%). Eleven patients (52%) did not receive any consolidation treatment.

Results

Clinical response to nivo-based therapy was assessed in 21 patients (100%). Efficiency of treatment is shown in Table 2. Overall response (ORR) was registered in 18 children (86%); CR, in 12 cases (57%); PR, in 6 patients (29%) and IR, in 3 cases (14%). Among the patients with IR, two children relapsed, and one patient is now in remission with the follow-up of 355 days. Monotherapy resulted in ORR of 92% (12 patients); CR, in 62% (8), and PR, in 30% of cases (4). Combination therapy demonstrated similar effectiveness, i.e., ORR, 6 (75%); CR, 4; (50%); PR, 2 (25%).

Table 2. Efficiency of Nivolumab-based therapy

Kozlov-tab02.jpg

The three-year OS rates comprised 95%. PFS rates at 1, 2 and 3 years were 69%, 58% and 29%, respectively (Fig. 1A and 1B). Median OS was not reached. With median follow-up of 391 days (47-1137), twenty patients (95%) were alive, and 14 (67%) remained in remission state. Median PFS was 24 months. Consolidation with HSCT (auto- or allo-) resulted in 3-year PFS of 75% (Fig. 2). Only 1 patient died in early posttransplant period due to infectious complications.

The general scheme of nivo-based therapy (mono- vs combined treatment), cHL stage (early vs advanced), tumor size (bulky+ vs bulky-), B symptoms, extranodal lesions, number of prior chemotherapy lines, preceding autoHSCT, number of nivo infusions (10 vs >10, see Fig. 3), and complications of therapy did not affect OS and PFS (p>0.1).

In the monotherapy group, complications of nivo were revealed in one adolescent (7.7%). This patient developed autoimmune thyroiditis which required hormone replacement therapy. It didn't lead to discontinuation of the drug. In combination therapy group, 2 patients (25%) developed transient cytopenias that could not be attributed solely to nivo and were probably associated with cytostatics.

Kozlov-fig01.jpg

Figure 1. Overall survival (A) and progression-free survival (B) of the patients treated with nivolumab (n=21)

Kozlov-fig02.jpg

Figure 2. Progression-free survival curves with HSCT vs without following HSCT in the patients treated with nivolumab

Figure 3. Progression-free survival curves among the patients treated with nivolumab (≤10 vs >10 infusions).




Discussion

ICIs have demonstrated high efficiency and acceptable safety profile both in adults and children in large cohorts of patients (Tables 3 and 4). Administration of ICIs in adult R-R HL results in overall response (ORR) of 64-82%, with 2-year PFS of approximately 30%-58.5% [1, 19]. The largest pediatric trial with pembro included 125 children. This study clearly demonstrated safety of ICIs in children. Only 7 (6%) had clinically significant adverse effects (grade 3-5). One patient (0.8%) with renal carcinoma experienced pembro-associated pulmonary edema and died.

Table 3. Efficiency of immune checkpoint inhibitors in adult cHL

Kozlov-tab03.jpg

Abbreviations: ORR, overall response rate; CR, complete response; PR, partial response; HSCT, hematopoietic stem cell transplantation; PFS, progression-free survival; N/A, not applicable

Table 4. Efficiency of immune checkpoint inhibitors in pediatric cohorts

Kozlov-tab04.jpg

Abbreviations: HL, Hodgkin's lymphoma; NHL, non- Hodgkin's lymphoma; ORR, overall response rate; CR, complete response; PR, partial response

No major interferences on the developing immune system were observed [20]. Another important trial included children with R-R cHL treated with combination of nivo and brentuximab vedotin. Drug-related complications were registered in 32% (grade 3-4) with neutropenia among the most common. Immune-mediated adverse effects were only grade 1-2 and included rash, hypersensitivity, infusion-related reactions and did not result in discontinuation of therapy [21].

In general, the results of the present study concerning nivo-based therapy in pediatric R-R cHL are in concordance with previously published data in adults and children [22]. Higher rates of CR in children and adolescents (57%) compared to adults (15-36%) may be associated with the differences of response evaluation in these studies, may represent a unique feature of pediatric sensitivity to IСIs or may be explained by limited patient number in the study [23, 24]. Despite similar ORR in mono- and combined therapy arms, the data from other investigators strongly support the opinion that additional drugs improve the effects of nivo [25, 26].

Suboptimal 3-year PFS of 29% in this heavily pretreated group (median number of prior lines – 4) replicates earlier data of CIs administration in adults and children [1, 20]. It is important to note that PFS rates at 1 and 2 years in our study are similar or higher than in above mentioned works and steadily decrease with time. It seems that PFS after nivo does not tend to reach plateau with time.

High ORR (86%) after nivo in R-R cHL solves a challenge of remission induction and bridging to HSCT that is now possible in the majority of children. There is an opinion of principal opportunity of ICIs to cure cHL but declining PFS curve argues it, and longer follow-up is needed to draw firm conclusion. Dissociation between high 3-year OS and low PFS marks a very characteristic feature of ICIs therapy in cHL that repairs immune tumor control and improves somatic status of a patient even in active disease. Slow subclinical progression probably is driven by other non-immune mechanisms of tumor escape. Median PFS in children and adolescents in our study is 24 months and well correlates with data in other publications [20]. Longer median PFS may be explained by combination of nivo with other drugs in 38%. The positive effects of nivo significantly prolong life expectancy with good quality of life. Consolidation of nivo-induced remission with HSCT (auto or allo) results in 3-year PFS of 75%. HSCT is a potential option to improve cure rates after ICIs.

There is no established consensus opinion when to proceed with HSCT after ICIs, and what type of HSCT should be chosen. Allogeneic HSCT may be preferable, due to presumed sensitivity of the patients to immunotherapy. But autologous HSCT still may be effective in chemorefractory cases, since a recovery of chemosensitivity after ICIs treatment is hypothesized [27]. There are investigators that use both allo-HSCT and auto-HSCT to consolidate the ICIs effect [22, 24]. At the same time, an impressively high 3-year OS rate (95%) after nivo in our study, even in patients with progression, questions the need for transplantation at all [28]. Extensive follow-up is required to understand how long this clinical stabilization of cHL will continue in the majority of patients. In other words, can cHL be "cured" with morphologically and visibly obvious tumor, and if these patients may have a near-normal life expectancy similar to heathy people? This proposal seems more fantastic than real, and a longer follow-up is needed to see whether such observations will appear. Despite theoretical importance, the classical prognostic factors did not affect OS and PFS in our study. It may be explained by the domination of chemoresistance in our patients that minimizes the role of all other factors. Higher number of nivo cycles also did not improve outcome in our study. It emphasizes the challenging unsolved problem of optimal nivo treatment duration. Hypothetically, earlier consolidation with HSCT can minimize nivo-associated complications without loss of efficiency.

Only one clinically significant AE of nivo therapy was registered in the study, i.e., autoimmune thyroiditis which is a typical complication of the drug. Other characteristic autoimmune AEs were not encountered, probably due to limited patient number. All children and adolescents received nivo in outpatient setting, thus reflecting high tolerability and technical simplicity of treatment.

Conclusion

Nivo-based therapy is effective in the majority of children and adolescents with R-R cHL. In heavily pretreated patients, long-term PFS remains suboptimal, despite excellent OS levels. Consolidation with HSCT after nivo results in 75% PFS at 3 years and should be considered in the majority of patients. Nivo-based therapy is relatively safe with only one clinically significant adverse effect (autoimmune thyroiditis) observed in our study. Nivo is technically simple and well tolerable treatment that is administered in an outpatient setting.

Conflict of interest

None declared.

References

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Introduction

Discovery and clinical success of ICIs entered a new era in oncology. The 2018 Nobel Prize in Medicine was awarded to James P. Allison and Tasuku Honjo "for their discovery of cancer therapy by inhibition of negative immune regulation". The principal role of immune system in tumor control was understood long ago. Earlier researchers mostly explored the opportunities to activate the immune system by stimulation of effector cells ("pressing gas pedal"). James P. Allison and Tasuku Honjo demonstrated that inhibition of checkpoints ("releasing the brake pedal") may effectively upregulate the immune system.

The ICIs demonstrate substantial efficiency in cHL. Pembrolizumab was approved for the treatment of children with cHL, but the role of other ICIs in pediatrics should only to be elucidated. Despite impressive progress in oncology, the children with refractory or resistant (R-R) cHL still demonstrate suboptimal prognosis if ≥3 lines of therapies have to be used [1]. This group of R-R cHL patients needs new approaches in management, and ICIs are among the most promising candidate drugs. The discovery of CIs introduced principally novel approach to cancer cure. This may convert cancer to one of chronic diseases [2].

The principal feature of immunity is the ability to differ between autoantigens and alloantigens. But the immune system is not ideal and regularly makes mistakes. These errors are often mild and non-significant but sometimes may lead to serious consequences such as oncological, autoimmune or infectious diseases. Studying molecular mechanisms of antigen procession, presentation, co-stimulation and inhibition is crucial for the treatment of patients with tumors.

PD-1 (programmed cell death-1) gene was discovered during the research of cell apoptosis [3]. It took a long journey to understand the function of PD-1 [2]. In terms of physiological role (immune inhibition) the definition of PD-1 is relatively correct, due to fundamental position of apoptosis in tolerance. But, in general, the term PD-1 does not precisely reflect the function of the protein.

Structurally PD-1 is a transmembrane protein and its interaction with ligands (PD-L1 or PD-L2) results in activation of PD-1/PD-L pathway [4, 5]. This effect leads to downregulation of autoreactive T cells and upregulation of T regulatory cells [6]. Development of autoimmune disorders in the model of PD-1 knockout mice proved significance of the pathway for adequate immune regulation [7]. Excessive PD-1 expression due to continuous antigen stimulation results in T-cell exhaustion and tolerance [8]. This mechanism may be realized in tumors.

PD-1 and ligands are expressed constitutive or inducibly on many tissues. PD-1 is expressed on immune cells (T-helpers, cytotoxic T-lymphocytes, natural killers, B cells, monocytes and dendritic cells) [9]. PD-L1 has extensive distribution throughout the body while PD-L2 is only present on macrophages and dendritic cells. PD-L1 can be expressed on non-hematological structures, such as endothelial cells, fibroblasts, mucous, pancreatic islet cells, astrocytes, neurons, trophoblasts, retina, heart, placenta, skeletal muscle, lung and kidney [10, 11]. Presence of PD-1 on endothelial cells may play an important role in the prevention of T cell migration into tissues and establishment of blood-organ immunological barriers [12]. Both PD-1 and PD-L1 are present on T cells, В-cells, macrophages and dendritic cells. These cells possess bimodal opportunity to regulate and to be regulated by the pathway. Some tumors also have PD-L1 on its surface, and it allows them to be "invisible" to immune system [13]. The expression of PD-1 and ligands is controlled by cytokines. For example, interferon 1 and tumor necrosis factor-α stimulate PD-L1 expression. Theoretically, combining these drugs with inducers of PD-1/PD-L1 may improve the efficiency of ICIs.

Nivo and pembro are PD-1 blocking antibodies that have been approved by the U.S. Food and Drug Administration for the treatment of сHL and some solid tumors. They were also registered in Russian Federation for the management of adult patients (nivo and pembro) and children with сHL (pembro). In the majority of сHL patients, ICIs induce durable clinical response. Complete or partial recovery of tumor immune control results in significant attenuation of disease progression. Amplification of 9p24.1 and subsequent overexpression of PD-L1 seems to be the characteristic feature of HL-specific Reed-Sternberg cells [14]. It explains high efficiency of ICIs in cHL. However, most HL patients relapse after treatment with ICIs. Therefore, it is important to improve the results by shifting to combination therapy, incorporation of ICIs earlier in treatment and consolidation with HSCT [15]. We are only in the beginning of CIs era, and appropriate schemes and schedules are only to be discovered. For example, lower dosage of nivolumab could be comparable to standard dosage of 3 mg/kg biweekly [16].

The aim of our work was to assess safety and effectiveness of nivo in childhood R-R cHL.

Patients and methods

Twenty-one children and adolescents with R-R Hodgkin's lymphoma (HL) received nivo-based therapy in Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation, Pavlov First St. Petersburg State Medical University (see Table 1 for patient´s characteristics). Median age was 16 years (9 to 18). Histological forms of HL were as follows: nodular sclerosis was diagnosed in 15 patients (71%); mixed cellularity cHL, 4 cases (19%), lymphocyte-rich cHL, 1 (5%) and nodular lymphocyte predominant Hodgkin's lymphoma, 1 (5%). At the onset of the disease, the early-stage favorable status was diagnosed in 4 patients (19%); early-stage unfavorable or advanced disease was diagnosed in 17 cases (81%). B-symptoms were documented in 12 patients (67%). Bulky disease (>7 cm) and extranodal lesions were registered in 12 (57%) and 14 (67%) children, respectively. The disease was refractory in 9 cases (43%), whereas resistant or multiple relapses occurred in 12 patients (57%).

Table 1. Patient´s characteristics (n=21)

Kozlov-tab01.jpg

Abbreviations: NSCHL (nodular sclerosis classical Hodgkin lymphoma), MCCHL (mixed cellularity classical Hodgkin lymphoma), NLPHL (nodular lymphocyte predominant Hodgkin's lymphoma), LRCHL (lymphocyte-rich classical Hodgkin lymphoma), OEPA/COPDAC (vincristine, etoposide, prednisolone, doxorubicin/cyclophosphamide, vincristine, prednisolone, dacarbazine), RT (radiotherapy), BEACOPP (bleomycin, etoposide, cytarabine, cyclophosphamide, vincristine, prednisolone, procarbazine), GDP (gemcitabine, dexamethasone, cisplatin), ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine), DHAP (dexamethasone, cisplatin, cytarabine), ChVPP (chlorbutine, vinblastine, prednisolone, procarbazine), IEP/ABVD (ifosfamide, etoposide, prednisolone/doxorubicin, bleomycin, vinblastine, dacarbazine), VIGEPP (vinorelbine, gemcitabine, procarbazine, prednisolone), auto-HSCT (autologous hematopoietic stem cell transplantation), GemOx (gemcitabine, oxaliplatin), ICE (ifosfamide, carboplatin, etoposide), OPPA/COPP (vincristine, prednisolone, procarbazine, doxorubicin/cyclophosphamide, vincristine, prednisolone, procarbazine), IEP (ifosfamide, etoposide, prednisolone), IGEV (ifosfamide, gemcitabine, vinorelbine), COPP (cyclophosphamide, vincristine, prednisolone, procarbazine), CEMP (cyclophosphamide, etoposide, mitoxantron, prednisolone), COPP/ABV (cyclophosphamide, vincristine, prednisolone, procarbazine/doxorubicin, bleomycin, vinblastine), BV (brentuximab vedotin), rel (relapse), ref (refractory), mr (multiple relapses), mono/comb (monotherapy/combination therapy), R/R (relapsed/refractory), CR (complete response), PR (partial response), IR (indeterminate response), N/A – not applicable.

Median number of previous therapy lines was 4 (2-7) with radiation therapy in 14 patients (67%), and autologous HSCT in 6 cases (29%). Prior to nivo therapy, 16 children (76%) had progression; 3 (14%), stabilization, and 2 (10%), partial remission according to Lugano criteria [17]. All the patients received nivo in an outpatient setting. Monotherapy was used in 13 (62%) and combination with other drugs in 8 (38%). In 5 children, combination therapy was indicated, based on opinion of attended physician. In 3 cases, other drugs were added after slow clinical response to the first nivo infusions, aiming to achieve faster clinical improvement. Treatment schedule consisted of 3 mg/kg of nivo biweekly in 11 (52%) or 40 mg of nivo biweekly in 10 (48%). Combinations of nivo with following drugs were used: brentuximab vedotin 1.8 mg/kg triweekly (n=4) with median of 5 cycles (4-7), bendamustine 180 mg/m2 triweekly (n=3) with median of 5 cycles (5-7) and gemcitabine 1000 mg/m2 №5 weekly (n=1). Median number of nivo cycles was 9 (2-28). Response to treatment was evaluated by the LYRIC criteria [18]. They represent modified Lugano recommendations, with the addition of indeterminate response (IR). This category describes possible pseudo-progression and allows to continue ICIs hoping for further best response without discontinuation of treatment in the patients with progressive disease according to previous criterial algorithms. After nivo-based treatment, 8 patients (38%) received auto- or allogeneic hematopoietic stem cell transplantation (HSCT). Conditioning regimen in autologous HSCT (n=4) was BeEAM (bendamustine, etoposide, cytarabine and melphalan). Haploidentical donors were employed in two allo-HSCTs, and two matched related siblings were used in two other cases. The conditioning regimen in allogeneic HSCT consisted of bendamustine 360 mg/m2 and Fludarabine 150 mg/m2. Graft-versus-host disease prophylaxis was based on posttransplant cyclophosphamide and calcineurin inhibitors. Radiation therapy was applied to consolidate the effect of nivo in 2 cases (10%). Eleven patients (52%) did not receive any consolidation treatment.

Results

Clinical response to nivo-based therapy was assessed in 21 patients (100%). Efficiency of treatment is shown in Table 2. Overall response (ORR) was registered in 18 children (86%); CR, in 12 cases (57%); PR, in 6 patients (29%) and IR, in 3 cases (14%). Among the patients with IR, two children relapsed, and one patient is now in remission with the follow-up of 355 days. Monotherapy resulted in ORR of 92% (12 patients); CR, in 62% (8), and PR, in 30% of cases (4). Combination therapy demonstrated similar effectiveness, i.e., ORR, 6 (75%); CR, 4; (50%); PR, 2 (25%).

Table 2. Efficiency of Nivolumab-based therapy

Kozlov-tab02.jpg

The three-year OS rates comprised 95%. PFS rates at 1, 2 and 3 years were 69%, 58% and 29%, respectively (Fig. 1A and 1B). Median OS was not reached. With median follow-up of 391 days (47-1137), twenty patients (95%) were alive, and 14 (67%) remained in remission state. Median PFS was 24 months. Consolidation with HSCT (auto- or allo-) resulted in 3-year PFS of 75% (Fig. 2). Only 1 patient died in early posttransplant period due to infectious complications.

The general scheme of nivo-based therapy (mono- vs combined treatment), cHL stage (early vs advanced), tumor size (bulky+ vs bulky-), B symptoms, extranodal lesions, number of prior chemotherapy lines, preceding autoHSCT, number of nivo infusions (10 vs >10, see Fig. 3), and complications of therapy did not affect OS and PFS (p>0.1).

In the monotherapy group, complications of nivo were revealed in one adolescent (7.7%). This patient developed autoimmune thyroiditis which required hormone replacement therapy. It didn't lead to discontinuation of the drug. In combination therapy group, 2 patients (25%) developed transient cytopenias that could not be attributed solely to nivo and were probably associated with cytostatics.

Kozlov-fig01.jpg

Figure 1. Overall survival (A) and progression-free survival (B) of the patients treated with nivolumab (n=21)

Kozlov-fig02.jpg

Figure 2. Progression-free survival curves with HSCT vs without following HSCT in the patients treated with nivolumab

Figure 3. Progression-free survival curves among the patients treated with nivolumab (≤10 vs >10 infusions).




Discussion

ICIs have demonstrated high efficiency and acceptable safety profile both in adults and children in large cohorts of patients (Tables 3 and 4). Administration of ICIs in adult R-R HL results in overall response (ORR) of 64-82%, with 2-year PFS of approximately 30%-58.5% [1, 19]. The largest pediatric trial with pembro included 125 children. This study clearly demonstrated safety of ICIs in children. Only 7 (6%) had clinically significant adverse effects (grade 3-5). One patient (0.8%) with renal carcinoma experienced pembro-associated pulmonary edema and died.

Table 3. Efficiency of immune checkpoint inhibitors in adult cHL

Kozlov-tab03.jpg

Abbreviations: ORR, overall response rate; CR, complete response; PR, partial response; HSCT, hematopoietic stem cell transplantation; PFS, progression-free survival; N/A, not applicable

Table 4. Efficiency of immune checkpoint inhibitors in pediatric cohorts

Kozlov-tab04.jpg

Abbreviations: HL, Hodgkin's lymphoma; NHL, non- Hodgkin's lymphoma; ORR, overall response rate; CR, complete response; PR, partial response

No major interferences on the developing immune system were observed [20]. Another important trial included children with R-R cHL treated with combination of nivo and brentuximab vedotin. Drug-related complications were registered in 32% (grade 3-4) with neutropenia among the most common. Immune-mediated adverse effects were only grade 1-2 and included rash, hypersensitivity, infusion-related reactions and did not result in discontinuation of therapy [21].

In general, the results of the present study concerning nivo-based therapy in pediatric R-R cHL are in concordance with previously published data in adults and children [22]. Higher rates of CR in children and adolescents (57%) compared to adults (15-36%) may be associated with the differences of response evaluation in these studies, may represent a unique feature of pediatric sensitivity to IСIs or may be explained by limited patient number in the study [23, 24]. Despite similar ORR in mono- and combined therapy arms, the data from other investigators strongly support the opinion that additional drugs improve the effects of nivo [25, 26].

Suboptimal 3-year PFS of 29% in this heavily pretreated group (median number of prior lines – 4) replicates earlier data of CIs administration in adults and children [1, 20]. It is important to note that PFS rates at 1 and 2 years in our study are similar or higher than in above mentioned works and steadily decrease with time. It seems that PFS after nivo does not tend to reach plateau with time.

High ORR (86%) after nivo in R-R cHL solves a challenge of remission induction and bridging to HSCT that is now possible in the majority of children. There is an opinion of principal opportunity of ICIs to cure cHL but declining PFS curve argues it, and longer follow-up is needed to draw firm conclusion. Dissociation between high 3-year OS and low PFS marks a very characteristic feature of ICIs therapy in cHL that repairs immune tumor control and improves somatic status of a patient even in active disease. Slow subclinical progression probably is driven by other non-immune mechanisms of tumor escape. Median PFS in children and adolescents in our study is 24 months and well correlates with data in other publications [20]. Longer median PFS may be explained by combination of nivo with other drugs in 38%. The positive effects of nivo significantly prolong life expectancy with good quality of life. Consolidation of nivo-induced remission with HSCT (auto or allo) results in 3-year PFS of 75%. HSCT is a potential option to improve cure rates after ICIs.

There is no established consensus opinion when to proceed with HSCT after ICIs, and what type of HSCT should be chosen. Allogeneic HSCT may be preferable, due to presumed sensitivity of the patients to immunotherapy. But autologous HSCT still may be effective in chemorefractory cases, since a recovery of chemosensitivity after ICIs treatment is hypothesized [27]. There are investigators that use both allo-HSCT and auto-HSCT to consolidate the ICIs effect [22, 24]. At the same time, an impressively high 3-year OS rate (95%) after nivo in our study, even in patients with progression, questions the need for transplantation at all [28]. Extensive follow-up is required to understand how long this clinical stabilization of cHL will continue in the majority of patients. In other words, can cHL be "cured" with morphologically and visibly obvious tumor, and if these patients may have a near-normal life expectancy similar to heathy people? This proposal seems more fantastic than real, and a longer follow-up is needed to see whether such observations will appear. Despite theoretical importance, the classical prognostic factors did not affect OS and PFS in our study. It may be explained by the domination of chemoresistance in our patients that minimizes the role of all other factors. Higher number of nivo cycles also did not improve outcome in our study. It emphasizes the challenging unsolved problem of optimal nivo treatment duration. Hypothetically, earlier consolidation with HSCT can minimize nivo-associated complications without loss of efficiency.

Only one clinically significant AE of nivo therapy was registered in the study, i.e., autoimmune thyroiditis which is a typical complication of the drug. Other characteristic autoimmune AEs were not encountered, probably due to limited patient number. All children and adolescents received nivo in outpatient setting, thus reflecting high tolerability and technical simplicity of treatment.

Conclusion

Nivo-based therapy is effective in the majority of children and adolescents with R-R cHL. In heavily pretreated patients, long-term PFS remains suboptimal, despite excellent OS levels. Consolidation with HSCT after nivo results in 75% PFS at 3 years and should be considered in the majority of patients. Nivo-based therapy is relatively safe with only one clinically significant adverse effect (autoimmune thyroiditis) observed in our study. Nivo is technically simple and well tolerable treatment that is administered in an outpatient setting.

Conflict of interest

None declared.

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string(19) "2015-09-03 10:45:07" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Авторы" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(7) "AUTHORS" ["DEFAULT_VALUE"]=> string(0) "" ["PROPERTY_TYPE"]=> string(1) "E" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "Y" ["XML_ID"]=> string(2) "24" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "3" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "Y" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(13) "EAutocomplete" ["USER_TYPE_SETTINGS"]=> array(9) { ["VIEW"]=> string(1) "E" ["SHOW_ADD"]=> string(1) "Y" ["MAX_WIDTH"]=> int(0) ["MIN_HEIGHT"]=> int(24) ["MAX_HEIGHT"]=> int(1000) ["BAN_SYM"]=> string(2) ",;" ["REP_SYM"]=> string(1) " " ["OTHER_REP_SYM"]=> string(0) "" ["IBLOCK_MESS"]=> string(1) "N" } 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string(0) "" [5]=> string(0) "" [6]=> string(0) "" [7]=> string(0) "" [8]=> string(0) "" [9]=> string(0) "" [10]=> string(0) "" [11]=> string(0) "" [12]=> string(0) "" [13]=> string(0) "" [14]=> string(0) "" [15]=> string(0) "" [16]=> string(0) "" } ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(17) { [0]=> string(3) "133" [1]=> string(3) "166" [2]=> string(3) "167" [3]=> string(4) "1784" [4]=> string(4) "1785" [5]=> string(3) "165" [6]=> string(4) "1786" [7]=> string(3) "259" [8]=> string(4) "1068" [9]=> string(4) "1787" [10]=> string(4) "1788" [11]=> string(3) "546" [12]=> string(3) "147" [13]=> string(3) "169" [14]=> string(3) "224" [15]=> string(2) "42" [16]=> string(2) "34" } ["~DESCRIPTION"]=> array(17) { [0]=> string(0) "" [1]=> string(0) "" [2]=> string(0) "" [3]=> string(0) "" [4]=> string(0) "" [5]=> string(0) "" [6]=> string(0) "" [7]=> string(0) "" [8]=> string(0) "" [9]=> string(0) "" [10]=> string(0) "" [11]=> string(0) "" [12]=> string(0) "" [13]=> string(0) "" [14]=> string(0) "" [15]=> string(0) "" [16]=> string(0) "" } ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> string(0) "" } ["AUTHOR_RU"]=> array(36) { ["ID"]=> string(2) "25" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Авторы" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(9) "AUTHOR_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "25" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" 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Козлов, Илья В. Казанцев, Татьяна В. Юхта, Полина С. Толкунова, Дарья А. Звягинцева, Асмик Г. Геворгян, Антон В. Малородов, Кирилл В. Лепик, Юрий Р. Залялов, Александр Н. Швецов, Анна В. Ботина, Вадим В. Байков, Елена В. Морозова, Юрий А. Пунанов, Наталья Б. Михайлова, Людмила С. Зубаровская, Борис В. Афанасьев</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(568) "

Андрей В. Козлов, Илья В. Казанцев, Татьяна В. Юхта, Полина С. Толкунова, Дарья А. Звягинцева, Асмик Г. Геворгян, Антон В. Малородов, Кирилл В. Лепик, Юрий Р. Залялов, Александр Н. Швецов, Анна В. Ботина, Вадим В. Байков, Елена В. Морозова, Юрий А. Пунанов, Наталья Б. Михайлова, Людмила С. Зубаровская, Борис В. Афанасьев

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_RU"]=> array(36) { ["ID"]=> string(2) "26" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(22) "Организации" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "26" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24863" ["VALUE"]=> array(2) { ["TEXT"]=> string(368) "<p>НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(356) "

НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24864" ["VALUE"]=> array(2) { ["TEXT"]=> string(1931) "<p style="text-align: justify;">Ингибиторы контрольных точек показали высокую эффективность в лечении классической лимфомы Ходжкина (кЛХ). Пембролизумаб одобрен для применения у детей. Назначение данного препарата приводит к высокой частоте ответа на терапию и является относительно безопасным. Роль ниволумаба у детей с кЛХ еще только предстоит определить. Целями представленной работы были оценка эффективности и оценка побочных эффектов у детей с рецидивирующим и рефрактерным течением кЛХ. Терапия на основе ниволумаба была проведена у 21-го предлеченного пациента (9-18 лет) с кЛХ. Общий ответ отмечался у 86 % (полный ответ – 57% и частичный ответ – 29%). Трехлетняя общая выживаемость и выживаемость без прогрессирования составили 95% и 29%, соответственно. Отмечалось только одно клинически значимое осложнение ниволумаба (аутоиммунный тиреоидит). Не было зарегистрировано тяжелых побочных явлений проводимой терапии.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Лимфома Ходжкина, рецидивирующая, рефрактерное течение, дети, ниволумаб.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1875) "

Ингибиторы контрольных точек показали высокую эффективность в лечении классической лимфомы Ходжкина (кЛХ). Пембролизумаб одобрен для применения у детей. Назначение данного препарата приводит к высокой частоте ответа на терапию и является относительно безопасным. Роль ниволумаба у детей с кЛХ еще только предстоит определить. Целями представленной работы были оценка эффективности и оценка побочных эффектов у детей с рецидивирующим и рефрактерным течением кЛХ. Терапия на основе ниволумаба была проведена у 21-го предлеченного пациента (9-18 лет) с кЛХ. Общий ответ отмечался у 86 % (полный ответ – 57% и частичный ответ – 29%). Трехлетняя общая выживаемость и выживаемость без прогрессирования составили 95% и 29%, соответственно. Отмечалось только одно клинически значимое осложнение ниволумаба (аутоиммунный тиреоидит). Не было зарегистрировано тяжелых побочных явлений проводимой терапии.

Ключевые слова

Лимфома Ходжкина, рецидивирующая, рефрактерное течение, дети, ниволумаб.

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Andrey V. Kozlov, Ilya V. Kazantzev, Tatyana V. Iukhta, Polina S. Tolkunova, Darya A. Zvyagintseva, Asmik G. Gevorgian, Anton V. Malorodov, Kirill V. Lepik, Yury R. Zalyalov, Alexander N. Shvetsov, Anna V. Botina, Vadim V. Baykov, Elena V. Morozova, Yury A. Punanov, Natalya B. Mikhailova, Ludmila S. Zubarovskaya, Boris V. Afanasyev

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Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia

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Keywords

Children, Hodgkin's lymphoma, relapsed, refractory, nivolumab.

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Kozlov, Ilya V. Kazantzev, Tatyana V. Iukhta, Polina S. Tolkunova, Darya A. Zvyagintseva, Asmik G. Gevorgian, Anton V. Malorodov, Kirill V. Lepik, Yury R. Zalyalov, Alexander N. Shvetsov, Anna V. Botina, Vadim V. Baykov, Elena V. Morozova, Yury A. Punanov, Natalya B. Mikhailova, Ludmila S. Zubarovskaya, Boris V. Afanasyev</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(340) "

Andrey V. Kozlov, Ilya V. Kazantzev, Tatyana V. Iukhta, Polina S. Tolkunova, Darya A. Zvyagintseva, Asmik G. Gevorgian, Anton V. Malorodov, Kirill V. Lepik, Yury R. Zalyalov, Alexander N. Shvetsov, Anna V. Botina, Vadim V. Baykov, Elena V. Morozova, Yury A. Punanov, Natalya B. Mikhailova, Ludmila S. Zubarovskaya, Boris V. Afanasyev

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Andrey V. Kozlov, Ilya V. Kazantzev, Tatyana V. Iukhta, Polina S. Tolkunova, Darya A. Zvyagintseva, Asmik G. Gevorgian, Anton V. Malorodov, Kirill V. Lepik, Yury R. Zalyalov, Alexander N. Shvetsov, Anna V. Botina, Vadim V. Baykov, Elena V. Morozova, Yury A. Punanov, Natalya B. Mikhailova, Ludmila S. Zubarovskaya, Boris V. Afanasyev

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Immune checkpoint inhibitors (ICIs) are rather efficient in classical Hodgkin's lymphoma (cHL). Pembrolizumab (pembro) is approved in children and demonstrates high response rates with acceptable toxicity. The role of nivolumab (nivo) in pediatric cHL is only to be elucidated. The aim of the presented study was to assess safety and efficiency of nivo in this age group with relapsed or refractory (R-R) cHL. Twenty-one pediatric heavily pre-treated patients 9-18 years old received nivo-based therapy. Overall response was registered in 86% (complete response – 57% and partial response – 29%). Three-year overall survival (OS) and progression free survival (PFS) were 95% and 29%, respectively. Only 1 clinically significant adverse effect (AE) of nivo was registered in the study (autoimmune thyroiditis). We did not observe any unacceptable toxicity of nivo.

Keywords

Children, Hodgkin's lymphoma, relapsed, refractory, nivolumab.

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Immune checkpoint inhibitors (ICIs) are rather efficient in classical Hodgkin's lymphoma (cHL). Pembrolizumab (pembro) is approved in children and demonstrates high response rates with acceptable toxicity. The role of nivolumab (nivo) in pediatric cHL is only to be elucidated. The aim of the presented study was to assess safety and efficiency of nivo in this age group with relapsed or refractory (R-R) cHL. Twenty-one pediatric heavily pre-treated patients 9-18 years old received nivo-based therapy. Overall response was registered in 86% (complete response – 57% and partial response – 29%). Three-year overall survival (OS) and progression free survival (PFS) were 95% and 29%, respectively. Only 1 clinically significant adverse effect (AE) of nivo was registered in the study (autoimmune thyroiditis). We did not observe any unacceptable toxicity of nivo.

Keywords

Children, Hodgkin's lymphoma, relapsed, refractory, nivolumab.

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Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia

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Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia

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Козлов, Илья В. Казанцев, Татьяна В. Юхта, Полина С. Толкунова, Дарья А. Звягинцева, Асмик Г. Геворгян, Антон В. Малородов, Кирилл В. Лепик, Юрий Р. Залялов, Александр Н. Швецов, Анна В. Ботина, Вадим В. Байков, Елена В. Морозова, Юрий А. Пунанов, Наталья Б. Михайлова, Людмила С. Зубаровская, Борис В. Афанасьев</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(568) "

Андрей В. Козлов, Илья В. Казанцев, Татьяна В. Юхта, Полина С. Толкунова, Дарья А. Звягинцева, Асмик Г. Геворгян, Антон В. Малородов, Кирилл В. Лепик, Юрий Р. Залялов, Александр Н. Швецов, Анна В. Ботина, Вадим В. Байков, Елена В. Морозова, Юрий А. Пунанов, Наталья Б. Михайлова, Людмила С. Зубаровская, Борис В. Афанасьев

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Андрей В. Козлов, Илья В. Казанцев, Татьяна В. Юхта, Полина С. Толкунова, Дарья А. Звягинцева, Асмик Г. Геворгян, Антон В. Малородов, Кирилл В. Лепик, Юрий Р. Залялов, Александр Н. Швецов, Анна В. Ботина, Вадим В. Байков, Елена В. Морозова, Юрий А. Пунанов, Наталья Б. Михайлова, Людмила С. Зубаровская, Борис В. Афанасьев

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Пембролизумаб одобрен для применения у детей. Назначение данного препарата приводит к высокой частоте ответа на терапию и является относительно безопасным. Роль ниволумаба у детей с кЛХ еще только предстоит определить. Целями представленной работы были оценка эффективности и оценка побочных эффектов у детей с рецидивирующим и рефрактерным течением кЛХ. Терапия на основе ниволумаба была проведена у 21-го предлеченного пациента (9-18 лет) с кЛХ. Общий ответ отмечался у 86 % (полный ответ – 57% и частичный ответ – 29%). Трехлетняя общая выживаемость и выживаемость без прогрессирования составили 95% и 29%, соответственно. Отмечалось только одно клинически значимое осложнение ниволумаба (аутоиммунный тиреоидит). Не было зарегистрировано тяжелых побочных явлений проводимой терапии.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Лимфома Ходжкина, рецидивирующая, рефрактерное течение, дети, ниволумаб.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1875) "

Ингибиторы контрольных точек показали высокую эффективность в лечении классической лимфомы Ходжкина (кЛХ). Пембролизумаб одобрен для применения у детей. Назначение данного препарата приводит к высокой частоте ответа на терапию и является относительно безопасным. Роль ниволумаба у детей с кЛХ еще только предстоит определить. Целями представленной работы были оценка эффективности и оценка побочных эффектов у детей с рецидивирующим и рефрактерным течением кЛХ. Терапия на основе ниволумаба была проведена у 21-го предлеченного пациента (9-18 лет) с кЛХ. Общий ответ отмечался у 86 % (полный ответ – 57% и частичный ответ – 29%). Трехлетняя общая выживаемость и выживаемость без прогрессирования составили 95% и 29%, соответственно. Отмечалось только одно клинически значимое осложнение ниволумаба (аутоиммунный тиреоидит). Не было зарегистрировано тяжелых побочных явлений проводимой терапии.

Ключевые слова

Лимфома Ходжкина, рецидивирующая, рефрактерное течение, дети, ниволумаб.

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Ингибиторы контрольных точек показали высокую эффективность в лечении классической лимфомы Ходжкина (кЛХ). Пембролизумаб одобрен для применения у детей. Назначение данного препарата приводит к высокой частоте ответа на терапию и является относительно безопасным. Роль ниволумаба у детей с кЛХ еще только предстоит определить. Целями представленной работы были оценка эффективности и оценка побочных эффектов у детей с рецидивирующим и рефрактерным течением кЛХ. Терапия на основе ниволумаба была проведена у 21-го предлеченного пациента (9-18 лет) с кЛХ. Общий ответ отмечался у 86 % (полный ответ – 57% и частичный ответ – 29%). Трехлетняя общая выживаемость и выживаемость без прогрессирования составили 95% и 29%, соответственно. Отмечалось только одно клинически значимое осложнение ниволумаба (аутоиммунный тиреоидит). Не было зарегистрировано тяжелых побочных явлений проводимой терапии.

Ключевые слова

Лимфома Ходжкина, рецидивирующая, рефрактерное течение, дети, ниволумаб.

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НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

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НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

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Introduction

Allogeneic transplantation of hematopoietic stem cells (allo-HSCT) is among superior advances in treatment of children with hematological and inherited disorders [1]. Improvement of treatment protocols based on the balanced intensification of chemotherapy (ChT) provides an increase in long-term survival of the children with acute myeloid leukemia (AML) to 70%, and acute lymphoblastic leukemia (ALL) in 90% of the cases. Chemotherapy followed by allogeneic HSCT is one of the most effective treatment methods remaining an integral part of programmed therapy for high-risk pediatric AML and ALL [2]. Relapse of acute leukemia remains a main indication for allo-HSCT, due to sufficient worsening of prognosis [17].

Along with high-risk acute leukemia in children, allo-HSCT is the only method of treatment in myelodysplastic syndrome (MDS), including juvenile myelo-monocytic leukemia (JMML) (14). Chronic myeloid leukemia (CML) deserves special indications, i.e., in cases of lost therapeutic response, intolerance to tirosine kinase inhibitors (TKI), or mutations associated with TKI resistance permit us to consider allo-HSCT a therapeutic option, due to high efficiency and individual indication strategy.

Allo-HSCT performance is accompanied by some serious complications associated with conditioning regimens, non-engraftment or graft hypofunction, and especially with relapses. Post-transplant relapse remains the most serious issue, being the main cause of mortality in these patients [1, 2, 9, 12]. Frequency of leukemia relapses after allo-HSCT is from 10 to 70% [1, 3, 4]. Prognosis for relapsing patients posttransplant is dismal, and the patients are planned for salvage therapy requiring personalized treatment approach [2]. Among possible therapies applicable after allo-HSCT, one may consider re-transplantation, the use of target and immunotherapy drugs. However, their efficiency of these options has not proven in randomized trials. Nevertheless, the reported experience of different centers is of sufficient interest for taking strategic clinical decisions. The range of problems associated with re-transplantation due to relapse is as follows – to date, the optimal timing for 2nd HSCT are not yet determined; there is no clear opinion on the graft source (bone marrow or peripheral stem cells), and donor characteristics (HLA matching, gender, age), as well as conditioning regimens, GVHD prophylaxis, subsequent therapies.

A retrospective analysis was performed at the R. M. Gorbacheva Memorial Research Institute for Children Oncology, Hematology and Transplantation concerning 50 pediatric patients with different malignant hematological diseases who were subjected to repeated allo-HSCT due to relapse or progression, primary or secondary non-engraftment. The aim of our study was to evaluate efficiency of 2nd allo-HSCT in the patients with acute leukemias, MDS, JMML, and CML in cases of evolving clinical relapse, or associated complications occurring after the 1st allo-HSCT.

Materials and methods

Table 1. Clinical characteristics of pediatric patients considered for 2nd allo-HSCT

Kozhokar-tab01.jpg

Abbreviations: BU, Busulfan; Treo, Treosulfan; Flu, Fludarabine; Cy, Cyclophosphamide; GIAC, Bu, Ara-C, CCNU, Cy; MAC, myeloablative conditioning, RIC, reduced-intensity conditioning.

The study included 50 children with a median age of 18 years (1 to 18 y.o.) subjected to 2nd allo-HSCT at our BMT clinic from 2007 to 2018. Their primary diagnoses were as follows: ALL, 24 patients; AML, 15 cases; mixed-phenotype AML, 2 patients; JMML, 6 patients; CML, 1 patient. Relapse of the primary disease was the most common indication for 2nd allo-HSCT was diagnosed in 36 cases (72%). Other indications for 2nd HSCT were as follows: primary non-engraftment in 11 patients (22%); secondary non-engraftment in 2 patients (4%); graft hypofunction in one case (2%) in presence of resistant/refractory clinical course. The disease characteristics and parameters of the 1st HSCT are presented in Table 1.

For 40% of the patients (n=20), unrelated HLA-matched donors were chosen for allo-HSCT; matched related donor was used in 15 cases (30%); haploidentical graft was used in 14 cases (28%); autologous HSCT was carried out in 1 patient (2%). At the time of 1st HSCT, myeloablative busulfan-containing regimen (MAC) was applied in 34 patients (68%). Dependent on the stage of disease, 16 patients (32%) achieved 1st complete hematological remission (CR); 2nd or 3rd CR was registered in 18 cases (36%). Sixteen patients (32%) were in resistant relapse state, or showed primary resistance.

Median duration of remission after the 1st allo-HSCT was 148 days (31 to 1084 days). Donor lymphocyte infusions (DLI) were performed in 20 patients after 1st allo-HSCT, for relapse prophylaxis. Of them, 17 children (85%) received the therapy due to minimal residual disease (MRD) or clinical relapse, and 3 patients (15%), due to graft hypofunction. The DLI proved to be ineffective in all these patients, thus being indicative for 2nd allo-HSCT.

The patients with progression or relapse after 1st HSCT (n=38), have received cytoreductive therapy before 2nd allo-HSCT by the following schedules:
• chemotherapy (ChT) in 24 patients using FLAG protocol, or ALL-REZ BFM 2002, and AML-BFM 2004 chemotherapy blocks;
• targeted drugs (hypomethylating agents or monoclonal antibodies), in 7 patients;
• combined application of ChT and targeted drugs (hypomethylating or monoclonal antibodies) in 7 cases.

In 10 patients of 38 who underwent ChT or targeted treatment, a remission of the disease was achieved; in 12 cases, cytoreduction was observed (marrow blast count reduction to 20%). In 16 patients, stabilization or progression of the disease was registered.

Ten patients with aplasia of hematopoiesis due to primary non-engraftment, 2 patients with secondary rejection, and 1 patient with severe graft hypofunction did not receive additional therapy. Clinical characteristics of the patients subjected to 2nd allo-HSCT are shown in Table 2.

Table 2. Clinical characteristics of the patients who underwent 2nd HSCT

Kozhokar-tab02.jpg

Abbreviations: BU, Busulfan; Treo, Treosulfan; Flu, Fludarabine; Cy, Cyclophosphamide; GIAC: Bu, Ara-C, CCNU, Cy; MAC, myeloablative conditioning, RIC, reduced-intensity conditioning; HSCs, hematopoietic stem cells; PBSC, peripheral blood stem cells.

The median time-lag between 1st and 2nd HSCT was 7.5 months. In majority of patients (n=41), the donors were changed to haploidentical HSCs donor. In 9 recipients, allo-HSCT was performed from the same donors, i.e., haploidentical transplants in 3 cases; unrelated grafts in 4 patients, and related matched donors were used in 2 cases. For 2nd allo-HSCT, the reduced-intensity conditioning regimens (RIC) were chosen for 40 patients, due to heavy pre-treatment and severe condition of the patients. Myeloablative conditioning was performed in 10 cases, because of high blast cell counts in bone marrow. Combined prophylaxis of acute graft-versus-host disease (GvHD) after 2nd allo-HSCT was based on the following immune suppression therapy, i.e., tacrolimus-based prophylaxis was administered to 38 patients; mTOR inhibitors were used in 31 cases; cyclosporine-A-based was applied in 7 patients. In 31 cases, GvHD prophylaxis was performed with cyclophosphamide (50 mg/kg) on D+3 and D+4 posttransplant. Antithymocyte globulin (ATG) was used for GVHD prophylaxis in 11 cases. Monotherapy with calcineurin inhibitors was applied in 7 children.

The Kaplan-Meier estimates were used to assess probability of OS (overall survival) and RFS (relapse-free survival). OS was defined as number of months from the date of 2nd allo-HSCT to the date of death. RFS defined as number of months from the date of 2nd allo-HSCT to the date of first documented relapse or progression. Cumulative incidence was used to estimate the probability of transplant-related mortality (TRM) and relapse. For TRM, the relapse was considered a competing event. These estimates are provided with 95% confidence intervals (CI). We didn’t perform any multivariate analysis, because of relatively small number of patients.

Results

Clinical engraftment after 2nd HSCT was registered in 44 patients (88% of total), with a median of neutrophil recovery of >500/mcL on D+21 (12 to 41), and documented clinical hematological remission. Primary non-engraftment was registered in 6 patients, including 4 cases with progression of the disease. The median observation term was 3 years 7 months (9 months to 10 years). Overall survival (OS) rate in the total group was 48% (Fig. 1), with relapse-free survival (RFS) of 60% (Fig. 3). OS among ALL patients was 46.2%; among the children with AML, 53.3%; for the group with myeloproliferative disorders (MDS, CML, JMML), 44.4%, as seen from Fig. 1.

OS among the patients with remission or cytoreduction achieved before 2nd allo-HSCT proved to be, respectively, 73.6% и 50%. Meanwhile, OS values in the patients who did not respond to the therapy, on in absence of remission (active disease) comprised only 17.6% (р=0.006), as shown in Fig. 2.

We could not demonstrate any significant difference in OS between the cases with remission of <5 months, and >5 months after 1st HSCT (respectively, 41.2% and 42.9%, p=0.7), based on median duration of the remission. Similarly, change of donor at the 2nd HSCT did not result into significant OS changes (50% versus 47%, p=0.4). Moreover, no statistically significant difference was obtained for the groups who received RIC or MAC conditioning (47% versus 50%, p=0.6).

Kozhokar-fig01.jpg

Figure 1. Five-year OS after 2nd allo-HSCT in the entire cohort (A); in patients with ALL (B); in patients with AML (C); in MPD cases (D) after 2nd allo-HSCT

Abscissa, months after allo-HSCT, ordinate, cumulative survival.

Kozhokar-fig02.jpg

Figure 2. Overall survival in the patients with different status prior to 2nd allo-HSCT (red graph, remission; green, cytoreduction; blue curve, no response)

Abscissa, terms after 2nd HSCT, months; ordinate cumulative survival.

Figure 3. Relapse-free survival in the entire group of patients after 2nd allo-HSCT

Abscissa, terms after 2nd HSCT, months; ordinate cumulative survival.





The study also concerned possible effects of acute or chronic GvHD upon OS levels. The 5-year OS in the patients (remission – 18 pts, cytoreduction – 12 pts, progression – 11 pts) who developed acute GVHD grade II-III was 63.6% (n=33), as compared to 9.1% (n=11) among GvHD-free cases (р=0.001). Meanwhile, the 5-year OS rate among patients with mild or moderate chronic GvHD reached 72.4% (n=29) when compared to the cases without chronic GvHD 14.3%, (n=7), p<0.0001).

From patients with high risk of relapse after 2nd allo-HSCT, 9 patients without acute or chronic GvHD were subjected to immunoadoptive therapy, i.e., infusion of donor lymphocytes (DLI), aiming to prevent potential relapse. Maintenance therapy was performed in 13 patients using 6-MP (mercaptopurine), hypomethylating agents (HMa) (5-azacytidine, dacogen), tyrosine kinase inhibitors (TKI). In summary, for the group of patients (n=13) who did not receive any prophylaxis (DLI) or supporting therapy (6-MP, HMa or TKI) after 2nd all-HSCT, due to acute or chronic GvHD OS 84.6%, (p=0.089).

Overall survival was 55.6% among the patients treated with DLI only. In the patients on maintenance therapy, the OS values proved to be 46.2%. In 9 cases of molecular recurrence (MRD, molecular or cytogenetic relapse) combined therapy was performed, i.e., chemotherapy, HMa (5-azacytidine, dacogen) and DLI, with OS of 22.2% (p=0.089).

We have analyzed the frequency of complications during early posttransplant period (D+100). The following toxic conditions were observed: severe mucositis (grade 3-4) was documented in 54% of cases (n=26); thrombotic microangiopathy, 22% (n=11); veno-occlusive disease, 16% (n=8); neurotoxicity, 16% (n=8). Among infectious complications, we observed cytomegalovirus reactivation (52%, n=26); SIRS syndrome, including sepsis, 44% (n=22); invasive mycoses, 18% (n=9).

Kozhokar-fig04.jpg

Figure 4. Effects of 2 competing events upon general mortality after 2nd HSCT, i.e., (1) cumulative relapse rate (34%; 95%CI, 21.6%-48%), and (2) TRM rate (18%; 95%CI, 8.8-29.8%)

Relapse or progression of disease remained the main cause of mortality after 2nd allo-HSCT (65%, n=17). The median time of the relapse development in these patients comprises 58 days.

Transplant-related mortality in this group was 18%, (95%CI, 8.8-29.8%) and the relapse rate (a competing event) was 34% (95%CI, 21.6% to 48%), as shown in Fig. 4.

Discussion

Hematopoietic stem cell transplantation is the only possible treatment method in the most high-risk malignancies in children (AML, ALL etc.) [2]. Despite significant advances in the area, the posttransplant relapses remain the quite serious and common issue, being the main cause of lethal outcomes posttransplant [1, 2, 9, 12, 15]. The relapse frequency in this cohort may vary from 10 to 70% [3, 4, 15]. Clinical prognosis for post-HSCT relapsing patients remains extremely unfavorable, and these patients were intended for the salvage therapy [2]. So far, there are no clear clinical recommendations for treatment of such patients, and the issue of therapeutic options still remains open for this group [10, 15].

A significant therapeutic effect in allogeneic HSCT is achieved due to immune-mediated reactions, e.g., transplant versus leukemia effect, the main factor able to overcome the resistance of malignant cells [4, 10]. However, subsequent administration of mono- or combined therapy is the most common strategy for treatment of the posttransplant relapses, i.e., reinduction polychemotherapy, immunoadoptive cell therapy (donor lymphocyte infusion), usage of targeted drugs including monoclonal antibodies (MAb) [12]. Intensive chemotherapy results into the disease stabilization with remission achieved in 40 to 60% [4], however, without long-lasting effect in most cases, with 2-year OS of <10% [4].

Therapeutic potential of bispecific anti-CD19 monoclonal antibodies in the patients with ALL relapse was evaluated in a multicenter study of the patients who relapsed after HSCT, with a median observation term of 7.5 months. The one-year overall survival in these patients was 25% following treatment with blinatumomab [7].

According to the study by Markova et al. [11] that included 41 children with posttransplant relapse of ALL, the response to blinatumomab was observed in 24 patients (59%); the two-year OS comprised 37%, 2-year relapse-free survival rate was 71%, with a median observation terms of 222 days (25 to 730 days).

Donor lymphocyte infusion is an effective treatment approach in such conditions [12]. On the ground of a retrospective study which included 171 cases, Shmid et al. have shown efficiency of donor lymphocytes when treating posttransplant relapses in AML patients. The 2-year OS among the patients achieving remission after DLI was 56%, as compared with OS of 21% in the patients that did not reach the remission state (>35% blasts in bone marrow). Meanwhile, the 2-year OS remained at 9% for the patients who did not receive DLI [6].

EBMT Acute Leukemia Working Party (M. A. Kharfan-Dabaja et al, 2018) has published a retrospective study in order to compare efficiency of repeated allo-HSCT and DLI, including 418 adult patients with AML relapse after 1st allo-HSCT. Repeated allo-HSCT was performed in 137 patients, and DLI, in 281 patients. Two-year survival following repeated allo-HSCT proved to be 26%, 5-year OS comprised 19%. Two-year OS among the DLI-treated patients was 25%, and 5-year OS, 15% [16]. In our study, the 5-year OS was 48% after repeated HSCT in general group.

Similarly, several larger studies have shown that repeated HSCT is a probable therapeutic approach [2]. In 2015, Ruutu et al. have summarized the results of 2632 repeated allo-HSCTs. Their results showed the 1-year OS rates of 40%, 5-year OS of 20% [5]. Another study from USA (Swati Naik et al., 2015) demonstrated results of repeated allo-HSCT in 43 children with relapses of different oncohematological disorders, with overall survival at 1, 5 and 10 years of, respectively, 48%, 24%, and 20% [3].

The results of multicenter retrospective study (EBMT-PDWP) were reported in 2018 [8]. Repeated allo-HSCT was performed in 373 cases; the 2- and 5-year OS values were 38% and 29%, respectively. The relapse-free survival was 30% at 2 years, and 30% at 5 years of observation. The median observation time in ALL group was 36.4 months, being 50.2 months for AML patients [8].

Despite current achievements in the posttransplant relapse treatment following allo-HSCT, using repeated allo-HSCT, the optimal timing of its performance is not yet determined, as well as preferable HSC source, change of donor (his/her gender and age), conditioning regimen, GvHD prophylaxis, posttransplant treatment, thus requiring additional multicenter studies, e.g. under participation of European teams active in oncohematology [18].

Conclusion

1. We have performed retrospective study concerning 50 pediatric patients with different blood malignancies that were subjected to repeated allogeneic HSCT due to different reasons, i.e. relapse/progression, primary or secondary non-engraftment.

2. According to our results, the repeated allo-HSCT in this cohort proved to be an effective treatment approach to the therapy of relapses in pediatric malignancies following failure of first allo-HSCT. The 2nd allo-HSCT may be effectively performed in stable somatic status, without active infections and toxic complications, upon development of remission or when achieving response to cytoreductive therapy before conditioning.

3. The option of repeated HSCT depends on clinical situation and presence of toxic complications in distinct cases. However, taking into account previous severe treatment, one should prefer reduced-intensity or reduced-toxicity conditioning regimens, despite absence of statistical difference between results from MAC and RIC cases. There is no difference upon donor change and allo-HSCT type, however, haploidentical donor seems to be preferred in this setting, due to availability, motivation and sooner performance of this HSCT mode.

4. With respect to soon development of relapses after repeated allo-HSCT (a median of 58 days), a decision on withdrawal of immune suppressive therapy and commencing posttransplant immunoadoptive treatment should be taken within D+30 to D+60 in absence of clinically significant GvHD. Administration of other therapies (DLI, hypomethylating and targeted drugs) causes a sufficient improvement of OS rates in the patients following repeated SC.

5. With development of novel monoclonal antibodies, as well as future CAR-T cell technologies, we need further studies of these therapeutic options in the posttransplant period for this cohort of patients.

Conflict of interest

Non declared.

References

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  14. Sakashita K, Matsuda K, Koike K. Diagnosis and treatment of juvenile myelomonocytic leukemia. Pediatrics Int. 2016; 58, 681-690.
  15. Bosi A Laszlo D, Labopin M, Reffeirs J, Michallet M, Gluckman E, Alessandrino PE, Locatelli F, Vernant JP, Sierra J, Jouet JP, Frassoni F. Acute Leukemia Working Party of the European Blood and Marrow Transplant Group. Second allogeneic bone marrow transplantation in acute leukemia: results of a survey by the European Cooperative Group for Blood and Marrow Transplantation. J Clin Oncol. 2001; 19(16): 3675-3684.
  16. Kharfan-Dabaja AM, Labopin M, Polge E, Nishihori T, Bazarbachi A, Finke J, Stadler M, Ehninger G, Lioure B, Schaap N, Afanasyev B, Yeshurun M, Isaksson C, Maertens J, Chalandon Y, Schmid C, Nagler A, Mohty M. Association of second allogeneic hematopoietic cell transplant vs donor lymphocyte infusion with overall survival in patients with acute myeloid leukemia relapse. JAMA Oncol. 2018; 4(9):1245-1253.
  17. Schrappe M, Hunger SP, Pui CH, Saha V. Outcomes after induction failure in childhood acute lymphoblastic leukemia. New Engl J Med. 2012; 366(15):1371-1381.
  18. Fedorova LV, Lepik KV, Popova MO, VlasovaYY, Kudyasheva OV, Rogacheva YA, Lepik EE, Porunova VV, Osipova AA, Zalyalov YR, Darskaya EI, Markova IV. Highlights of the 24th European Hematology Association Congress, Amsterdam 2019. Cell Ther Transplant 2019; 8(2): 82-90.
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Introduction

Allogeneic transplantation of hematopoietic stem cells (allo-HSCT) is among superior advances in treatment of children with hematological and inherited disorders [1]. Improvement of treatment protocols based on the balanced intensification of chemotherapy (ChT) provides an increase in long-term survival of the children with acute myeloid leukemia (AML) to 70%, and acute lymphoblastic leukemia (ALL) in 90% of the cases. Chemotherapy followed by allogeneic HSCT is one of the most effective treatment methods remaining an integral part of programmed therapy for high-risk pediatric AML and ALL [2]. Relapse of acute leukemia remains a main indication for allo-HSCT, due to sufficient worsening of prognosis [17].

Along with high-risk acute leukemia in children, allo-HSCT is the only method of treatment in myelodysplastic syndrome (MDS), including juvenile myelo-monocytic leukemia (JMML) (14). Chronic myeloid leukemia (CML) deserves special indications, i.e., in cases of lost therapeutic response, intolerance to tirosine kinase inhibitors (TKI), or mutations associated with TKI resistance permit us to consider allo-HSCT a therapeutic option, due to high efficiency and individual indication strategy.

Allo-HSCT performance is accompanied by some serious complications associated with conditioning regimens, non-engraftment or graft hypofunction, and especially with relapses. Post-transplant relapse remains the most serious issue, being the main cause of mortality in these patients [1, 2, 9, 12]. Frequency of leukemia relapses after allo-HSCT is from 10 to 70% [1, 3, 4]. Prognosis for relapsing patients posttransplant is dismal, and the patients are planned for salvage therapy requiring personalized treatment approach [2]. Among possible therapies applicable after allo-HSCT, one may consider re-transplantation, the use of target and immunotherapy drugs. However, their efficiency of these options has not proven in randomized trials. Nevertheless, the reported experience of different centers is of sufficient interest for taking strategic clinical decisions. The range of problems associated with re-transplantation due to relapse is as follows – to date, the optimal timing for 2nd HSCT are not yet determined; there is no clear opinion on the graft source (bone marrow or peripheral stem cells), and donor characteristics (HLA matching, gender, age), as well as conditioning regimens, GVHD prophylaxis, subsequent therapies.

A retrospective analysis was performed at the R. M. Gorbacheva Memorial Research Institute for Children Oncology, Hematology and Transplantation concerning 50 pediatric patients with different malignant hematological diseases who were subjected to repeated allo-HSCT due to relapse or progression, primary or secondary non-engraftment. The aim of our study was to evaluate efficiency of 2nd allo-HSCT in the patients with acute leukemias, MDS, JMML, and CML in cases of evolving clinical relapse, or associated complications occurring after the 1st allo-HSCT.

Materials and methods

Table 1. Clinical characteristics of pediatric patients considered for 2nd allo-HSCT

Kozhokar-tab01.jpg

Abbreviations: BU, Busulfan; Treo, Treosulfan; Flu, Fludarabine; Cy, Cyclophosphamide; GIAC, Bu, Ara-C, CCNU, Cy; MAC, myeloablative conditioning, RIC, reduced-intensity conditioning.

The study included 50 children with a median age of 18 years (1 to 18 y.o.) subjected to 2nd allo-HSCT at our BMT clinic from 2007 to 2018. Their primary diagnoses were as follows: ALL, 24 patients; AML, 15 cases; mixed-phenotype AML, 2 patients; JMML, 6 patients; CML, 1 patient. Relapse of the primary disease was the most common indication for 2nd allo-HSCT was diagnosed in 36 cases (72%). Other indications for 2nd HSCT were as follows: primary non-engraftment in 11 patients (22%); secondary non-engraftment in 2 patients (4%); graft hypofunction in one case (2%) in presence of resistant/refractory clinical course. The disease characteristics and parameters of the 1st HSCT are presented in Table 1.

For 40% of the patients (n=20), unrelated HLA-matched donors were chosen for allo-HSCT; matched related donor was used in 15 cases (30%); haploidentical graft was used in 14 cases (28%); autologous HSCT was carried out in 1 patient (2%). At the time of 1st HSCT, myeloablative busulfan-containing regimen (MAC) was applied in 34 patients (68%). Dependent on the stage of disease, 16 patients (32%) achieved 1st complete hematological remission (CR); 2nd or 3rd CR was registered in 18 cases (36%). Sixteen patients (32%) were in resistant relapse state, or showed primary resistance.

Median duration of remission after the 1st allo-HSCT was 148 days (31 to 1084 days). Donor lymphocyte infusions (DLI) were performed in 20 patients after 1st allo-HSCT, for relapse prophylaxis. Of them, 17 children (85%) received the therapy due to minimal residual disease (MRD) or clinical relapse, and 3 patients (15%), due to graft hypofunction. The DLI proved to be ineffective in all these patients, thus being indicative for 2nd allo-HSCT.

The patients with progression or relapse after 1st HSCT (n=38), have received cytoreductive therapy before 2nd allo-HSCT by the following schedules:
• chemotherapy (ChT) in 24 patients using FLAG protocol, or ALL-REZ BFM 2002, and AML-BFM 2004 chemotherapy blocks;
• targeted drugs (hypomethylating agents or monoclonal antibodies), in 7 patients;
• combined application of ChT and targeted drugs (hypomethylating or monoclonal antibodies) in 7 cases.

In 10 patients of 38 who underwent ChT or targeted treatment, a remission of the disease was achieved; in 12 cases, cytoreduction was observed (marrow blast count reduction to 20%). In 16 patients, stabilization or progression of the disease was registered.

Ten patients with aplasia of hematopoiesis due to primary non-engraftment, 2 patients with secondary rejection, and 1 patient with severe graft hypofunction did not receive additional therapy. Clinical characteristics of the patients subjected to 2nd allo-HSCT are shown in Table 2.

Table 2. Clinical characteristics of the patients who underwent 2nd HSCT

Kozhokar-tab02.jpg

Abbreviations: BU, Busulfan; Treo, Treosulfan; Flu, Fludarabine; Cy, Cyclophosphamide; GIAC: Bu, Ara-C, CCNU, Cy; MAC, myeloablative conditioning, RIC, reduced-intensity conditioning; HSCs, hematopoietic stem cells; PBSC, peripheral blood stem cells.

The median time-lag between 1st and 2nd HSCT was 7.5 months. In majority of patients (n=41), the donors were changed to haploidentical HSCs donor. In 9 recipients, allo-HSCT was performed from the same donors, i.e., haploidentical transplants in 3 cases; unrelated grafts in 4 patients, and related matched donors were used in 2 cases. For 2nd allo-HSCT, the reduced-intensity conditioning regimens (RIC) were chosen for 40 patients, due to heavy pre-treatment and severe condition of the patients. Myeloablative conditioning was performed in 10 cases, because of high blast cell counts in bone marrow. Combined prophylaxis of acute graft-versus-host disease (GvHD) after 2nd allo-HSCT was based on the following immune suppression therapy, i.e., tacrolimus-based prophylaxis was administered to 38 patients; mTOR inhibitors were used in 31 cases; cyclosporine-A-based was applied in 7 patients. In 31 cases, GvHD prophylaxis was performed with cyclophosphamide (50 mg/kg) on D+3 and D+4 posttransplant. Antithymocyte globulin (ATG) was used for GVHD prophylaxis in 11 cases. Monotherapy with calcineurin inhibitors was applied in 7 children.

The Kaplan-Meier estimates were used to assess probability of OS (overall survival) and RFS (relapse-free survival). OS was defined as number of months from the date of 2nd allo-HSCT to the date of death. RFS defined as number of months from the date of 2nd allo-HSCT to the date of first documented relapse or progression. Cumulative incidence was used to estimate the probability of transplant-related mortality (TRM) and relapse. For TRM, the relapse was considered a competing event. These estimates are provided with 95% confidence intervals (CI). We didn’t perform any multivariate analysis, because of relatively small number of patients.

Results

Clinical engraftment after 2nd HSCT was registered in 44 patients (88% of total), with a median of neutrophil recovery of >500/mcL on D+21 (12 to 41), and documented clinical hematological remission. Primary non-engraftment was registered in 6 patients, including 4 cases with progression of the disease. The median observation term was 3 years 7 months (9 months to 10 years). Overall survival (OS) rate in the total group was 48% (Fig. 1), with relapse-free survival (RFS) of 60% (Fig. 3). OS among ALL patients was 46.2%; among the children with AML, 53.3%; for the group with myeloproliferative disorders (MDS, CML, JMML), 44.4%, as seen from Fig. 1.

OS among the patients with remission or cytoreduction achieved before 2nd allo-HSCT proved to be, respectively, 73.6% и 50%. Meanwhile, OS values in the patients who did not respond to the therapy, on in absence of remission (active disease) comprised only 17.6% (р=0.006), as shown in Fig. 2.

We could not demonstrate any significant difference in OS between the cases with remission of <5 months, and >5 months after 1st HSCT (respectively, 41.2% and 42.9%, p=0.7), based on median duration of the remission. Similarly, change of donor at the 2nd HSCT did not result into significant OS changes (50% versus 47%, p=0.4). Moreover, no statistically significant difference was obtained for the groups who received RIC or MAC conditioning (47% versus 50%, p=0.6).

Kozhokar-fig01.jpg

Figure 1. Five-year OS after 2nd allo-HSCT in the entire cohort (A); in patients with ALL (B); in patients with AML (C); in MPD cases (D) after 2nd allo-HSCT

Abscissa, months after allo-HSCT, ordinate, cumulative survival.

Kozhokar-fig02.jpg

Figure 2. Overall survival in the patients with different status prior to 2nd allo-HSCT (red graph, remission; green, cytoreduction; blue curve, no response)

Abscissa, terms after 2nd HSCT, months; ordinate cumulative survival.

Figure 3. Relapse-free survival in the entire group of patients after 2nd allo-HSCT

Abscissa, terms after 2nd HSCT, months; ordinate cumulative survival.





The study also concerned possible effects of acute or chronic GvHD upon OS levels. The 5-year OS in the patients (remission – 18 pts, cytoreduction – 12 pts, progression – 11 pts) who developed acute GVHD grade II-III was 63.6% (n=33), as compared to 9.1% (n=11) among GvHD-free cases (р=0.001). Meanwhile, the 5-year OS rate among patients with mild or moderate chronic GvHD reached 72.4% (n=29) when compared to the cases without chronic GvHD 14.3%, (n=7), p<0.0001).

From patients with high risk of relapse after 2nd allo-HSCT, 9 patients without acute or chronic GvHD were subjected to immunoadoptive therapy, i.e., infusion of donor lymphocytes (DLI), aiming to prevent potential relapse. Maintenance therapy was performed in 13 patients using 6-MP (mercaptopurine), hypomethylating agents (HMa) (5-azacytidine, dacogen), tyrosine kinase inhibitors (TKI). In summary, for the group of patients (n=13) who did not receive any prophylaxis (DLI) or supporting therapy (6-MP, HMa or TKI) after 2nd all-HSCT, due to acute or chronic GvHD OS 84.6%, (p=0.089).

Overall survival was 55.6% among the patients treated with DLI only. In the patients on maintenance therapy, the OS values proved to be 46.2%. In 9 cases of molecular recurrence (MRD, molecular or cytogenetic relapse) combined therapy was performed, i.e., chemotherapy, HMa (5-azacytidine, dacogen) and DLI, with OS of 22.2% (p=0.089).

We have analyzed the frequency of complications during early posttransplant period (D+100). The following toxic conditions were observed: severe mucositis (grade 3-4) was documented in 54% of cases (n=26); thrombotic microangiopathy, 22% (n=11); veno-occlusive disease, 16% (n=8); neurotoxicity, 16% (n=8). Among infectious complications, we observed cytomegalovirus reactivation (52%, n=26); SIRS syndrome, including sepsis, 44% (n=22); invasive mycoses, 18% (n=9).

Kozhokar-fig04.jpg

Figure 4. Effects of 2 competing events upon general mortality after 2nd HSCT, i.e., (1) cumulative relapse rate (34%; 95%CI, 21.6%-48%), and (2) TRM rate (18%; 95%CI, 8.8-29.8%)

Relapse or progression of disease remained the main cause of mortality after 2nd allo-HSCT (65%, n=17). The median time of the relapse development in these patients comprises 58 days.

Transplant-related mortality in this group was 18%, (95%CI, 8.8-29.8%) and the relapse rate (a competing event) was 34% (95%CI, 21.6% to 48%), as shown in Fig. 4.

Discussion

Hematopoietic stem cell transplantation is the only possible treatment method in the most high-risk malignancies in children (AML, ALL etc.) [2]. Despite significant advances in the area, the posttransplant relapses remain the quite serious and common issue, being the main cause of lethal outcomes posttransplant [1, 2, 9, 12, 15]. The relapse frequency in this cohort may vary from 10 to 70% [3, 4, 15]. Clinical prognosis for post-HSCT relapsing patients remains extremely unfavorable, and these patients were intended for the salvage therapy [2]. So far, there are no clear clinical recommendations for treatment of such patients, and the issue of therapeutic options still remains open for this group [10, 15].

A significant therapeutic effect in allogeneic HSCT is achieved due to immune-mediated reactions, e.g., transplant versus leukemia effect, the main factor able to overcome the resistance of malignant cells [4, 10]. However, subsequent administration of mono- or combined therapy is the most common strategy for treatment of the posttransplant relapses, i.e., reinduction polychemotherapy, immunoadoptive cell therapy (donor lymphocyte infusion), usage of targeted drugs including monoclonal antibodies (MAb) [12]. Intensive chemotherapy results into the disease stabilization with remission achieved in 40 to 60% [4], however, without long-lasting effect in most cases, with 2-year OS of <10% [4].

Therapeutic potential of bispecific anti-CD19 monoclonal antibodies in the patients with ALL relapse was evaluated in a multicenter study of the patients who relapsed after HSCT, with a median observation term of 7.5 months. The one-year overall survival in these patients was 25% following treatment with blinatumomab [7].

According to the study by Markova et al. [11] that included 41 children with posttransplant relapse of ALL, the response to blinatumomab was observed in 24 patients (59%); the two-year OS comprised 37%, 2-year relapse-free survival rate was 71%, with a median observation terms of 222 days (25 to 730 days).

Donor lymphocyte infusion is an effective treatment approach in such conditions [12]. On the ground of a retrospective study which included 171 cases, Shmid et al. have shown efficiency of donor lymphocytes when treating posttransplant relapses in AML patients. The 2-year OS among the patients achieving remission after DLI was 56%, as compared with OS of 21% in the patients that did not reach the remission state (>35% blasts in bone marrow). Meanwhile, the 2-year OS remained at 9% for the patients who did not receive DLI [6].

EBMT Acute Leukemia Working Party (M. A. Kharfan-Dabaja et al, 2018) has published a retrospective study in order to compare efficiency of repeated allo-HSCT and DLI, including 418 adult patients with AML relapse after 1st allo-HSCT. Repeated allo-HSCT was performed in 137 patients, and DLI, in 281 patients. Two-year survival following repeated allo-HSCT proved to be 26%, 5-year OS comprised 19%. Two-year OS among the DLI-treated patients was 25%, and 5-year OS, 15% [16]. In our study, the 5-year OS was 48% after repeated HSCT in general group.

Similarly, several larger studies have shown that repeated HSCT is a probable therapeutic approach [2]. In 2015, Ruutu et al. have summarized the results of 2632 repeated allo-HSCTs. Their results showed the 1-year OS rates of 40%, 5-year OS of 20% [5]. Another study from USA (Swati Naik et al., 2015) demonstrated results of repeated allo-HSCT in 43 children with relapses of different oncohematological disorders, with overall survival at 1, 5 and 10 years of, respectively, 48%, 24%, and 20% [3].

The results of multicenter retrospective study (EBMT-PDWP) were reported in 2018 [8]. Repeated allo-HSCT was performed in 373 cases; the 2- and 5-year OS values were 38% and 29%, respectively. The relapse-free survival was 30% at 2 years, and 30% at 5 years of observation. The median observation time in ALL group was 36.4 months, being 50.2 months for AML patients [8].

Despite current achievements in the posttransplant relapse treatment following allo-HSCT, using repeated allo-HSCT, the optimal timing of its performance is not yet determined, as well as preferable HSC source, change of donor (his/her gender and age), conditioning regimen, GvHD prophylaxis, posttransplant treatment, thus requiring additional multicenter studies, e.g. under participation of European teams active in oncohematology [18].

Conclusion

1. We have performed retrospective study concerning 50 pediatric patients with different blood malignancies that were subjected to repeated allogeneic HSCT due to different reasons, i.e. relapse/progression, primary or secondary non-engraftment.

2. According to our results, the repeated allo-HSCT in this cohort proved to be an effective treatment approach to the therapy of relapses in pediatric malignancies following failure of first allo-HSCT. The 2nd allo-HSCT may be effectively performed in stable somatic status, without active infections and toxic complications, upon development of remission or when achieving response to cytoreductive therapy before conditioning.

3. The option of repeated HSCT depends on clinical situation and presence of toxic complications in distinct cases. However, taking into account previous severe treatment, one should prefer reduced-intensity or reduced-toxicity conditioning regimens, despite absence of statistical difference between results from MAC and RIC cases. There is no difference upon donor change and allo-HSCT type, however, haploidentical donor seems to be preferred in this setting, due to availability, motivation and sooner performance of this HSCT mode.

4. With respect to soon development of relapses after repeated allo-HSCT (a median of 58 days), a decision on withdrawal of immune suppressive therapy and commencing posttransplant immunoadoptive treatment should be taken within D+30 to D+60 in absence of clinically significant GvHD. Administration of other therapies (DLI, hypomethylating and targeted drugs) causes a sufficient improvement of OS rates in the patients following repeated SC.

5. With development of novel monoclonal antibodies, as well as future CAR-T cell technologies, we need further studies of these therapeutic options in the posttransplant period for this cohort of patients.

Conflict of interest

Non declared.

References

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  8. Yaniv I, Krauss A, Beohou E, Dalissier A, Corbacioglu S, Zecca M, Afanasyev B, Berger M, Diaz M, Kalwak K, Sedlacek P, Varotto S, Peters C, Bader P. Second hematopoietic stem cell transplantation for post-transplant relapsed acute leukemia in children: a retrospective EBMT-PDWP study. Biol Blood Marrow Transplant. 2018;24(8):1629-1642.
  9. Duncan C, Majhail N, Zhiwei R, Cahn WJY. Long-term survival and late effects among one-year survivors of second allogeneic hematopoietic cell transplantation for relapsed acute leukemia and myelodysplastic syndromes. Biol Blood Marrow Transplant. 2015; 21:151-158.
  10. Blau I, Basara N, Bischoff M, Günzelmann S, Römer E, Kirsten D, Schmetzer B, M Kiehl M, Fauser A. Second allogeneic hematopoietic stem cell transplantation as treatment for leukemia relapsing following a first transplant. Bone Marrow Transplantation. 2000; 25(1): 41-45.
  11. Markova I, Zubarovskaya L, Paina O, Bondarenko S, Kozhokar P, Frolova A, Rakhmanova Zh, Galas M, Ekushov K, Babenko E, Gindina T, Barkhatov I, Semenova E, Moiseev I. Assesment of blinatumomab efficacy and safety in treatment of relapses and refractory forms of B-lineage acute lymphoblastic leukemia in children. Pediatria. 2019; 98(4):158-164 (In Russian).
  12. Semenova E, Stancheva N, Zubarovskaya N, Babenko E, Slesarchuk O, Estrina M, Zubarovskaya L, Afanasyev B. Post-transplant relapses of acute leukemia in children and adolescents. Bone Marrow Transplantation. 2010; 45 (Suppl 2):94.
  13. Semenova E, Stancheva N, Alyanskiy A, Tretyakova M, Razumova S, Borovkova A, Babenko E, Bondarenko S, Shiryaev S, Bykova T, Paina O, Zubarovskaya L, Kozlov A, Afanasyev B. Results of second allogeneic stem cell transplantation for children and adolescents with acute leukaemia. Bone Marrow Transplantation. 2011; 46(Suppl.1): 273.
  14. Sakashita K, Matsuda K, Koike K. Diagnosis and treatment of juvenile myelomonocytic leukemia. Pediatrics Int. 2016; 58, 681-690.
  15. Bosi A Laszlo D, Labopin M, Reffeirs J, Michallet M, Gluckman E, Alessandrino PE, Locatelli F, Vernant JP, Sierra J, Jouet JP, Frassoni F. Acute Leukemia Working Party of the European Blood and Marrow Transplant Group. Second allogeneic bone marrow transplantation in acute leukemia: results of a survey by the European Cooperative Group for Blood and Marrow Transplantation. J Clin Oncol. 2001; 19(16): 3675-3684.
  16. Kharfan-Dabaja AM, Labopin M, Polge E, Nishihori T, Bazarbachi A, Finke J, Stadler M, Ehninger G, Lioure B, Schaap N, Afanasyev B, Yeshurun M, Isaksson C, Maertens J, Chalandon Y, Schmid C, Nagler A, Mohty M. Association of second allogeneic hematopoietic cell transplant vs donor lymphocyte infusion with overall survival in patients with acute myeloid leukemia relapse. JAMA Oncol. 2018; 4(9):1245-1253.
  17. Schrappe M, Hunger SP, Pui CH, Saha V. Outcomes after induction failure in childhood acute lymphoblastic leukemia. New Engl J Med. 2012; 366(15):1371-1381.
  18. Fedorova LV, Lepik KV, Popova MO, VlasovaYY, Kudyasheva OV, Rogacheva YA, Lepik EE, Porunova VV, Osipova AA, Zalyalov YR, Darskaya EI, Markova IV. Highlights of the 24th European Hematology Association Congress, Amsterdam 2019. Cell Ther Transplant 2019; 8(2): 82-90.
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Несмотря на это, уровень рецидивов варьирует от 10 до 70%. До сих пор отсутствует оптимальный подход к терапии рецидива после алло-ТГСК. Возможные терапевтические опции включают в себя реиндукцию, иммуноадоптивную терапию, таргетную терапию, иммунотерапию (CAR T-клеточную терапию), повторную трансплантацию. В данной публикации представлено ретроспективное исследование пациентов с рефрактерным течением онкогематологических заболеваний, а также отторжением трансплантата в группе высокого риска, в связи с чем выполнялась повторная алло-ТГСК. Целью нашей работы был анализ результатов повторной алло-ТГСК у 50 детей с различными онкогематологическими заболеваниями: ОЛЛ – 24, ОМЛ – 15, МДС и ХМПЗ – 11 пациентов. Общая выживаемость (ОВ) по методу Каплан-Майер во всей группе составила 48%, безрецидивная выживаемость (БРВ) – 60%. Медиана наблюдения составила 3 года 7 мес. Пятилетняя ОВ в группе ОЛЛ была 46,2%, в группе ОМЛ – 53,3%, в группе МДС и МПЗ – 44,4%. Причины летальности: рецидив/прогрессия в 17 случаях (65%).Трансплантационная летальность составила 18% (95% ДИ, 8,8%-29,8%). Кумулятивная частота рецидива составила 34% (95% ДИ, 21,6%-48%).</p> <h3>Заключение</h3> <p style="text-align: justify;">Повторная алло-ТГСК – эффективный метод терапии у пациентов с рецидивом заболевания после первой ТГСК. Пациенты, достигшие ремиссии или циторедукции перед алло-ТГСК, имеют статистически достоверный лучший прогноз. Развитие хронической РТПХ легкой и средней степени статистически улучшает ОВ. Не получено достоверной разницы между РИК и МАК. Посттрансплантационная терапия может улучшить результаты повторной алло-ТГСК.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Рецидив острого лейкоза, повторная алло-ТГСК, посттрансплантационная терапия, дети. </p>" ["ELEMENT_PREVIEW_PICTURE_FILE_TITLE"]=> string(203) "Эффективность повторной аллогенной ТГСК у детей с острыми лейкозами при рецидиве после первой трансплантации" ["ELEMENT_DETAIL_PICTURE_FILE_ALT"]=> string(203) "Эффективность повторной аллогенной ТГСК у детей с острыми лейкозами при рецидиве после первой трансплантации" ["ELEMENT_DETAIL_PICTURE_FILE_TITLE"]=> string(203) "Эффективность повторной аллогенной ТГСК у детей с острыми лейкозами при рецидиве после первой трансплантации" ["SECTION_META_TITLE"]=> string(203) "Эффективность повторной аллогенной ТГСК у детей с острыми лейкозами при рецидиве после первой трансплантации" ["SECTION_META_KEYWORDS"]=> string(203) "Эффективность повторной аллогенной ТГСК у детей с острыми лейкозами при рецидиве после первой 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Кожокарь<sup>1</sup>, Олеся В. Паина<sup>1</sup>, Анастасия С. Фролова<sup>1</sup>, Джемал З. Рахманова<sup>1</sup>, Анастасия C. Боровкова<sup>1</sup>, Елена В. Семенова<sup>1</sup>, Анна А. Осипова<sup>1</sup>, Кирилл А. Екушов<sup>1</sup>, Ольга А. Слесарчук<sup>1</sup>, Варвара Н. Овечкина<sup>1</sup>, Елена В. Бабенко<sup>1</sup>, Алина А. Витрищак<sup>1</sup>, Борис И. Смирнов<sup>2</sup>, Людмила С. Зубаровская<sup>1</sup>, Борис В. Афанасьев<sup>1</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(703) "

Полина В. Кожокарь1, Олеся В. Паина1, Анастасия С. Фролова1, Джемал З. Рахманова1, Анастасия C. Боровкова1, Елена В. Семенова1, Анна А. Осипова1, Кирилл А. Екушов1, Ольга А. Слесарчук1, Варвара Н. Овечкина1, Елена В. Бабенко1, Алина А. Витрищак1, Борис И. Смирнов2, Людмила С. Зубаровская1, Борис В. Афанасьев1

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия
2 Санкт-Петербургский государственный электротехнический университет, Санкт-Петербург, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24579" ["VALUE"]=> array(2) { ["TEXT"]=> string(3538) "<p style="text-align: justify;">Аллогенная трансплантация гемопоэтических стволовых клеток (алло-ТГСК) является стандартом терапии в группе высокого риска онкогематологических заболеваний. Несмотря на это, уровень рецидивов варьирует от 10 до 70%. До сих пор отсутствует оптимальный подход к терапии рецидива после алло-ТГСК. Возможные терапевтические опции включают в себя реиндукцию, иммуноадоптивную терапию, таргетную терапию, иммунотерапию (CAR T-клеточную терапию), повторную трансплантацию. В данной публикации представлено ретроспективное исследование пациентов с рефрактерным течением онкогематологических заболеваний, а также отторжением трансплантата в группе высокого риска, в связи с чем выполнялась повторная алло-ТГСК. Целью нашей работы был анализ результатов повторной алло-ТГСК у 50 детей с различными онкогематологическими заболеваниями: ОЛЛ – 24, ОМЛ – 15, МДС и ХМПЗ – 11 пациентов. Общая выживаемость (ОВ) по методу Каплан-Майер во всей группе составила 48%, безрецидивная выживаемость (БРВ) – 60%. Медиана наблюдения составила 3 года 7 мес. Пятилетняя ОВ в группе ОЛЛ была 46,2%, в группе ОМЛ – 53,3%, в группе МДС и МПЗ – 44,4%. Причины летальности: рецидив/прогрессия в 17 случаях (65%).Трансплантационная летальность составила 18% (95% ДИ, 8,8%-29,8%). Кумулятивная частота рецидива составила 34% (95% ДИ, 21,6%-48%).</p> <h3>Заключение</h3> <p style="text-align: justify;">Повторная алло-ТГСК – эффективный метод терапии у пациентов с рецидивом заболевания после первой ТГСК. Пациенты, достигшие ремиссии или циторедукции перед алло-ТГСК, имеют статистически достоверный лучший прогноз. Развитие хронической РТПХ легкой и средней степени статистически улучшает ОВ. Не получено достоверной разницы между РИК и МАК. Посттрансплантационная терапия может улучшить результаты повторной алло-ТГСК.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Рецидив острого лейкоза, повторная алло-ТГСК, посттрансплантационная терапия, дети. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(3448) "

Аллогенная трансплантация гемопоэтических стволовых клеток (алло-ТГСК) является стандартом терапии в группе высокого риска онкогематологических заболеваний. Несмотря на это, уровень рецидивов варьирует от 10 до 70%. До сих пор отсутствует оптимальный подход к терапии рецидива после алло-ТГСК. Возможные терапевтические опции включают в себя реиндукцию, иммуноадоптивную терапию, таргетную терапию, иммунотерапию (CAR T-клеточную терапию), повторную трансплантацию. В данной публикации представлено ретроспективное исследование пациентов с рефрактерным течением онкогематологических заболеваний, а также отторжением трансплантата в группе высокого риска, в связи с чем выполнялась повторная алло-ТГСК. Целью нашей работы был анализ результатов повторной алло-ТГСК у 50 детей с различными онкогематологическими заболеваниями: ОЛЛ – 24, ОМЛ – 15, МДС и ХМПЗ – 11 пациентов. Общая выживаемость (ОВ) по методу Каплан-Майер во всей группе составила 48%, безрецидивная выживаемость (БРВ) – 60%. Медиана наблюдения составила 3 года 7 мес. Пятилетняя ОВ в группе ОЛЛ была 46,2%, в группе ОМЛ – 53,3%, в группе МДС и МПЗ – 44,4%. Причины летальности: рецидив/прогрессия в 17 случаях (65%).Трансплантационная летальность составила 18% (95% ДИ, 8,8%-29,8%). Кумулятивная частота рецидива составила 34% (95% ДИ, 21,6%-48%).

Заключение

Повторная алло-ТГСК – эффективный метод терапии у пациентов с рецидивом заболевания после первой ТГСК. Пациенты, достигшие ремиссии или циторедукции перед алло-ТГСК, имеют статистически достоверный лучший прогноз. Развитие хронической РТПХ легкой и средней степени статистически улучшает ОВ. Не получено достоверной разницы между РИК и МАК. Посттрансплантационная терапия может улучшить результаты повторной алло-ТГСК.

Ключевые слова

Рецидив острого лейкоза, повторная алло-ТГСК, посттрансплантационная терапия, дети.

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Polina V. Kozhokar1, Olesya V. Paina1, Anastasia S. Frolova1, Zhemal Z. Rakhmanova1, Anastasia S. Borovkova1, Elena V. Semenova1, Anna A. Osipova1, Kirill A. Ekushov1, Olga A. Slesarchuk1, Varvara N. Ovechkina1, Elena V. Babenko1, Alina A. Vitrishchak1, Boris I. Smirnov2, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia
2 Saint Petersburg State Electrotechnical University, St. Petersburg, Russia

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is effective treatment in high risk hematological malignancies. Nevertheless, the relapse rates after allo-HSCT range from 10% to 70%.There is no optimal strategy of the relapse therapy after allo-HSCT. Possible therapeutic options include re-induction chemotherapy, immunoadoptive therapy (DLI), target drugs, immunotherapy (CAR-T) and second allo-HSCT. The presented study is a retrospective single-institution experience of second allo-HSCT in the patients (pts) with acute leukemia relapses or graft failure in high-risk cases. The aim of our study was to analyze the outcomes after second allo-HSCT in 50 children with hematological malignancies, i.e., ALL (n=24), AML (n=15), MPDs/MDS (n=11).

Results

Forty-four patients achieved engraftment, with median neutrophil engraftment time of 21 days (12 to 41). Remission was achieved in 44 pts (88%). Median follow-up period was 3 years 7 months. Overall survival (OS), according to Kaplan-Meier method, was 48% in the whole group. Relapse-free survival (RFS) was 60%. The five-year OS in ALL group was 46.2%; in AML group, 53.3%; in MPDs/MDS, 44.4%. Causes of death were as follows: relapse/progression in 65% (n=17), transplant-related mortality (TRM), in 18% (n=9; 95%CI, 8.8%-29.8%); cumulative relapse rate was 34% (95% CI, 21.6%-48%).

Conclusion

Second allo-HSCT is an effective treatment option in cases of relapse after 1st allo-HSCT. The patients that achieved remission or even blast cytoreduction prior to 2nd allo-HSCT had better outcome. Clinical manifestations of acute and chronic GVHD can significantly improve the OS. Results of 2nd allo-HSCT were comparable when using RIC or MAC conditioning regimens. Posttransplant therapy is required to improve results after 2nd HSCT.

Keywords

Leukemia relapse, second allogeneic HSCT, posttransplant therapy, children.

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Kozhokar<sup>1</sup>, Olesya V. Paina<sup>1</sup>, Anastasia S. Frolova<sup>1</sup>, Zhemal Z. Rakhmanova<sup>1</sup>, Anastasia S. Borovkova<sup>1</sup>, Elena V. Semenova<sup>1</sup>, Anna A. Osipova<sup>1</sup>, Kirill A. Ekushov<sup>1</sup>, Olga A. Slesarchuk<sup>1</sup>, Varvara N. Ovechkina<sup>1</sup>, Elena V. Babenko<sup>1</sup>, Alina A. Vitrishchak<sup>1</sup>, Boris I. Smirnov<sup>2</sup>, Ludmila S. Zubarovskaya<sup>1</sup>, Boris V. Afanasyev<sup>1</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(490) "

Polina V. Kozhokar1, Olesya V. Paina1, Anastasia S. Frolova1, Zhemal Z. Rakhmanova1, Anastasia S. Borovkova1, Elena V. Semenova1, Anna A. Osipova1, Kirill A. Ekushov1, Olga A. Slesarchuk1, Varvara N. Ovechkina1, Elena V. Babenko1, Alina A. Vitrishchak1, Boris I. Smirnov2, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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Polina V. Kozhokar1, Olesya V. Paina1, Anastasia S. Frolova1, Zhemal Z. Rakhmanova1, Anastasia S. Borovkova1, Elena V. Semenova1, Anna A. Osipova1, Kirill A. Ekushov1, Olga A. Slesarchuk1, Varvara N. Ovechkina1, Elena V. Babenko1, Alina A. Vitrishchak1, Boris I. Smirnov2, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is effective treatment in high risk hematological malignancies. Nevertheless, the relapse rates after allo-HSCT range from 10% to 70%.There is no optimal strategy of the relapse therapy after allo-HSCT. Possible therapeutic options include re-induction chemotherapy, immunoadoptive therapy (DLI), target drugs, immunotherapy (CAR-T) and second allo-HSCT. The presented study is a retrospective single-institution experience of second allo-HSCT in the patients (pts) with acute leukemia relapses or graft failure in high-risk cases. The aim of our study was to analyze the outcomes after second allo-HSCT in 50 children with hematological malignancies, i.e., ALL (n=24), AML (n=15), MPDs/MDS (n=11).

Results

Forty-four patients achieved engraftment, with median neutrophil engraftment time of 21 days (12 to 41). Remission was achieved in 44 pts (88%). Median follow-up period was 3 years 7 months. Overall survival (OS), according to Kaplan-Meier method, was 48% in the whole group. Relapse-free survival (RFS) was 60%. The five-year OS in ALL group was 46.2%; in AML group, 53.3%; in MPDs/MDS, 44.4%. Causes of death were as follows: relapse/progression in 65% (n=17), transplant-related mortality (TRM), in 18% (n=9; 95%CI, 8.8%-29.8%); cumulative relapse rate was 34% (95% CI, 21.6%-48%).

Conclusion

Second allo-HSCT is an effective treatment option in cases of relapse after 1st allo-HSCT. The patients that achieved remission or even blast cytoreduction prior to 2nd allo-HSCT had better outcome. Clinical manifestations of acute and chronic GVHD can significantly improve the OS. Results of 2nd allo-HSCT were comparable when using RIC or MAC conditioning regimens. Posttransplant therapy is required to improve results after 2nd HSCT.

Keywords

Leukemia relapse, second allogeneic HSCT, posttransplant therapy, children.

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is effective treatment in high risk hematological malignancies. Nevertheless, the relapse rates after allo-HSCT range from 10% to 70%.There is no optimal strategy of the relapse therapy after allo-HSCT. Possible therapeutic options include re-induction chemotherapy, immunoadoptive therapy (DLI), target drugs, immunotherapy (CAR-T) and second allo-HSCT. The presented study is a retrospective single-institution experience of second allo-HSCT in the patients (pts) with acute leukemia relapses or graft failure in high-risk cases. The aim of our study was to analyze the outcomes after second allo-HSCT in 50 children with hematological malignancies, i.e., ALL (n=24), AML (n=15), MPDs/MDS (n=11).

Results

Forty-four patients achieved engraftment, with median neutrophil engraftment time of 21 days (12 to 41). Remission was achieved in 44 pts (88%). Median follow-up period was 3 years 7 months. Overall survival (OS), according to Kaplan-Meier method, was 48% in the whole group. Relapse-free survival (RFS) was 60%. The five-year OS in ALL group was 46.2%; in AML group, 53.3%; in MPDs/MDS, 44.4%. Causes of death were as follows: relapse/progression in 65% (n=17), transplant-related mortality (TRM), in 18% (n=9; 95%CI, 8.8%-29.8%); cumulative relapse rate was 34% (95% CI, 21.6%-48%).

Conclusion

Second allo-HSCT is an effective treatment option in cases of relapse after 1st allo-HSCT. The patients that achieved remission or even blast cytoreduction prior to 2nd allo-HSCT had better outcome. Clinical manifestations of acute and chronic GVHD can significantly improve the OS. Results of 2nd allo-HSCT were comparable when using RIC or MAC conditioning regimens. Posttransplant therapy is required to improve results after 2nd HSCT.

Keywords

Leukemia relapse, second allogeneic HSCT, posttransplant therapy, children.

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia
2 Saint Petersburg State Electrotechnical University, St. Petersburg, Russia

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia
2 Saint Petersburg State Electrotechnical University, St. Petersburg, Russia

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Кожокарь<sup>1</sup>, Олеся В. Паина<sup>1</sup>, Анастасия С. Фролова<sup>1</sup>, Джемал З. Рахманова<sup>1</sup>, Анастасия C. Боровкова<sup>1</sup>, Елена В. Семенова<sup>1</sup>, Анна А. Осипова<sup>1</sup>, Кирилл А. Екушов<sup>1</sup>, Ольга А. Слесарчук<sup>1</sup>, Варвара Н. Овечкина<sup>1</sup>, Елена В. Бабенко<sup>1</sup>, Алина А. Витрищак<sup>1</sup>, Борис И. Смирнов<sup>2</sup>, Людмила С. Зубаровская<sup>1</sup>, Борис В. Афанасьев<sup>1</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(703) "

Полина В. Кожокарь1, Олеся В. Паина1, Анастасия С. Фролова1, Джемал З. Рахманова1, Анастасия C. Боровкова1, Елена В. Семенова1, Анна А. Осипова1, Кирилл А. Екушов1, Ольга А. Слесарчук1, Варвара Н. Овечкина1, Елена В. Бабенко1, Алина А. Витрищак1, Борис И. Смирнов2, Людмила С. Зубаровская1, Борис В. Афанасьев1

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Полина В. Кожокарь1, Олеся В. Паина1, Анастасия С. Фролова1, Джемал З. Рахманова1, Анастасия C. Боровкова1, Елена В. Семенова1, Анна А. Осипова1, Кирилл А. Екушов1, Ольга А. Слесарчук1, Варвара Н. Овечкина1, Елена В. Бабенко1, Алина А. Витрищак1, Борис И. Смирнов2, Людмила С. Зубаровская1, Борис В. Афанасьев1

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Kozhokar" ["LINK_ELEMENT_VALUE"]=> bool(false) } ["SUMMARY_RU"]=> array(37) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24579" ["VALUE"]=> array(2) { ["TEXT"]=> string(3538) "<p style="text-align: justify;">Аллогенная трансплантация гемопоэтических стволовых клеток (алло-ТГСК) является стандартом терапии в группе высокого риска онкогематологических заболеваний. Несмотря на это, уровень рецидивов варьирует от 10 до 70%. До сих пор отсутствует оптимальный подход к терапии рецидива после алло-ТГСК. Возможные терапевтические опции включают в себя реиндукцию, иммуноадоптивную терапию, таргетную терапию, иммунотерапию (CAR T-клеточную терапию), повторную трансплантацию. В данной публикации представлено ретроспективное исследование пациентов с рефрактерным течением онкогематологических заболеваний, а также отторжением трансплантата в группе высокого риска, в связи с чем выполнялась повторная алло-ТГСК. Целью нашей работы был анализ результатов повторной алло-ТГСК у 50 детей с различными онкогематологическими заболеваниями: ОЛЛ – 24, ОМЛ – 15, МДС и ХМПЗ – 11 пациентов. Общая выживаемость (ОВ) по методу Каплан-Майер во всей группе составила 48%, безрецидивная выживаемость (БРВ) – 60%. Медиана наблюдения составила 3 года 7 мес. Пятилетняя ОВ в группе ОЛЛ была 46,2%, в группе ОМЛ – 53,3%, в группе МДС и МПЗ – 44,4%. Причины летальности: рецидив/прогрессия в 17 случаях (65%).Трансплантационная летальность составила 18% (95% ДИ, 8,8%-29,8%). Кумулятивная частота рецидива составила 34% (95% ДИ, 21,6%-48%).</p> <h3>Заключение</h3> <p style="text-align: justify;">Повторная алло-ТГСК – эффективный метод терапии у пациентов с рецидивом заболевания после первой ТГСК. Пациенты, достигшие ремиссии или циторедукции перед алло-ТГСК, имеют статистически достоверный лучший прогноз. Развитие хронической РТПХ легкой и средней степени статистически улучшает ОВ. Не получено достоверной разницы между РИК и МАК. Посттрансплантационная терапия может улучшить результаты повторной алло-ТГСК.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Рецидив острого лейкоза, повторная алло-ТГСК, посттрансплантационная терапия, дети. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(3448) "

Аллогенная трансплантация гемопоэтических стволовых клеток (алло-ТГСК) является стандартом терапии в группе высокого риска онкогематологических заболеваний. Несмотря на это, уровень рецидивов варьирует от 10 до 70%. До сих пор отсутствует оптимальный подход к терапии рецидива после алло-ТГСК. Возможные терапевтические опции включают в себя реиндукцию, иммуноадоптивную терапию, таргетную терапию, иммунотерапию (CAR T-клеточную терапию), повторную трансплантацию. В данной публикации представлено ретроспективное исследование пациентов с рефрактерным течением онкогематологических заболеваний, а также отторжением трансплантата в группе высокого риска, в связи с чем выполнялась повторная алло-ТГСК. Целью нашей работы был анализ результатов повторной алло-ТГСК у 50 детей с различными онкогематологическими заболеваниями: ОЛЛ – 24, ОМЛ – 15, МДС и ХМПЗ – 11 пациентов. Общая выживаемость (ОВ) по методу Каплан-Майер во всей группе составила 48%, безрецидивная выживаемость (БРВ) – 60%. Медиана наблюдения составила 3 года 7 мес. Пятилетняя ОВ в группе ОЛЛ была 46,2%, в группе ОМЛ – 53,3%, в группе МДС и МПЗ – 44,4%. Причины летальности: рецидив/прогрессия в 17 случаях (65%).Трансплантационная летальность составила 18% (95% ДИ, 8,8%-29,8%). Кумулятивная частота рецидива составила 34% (95% ДИ, 21,6%-48%).

Заключение

Повторная алло-ТГСК – эффективный метод терапии у пациентов с рецидивом заболевания после первой ТГСК. Пациенты, достигшие ремиссии или циторедукции перед алло-ТГСК, имеют статистически достоверный лучший прогноз. Развитие хронической РТПХ легкой и средней степени статистически улучшает ОВ. Не получено достоверной разницы между РИК и МАК. Посттрансплантационная терапия может улучшить результаты повторной алло-ТГСК.

Ключевые слова

Рецидив острого лейкоза, повторная алло-ТГСК, посттрансплантационная терапия, дети.

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Аллогенная трансплантация гемопоэтических стволовых клеток (алло-ТГСК) является стандартом терапии в группе высокого риска онкогематологических заболеваний. Несмотря на это, уровень рецидивов варьирует от 10 до 70%. До сих пор отсутствует оптимальный подход к терапии рецидива после алло-ТГСК. Возможные терапевтические опции включают в себя реиндукцию, иммуноадоптивную терапию, таргетную терапию, иммунотерапию (CAR T-клеточную терапию), повторную трансплантацию. В данной публикации представлено ретроспективное исследование пациентов с рефрактерным течением онкогематологических заболеваний, а также отторжением трансплантата в группе высокого риска, в связи с чем выполнялась повторная алло-ТГСК. Целью нашей работы был анализ результатов повторной алло-ТГСК у 50 детей с различными онкогематологическими заболеваниями: ОЛЛ – 24, ОМЛ – 15, МДС и ХМПЗ – 11 пациентов. Общая выживаемость (ОВ) по методу Каплан-Майер во всей группе составила 48%, безрецидивная выживаемость (БРВ) – 60%. Медиана наблюдения составила 3 года 7 мес. Пятилетняя ОВ в группе ОЛЛ была 46,2%, в группе ОМЛ – 53,3%, в группе МДС и МПЗ – 44,4%. Причины летальности: рецидив/прогрессия в 17 случаях (65%).Трансплантационная летальность составила 18% (95% ДИ, 8,8%-29,8%). Кумулятивная частота рецидива составила 34% (95% ДИ, 21,6%-48%).

Заключение

Повторная алло-ТГСК – эффективный метод терапии у пациентов с рецидивом заболевания после первой ТГСК. Пациенты, достигшие ремиссии или циторедукции перед алло-ТГСК, имеют статистически достоверный лучший прогноз. Развитие хронической РТПХ легкой и средней степени статистически улучшает ОВ. Не получено достоверной разницы между РИК и МАК. Посттрансплантационная терапия может улучшить результаты повторной алло-ТГСК.

Ключевые слова

Рецидив острого лейкоза, повторная алло-ТГСК, посттрансплантационная терапия, дети.

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия
2 Санкт-Петербургский государственный электротехнический университет, Санкт-Петербург, Россия

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия
2 Санкт-Петербургский государственный электротехнический университет, Санкт-Петербург, Россия

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Introduction

Dementia is an incurable loss of mental abilities. Dementia in elderly persons is a frequent condition and presents a large public health problem worldwide [1]. It has many different causes, among them primary genetic factors or the sequelae of other diseases such as vascular disorders. The pathogenesis of these forms of dementia is in general poorly understood, which is the major reason for the helpless attempts at developing therapies. Dementia in children – in contrast – is a rare phenomenon. Its causes are frequently well defined genetically, and its pathogenesis is sometimes well understood, which offers chances to develop a rational therapeutic approach.

The most frequent cause of dementia in young persons is a group of diseases called the Neuronal Ceroid-Lipofuscinoses (NCL). This group comprises more than a dozen diseases that are caused by mutations in different genes. All NCL have characteristic features in common: a variable clinical syndrome of dementia, epilepsy and retinopathy, as well as intracellular storage of an abnormal wax-like material called ceroid lipofuscin. The storage process causes degeneration and death of neuronal and retinal cells. NCL are presently classified according to the responsible mutated genes (CLN1, CLN2 etc.). Some of the gene mutations cause deficiencies of soluble lysosomal enzymes, others lead to dysfunction of lysosomal membrane proteins [2].

CLN2 disease, also called classical late-infantile NCL or Janský-Bielschowsky disease, typically strikes healthy-looking and normally developed 3-year-old toddlers. At this age, the disease manifests itself either strikingly with severe epilepsy, or more gradually with a slowing of further development. This is followed by dramatic loss of all mental and motor abilities and paralleled by severe brain atrophy. At the age of about 6 years, the patients are completely helpless and blind. Death usually occurs at the age of 10 to 15 years. Several cases with later manifestation and slower course of the disease have been described [3].

The disease is caused by a profound deficiency of the lysosomal enzyme tripeptidyl peptidase 1 (TPP1) in the brain. TPP1 is a protease, targeted to lysosomes via a mannose 6-phosphate receptor.

It cleaves tripeptides and is activated by clipping of a prosegment. The natural substrate and function of the enzyme are unknown, but it is clear that the deficiency of the enzyme causes storage of material and neurodegeneration.

Replacing a deficient brain protein

Replacing the missing enzyme in the brain of CLN2 patients became an attractive concept, as many enzymes can now be fabricated, and because free lysosomal enzymes are frequently taken up easily by cells [4]. Human recombinant TPP1 was made by BioMarin. However, as the protein does not cross the blood-brain barrier, injection into the CSF space was used in pre-clinical experiments (Fig. 1). In TPP1-deficient mice this led to attenuation of the disease and extended survival. Important studies were done with a natural dog model of CLN2 disease. These TPP1-deficient dogs received the enzyme by infusion into the lumbar CSF space. Their functional improvement and prolonged survival were impressive compared with untreated dogs, which persuaded us to use the treatment for patients. Studies in monkeys demonstrated that the enzyme, when injected into CSF, reached wide areas of brain.

In a clinical trial, we used the method illustrated in Fig. 2 for the application of TPP1. The enzyme (300 mg of the recombinant human TPP1, cerliponase A, Brineura©) is infused every 2 weeks through the skin into an implanted port, from where it is passed on over a thin tube to a lateral brain ventricle.

Kohlschütter-fig01.jpg

Figure 1. Preclinical studies with intrathecal application of TPP1 in various animal species and conclusions from results

Kohlschutter_fig02.jpg

Figure 2. Method used to apply TPP1 in patients












Kohlschutter_fig03.jpg

Figure 3. Results of clinical scoring of CLN2 patients from 0 to 12 years of age

Note: The score used here is a combined score for the ability of a child to walk and talk. Normal walking and talking abilities result in 3 points for each ability (6 points on this scale). Loss of abilities is scored with 2 points for a minor disturbance, 1 point for a major disturbance, and 0 points for total loss of the respective function. There is a dramatic loss of abilities between 3 and 6 years of age. The course of the disease is very uniform. (Redrawn from [5]).

Measuring efficacy of a new treatment in a rare degenerative brain disease poses the serious problem of control patients. Placebo controls were unacceptable because of the aggressiveness of the procedure and the rarity of the condition. Our solution was to use a clinical scoring system we had specifically developed for CLN2 disease. Scoring of a large number of CLN2 patients over many years had resulted in a rather precise quantitative description of the disease course and its variability [5]. Fig. 3 shows that the clinical course of CLN2 disease is characterized (1) by a dramatic loss of motor and language abilities between the ages of three and six years and (2) by great uniformity in the majority of patients. On this basis it was decided that historical untreated patients could be used as controls.

Clinical trial

A clinical trial with intrathecal TPP1 replacement therapy was performed with international cooperation and Angela Schulz as principal investigator as shown in Fig. 4. This was an open-label phase I/II dose escalation study performed 2013-2016. An extension study is presently ongoing.

Enrolled were twenty-four patients. Of them, 23 completed the study. Efficacy was measured against matched historical controls. Adverse events were relatively minor: We had some infections that could be managed easily, and there were some failures of the intraventricular device. None of the adverse events led to discontinuation of treatment [6].

Results of the trial are illustrated by Fig. 5, which shows the striking capacity of the treatment to halt the expected dramatic loss of motor and language abilities.

Kohlschutter_fig04.jpg

Figure 4. Investigators and participant institutions at the clinical trial with enzyme replacement therapy for CLN2 disease

Kohlschutter_fig05.jpg

Figure 5. Risk of losing motor and language abilities in 23 children with CLN2 disease treated with intraventricular TPP1 (cerliponase A, Brineura©) over a three-year period (blue line), compared to matched untreated historical controls (red line). Probabilities of no functional decline were calculated on the basis of motor-language scoring (see figure 3). From [6]













Summary and conclusions

Effective treatment of CLN2 disease, a rare childhood dementia, has become possible through a combination of favorable factors:
(1) The pathogenetic mechanism was known (lack of a lysosomal enzyme in brain).
(2) The deficient protein could be synthesized.
(3) For preclinical studies, a large experimental animal (natural dog model) was available.
(4) The blood-brain barrier was overcome by intra-ventricular infusion.
(5) The clinical course of the disease and its variability were sufficiently known. Historical controls could therefore be used and placebo controls avoided.

Many questions remain. We have no long-term results of this treatment. Will life-long treatment be necessary? What will be the further development of the treated patients? Are we creating a chronic disease from a dramatically cruel, relatively acute condition? An additional therapeutic approach to the retinopathy will have to be developed. Will new treatments, such as gene therapy, be safe and more effective than enzyme replacement [7]? At any rate, the results of this trial with replacement of a deficient brain protein has pushed open a door. Some principles underlying this study of a rare childhood disease may be applicable to other, much more frequent forms of dementia.

Conflict of interests

None declared.

References

  1. World Health Organization. Dementia: a public health priority. 2012, Geneva: Publications of the World Health Organization.
  2. Nita DA, Mole SE, Minassian BA. Neuronal ceroid lipofuscinoses. Epileptic Disord, 2016; 18(S2): 73-88.
  3. Kohlschütter A, Schulz A. CLN2 Disease (Classic Late Infantile Neuronal Ceroid Lipofuscinosis). Pediatric Endocrinology (Diabetes, Nutrition, Metabolism) Reviews, 2016; 13(Suppl 1): 682-688.
  4. Neufeld EF. Enzyme replacement therapy – a brief history, in Fabry Disease: Perspectives from 5 Years of FOS, A. Mehta, M. Beck, and G. Sunder-Plassmann, Editors. 2006: Oxford.
  5. Nickel M., Simonati A, Jacoby D, Lezius S, Kilian D, Van de Graaf B, Pagovich OE, Kosofsky B, Yohay K, Downs M, Slasor P, Ajayi T, Crystal RG, Kohlschutter A, Sondhi D, Schulz A. Disease characteristics and progression in patients with late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease: an observational cohort study. Lancet Child Adolesc Health, 2018; 2(8): 582-590.
  6. Schulz A, Ajayi T, Specchio N, de Los Reyes E, Gissen P, Ballon D, Dyke JP, Cahan H, Slasor P, Jacoby D, Kohlschutter A, and CLN Study Group. Study of Intraventricular Cerliponase Alfa for CLN2 Disease. N Engl J Med, 2018; 378(20): 898-1907.
  7. Kohlschütter A, Schulz A, Bartsch U, Storch S. Current and Emerging Treatment Strategies for Neuronal Ceroid Lipofuscinoses. CNS Drugs, 2019; 33(4): 315-325.
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Introduction

Dementia is an incurable loss of mental abilities. Dementia in elderly persons is a frequent condition and presents a large public health problem worldwide [1]. It has many different causes, among them primary genetic factors or the sequelae of other diseases such as vascular disorders. The pathogenesis of these forms of dementia is in general poorly understood, which is the major reason for the helpless attempts at developing therapies. Dementia in children – in contrast – is a rare phenomenon. Its causes are frequently well defined genetically, and its pathogenesis is sometimes well understood, which offers chances to develop a rational therapeutic approach.

The most frequent cause of dementia in young persons is a group of diseases called the Neuronal Ceroid-Lipofuscinoses (NCL). This group comprises more than a dozen diseases that are caused by mutations in different genes. All NCL have characteristic features in common: a variable clinical syndrome of dementia, epilepsy and retinopathy, as well as intracellular storage of an abnormal wax-like material called ceroid lipofuscin. The storage process causes degeneration and death of neuronal and retinal cells. NCL are presently classified according to the responsible mutated genes (CLN1, CLN2 etc.). Some of the gene mutations cause deficiencies of soluble lysosomal enzymes, others lead to dysfunction of lysosomal membrane proteins [2].

CLN2 disease, also called classical late-infantile NCL or Janský-Bielschowsky disease, typically strikes healthy-looking and normally developed 3-year-old toddlers. At this age, the disease manifests itself either strikingly with severe epilepsy, or more gradually with a slowing of further development. This is followed by dramatic loss of all mental and motor abilities and paralleled by severe brain atrophy. At the age of about 6 years, the patients are completely helpless and blind. Death usually occurs at the age of 10 to 15 years. Several cases with later manifestation and slower course of the disease have been described [3].

The disease is caused by a profound deficiency of the lysosomal enzyme tripeptidyl peptidase 1 (TPP1) in the brain. TPP1 is a protease, targeted to lysosomes via a mannose 6-phosphate receptor.

It cleaves tripeptides and is activated by clipping of a prosegment. The natural substrate and function of the enzyme are unknown, but it is clear that the deficiency of the enzyme causes storage of material and neurodegeneration.

Replacing a deficient brain protein

Replacing the missing enzyme in the brain of CLN2 patients became an attractive concept, as many enzymes can now be fabricated, and because free lysosomal enzymes are frequently taken up easily by cells [4]. Human recombinant TPP1 was made by BioMarin. However, as the protein does not cross the blood-brain barrier, injection into the CSF space was used in pre-clinical experiments (Fig. 1). In TPP1-deficient mice this led to attenuation of the disease and extended survival. Important studies were done with a natural dog model of CLN2 disease. These TPP1-deficient dogs received the enzyme by infusion into the lumbar CSF space. Their functional improvement and prolonged survival were impressive compared with untreated dogs, which persuaded us to use the treatment for patients. Studies in monkeys demonstrated that the enzyme, when injected into CSF, reached wide areas of brain.

In a clinical trial, we used the method illustrated in Fig. 2 for the application of TPP1. The enzyme (300 mg of the recombinant human TPP1, cerliponase A, Brineura©) is infused every 2 weeks through the skin into an implanted port, from where it is passed on over a thin tube to a lateral brain ventricle.

Kohlschütter-fig01.jpg

Figure 1. Preclinical studies with intrathecal application of TPP1 in various animal species and conclusions from results

Kohlschutter_fig02.jpg

Figure 2. Method used to apply TPP1 in patients












Kohlschutter_fig03.jpg

Figure 3. Results of clinical scoring of CLN2 patients from 0 to 12 years of age

Note: The score used here is a combined score for the ability of a child to walk and talk. Normal walking and talking abilities result in 3 points for each ability (6 points on this scale). Loss of abilities is scored with 2 points for a minor disturbance, 1 point for a major disturbance, and 0 points for total loss of the respective function. There is a dramatic loss of abilities between 3 and 6 years of age. The course of the disease is very uniform. (Redrawn from [5]).

Measuring efficacy of a new treatment in a rare degenerative brain disease poses the serious problem of control patients. Placebo controls were unacceptable because of the aggressiveness of the procedure and the rarity of the condition. Our solution was to use a clinical scoring system we had specifically developed for CLN2 disease. Scoring of a large number of CLN2 patients over many years had resulted in a rather precise quantitative description of the disease course and its variability [5]. Fig. 3 shows that the clinical course of CLN2 disease is characterized (1) by a dramatic loss of motor and language abilities between the ages of three and six years and (2) by great uniformity in the majority of patients. On this basis it was decided that historical untreated patients could be used as controls.

Clinical trial

A clinical trial with intrathecal TPP1 replacement therapy was performed with international cooperation and Angela Schulz as principal investigator as shown in Fig. 4. This was an open-label phase I/II dose escalation study performed 2013-2016. An extension study is presently ongoing.

Enrolled were twenty-four patients. Of them, 23 completed the study. Efficacy was measured against matched historical controls. Adverse events were relatively minor: We had some infections that could be managed easily, and there were some failures of the intraventricular device. None of the adverse events led to discontinuation of treatment [6].

Results of the trial are illustrated by Fig. 5, which shows the striking capacity of the treatment to halt the expected dramatic loss of motor and language abilities.

Kohlschutter_fig04.jpg

Figure 4. Investigators and participant institutions at the clinical trial with enzyme replacement therapy for CLN2 disease

Kohlschutter_fig05.jpg

Figure 5. Risk of losing motor and language abilities in 23 children with CLN2 disease treated with intraventricular TPP1 (cerliponase A, Brineura©) over a three-year period (blue line), compared to matched untreated historical controls (red line). Probabilities of no functional decline were calculated on the basis of motor-language scoring (see figure 3). From [6]













Summary and conclusions

Effective treatment of CLN2 disease, a rare childhood dementia, has become possible through a combination of favorable factors:
(1) The pathogenetic mechanism was known (lack of a lysosomal enzyme in brain).
(2) The deficient protein could be synthesized.
(3) For preclinical studies, a large experimental animal (natural dog model) was available.
(4) The blood-brain barrier was overcome by intra-ventricular infusion.
(5) The clinical course of the disease and its variability were sufficiently known. Historical controls could therefore be used and placebo controls avoided.

Many questions remain. We have no long-term results of this treatment. Will life-long treatment be necessary? What will be the further development of the treated patients? Are we creating a chronic disease from a dramatically cruel, relatively acute condition? An additional therapeutic approach to the retinopathy will have to be developed. Will new treatments, such as gene therapy, be safe and more effective than enzyme replacement [7]? At any rate, the results of this trial with replacement of a deficient brain protein has pushed open a door. Some principles underlying this study of a rare childhood disease may be applicable to other, much more frequent forms of dementia.

Conflict of interests

None declared.

References

  1. World Health Organization. Dementia: a public health priority. 2012, Geneva: Publications of the World Health Organization.
  2. Nita DA, Mole SE, Minassian BA. Neuronal ceroid lipofuscinoses. Epileptic Disord, 2016; 18(S2): 73-88.
  3. Kohlschütter A, Schulz A. CLN2 Disease (Classic Late Infantile Neuronal Ceroid Lipofuscinosis). Pediatric Endocrinology (Diabetes, Nutrition, Metabolism) Reviews, 2016; 13(Suppl 1): 682-688.
  4. Neufeld EF. Enzyme replacement therapy – a brief history, in Fabry Disease: Perspectives from 5 Years of FOS, A. Mehta, M. Beck, and G. Sunder-Plassmann, Editors. 2006: Oxford.
  5. Nickel M., Simonati A, Jacoby D, Lezius S, Kilian D, Van de Graaf B, Pagovich OE, Kosofsky B, Yohay K, Downs M, Slasor P, Ajayi T, Crystal RG, Kohlschutter A, Sondhi D, Schulz A. Disease characteristics and progression in patients with late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease: an observational cohort study. Lancet Child Adolesc Health, 2018; 2(8): 582-590.
  6. Schulz A, Ajayi T, Specchio N, de Los Reyes E, Gissen P, Ballon D, Dyke JP, Cahan H, Slasor P, Jacoby D, Kohlschutter A, and CLN Study Group. Study of Intraventricular Cerliponase Alfa for CLN2 Disease. N Engl J Med, 2018; 378(20): 898-1907.
  7. Kohlschütter A, Schulz A, Bartsch U, Storch S. Current and Emerging Treatment Strategies for Neuronal Ceroid Lipofuscinoses. CNS Drugs, 2019; 33(4): 315-325.
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Оно вызывается дефицитом лизосомного фермента трипептидил-пептидазы 1 (ТРР1) в нервной системе. Настоящая статья является обзором разработок по замещению дефектного энзима посредством повторных инфузий рекомбинантного ТРР1 в желудочки головного мозга. Показана эффективность метода в плане сдерживания быстрой прогрессии заболевания.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Нейрональный цероидный липофусциноз 2, трипептидил-пептидаза 1, дефицит, деменция, рекомбинантный энзим, локальная инфузия, клинический эффект.</p> " ["ELEMENT_PREVIEW_PICTURE_FILE_TITLE"]=> string(159) "Интратекальная заместительная энзимотерапия нейронального цероидного липофусциноза" ["ELEMENT_DETAIL_PICTURE_FILE_ALT"]=> string(159) "Интратекальная заместительная энзимотерапия нейронального цероидного липофусциноза" ["ELEMENT_DETAIL_PICTURE_FILE_TITLE"]=> string(159) "Интратекальная заместительная энзимотерапия нейронального цероидного липофусциноза" ["SECTION_META_TITLE"]=> string(159) "Интратекальная заместительная энзимотерапия нейронального цероидного липофусциноза" ["SECTION_META_KEYWORDS"]=> string(159) "Интратекальная заместительная энзимотерапия нейронального цероидного липофусциноза" ["SECTION_META_DESCRIPTION"]=> string(159) 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["AUTHOR_RU"]=> array(36) { ["ID"]=> string(2) "25" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Авторы" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(9) "AUTHOR_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "25" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24500" ["VALUE"]=> array(2) { ["TEXT"]=> string(54) 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Альфред Кольшюттер

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_RU"]=> array(36) { ["ID"]=> string(2) "26" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(22) "Организации" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "26" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24501" ["VALUE"]=> array(2) { ["TEXT"]=> string(151) "<p>Университетский медицинский центр Гамбург-Эппендорф, Гамбург, Германия</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(139) "

Университетский медицинский центр Гамбург-Эппендорф, Гамбург, Германия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24502" ["VALUE"]=> array(2) { ["TEXT"]=> string(1413) "<p style="text-align: justify;">Нейрональный цероидный липофусциноз (CLN2) является наследственным, быстро прогрессирующим заболеванием раннего возраста, ведущим к деменции, резкой утрате всех навыков и ранней гибели пациента. Оно вызывается дефицитом лизосомного фермента трипептидил-пептидазы 1 (ТРР1) в нервной системе. Настоящая статья является обзором разработок по замещению дефектного энзима посредством повторных инфузий рекомбинантного ТРР1 в желудочки головного мозга. Показана эффективность метода в плане сдерживания быстрой прогрессии заболевания.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Нейрональный цероидный липофусциноз 2, трипептидил-пептидаза 1, дефицит, деменция, рекомбинантный энзим, локальная инфузия, клинический эффект.</p> " ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1357) "

Нейрональный цероидный липофусциноз (CLN2) является наследственным, быстро прогрессирующим заболеванием раннего возраста, ведущим к деменции, резкой утрате всех навыков и ранней гибели пациента. Оно вызывается дефицитом лизосомного фермента трипептидил-пептидазы 1 (ТРР1) в нервной системе. Настоящая статья является обзором разработок по замещению дефектного энзима посредством повторных инфузий рекомбинантного ТРР1 в желудочки головного мозга. Показана эффективность метода в плане сдерживания быстрой прогрессии заболевания.

Ключевые слова

Нейрональный цероидный липофусциноз 2, трипептидил-пептидаза 1, дефицит, деменция, рекомбинантный энзим, локальная инфузия, клинический эффект.

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Alfried Kohlschütter

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University Medical Center Hamburg-Eppendorf, Hamburg, Germany

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Neuronal сeroid-lipofuscinosis 2 (CLN2) is a genetic, rapidly progressive brain disorder of young humans. It leads to dementia, dramatic loss of all abilities and early death. It is caused by the deficiency of the lysosomal enzyme tripeptidyl peptidase 1 (TPP1) in the nervous system. This article is an overview of the development of replacing the deficient enzyme by repeated infusion of recombinant TPP1 in a brain ventricle, shown to be effective in halting the rapid progression of the disease.

Keywords

Neuronal сeroid-lipofuscinosis 2, tripeptidyl peptidase 1, deficiency, dementia, recombinant enzyme, local infusion, clinical effect.

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Alfried Kohlschütter

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Alfried Kohlschütter

" } ["SUMMARY_EN"]=> array(37) { ["ID"]=> string(2) "39" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(21) "Description / Summary" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "39" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "24506" ["VALUE"]=> array(2) { ["TEXT"]=> string(783) "<p style="text-align: justify;">Neuronal сeroid-lipofuscinosis 2 (CLN2) is a genetic, rapidly progressive brain disorder of young humans. It leads to dementia, dramatic loss of all abilities and early death. It is caused by the deficiency of the lysosomal enzyme tripeptidyl peptidase 1 (TPP1) in the nervous system. This article is an overview of the development of replacing the deficient enzyme by repeated infusion of recombinant TPP1 in a brain ventricle, shown to be effective in halting the rapid progression of the disease.</p> <h2>Keywords</h2> <p style="text-align: justify;">Neuronal сeroid-lipofuscinosis 2, tripeptidyl peptidase 1, deficiency, dementia, recombinant enzyme, local infusion, clinical effect.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(727) "

Neuronal сeroid-lipofuscinosis 2 (CLN2) is a genetic, rapidly progressive brain disorder of young humans. It leads to dementia, dramatic loss of all abilities and early death. It is caused by the deficiency of the lysosomal enzyme tripeptidyl peptidase 1 (TPP1) in the nervous system. This article is an overview of the development of replacing the deficient enzyme by repeated infusion of recombinant TPP1 in a brain ventricle, shown to be effective in halting the rapid progression of the disease.

Keywords

Neuronal сeroid-lipofuscinosis 2, tripeptidyl peptidase 1, deficiency, dementia, recombinant enzyme, local infusion, clinical effect.

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Neuronal сeroid-lipofuscinosis 2 (CLN2) is a genetic, rapidly progressive brain disorder of young humans. It leads to dementia, dramatic loss of all abilities and early death. It is caused by the deficiency of the lysosomal enzyme tripeptidyl peptidase 1 (TPP1) in the nervous system. This article is an overview of the development of replacing the deficient enzyme by repeated infusion of recombinant TPP1 in a brain ventricle, shown to be effective in halting the rapid progression of the disease.

Keywords

Neuronal сeroid-lipofuscinosis 2, tripeptidyl peptidase 1, deficiency, dementia, recombinant enzyme, local infusion, clinical effect.

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University Medical Center Hamburg-Eppendorf, Hamburg, Germany

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University Medical Center Hamburg-Eppendorf, Hamburg, Germany

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Альфред Кольшюттер

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Альфред Кольшюттер

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прогрессирующим заболеванием раннего возраста, ведущим к деменции, резкой утрате всех навыков и ранней гибели пациента. Оно вызывается дефицитом лизосомного фермента трипептидил-пептидазы 1 (ТРР1) в нервной системе. Настоящая статья является обзором разработок по замещению дефектного энзима посредством повторных инфузий рекомбинантного ТРР1 в желудочки головного мозга. Показана эффективность метода в плане сдерживания быстрой прогрессии заболевания.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Нейрональный цероидный липофусциноз 2, трипептидил-пептидаза 1, дефицит, деменция, рекомбинантный энзим, локальная инфузия, клинический эффект.</p> " ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1357) "

Нейрональный цероидный липофусциноз (CLN2) является наследственным, быстро прогрессирующим заболеванием раннего возраста, ведущим к деменции, резкой утрате всех навыков и ранней гибели пациента. Оно вызывается дефицитом лизосомного фермента трипептидил-пептидазы 1 (ТРР1) в нервной системе. Настоящая статья является обзором разработок по замещению дефектного энзима посредством повторных инфузий рекомбинантного ТРР1 в желудочки головного мозга. Показана эффективность метода в плане сдерживания быстрой прогрессии заболевания.

Ключевые слова

Нейрональный цероидный липофусциноз 2, трипептидил-пептидаза 1, дефицит, деменция, рекомбинантный энзим, локальная инфузия, клинический эффект.

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Нейрональный цероидный липофусциноз (CLN2) является наследственным, быстро прогрессирующим заболеванием раннего возраста, ведущим к деменции, резкой утрате всех навыков и ранней гибели пациента. Оно вызывается дефицитом лизосомного фермента трипептидил-пептидазы 1 (ТРР1) в нервной системе. Настоящая статья является обзором разработок по замещению дефектного энзима посредством повторных инфузий рекомбинантного ТРР1 в желудочки головного мозга. Показана эффективность метода в плане сдерживания быстрой прогрессии заболевания.

Ключевые слова

Нейрональный цероидный липофусциноз 2, трипептидил-пептидаза 1, дефицит, деменция, рекомбинантный энзим, локальная инфузия, клинический эффект.

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Университетский медицинский центр Гамбург-Эппендорф, Гамбург, Германия

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Университетский медицинский центр Гамбург-Эппендорф, Гамбург, Германия

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Introduction

Normal microbiota colonizing mucosal surfaces is usually identified at clinical laboratories by means of aerobic cultures in standard agar cultures. It comprises, mostly, saprophytic and oppor-tunistic bacteria. In particular, the microflora of normal oral mucosa is well known, and the most common bacterial species are identified [1, 2]. Members of normal oral microbiota exist as com-mensal flora in a symbiotic state within host tissue, thus suppressing colonization with more path-ogenic bacterial species as presented in excellent review by Hull, Chow [1]. The most common aerobic species isolated in clinical cultures from oral cavity and oropharynx mucosa include Gram-positive Streptococci (e.c., S.viridans), Staphylococcus epidermidis, Corynebacterium spp., Neisseria spp., etc. Moreover, oral cavity, and, especially, ginvival mucosa contain multiple an-aerobic flora which is represented by hundreds species, most of which could be detected only by DNA-based diagnostic techniques [3].

Intensive chemotherapy of cancer and, especially, hematopoietic stem cell transplantation (HSCT) are followed by severe immunosuppression. I.e., pronounced neutro-and lymphopenia develops within 1-2 weeks after HSCT, accomplished by reactivation of endogenous viruses, as well as opportunistic bacteria and nosocomial pathogens which may colonize different mucosal surfaces and replace conventional microflora, thus leading to local dysbacteriosis [4]. Local infections are a common consequence of severe leukopenia. E.g., a previous study of 143 HSCT patients [5] has shown nosocomial bacterial infections in ca. 25% of cases, especially, septicemia (43%), and respiratory infections. Some pathogenetic links between infections and oral mucositis were suggested by Laheji et al. [6].

In most oncohematological clinics, the bacterial cultures from local biomaterials are performed by clinical indications, e.g., due to febrile neutropenia or local inflammatory loci. Surveillance microbial diagnostics is also sometimes implemented, however, without any clinical benefits [7]. Majority of these studies concern reactivation/reinfection with different viruses, in particular, herpesviruses, parvoviruses etc. Studies in bacterial infections mainly deal with isolation of aerobically cultivated pathogenic strains, their toxins and antibiotic resistance, mainly, Pseudomonas spp., Klebsiella pneumoniae, Clostridium difficile or enteropathogenic E.coli infections.

To our knowledge, there were only few studies of microbial landscape in oral mucosa at different periods after HSCT [7]. In most cases, these studies are epidemiologically oriented, and provide relative frequencies of local pathogenic microorganisms in HSCT patients, and their potential correlations with clinically significant infections [8].

Only few works concern time dynamics of the microbial landscape in the patients after HSCT, however, lacking sufficient data on possible relations between the shifts of oral microbiota and common HSCT complications, i.e., local infections, oral mucositis, or acute graft-versus-host disease (aGVHD).

The aim of the present study was to estimate the frequency of cultivable aerobic microflora obtained from oral mucosa smears taken before HSCT and during 4 months posttransplant. We have evaluated time course for the most common microorganisms, as well as probable interactions between the frequency of their detection rates and occurrence of characteristic complications after HSCT, including mucositis, febrile neutropenia, acute GVHD, and clinically significant infectious complications.

Patients and methods

In the present study, we have evaluated results of clinical bacterial cultures from 630 smears of the oropharynx and tongue taken from 202 patients at the age of 1 to 69 (108 males and 94 females) subjected to allogeneic HSCT at the R. Gorbacheva Memorial Institute of Children Oncology, Hematology and Transplantation from January 2016 to December 2017. Allogeneic HSCT was performed for acute myeloblastic leukemia (AML, n-63), chronic myeloid leukemia (CML, n=28), acute lymphoblastic leukemia (ALL, n=34), severe aplastic anemia (SAA, n=22), refractory anemia (RA, n=6), plasma cell dysplasia (7 cases), primary myelofibrosis (PMF, n=10). Inborn genetic disorders were treated in 9 children, Hodgkin lymphoma, in 6 patients, non-Hodgkin’s lymphomas, in 4 cases, juvenile myelomonocytic leukemia, in 3 patients; polycythemia vera, in 2 patients, essential thrombocytopenia, etc. Myeloablative conditioning regimens were performed in for 122 patients, and non-myeloablative protocols were applied in 80 cases. Bone marrow was used as a source of stem cells in 97 cases, and peripheral stem cells, in 105 patients. HSCT was carried out from related HLA-compatible donors (n=35), related haploidentical donors (33 patients), or unrelated HLA-matched donors (112 cases). Patients or their close relatives signed appropriate informed consent for their participation in the research program, and usage of their personal medical data for the scientific evaluation. The smears for bacteriological studies were taken from oropharynx or tongue. Subsequent sampling was made before HSCT and within 120 days (4 months posttransplant), according to clinical indications from the attained physicians. The biomaterials were conserved, stored and processed at the Department of Clinical Microbiology, being seeded on agar plates and cultured on the conventional nutrient media under aerobic conditions.

Statistical analysis included the patients with at least 1 result before HSCT, and 2 results within 4 months posttransplant. All the data on clinical characteristics of the patients, HSCT parameters, conditioning therapy, posttransplant complications, and bacterial cultures were taken from the hospital reports of R. Gorbacheva Memorial Institute, and laboratory database at the 1st St. Petersburg State I. Pavlov Medical University. Statistical evaluation was performed by means of the STATISTIСA 5.0 software, by means of non-parametric single-factor analysis using Hi-square criterion and Pearson correlation quotients to evaluate significance of differences between the samples. In some series, parametric methods were used using Student t-test.

Results

Common bacteria detectable in oral cavity

Total sample included 630 cultures from oral smears, with positive results for 389 specimens (61.8%). One microbial species was detected in 250 cases; 2 species, в 117 cultures, and 3 microbial species, in 22 cultures. The most common microorganisms were as follows: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp., 66/630 (10.5%); Corynebacterium spp., 78/630 (12.4%). Other bacteria were detected in <1% of the cultures (S. saprophyticus., Pseudomonas spp., S.faecalis, S.faecium). For statistical reasons, only 5 most common bacterial species were included into further analysis, i.e., S.viridans , K.pneumoniae, S.epidermidis, Neisseria spp., Corynebacterum spp.

Age factor

Frequency of the five common bacterial species in the oral cavity smears is shown in Table 1. For the age groups of 0-5, 6-14, 15-21 y.o., and adult persons (>22 y.o.), some significant age dependencies were revealed. I.e., S.viridans detection was maximal in smaller children (0 to 5 years old), as compared to the groups of 6-14 and 15-21 (p<0.02), then showing an increase in adult patients. Similar tendency was seen for Klebsiella pneumoniae, with higher detection rates in small children and adult patients.

Table 1. Detection of the common bacterial species in the specimens from oral cavity in children and adults at the whole observation period (-60 to +120 days post-HSCT)

Chukhlovin-tab01.jpg

Time dependence of microbial detection

Frequency of positive cultures was time-dependent, and varied for different microorganisms (Table 2). However, a significant drop was evident for all the detectable microbial species during 1st month posttransplant, most obviously, due to intensive antibacterial prophylaxis started before HSCT. The early suppression was most pronounced for S.viridans, and S.epidermidis, a normal component of oral microflora. Interestingly, an initial marginal decrease of K.pneumoniae detection was followed by its sharp increase at 2-4 months (Fig. 1).

Table 2. Time dependence for the detection frequency of common aerobic microorganisms cultured from the oral cavity of HSCT patients

Chukhlovin-tab02.jpg

Note: The difference levels (p values) were determined by the non-parametric Hi-square test. This time dynamics for 3 distinct bacterial species is also shown in Fig. 1.

Chukhlovin-fig01.jpg

Figure 1. Prevalence of S.viridans (A), S.epidermidis (B), and K.pneumoniae (C) in bacterial cultures within 1-4 months after HSCT

Abscissa, terms posttransplant (months). Ordinate, frequency of positive results. Points at the graph show M+m values.

HSCT parameters

As seen from Table 3, we have not found any significant associations between the frequency of positive cultures of common oral microbes, and source of stem cells (bone marrow vs peripheral stem cells), or type of HSCT (related vs unrelated vs haploidentical HSCT). Meanwhile, decreased detection rates of S.epidermidis proved to be significantly associated with more intensive (myeloablative) therapy, as compared to reduced-intensity regimens (Table 3). As expected, K.pneumoniae was associated with clinically significant infectious complications of either location.

Table 3. Detection rates for some common oral microorganisms in HSCT recipients over 120 days post-HSCT: dependence on transplant characteristics and posttransplant complications

Chukhlovin-tab03.jpg

Mucositis, febrile neutropenia and clinical infections

In more than 50% of patients, oral mucositis was observed within early terms after HSCT. Our data have confirmed higher frequency of oral mucositis after myeloablative conditioning treat-ment (181/330, 54.9%) against 33.1% (80/242) following reduced-intensity conditioning (р=2×10-7). Moreover, higher occurrence of febrile neutropenia was found in the group of patients with mucositis (50.3%) against 30.7% in mucositis-free cases (р=4×10-8), as seen from Table 3. Taking into account similar terms of mucositis and dysbacteriosis (1st month posttransplant), one could suggest infectious component for the oral inflammation. However, we did not reveal any significant correlations between mucositis rates, and frequency of positive cultures of the common microorganisms from oral mucosa (Table 3), thus suggesting a minimal role of these bacteria in genesis of the posttransplant oral inflammation. In addition, we have not revealed any significant correlations between presence of the major species of oral microflora, and acute skin GVHD (Table 3). Absence of correlations between bacterial landscape and main clinical complications may be connected with active antibacterial therapy over the period of post-transplant leukopenia (1-2 months post-HSCT).

Further, we have performed some comparisons between the frequencies of bacterial associations, rates of febrile neutropenia and clinically significant infections posttransplant. This survey has shown that the more frequent associations of >3 microbial species tends to correlate with higher FUO prevalence (Table 4). Increased incidence of FUO was also found after myeloablative conditioning (р=0.001), as well as in the group with oral mucositis (p=4×10-8), as well as in cases of skin aGvHD (p=0.002), thus reflecting evident inflammatory component in the both types of skin and mucosal damage, however, without any association with. Hence, early neutropenic fever is more likely associated with cytostatic chemotherapy and allogeneic HSCT, rather than with local clinically significant infections posttransplant.

Interestingly, the numbers of transplanted hematopoietic stem cells (CD34+ cells) have shown a distinct direct correlation with occurrence of early mucositis (r=0.20; p=8×107) thus again suggesting a clear relation between oral mucositis and potential immune effects of allogeneic hematopoietic cells posttransplant.

Table 4. Frequency of FUO and microbial associations: effects of different HSCT parameters and posttransplant complications

Chukhlovin-tab04.jpg

Microbial resistance

Klebsiella is the mostly discussed bacterial pathogen with high prevalence of antibiotic-resistant strains. We have tested in vitro the resistance of K.pneumoniae isolates seeded from oral cavity of 11 HSCT patients in 2017 (Table 5). Majority of the isolates showed resistance for most antibiotics commonly used in septic HSCT patients. However, most of the K.pneumoniae isolates proved to be sensitive to amikacin, gentamycin and meropenem.

Table 5. Differential in vitro antibiotic sensitivity of K.pneumoniae isolates obtained from oral cavity after hematopoietic stem cell transplantation

Chukhlovin-tab05.jpg

Note: R, resistance; S, sensitivity of the microorganism; I, intermediate values

Of note, in the patient F.Z., the initial sensitive phenotype was 1 month later changed to polyresistance, except of amikacin and meropenem, thus, probably, reflecting its replacement by a resistant bacterial strain.

Bacterial pathogens at the sites of dental infections

In 10 cases, tooth extraction was performed during 1st month after HSCT, due to acute pulpitis and local septic process. Bacterial isolates from the post-extraction wounds were obtained in 10 cases, and the following bacteria were detected: Pseudomonas aeruginosa in 3 samples, S.viridans in 2 cases, Neisseria spp., S.faecalis, S.epidermidis were found in other specimens. Of them, only P.aeruginosa is a well-known pathogenic agent to cause purulent local inflammation.

Discussion

Overall rates of positive microbial cultures from oral cavity were rather high (61.8%). Cytotoxic damage to oral epithelium due to previous chemotherapy, as well as deep leukopenia after conditioning treatment and HSCT are the key pre-requisites for oral bacterial colonization [9]. However, conventional culturing of oral samples taken at different terms post HSCT (D-60 to D+120) have shown a sufficient decrease in cultivable oral microflora within 1st month posttransplant. Such suppression of microflora could be readily explained by anti-microbial treatment administered during intensive cytostatic therapy of cancer [10, 11]. In our study, a deep suppression was shown for S.viridans, S.epidermidis, and K. pneumoniae. The latter is the known Gram-negative pathogen causing infectious complications at later terms (2-4 months posttransplant), with a tendency for polyresistance for antibiotics, as confirmed in our study.

Microbial associations of 3 or more bacteria could be found in some samples. Of note, posttransplant clinically significant infections proved to be much more often in cases with >3 microorganisms found in the oral samples, thus suggesting the microbial associations to be a marker of suppressed antimicrobial immunity post-HSCT.

Like as other common posttransplant complications, clinical infectious conditions did not show any direct correlations with either positive oral bacterial cultures, or early post-transplant mucositis (Table 3 and 4). Rather, fever of unknown origin (FUO), an early inflammatory condition without clear infectious reason, had a distinct relationship with myeloablative treatment, oral mucositis, and skin GvHD. Oral mucositis may be, at least, in part, dependent on common herpesvirus activation post-HSCT [12].

Among common bacterial species found in oral cavity of the patients, Klebsiella pneumoniae is known to produce a number of polyresistant strains, as confirmed in our study (Table 5). This feature of K.pneumoniae is typical to nosocomial infections. Decreased rates of Klebsiella detection at early terms (1st month) following HSCT could be explained by relative sensitivity of most endogenous bacterial populations to routine decontaminating therapy. At later terms (2nd and 3rd months) the sensitivity-adapted antibiotic treatment in the patients with prolonged infectious complications under the ICU conditions, may cause selection of Klebsiella strains with extended resistance spectrum as, it was revealed in our F.Z. patient at 5-6 months after HSCT.

Therefore, phenotypic and molecular monitoring of standard lactamase genes in clinical isolates before and after HSCT may further elucidate the mechanisms of resistance selection among Klebsiella and other Gram-negative bacteia, aiming for development of combined treatment schedules [13].

In this respect, the role of oral bacterial infection in development of mucositis and GvHD still remains unclear. Meanwhile, over last decades, a crucial role of gut microbiome and altered intestinal mucosa due to broad-spectrum antibacterial therapy becomes more clear and clinically confirmed, both for infectious complications and acute GvHD [14, 15, 16].

Conclusion

Cytotoxic damage of oral mucosa during intensive chemotherapy may create sufficient prerequisites for bacterial colonization. Moreover, antibacterial prophylaxis in HSCT patients causes deep suppression of oral microflora during 1st month post-HSCT, despite severe leukopenia in the patients. Known antibacterial pathogens, e.g., K.pneumoniae, or P.aerugunosa are revealed in oral cavity within 1-3 months posttransplant.

The consequences of combined anticancer and antibacterial treatment in HSCT patients deserve further studies, in particular, its correlation with mucositis, acute GvHD which may be still underlied by mixed microbial and viral infections. Bacterial imbalance post-HSCT may be a pre-requisite for additional anti-infectious therapy in complex clinical conditions involving infectious/cytotoxic/autoaggressive pathogenetic components. Significant shifts in common bacterial landscape caused by immunotoxic treatment and antibacterial therapy enable growth of other bacterial and fungal pathogens that should be studied in details by means of NGS techniques which should reveal, e.g., anaerobic pathogenic bacteria in posttransplant conditions.

References

  1. Hull MW, Chow AW. Indigenous microflora and innate immunity of the head and neck. Infect Dis Clin N Am 2007; 21: 265-282.
  2. Hegde MC, Kumar A, Bhat G, Sreedharan S. Oral microflora: a comparative study in HIV and normal patients. Indian J Otolaryngol Head Neck Surg. 2014; 66(Suppl 1): S126-S132.
  3. Aas JA, Paster BJ, Stokes LN, Olsen I, Dewhirst FE. Defining the normal bacterial flora of the oral cavity. J. Clin. Microbiol. 2005; 43(11): 5721-5732.
  4. Chukhlovin AB, Pankratova OS. Opportunistic microflora at unusual sites: marker pathogens in severe posttransplant immune deficiency. Cell Ther Transplant. 2017; 6(4): 28-41.
  5. Marena C, Zecca M, Carenini ML, Bruschi A, Bassi ML, Olivieri P, Azzaretti S, Locatelli F. Incidence of, and risk factors for, nosocomial infections among hematopoietic stem cell transplantation recipients, with impact on procedure-related mortality. Infect Control Hosp Epidemiol. 2001;22(8):510-517.
  6. Lahei AMGA, de Soet JJ, von dem Borne PA, Kuijper EJ, Kraneveld EA, van Loveren C, Raber-Durlacher JE. Oral bacteria and yeasts in relationship to oral ulcerations in hematopoietic stem cell transplant recipients. Support Care Cancer. 2012; 20:3231-3240.
  7. Czirók E, Prinz GY, Dénes R, Reményi P, Herendi A. Value of surveillance cultures in a bone marrow transplantation unit. J Med Microbiol. 1997;46(9):785-791.
  8. Vavilov VN, Averianova MY, Bondarenko SN, Stancheva NV, Zubarovskaya LS, Afanasyev BV. Bacterial infections within early period after allogeneic bone marrow transplantation. Ter Arkhiv, 2015; 87(7): 88-93 (In Russian).
  9. Grigoriants AP, Rabinowitch IM, Chukhlovin AB. Stomatological problems and infectious complications after hematopoietic stem cell transplantation. Cell Ther Transplant 2017; 7(2):10-19.
  10. Bergmann OJ. Alterations in oral microflora and pathogenesis of acute oral infections during remission-induction therapy in patients with acute myeloid leukaemia. Scand J Infect Dis. 1991;23(3):355-66.
  11. Jones LR, Toth BB, Keene HJ. Effects of total body irradiation on salivary gland function and caries-associated oral microflora in bone marrow transplant patients. Oral Surg Oral Med Oral Pathol. 1992;73(6):670-676.
  12. Pankratova OS, Chukhlovin AB, Shiryaev SN, Eismont YA, Vavilov VN, Zubarovskaya LS, Afanasyev BV. Herpesviruses and oral ulcerations in hematopoietic SCT recipients. Bone Marrow Transplantation. 2013; 48:1364-1365.
  13. Fritzenwanker M, Imirzalioglu C, Herold S, Wagenlehner FM, Zimmer KP, Chakraborty T. Treatment Options for Carbapenem- Resistant Gram-Negative Infections. Dtsch Arztebl Int. 2018 ;115(20-21):345-352.
  14. Blijlevens NMA, Donnelly JP, De Pauw BE. Mucosal barrier injury: biology, pathology, clinical counterparts and consequences of intensive treatment for haematological malignancy: an overview. Bone Marrow Transplantation (2000) 25, 1269-1278.
  15. Weber D, Jenq RR, Peled JU, Taur Y, Hiergeist A, Koestler J, Dettmer K, Weber M, Wolff D, Hahn J, Pamer EG, Herr W, Gessner A, Oefner PJ, van den Brink MRM, Holler E. Microbiota disruption induced by early use of broad-spectrum antibiotics is an independent risk factor of outcome after allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2017; 23(5):845-852.
  16. Goloshchapov OV, Kucher MA, Chukhlovin AB. Gut microbiome in hematopoietic stem cell transplantation: patient- and treatment-related factors. Cell Ther Transplant. 2018; 7(4):16-28.
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Introduction

Normal microbiota colonizing mucosal surfaces is usually identified at clinical laboratories by means of aerobic cultures in standard agar cultures. It comprises, mostly, saprophytic and oppor-tunistic bacteria. In particular, the microflora of normal oral mucosa is well known, and the most common bacterial species are identified [1, 2]. Members of normal oral microbiota exist as com-mensal flora in a symbiotic state within host tissue, thus suppressing colonization with more path-ogenic bacterial species as presented in excellent review by Hull, Chow [1]. The most common aerobic species isolated in clinical cultures from oral cavity and oropharynx mucosa include Gram-positive Streptococci (e.c., S.viridans), Staphylococcus epidermidis, Corynebacterium spp., Neisseria spp., etc. Moreover, oral cavity, and, especially, ginvival mucosa contain multiple an-aerobic flora which is represented by hundreds species, most of which could be detected only by DNA-based diagnostic techniques [3].

Intensive chemotherapy of cancer and, especially, hematopoietic stem cell transplantation (HSCT) are followed by severe immunosuppression. I.e., pronounced neutro-and lymphopenia develops within 1-2 weeks after HSCT, accomplished by reactivation of endogenous viruses, as well as opportunistic bacteria and nosocomial pathogens which may colonize different mucosal surfaces and replace conventional microflora, thus leading to local dysbacteriosis [4]. Local infections are a common consequence of severe leukopenia. E.g., a previous study of 143 HSCT patients [5] has shown nosocomial bacterial infections in ca. 25% of cases, especially, septicemia (43%), and respiratory infections. Some pathogenetic links between infections and oral mucositis were suggested by Laheji et al. [6].

In most oncohematological clinics, the bacterial cultures from local biomaterials are performed by clinical indications, e.g., due to febrile neutropenia or local inflammatory loci. Surveillance microbial diagnostics is also sometimes implemented, however, without any clinical benefits [7]. Majority of these studies concern reactivation/reinfection with different viruses, in particular, herpesviruses, parvoviruses etc. Studies in bacterial infections mainly deal with isolation of aerobically cultivated pathogenic strains, their toxins and antibiotic resistance, mainly, Pseudomonas spp., Klebsiella pneumoniae, Clostridium difficile or enteropathogenic E.coli infections.

To our knowledge, there were only few studies of microbial landscape in oral mucosa at different periods after HSCT [7]. In most cases, these studies are epidemiologically oriented, and provide relative frequencies of local pathogenic microorganisms in HSCT patients, and their potential correlations with clinically significant infections [8].

Only few works concern time dynamics of the microbial landscape in the patients after HSCT, however, lacking sufficient data on possible relations between the shifts of oral microbiota and common HSCT complications, i.e., local infections, oral mucositis, or acute graft-versus-host disease (aGVHD).

The aim of the present study was to estimate the frequency of cultivable aerobic microflora obtained from oral mucosa smears taken before HSCT and during 4 months posttransplant. We have evaluated time course for the most common microorganisms, as well as probable interactions between the frequency of their detection rates and occurrence of characteristic complications after HSCT, including mucositis, febrile neutropenia, acute GVHD, and clinically significant infectious complications.

Patients and methods

In the present study, we have evaluated results of clinical bacterial cultures from 630 smears of the oropharynx and tongue taken from 202 patients at the age of 1 to 69 (108 males and 94 females) subjected to allogeneic HSCT at the R. Gorbacheva Memorial Institute of Children Oncology, Hematology and Transplantation from January 2016 to December 2017. Allogeneic HSCT was performed for acute myeloblastic leukemia (AML, n-63), chronic myeloid leukemia (CML, n=28), acute lymphoblastic leukemia (ALL, n=34), severe aplastic anemia (SAA, n=22), refractory anemia (RA, n=6), plasma cell dysplasia (7 cases), primary myelofibrosis (PMF, n=10). Inborn genetic disorders were treated in 9 children, Hodgkin lymphoma, in 6 patients, non-Hodgkin’s lymphomas, in 4 cases, juvenile myelomonocytic leukemia, in 3 patients; polycythemia vera, in 2 patients, essential thrombocytopenia, etc. Myeloablative conditioning regimens were performed in for 122 patients, and non-myeloablative protocols were applied in 80 cases. Bone marrow was used as a source of stem cells in 97 cases, and peripheral stem cells, in 105 patients. HSCT was carried out from related HLA-compatible donors (n=35), related haploidentical donors (33 patients), or unrelated HLA-matched donors (112 cases). Patients or their close relatives signed appropriate informed consent for their participation in the research program, and usage of their personal medical data for the scientific evaluation. The smears for bacteriological studies were taken from oropharynx or tongue. Subsequent sampling was made before HSCT and within 120 days (4 months posttransplant), according to clinical indications from the attained physicians. The biomaterials were conserved, stored and processed at the Department of Clinical Microbiology, being seeded on agar plates and cultured on the conventional nutrient media under aerobic conditions.

Statistical analysis included the patients with at least 1 result before HSCT, and 2 results within 4 months posttransplant. All the data on clinical characteristics of the patients, HSCT parameters, conditioning therapy, posttransplant complications, and bacterial cultures were taken from the hospital reports of R. Gorbacheva Memorial Institute, and laboratory database at the 1st St. Petersburg State I. Pavlov Medical University. Statistical evaluation was performed by means of the STATISTIСA 5.0 software, by means of non-parametric single-factor analysis using Hi-square criterion and Pearson correlation quotients to evaluate significance of differences between the samples. In some series, parametric methods were used using Student t-test.

Results

Common bacteria detectable in oral cavity

Total sample included 630 cultures from oral smears, with positive results for 389 specimens (61.8%). One microbial species was detected in 250 cases; 2 species, в 117 cultures, and 3 microbial species, in 22 cultures. The most common microorganisms were as follows: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp., 66/630 (10.5%); Corynebacterium spp., 78/630 (12.4%). Other bacteria were detected in <1% of the cultures (S. saprophyticus., Pseudomonas spp., S.faecalis, S.faecium). For statistical reasons, only 5 most common bacterial species were included into further analysis, i.e., S.viridans , K.pneumoniae, S.epidermidis, Neisseria spp., Corynebacterum spp.

Age factor

Frequency of the five common bacterial species in the oral cavity smears is shown in Table 1. For the age groups of 0-5, 6-14, 15-21 y.o., and adult persons (>22 y.o.), some significant age dependencies were revealed. I.e., S.viridans detection was maximal in smaller children (0 to 5 years old), as compared to the groups of 6-14 and 15-21 (p<0.02), then showing an increase in adult patients. Similar tendency was seen for Klebsiella pneumoniae, with higher detection rates in small children and adult patients.

Table 1. Detection of the common bacterial species in the specimens from oral cavity in children and adults at the whole observation period (-60 to +120 days post-HSCT)

Chukhlovin-tab01.jpg

Time dependence of microbial detection

Frequency of positive cultures was time-dependent, and varied for different microorganisms (Table 2). However, a significant drop was evident for all the detectable microbial species during 1st month posttransplant, most obviously, due to intensive antibacterial prophylaxis started before HSCT. The early suppression was most pronounced for S.viridans, and S.epidermidis, a normal component of oral microflora. Interestingly, an initial marginal decrease of K.pneumoniae detection was followed by its sharp increase at 2-4 months (Fig. 1).

Table 2. Time dependence for the detection frequency of common aerobic microorganisms cultured from the oral cavity of HSCT patients

Chukhlovin-tab02.jpg

Note: The difference levels (p values) were determined by the non-parametric Hi-square test. This time dynamics for 3 distinct bacterial species is also shown in Fig. 1.

Chukhlovin-fig01.jpg

Figure 1. Prevalence of S.viridans (A), S.epidermidis (B), and K.pneumoniae (C) in bacterial cultures within 1-4 months after HSCT

Abscissa, terms posttransplant (months). Ordinate, frequency of positive results. Points at the graph show M+m values.

HSCT parameters

As seen from Table 3, we have not found any significant associations between the frequency of positive cultures of common oral microbes, and source of stem cells (bone marrow vs peripheral stem cells), or type of HSCT (related vs unrelated vs haploidentical HSCT). Meanwhile, decreased detection rates of S.epidermidis proved to be significantly associated with more intensive (myeloablative) therapy, as compared to reduced-intensity regimens (Table 3). As expected, K.pneumoniae was associated with clinically significant infectious complications of either location.

Table 3. Detection rates for some common oral microorganisms in HSCT recipients over 120 days post-HSCT: dependence on transplant characteristics and posttransplant complications

Chukhlovin-tab03.jpg

Mucositis, febrile neutropenia and clinical infections

In more than 50% of patients, oral mucositis was observed within early terms after HSCT. Our data have confirmed higher frequency of oral mucositis after myeloablative conditioning treat-ment (181/330, 54.9%) against 33.1% (80/242) following reduced-intensity conditioning (р=2×10-7). Moreover, higher occurrence of febrile neutropenia was found in the group of patients with mucositis (50.3%) against 30.7% in mucositis-free cases (р=4×10-8), as seen from Table 3. Taking into account similar terms of mucositis and dysbacteriosis (1st month posttransplant), one could suggest infectious component for the oral inflammation. However, we did not reveal any significant correlations between mucositis rates, and frequency of positive cultures of the common microorganisms from oral mucosa (Table 3), thus suggesting a minimal role of these bacteria in genesis of the posttransplant oral inflammation. In addition, we have not revealed any significant correlations between presence of the major species of oral microflora, and acute skin GVHD (Table 3). Absence of correlations between bacterial landscape and main clinical complications may be connected with active antibacterial therapy over the period of post-transplant leukopenia (1-2 months post-HSCT).

Further, we have performed some comparisons between the frequencies of bacterial associations, rates of febrile neutropenia and clinically significant infections posttransplant. This survey has shown that the more frequent associations of >3 microbial species tends to correlate with higher FUO prevalence (Table 4). Increased incidence of FUO was also found after myeloablative conditioning (р=0.001), as well as in the group with oral mucositis (p=4×10-8), as well as in cases of skin aGvHD (p=0.002), thus reflecting evident inflammatory component in the both types of skin and mucosal damage, however, without any association with. Hence, early neutropenic fever is more likely associated with cytostatic chemotherapy and allogeneic HSCT, rather than with local clinically significant infections posttransplant.

Interestingly, the numbers of transplanted hematopoietic stem cells (CD34+ cells) have shown a distinct direct correlation with occurrence of early mucositis (r=0.20; p=8×107) thus again suggesting a clear relation between oral mucositis and potential immune effects of allogeneic hematopoietic cells posttransplant.

Table 4. Frequency of FUO and microbial associations: effects of different HSCT parameters and posttransplant complications

Chukhlovin-tab04.jpg

Microbial resistance

Klebsiella is the mostly discussed bacterial pathogen with high prevalence of antibiotic-resistant strains. We have tested in vitro the resistance of K.pneumoniae isolates seeded from oral cavity of 11 HSCT patients in 2017 (Table 5). Majority of the isolates showed resistance for most antibiotics commonly used in septic HSCT patients. However, most of the K.pneumoniae isolates proved to be sensitive to amikacin, gentamycin and meropenem.

Table 5. Differential in vitro antibiotic sensitivity of K.pneumoniae isolates obtained from oral cavity after hematopoietic stem cell transplantation

Chukhlovin-tab05.jpg

Note: R, resistance; S, sensitivity of the microorganism; I, intermediate values

Of note, in the patient F.Z., the initial sensitive phenotype was 1 month later changed to polyresistance, except of amikacin and meropenem, thus, probably, reflecting its replacement by a resistant bacterial strain.

Bacterial pathogens at the sites of dental infections

In 10 cases, tooth extraction was performed during 1st month after HSCT, due to acute pulpitis and local septic process. Bacterial isolates from the post-extraction wounds were obtained in 10 cases, and the following bacteria were detected: Pseudomonas aeruginosa in 3 samples, S.viridans in 2 cases, Neisseria spp., S.faecalis, S.epidermidis were found in other specimens. Of them, only P.aeruginosa is a well-known pathogenic agent to cause purulent local inflammation.

Discussion

Overall rates of positive microbial cultures from oral cavity were rather high (61.8%). Cytotoxic damage to oral epithelium due to previous chemotherapy, as well as deep leukopenia after conditioning treatment and HSCT are the key pre-requisites for oral bacterial colonization [9]. However, conventional culturing of oral samples taken at different terms post HSCT (D-60 to D+120) have shown a sufficient decrease in cultivable oral microflora within 1st month posttransplant. Such suppression of microflora could be readily explained by anti-microbial treatment administered during intensive cytostatic therapy of cancer [10, 11]. In our study, a deep suppression was shown for S.viridans, S.epidermidis, and K. pneumoniae. The latter is the known Gram-negative pathogen causing infectious complications at later terms (2-4 months posttransplant), with a tendency for polyresistance for antibiotics, as confirmed in our study.

Microbial associations of 3 or more bacteria could be found in some samples. Of note, posttransplant clinically significant infections proved to be much more often in cases with >3 microorganisms found in the oral samples, thus suggesting the microbial associations to be a marker of suppressed antimicrobial immunity post-HSCT.

Like as other common posttransplant complications, clinical infectious conditions did not show any direct correlations with either positive oral bacterial cultures, or early post-transplant mucositis (Table 3 and 4). Rather, fever of unknown origin (FUO), an early inflammatory condition without clear infectious reason, had a distinct relationship with myeloablative treatment, oral mucositis, and skin GvHD. Oral mucositis may be, at least, in part, dependent on common herpesvirus activation post-HSCT [12].

Among common bacterial species found in oral cavity of the patients, Klebsiella pneumoniae is known to produce a number of polyresistant strains, as confirmed in our study (Table 5). This feature of K.pneumoniae is typical to nosocomial infections. Decreased rates of Klebsiella detection at early terms (1st month) following HSCT could be explained by relative sensitivity of most endogenous bacterial populations to routine decontaminating therapy. At later terms (2nd and 3rd months) the sensitivity-adapted antibiotic treatment in the patients with prolonged infectious complications under the ICU conditions, may cause selection of Klebsiella strains with extended resistance spectrum as, it was revealed in our F.Z. patient at 5-6 months after HSCT.

Therefore, phenotypic and molecular monitoring of standard lactamase genes in clinical isolates before and after HSCT may further elucidate the mechanisms of resistance selection among Klebsiella and other Gram-negative bacteia, aiming for development of combined treatment schedules [13].

In this respect, the role of oral bacterial infection in development of mucositis and GvHD still remains unclear. Meanwhile, over last decades, a crucial role of gut microbiome and altered intestinal mucosa due to broad-spectrum antibacterial therapy becomes more clear and clinically confirmed, both for infectious complications and acute GvHD [14, 15, 16].

Conclusion

Cytotoxic damage of oral mucosa during intensive chemotherapy may create sufficient prerequisites for bacterial colonization. Moreover, antibacterial prophylaxis in HSCT patients causes deep suppression of oral microflora during 1st month post-HSCT, despite severe leukopenia in the patients. Known antibacterial pathogens, e.g., K.pneumoniae, or P.aerugunosa are revealed in oral cavity within 1-3 months posttransplant.

The consequences of combined anticancer and antibacterial treatment in HSCT patients deserve further studies, in particular, its correlation with mucositis, acute GvHD which may be still underlied by mixed microbial and viral infections. Bacterial imbalance post-HSCT may be a pre-requisite for additional anti-infectious therapy in complex clinical conditions involving infectious/cytotoxic/autoaggressive pathogenetic components. Significant shifts in common bacterial landscape caused by immunotoxic treatment and antibacterial therapy enable growth of other bacterial and fungal pathogens that should be studied in details by means of NGS techniques which should reveal, e.g., anaerobic pathogenic bacteria in posttransplant conditions.

References

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  2. Hegde MC, Kumar A, Bhat G, Sreedharan S. Oral microflora: a comparative study in HIV and normal patients. Indian J Otolaryngol Head Neck Surg. 2014; 66(Suppl 1): S126-S132.
  3. Aas JA, Paster BJ, Stokes LN, Olsen I, Dewhirst FE. Defining the normal bacterial flora of the oral cavity. J. Clin. Microbiol. 2005; 43(11): 5721-5732.
  4. Chukhlovin AB, Pankratova OS. Opportunistic microflora at unusual sites: marker pathogens in severe posttransplant immune deficiency. Cell Ther Transplant. 2017; 6(4): 28-41.
  5. Marena C, Zecca M, Carenini ML, Bruschi A, Bassi ML, Olivieri P, Azzaretti S, Locatelli F. Incidence of, and risk factors for, nosocomial infections among hematopoietic stem cell transplantation recipients, with impact on procedure-related mortality. Infect Control Hosp Epidemiol. 2001;22(8):510-517.
  6. Lahei AMGA, de Soet JJ, von dem Borne PA, Kuijper EJ, Kraneveld EA, van Loveren C, Raber-Durlacher JE. Oral bacteria and yeasts in relationship to oral ulcerations in hematopoietic stem cell transplant recipients. Support Care Cancer. 2012; 20:3231-3240.
  7. Czirók E, Prinz GY, Dénes R, Reményi P, Herendi A. Value of surveillance cultures in a bone marrow transplantation unit. J Med Microbiol. 1997;46(9):785-791.
  8. Vavilov VN, Averianova MY, Bondarenko SN, Stancheva NV, Zubarovskaya LS, Afanasyev BV. Bacterial infections within early period after allogeneic bone marrow transplantation. Ter Arkhiv, 2015; 87(7): 88-93 (In Russian).
  9. Grigoriants AP, Rabinowitch IM, Chukhlovin AB. Stomatological problems and infectious complications after hematopoietic stem cell transplantation. Cell Ther Transplant 2017; 7(2):10-19.
  10. Bergmann OJ. Alterations in oral microflora and pathogenesis of acute oral infections during remission-induction therapy in patients with acute myeloid leukaemia. Scand J Infect Dis. 1991;23(3):355-66.
  11. Jones LR, Toth BB, Keene HJ. Effects of total body irradiation on salivary gland function and caries-associated oral microflora in bone marrow transplant patients. Oral Surg Oral Med Oral Pathol. 1992;73(6):670-676.
  12. Pankratova OS, Chukhlovin AB, Shiryaev SN, Eismont YA, Vavilov VN, Zubarovskaya LS, Afanasyev BV. Herpesviruses and oral ulcerations in hematopoietic SCT recipients. Bone Marrow Transplantation. 2013; 48:1364-1365.
  13. Fritzenwanker M, Imirzalioglu C, Herold S, Wagenlehner FM, Zimmer KP, Chakraborty T. Treatment Options for Carbapenem- Resistant Gram-Negative Infections. Dtsch Arztebl Int. 2018 ;115(20-21):345-352.
  14. Blijlevens NMA, Donnelly JP, De Pauw BE. Mucosal barrier injury: biology, pathology, clinical counterparts and consequences of intensive treatment for haematological malignancy: an overview. Bone Marrow Transplantation (2000) 25, 1269-1278.
  15. Weber D, Jenq RR, Peled JU, Taur Y, Hiergeist A, Koestler J, Dettmer K, Weber M, Wolff D, Hahn J, Pamer EG, Herr W, Gessner A, Oefner PJ, van den Brink MRM, Holler E. Microbiota disruption induced by early use of broad-spectrum antibiotics is an independent risk factor of outcome after allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2017; 23(5):845-852.
  16. Goloshchapov OV, Kucher MA, Chukhlovin AB. Gut microbiome in hematopoietic stem cell transplantation: patient- and treatment-related factors. Cell Ther Transplant. 2018; 7(4):16-28.
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"L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "25" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25083" ["VALUE"]=> array(2) { ["TEXT"]=> string(444) "<p>Алексей Б. Чухловин<sup>1</sup>, Анна А. Спиридонова<sup>2</sup>, Ирина Б. Баранова<sup>3</sup>, Артур П. Григорьянц<sup>3</sup>, Мария Д. Владовская<sup>1</sup>, Людмила С. Зубаровская<sup>1</sup>, Борис В. Афанасьев<sup>1</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(348) "

Алексей Б. Чухловин1, Анна А. Спиридонова2, Ирина Б. Баранова3, Артур П. Григорьянц3, Мария Д. Владовская1, Людмила С. Зубаровская1, Борис В. Афанасьев1

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
2 Отделение клинической микробиологии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25085" ["VALUE"]=> array(2) { ["TEXT"]=> string(5325) "<p style="text-align: justify;">Нормальная аэробная и факультативно-анаэробная микробиота, колонизирующая слизистую оболочку рта, часто выявляется в клинических лабораториях. Ее состав может быть важным показателем иммунокомпромиссных состояний. Данные параметры мало изучены у пациентов после трансплантации гемопоэтических клеток (ТГСК). Целью настоящей работы была оценка выявляемости обычной аэробной и факультативно-анаэробной микробиоты, культивированной из биоматериала полости рта до ТГСК и, по клиническим показаниям, в течение 4 мес. после этого лечения.</p> <h3>Пациенты и методы</h3> <p style="text-align: justify;">Мы оценили результаты посевов образцов, взятых из ротовой полости у 202 больных с онкогематологическими и врожденными заболеваниями в возрасте от 1 до 69 лет, которым была проведена аллогенная ТГСК. Анализ проводился для 3 возрастных групп: 1-5, 6-14, 15-21 и >22 лет.</p> <h3>Результаты</h3> <p style="text-align: justify;">После 630 проведенных бактериологических исследований, позитивные результаты культивирования получены в 61.8% образцов. Наиболее частыми микроорганизмами были следующие: <i>S.viridans</i> 245/630 (38.9%); <i>K.pneumoniae</i> 42/630 (6.7%); <i>S.epidermidis</i> 120/630 (19.1%); <i>Neisseria spp.</i> 66/630 (10.5%); <i>Corynebacterium spp.</i> 78/630 (12.4%). Частота выявления микроорганизмов зависела от времени после ТГСК, а именно отмечено снижение высеваемости <i>S.epidermidis, Corynebacterium spp.</i> и <i>Klebsiella spp.</i> в течение 1-го месяца после ТГСК, что можно объяснить эффективной ранней антибактериальной деконтаминацией пациентов, начиная с момента кондиционирования. Нами показано, что частота высеваемости <i>S.viridans</i> и <i>K.pneumoniae</i> в этих образцах была различной для отдельных возрастных групп, будучи существенно повышенной у детей самого младшего возраста (до 5 лет) и у взрослых пациентов (>22 лет), по сравнению со старшими детьми и подростками. Высеваемость <i>K.pneumoniae</i> в образцах из полости рта оказалась существенно повышенной через 2-3 месяца после ТГСК, что сопровождалось тяжелыми инфекционными осложнениями и наличием резистентности клинических изолятов <i>Klebsiella</i> к большинству антибиотиков. По клиническим показаниям проведена экстракция зубов в 10 случаях в течение 1-го мес. после ТГСК. Посевы раневого отделяемого из десен показали наличие <i>Pseudomonas aeruginosa</i> в 3 образцах, <i>S.viridans</i> – в 2 случаях.</p> <h3>Выводы</h3> <p style="text-align: justify;">Иммунотоксические эффекты цитостатической терапии и анализ микробиоты после ТГСК заслуживают дальнейших исследований, в том числе – анализ биологического разнообразия микробиоты полости рта посредством секвенирования гена 16S rRNA. Эти результаты могут стать основой для рациональной антибактериальной терапии при ТГСК.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Онкогематология, дети, химиотерапия, трансплантация гемопоэтических стволовых клеток, бактериальные культуры, факторы риска.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(5005) "

Нормальная аэробная и факультативно-анаэробная микробиота, колонизирующая слизистую оболочку рта, часто выявляется в клинических лабораториях. Ее состав может быть важным показателем иммунокомпромиссных состояний. Данные параметры мало изучены у пациентов после трансплантации гемопоэтических клеток (ТГСК). Целью настоящей работы была оценка выявляемости обычной аэробной и факультативно-анаэробной микробиоты, культивированной из биоматериала полости рта до ТГСК и, по клиническим показаниям, в течение 4 мес. после этого лечения.

Пациенты и методы

Мы оценили результаты посевов образцов, взятых из ротовой полости у 202 больных с онкогематологическими и врожденными заболеваниями в возрасте от 1 до 69 лет, которым была проведена аллогенная ТГСК. Анализ проводился для 3 возрастных групп: 1-5, 6-14, 15-21 и >22 лет.

Результаты

После 630 проведенных бактериологических исследований, позитивные результаты культивирования получены в 61.8% образцов. Наиболее частыми микроорганизмами были следующие: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). Частота выявления микроорганизмов зависела от времени после ТГСК, а именно отмечено снижение высеваемости S.epidermidis, Corynebacterium spp. и Klebsiella spp. в течение 1-го месяца после ТГСК, что можно объяснить эффективной ранней антибактериальной деконтаминацией пациентов, начиная с момента кондиционирования. Нами показано, что частота высеваемости S.viridans и K.pneumoniae в этих образцах была различной для отдельных возрастных групп, будучи существенно повышенной у детей самого младшего возраста (до 5 лет) и у взрослых пациентов (>22 лет), по сравнению со старшими детьми и подростками. Высеваемость K.pneumoniae в образцах из полости рта оказалась существенно повышенной через 2-3 месяца после ТГСК, что сопровождалось тяжелыми инфекционными осложнениями и наличием резистентности клинических изолятов Klebsiella к большинству антибиотиков. По клиническим показаниям проведена экстракция зубов в 10 случаях в течение 1-го мес. после ТГСК. Посевы раневого отделяемого из десен показали наличие Pseudomonas aeruginosa в 3 образцах, S.viridans – в 2 случаях.

Выводы

Иммунотоксические эффекты цитостатической терапии и анализ микробиоты после ТГСК заслуживают дальнейших исследований, в том числе – анализ биологического разнообразия микробиоты полости рта посредством секвенирования гена 16S rRNA. Эти результаты могут стать основой для рациональной антибактериальной терапии при ТГСК.

Ключевые слова

Онкогематология, дети, химиотерапия, трансплантация гемопоэтических стволовых клеток, бактериальные культуры, факторы риска.

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Alexei B. Chukhlovin1, Anna A. Spiridonova2, Irina B. Baranova3, Artur P. Grigoriants3, Maria D. Vladovskaya1, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia
2 Department of Clinical Microbiology, Pavlov University, St. Petersburg, Russia
3 Department of Orofacial Surgery, Pavlov University, St. Petersburg, Russia

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Normal aerobic and facultative anaerobic microbiota colonizing oral mucosa is usually identified at clinical laboratories. Its composition may be important index of immunocompromised conditions. These parameters are scarcely studied in patients undergoing hematopoietic stem cell transplantation (HSCT). The aim of this work was to evaluate incidence of common aerobic and facultative anaerobic microbiota cultured from oral samples taken before HSCT and, by clinical indications, within 4 months after the treatment.

Patients and methods

We evaluated results of bacterial cultures from oral smears taken in 202 patients with oncohematological and inborn diseases at the age ranging from 1 to 69 years subjected to allogeneic HSCT. The analysis was performed for 3 age groups: 1-5, 6-14, 15-21, and >22 years old.

Results

In total observation group of 630 oral samples, the bacterial cultures proved to be positive in 61.8% of specimens. The most common microorganisms were as follows: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). The incidence of microbial detection was time-dependent, with significant decrease in S.epidermidis, Corynebacterium spp. and Klebsiella spp. during 1st month posttransplant which could be explained by early effective antibacterial decontamination since the time of conditioning in early posttransplant period. We have shown that the frequency of positive tests for S.viridans and K.pneumoniae in these samples were different for distinct age groups, i.e., the positivity rates were significantly higher in youngest children (up to 5 years old) and in adult patients (>22 years old), as compared with elder children and adolesсents. Incidence of K.pneumoniae in oral samples was found to be sufficiently increased 2-3 months after HSCT, being associated with severe infectious complications, with broad antibiotic resistance in most culturable Klebsiella isolates from the patients. For clinical indications, teeth extraction was made in 10 cases during 1st month after HSCT, with Pseudomonas aeruginosa in 3 samples, S.viridans in 2 cases isolated from the local gum wounds. In conclusion, the immunotoxic effects of cytostatic therapy and microbiota analysis post-HSCT deserve further studies, including biodiversity analysis of oral microbiota by means of 16S rRNA gene sequencing. These results may represent a basis for rational antibacterial therapy in HSCT.

Keywords

Oncohematology, children, chemotherapy, hematopoietic stem cell transplantation, bacterial cultures, risk factors.

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Alexei B. Chukhlovin1, Anna A. Spiridonova2, Irina B. Baranova3, Artur P. Grigoriants3, Maria D. Vladovskaya1, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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Alexei B. Chukhlovin1, Anna A. Spiridonova2, Irina B. Baranova3, Artur P. Grigoriants3, Maria D. Vladovskaya1, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

" } ["SUMMARY_EN"]=> array(37) { ["ID"]=> string(2) "39" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(21) "Description / Summary" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "39" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25098" ["VALUE"]=> array(2) { ["TEXT"]=> string(3211) "<p style="text-align: justify;">Normal aerobic and facultative anaerobic microbiota colonizing oral mucosa is usually identified at clinical laboratories. Its composition may be important index of immunocompromised conditions. These parameters are scarcely studied in patients undergoing hematopoietic stem cell transplantation (HSCT). The aim of this work was to evaluate incidence of common aerobic and facultative anaerobic microbiota cultured from oral samples taken before HSCT and, by clinical indications, within 4 months after the treatment.</p> <h3>Patients and methods</h3> <p style="text-align: justify;">We evaluated results of bacterial cultures from oral smears taken in 202 patients with oncohematological and inborn diseases at the age ranging from 1 to 69 years subjected to allogeneic HSCT. The analysis was performed for 3 age groups: 1-5, 6-14, 15-21, and >22 years old. </p> <h3>Results</h3> <p style="text-align: justify;">In total observation group of 630 oral samples, the bacterial cultures proved to be positive in 61.8% of specimens. The most common microorganisms were as follows: <i>S.viridans</i> 245/630 (38.9%); <i>K.pneumoniae</i> 42/630 (6.7%); <i>S.epidermidis</i> 120/630 (19.1%); <i>Neisseria spp.</i> 66/630 (10.5%); <i>Corynebacterium spp.</i> 78/630 (12.4%). The incidence of microbial detection was time-dependent, with significant decrease in <i>S.epidermidis, Corynebacterium spp.</i> and <i>Klebsiella spp.</i> during 1st month posttransplant which could be explained by early effective antibacterial decontamination since the time of conditioning in early posttransplant period. We have shown that the frequency of positive tests for <i>S.viridans</i> and <i>K.pneumoniae</i> in these samples were different for distinct age groups, i.e., the positivity rates were significantly higher in youngest children (up to 5 years old) and in adult patients (>22 years old), as compared with elder children and adolesсents. Incidence of <i>K.pneumoniae</i> in oral samples was found to be sufficiently increased 2-3 months after HSCT, being associated with severe infectious complications, with broad antibiotic resistance in most culturable <i>Klebsiella</i> isolates from the patients. For clinical indications, teeth extraction was made in 10 cases during 1<sup>st</sup> month after HSCT, with <i>Pseudomonas aeruginosa</i> in 3 samples, <i>S.viridans</i> in 2 cases isolated from the local gum wounds. In conclusion, the immunotoxic effects of cytostatic therapy and microbiota analysis post-HSCT deserve further studies, including biodiversity analysis of oral microbiota by means of 16S rRNA gene sequencing. These results may represent a basis for rational antibacterial therapy in HSCT. </p> <h2>Keywords</h2> <p style="text-align: justify;">Oncohematology, children, chemotherapy, hematopoietic stem cell transplantation, bacterial cultures, risk factors. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2913) "

Normal aerobic and facultative anaerobic microbiota colonizing oral mucosa is usually identified at clinical laboratories. Its composition may be important index of immunocompromised conditions. These parameters are scarcely studied in patients undergoing hematopoietic stem cell transplantation (HSCT). The aim of this work was to evaluate incidence of common aerobic and facultative anaerobic microbiota cultured from oral samples taken before HSCT and, by clinical indications, within 4 months after the treatment.

Patients and methods

We evaluated results of bacterial cultures from oral smears taken in 202 patients with oncohematological and inborn diseases at the age ranging from 1 to 69 years subjected to allogeneic HSCT. The analysis was performed for 3 age groups: 1-5, 6-14, 15-21, and >22 years old.

Results

In total observation group of 630 oral samples, the bacterial cultures proved to be positive in 61.8% of specimens. The most common microorganisms were as follows: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). The incidence of microbial detection was time-dependent, with significant decrease in S.epidermidis, Corynebacterium spp. and Klebsiella spp. during 1st month posttransplant which could be explained by early effective antibacterial decontamination since the time of conditioning in early posttransplant period. We have shown that the frequency of positive tests for S.viridans and K.pneumoniae in these samples were different for distinct age groups, i.e., the positivity rates were significantly higher in youngest children (up to 5 years old) and in adult patients (>22 years old), as compared with elder children and adolesсents. Incidence of K.pneumoniae in oral samples was found to be sufficiently increased 2-3 months after HSCT, being associated with severe infectious complications, with broad antibiotic resistance in most culturable Klebsiella isolates from the patients. For clinical indications, teeth extraction was made in 10 cases during 1st month after HSCT, with Pseudomonas aeruginosa in 3 samples, S.viridans in 2 cases isolated from the local gum wounds. In conclusion, the immunotoxic effects of cytostatic therapy and microbiota analysis post-HSCT deserve further studies, including biodiversity analysis of oral microbiota by means of 16S rRNA gene sequencing. These results may represent a basis for rational antibacterial therapy in HSCT.

Keywords

Oncohematology, children, chemotherapy, hematopoietic stem cell transplantation, bacterial cultures, risk factors.

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(21) "Description / Summary" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(2913) "

Normal aerobic and facultative anaerobic microbiota colonizing oral mucosa is usually identified at clinical laboratories. Its composition may be important index of immunocompromised conditions. These parameters are scarcely studied in patients undergoing hematopoietic stem cell transplantation (HSCT). The aim of this work was to evaluate incidence of common aerobic and facultative anaerobic microbiota cultured from oral samples taken before HSCT and, by clinical indications, within 4 months after the treatment.

Patients and methods

We evaluated results of bacterial cultures from oral smears taken in 202 patients with oncohematological and inborn diseases at the age ranging from 1 to 69 years subjected to allogeneic HSCT. The analysis was performed for 3 age groups: 1-5, 6-14, 15-21, and >22 years old.

Results

In total observation group of 630 oral samples, the bacterial cultures proved to be positive in 61.8% of specimens. The most common microorganisms were as follows: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). The incidence of microbial detection was time-dependent, with significant decrease in S.epidermidis, Corynebacterium spp. and Klebsiella spp. during 1st month posttransplant which could be explained by early effective antibacterial decontamination since the time of conditioning in early posttransplant period. We have shown that the frequency of positive tests for S.viridans and K.pneumoniae in these samples were different for distinct age groups, i.e., the positivity rates were significantly higher in youngest children (up to 5 years old) and in adult patients (>22 years old), as compared with elder children and adolesсents. Incidence of K.pneumoniae in oral samples was found to be sufficiently increased 2-3 months after HSCT, being associated with severe infectious complications, with broad antibiotic resistance in most culturable Klebsiella isolates from the patients. For clinical indications, teeth extraction was made in 10 cases during 1st month after HSCT, with Pseudomonas aeruginosa in 3 samples, S.viridans in 2 cases isolated from the local gum wounds. In conclusion, the immunotoxic effects of cytostatic therapy and microbiota analysis post-HSCT deserve further studies, including biodiversity analysis of oral microbiota by means of 16S rRNA gene sequencing. These results may represent a basis for rational antibacterial therapy in HSCT.

Keywords

Oncohematology, children, chemotherapy, hematopoietic stem cell transplantation, bacterial cultures, risk factors.

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia
2 Department of Clinical Microbiology, Pavlov University, St. Petersburg, Russia
3 Department of Orofacial Surgery, Pavlov University, St. Petersburg, Russia

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia
2 Department of Clinical Microbiology, Pavlov University, St. Petersburg, Russia
3 Department of Orofacial Surgery, Pavlov University, St. Petersburg, Russia

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Алексей Б. Чухловин1, Анна А. Спиридонова2, Ирина Б. Баранова3, Артур П. Григорьянц3, Мария Д. Владовская1, Людмила С. Зубаровская1, Борис В. Афанасьев1

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Chukhlovin" ["LINK_ELEMENT_VALUE"]=> bool(false) } ["SUMMARY_RU"]=> array(37) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25085" ["VALUE"]=> array(2) { ["TEXT"]=> string(5325) "<p style="text-align: justify;">Нормальная аэробная и факультативно-анаэробная микробиота, колонизирующая слизистую оболочку рта, часто выявляется в клинических лабораториях. Ее состав может быть важным показателем иммунокомпромиссных состояний. Данные параметры мало изучены у пациентов после трансплантации гемопоэтических клеток (ТГСК). Целью настоящей работы была оценка выявляемости обычной аэробной и факультативно-анаэробной микробиоты, культивированной из биоматериала полости рта до ТГСК и, по клиническим показаниям, в течение 4 мес. после этого лечения.</p> <h3>Пациенты и методы</h3> <p style="text-align: justify;">Мы оценили результаты посевов образцов, взятых из ротовой полости у 202 больных с онкогематологическими и врожденными заболеваниями в возрасте от 1 до 69 лет, которым была проведена аллогенная ТГСК. Анализ проводился для 3 возрастных групп: 1-5, 6-14, 15-21 и >22 лет.</p> <h3>Результаты</h3> <p style="text-align: justify;">После 630 проведенных бактериологических исследований, позитивные результаты культивирования получены в 61.8% образцов. Наиболее частыми микроорганизмами были следующие: <i>S.viridans</i> 245/630 (38.9%); <i>K.pneumoniae</i> 42/630 (6.7%); <i>S.epidermidis</i> 120/630 (19.1%); <i>Neisseria spp.</i> 66/630 (10.5%); <i>Corynebacterium spp.</i> 78/630 (12.4%). Частота выявления микроорганизмов зависела от времени после ТГСК, а именно отмечено снижение высеваемости <i>S.epidermidis, Corynebacterium spp.</i> и <i>Klebsiella spp.</i> в течение 1-го месяца после ТГСК, что можно объяснить эффективной ранней антибактериальной деконтаминацией пациентов, начиная с момента кондиционирования. Нами показано, что частота высеваемости <i>S.viridans</i> и <i>K.pneumoniae</i> в этих образцах была различной для отдельных возрастных групп, будучи существенно повышенной у детей самого младшего возраста (до 5 лет) и у взрослых пациентов (>22 лет), по сравнению со старшими детьми и подростками. Высеваемость <i>K.pneumoniae</i> в образцах из полости рта оказалась существенно повышенной через 2-3 месяца после ТГСК, что сопровождалось тяжелыми инфекционными осложнениями и наличием резистентности клинических изолятов <i>Klebsiella</i> к большинству антибиотиков. По клиническим показаниям проведена экстракция зубов в 10 случаях в течение 1-го мес. после ТГСК. Посевы раневого отделяемого из десен показали наличие <i>Pseudomonas aeruginosa</i> в 3 образцах, <i>S.viridans</i> – в 2 случаях.</p> <h3>Выводы</h3> <p style="text-align: justify;">Иммунотоксические эффекты цитостатической терапии и анализ микробиоты после ТГСК заслуживают дальнейших исследований, в том числе – анализ биологического разнообразия микробиоты полости рта посредством секвенирования гена 16S rRNA. Эти результаты могут стать основой для рациональной антибактериальной терапии при ТГСК.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Онкогематология, дети, химиотерапия, трансплантация гемопоэтических стволовых клеток, бактериальные культуры, факторы риска.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(5005) "

Нормальная аэробная и факультативно-анаэробная микробиота, колонизирующая слизистую оболочку рта, часто выявляется в клинических лабораториях. Ее состав может быть важным показателем иммунокомпромиссных состояний. Данные параметры мало изучены у пациентов после трансплантации гемопоэтических клеток (ТГСК). Целью настоящей работы была оценка выявляемости обычной аэробной и факультативно-анаэробной микробиоты, культивированной из биоматериала полости рта до ТГСК и, по клиническим показаниям, в течение 4 мес. после этого лечения.

Пациенты и методы

Мы оценили результаты посевов образцов, взятых из ротовой полости у 202 больных с онкогематологическими и врожденными заболеваниями в возрасте от 1 до 69 лет, которым была проведена аллогенная ТГСК. Анализ проводился для 3 возрастных групп: 1-5, 6-14, 15-21 и >22 лет.

Результаты

После 630 проведенных бактериологических исследований, позитивные результаты культивирования получены в 61.8% образцов. Наиболее частыми микроорганизмами были следующие: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). Частота выявления микроорганизмов зависела от времени после ТГСК, а именно отмечено снижение высеваемости S.epidermidis, Corynebacterium spp. и Klebsiella spp. в течение 1-го месяца после ТГСК, что можно объяснить эффективной ранней антибактериальной деконтаминацией пациентов, начиная с момента кондиционирования. Нами показано, что частота высеваемости S.viridans и K.pneumoniae в этих образцах была различной для отдельных возрастных групп, будучи существенно повышенной у детей самого младшего возраста (до 5 лет) и у взрослых пациентов (>22 лет), по сравнению со старшими детьми и подростками. Высеваемость K.pneumoniae в образцах из полости рта оказалась существенно повышенной через 2-3 месяца после ТГСК, что сопровождалось тяжелыми инфекционными осложнениями и наличием резистентности клинических изолятов Klebsiella к большинству антибиотиков. По клиническим показаниям проведена экстракция зубов в 10 случаях в течение 1-го мес. после ТГСК. Посевы раневого отделяемого из десен показали наличие Pseudomonas aeruginosa в 3 образцах, S.viridans – в 2 случаях.

Выводы

Иммунотоксические эффекты цитостатической терапии и анализ микробиоты после ТГСК заслуживают дальнейших исследований, в том числе – анализ биологического разнообразия микробиоты полости рта посредством секвенирования гена 16S rRNA. Эти результаты могут стать основой для рациональной антибактериальной терапии при ТГСК.

Ключевые слова

Онкогематология, дети, химиотерапия, трансплантация гемопоэтических стволовых клеток, бактериальные культуры, факторы риска.

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Нормальная аэробная и факультативно-анаэробная микробиота, колонизирующая слизистую оболочку рта, часто выявляется в клинических лабораториях. Ее состав может быть важным показателем иммунокомпромиссных состояний. Данные параметры мало изучены у пациентов после трансплантации гемопоэтических клеток (ТГСК). Целью настоящей работы была оценка выявляемости обычной аэробной и факультативно-анаэробной микробиоты, культивированной из биоматериала полости рта до ТГСК и, по клиническим показаниям, в течение 4 мес. после этого лечения.

Пациенты и методы

Мы оценили результаты посевов образцов, взятых из ротовой полости у 202 больных с онкогематологическими и врожденными заболеваниями в возрасте от 1 до 69 лет, которым была проведена аллогенная ТГСК. Анализ проводился для 3 возрастных групп: 1-5, 6-14, 15-21 и >22 лет.

Результаты

После 630 проведенных бактериологических исследований, позитивные результаты культивирования получены в 61.8% образцов. Наиболее частыми микроорганизмами были следующие: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). Частота выявления микроорганизмов зависела от времени после ТГСК, а именно отмечено снижение высеваемости S.epidermidis, Corynebacterium spp. и Klebsiella spp. в течение 1-го месяца после ТГСК, что можно объяснить эффективной ранней антибактериальной деконтаминацией пациентов, начиная с момента кондиционирования. Нами показано, что частота высеваемости S.viridans и K.pneumoniae в этих образцах была различной для отдельных возрастных групп, будучи существенно повышенной у детей самого младшего возраста (до 5 лет) и у взрослых пациентов (>22 лет), по сравнению со старшими детьми и подростками. Высеваемость K.pneumoniae в образцах из полости рта оказалась существенно повышенной через 2-3 месяца после ТГСК, что сопровождалось тяжелыми инфекционными осложнениями и наличием резистентности клинических изолятов Klebsiella к большинству антибиотиков. По клиническим показаниям проведена экстракция зубов в 10 случаях в течение 1-го мес. после ТГСК. Посевы раневого отделяемого из десен показали наличие Pseudomonas aeruginosa в 3 образцах, S.viridans – в 2 случаях.

Выводы

Иммунотоксические эффекты цитостатической терапии и анализ микробиоты после ТГСК заслуживают дальнейших исследований, в том числе – анализ биологического разнообразия микробиоты полости рта посредством секвенирования гена 16S rRNA. Эти результаты могут стать основой для рациональной антибактериальной терапии при ТГСК.

Ключевые слова

Онкогематология, дети, химиотерапия, трансплантация гемопоэтических стволовых клеток, бактериальные культуры, факторы риска.

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
2 Отделение клинической микробиологии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
2 Отделение клинической микробиологии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

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Introduction

Incidence of parvovirus B19 (PVB19) infections is registered everywhere in the world, with specific antibodies detectable in 70-75% of adult population [1, 2]. In immunocompetent persons, the PVB19 infection typically manifests as infectious erythema or arthropathy [2, 3, 4]. In certain cohorts, however, this infection may proceed as a severe disorder, e.g., in hematological patients where it may cause aplastic crisis, in pregnant women, as well as in immunocopromised patients [2, 4, 5]. Clinical pattern in cases of pronounced immune deficiency is more variable, i.e., chronic persistent anemia, acute myocarditis, hepatitis, glomerulonephritis, neurological signs are observed [6, 7, 8, 9, 10].

In the present report, we describe for the first time a clinical case with atypical clinical course of a parvovirus-associated infection presenting as acute haemorrhagic enteritis which developed after hematopoietic stem cell transplantation (HSCT). The patient manifested with severe enteric bleeding resistant to common hemostatic therapy. Upon autopsy, the PVB19-specific antigens were detected, along with virus-specific nucleotide sequences revealed in gastric, enteric and myocardial samples.

Case report

A male patient, 52, was admitted to the clinic of R. Gorbacheva Memorial Institute with previously diagnosed chronic myeloid leukemia (Ph-). Standard virological examination of both donor and patient was performed before the HSCT, according to the institutional protocol. IgG antibodies to cytomegalovirus, Epstein-Barr virus, Herpes simples type 1 and 2 were detected in blood sera, along with negative serological tests for HBV, HCV and AIDS virus. Relatives of the patient has provided a written informed consent for the publication of his personal medical data.

The patient received Ruxolitinib therapy with evident clinical improvement. Therefore, a decision of allogeneic HSCT was approved. Upon admission, clinical blood analysis showed hypochromic anemia (ery, 3.3*1012/L; Hb, 86 g/L; platelets, 77*109/L). Myeloablative conditioning regimen was applied pre-transplant, i.e., Fludarabine (50 mg/d), Busulfan (344 mg/d), Ruxolitinib (45 mg/d). The patient tolerated well the therapy, and no signs of active infection were observed at the time of HSCT.

Hematopoietic transplantation from a related donor was performed on D0. The graft parameters were as follows: total volume of 352 mL containing 94.4×109 nucleated cells (10.9×108/kg body mass); CD34+ cells, 0.92% (10.0×106/kg); CD3+ cells, 21.9% (23.9×107/kg).

Since the day +1 (D+1), the first-line antibiotics were administered, due to ongoing febrile neutropenia (Cefoperazon + Sulbactam, 1 g + 1 g twice a day). Immunosuppressive therapy was also started: Cyclophosphfan 4500 mg/day (D+3 to D+4) followed by Ruxolitinib since D+5 (15 mg daily).

Since D+10, a negative clinical trend, i.e., development of grade 3 oral mucositis was observed, thus requiring administration of opioid analgetics (Fentanyl infused at 0.5 mg/kg/h). The signs of haemorrhagic syndrome appeared as petechial rush on skin and mucosae, along with periodical nasal bleedings. The patient was administered parenteral nutrition. Vancomycin (500 mg, 4× daily) was added to basic antibacterial therapy, due to increased serum C-reactive protein levels.

Clinically, the patient’s state remained moderately severe on D+11 to D+14, with persisting trilineage cytopenia, pronounced haemorrhagic signs on the skin and oral mucosa, and daily requirements for blood components. Mucositis symptoms were gradually resolved since D+15, thus allowing unaided peroral nutrition.

By the day +17, a febrile fever episode with chills was successfully cured with antipyretics. However, an increase in general fatigue was observed during subsequent hours accompanied by repeated fever attack with chills, followed by the bile vomiting with blood admixture. Therefore, Vancomycin treatment has been changed to Linezolid (600 mg twice daily); Cefoperazon + Sulbactam therapy was changed to Meropenem (1 g twice daily). Immunosuppressive treatment by Ruxolitinib was also discontinued.

On D+18, the body temperature was sub-febrile, pale skin, general fatigue, disorientation. Clinical blood analysis showed a decreased Hb by 20 g/L, despite erythrocyte mass transfusion (2 doses). Gastroabdominal bleeding was suspected. The patient was delivered to ICU due to instable hemodynamics (blood hypotension to 75/45 mm Hg), thus requiring sympathomimetic drugs at moderate doses, i.e., noradrenaline (0.04 mcg/kg/min). Urgent fibrogastrocopy has revealed erosive esophagitis and gastritis. We were unable to determine the source of bleeding. The signs of continuous bleeding were traceable on Day +19, i.e., dark, melena-like stool with blood clots, at a daily volume of 4 liters. Conservative hemostatic therapy (transfusion of blood components, fresh-frozen plasma, cryoprecipitate, Prothromplex (2400 U daily), antifibrinolytic drugs, aminomethylbenzoic acid (100 mg 3× daily), Terlipressine (1 mg 4× a day) was not effective, with blood Hb levels reaching 25 g/L without any changes. The patient was intubated in order to perform artificial lung ventilation.

Computer tomography of abdominal area with Optiray contrast was performed, yielding no evidence of gastrointestinal bleeding. Fibrocolonoscopy was also made, however, without any findings suggestive for hemorrhage sources: the colic walls along their entire length were covered with blood-impregnated mucinous secretions. Due to absence of evident colon bleeding accompanied by blood clots in the colon lumen and diffuse blood distribution, we suggested a small intestinal bleeding in this case.

By the D+20, the clinical state remained extremely severe and unstable, due to continuing hemorrhage treated with massive conservative hemostatic therapy and inotropic support (epinephrine infused at 0.05 mg/kg/min).

Despite high probability of surgical intervention, due to recurrent bleeding and anemia progression, we still decided to perform a laparotomy aiming or detection of the bleeding source and achieving surgical hemostasis. Upon revision of abdominal cavity, the small intestine in its upper third and more distal part was found to be filled with blood masses. No visible pathological changes were found during the inspection and palpatory revision of small intestine. After passing the Treitz ligament with fibrogastroscopic probe, a number of acute mucosal erosions have been revealed that were covered with hematin and sometimes with blood clots (Fig. 1). During this surgical intervention, 8 to 10 such loci were closed by sutures. The following conclusion was drawn after the laparotomy: Erosive esophagitis; acute erosive haemorrhagic gastritis; Continuous bleeding from the jejunal erosions.

Figure 1. Images obtained at surgical intervention of the patient with GIT bleeding

Goloshchapov-fig01.jpg

A – Macroscopic view of the small intestinal wall: multiple focal hemorrhages with distinct contours (0.2 to 0.8 cm in size) protruding to the lumen are visible in the intestinal wall, mucosae are also showing erosive defects up to 0.3-0.4 cm (shown by arrow). B – Closing of a bleeding source with single sutures when the gastroscope was passed behind the Treitz ligament.

On the D+21, no sufficient dynamics was observed and ALV was continued. Stable febrile fever persisted without any response to antipyretics; hemodynamics was supported by norepinehrine (0.06 mcg/kg/min). Stool was absent, with haemorrhagic secretion from the surgical wound (520 mL). Blood Hb level remained stably low. On day+22, the patient had dark stool with bloot clots. On day +24, the patient developed pronounced negative symptoms associated with continuing intestinal bleeding (blood admixture in stool, blood Hb drop by 35 g/L within 12 hours, followed by haemorrhagic shock that was refractory to vasopressor drugs, infusion therapy by salt solutions and substitution hemotransfusions. The patient entered terminal phase with arrested blood flow and no effect from resuscitation measures.

Upon postmortem pathological examination, large amounts of blood are seen in enteric and colonic lumen, along with numerous hemorrhages and erosions on the jejunal mucosa. Upon histological examination, the signs of altered blood flow in the large bowel were evident, i.e., macrofocal, partly confluent heporrhages to submucous layers of intestinal wall, as well as in myocardium as extended confluent perivascular and perimuscular hemorrhages without pronounced perifocal cellular infiltration (Fig. 2 A, С). Mucosal epithelium of the large bowel was desquamated along the whole length, mostly affecting superficial layers of mucosa, and its stroma showed extensive infiltration with polymorphic cells. In the myocardium, perivascular pathological cellular infiltration was weakly pronounced. Immunohistochemical studies have shown expression of parvovirus B19 antigen revealed in stromal elements of intestines and myocardium (Fig. 2, B, D).

Figure 2. Postmortem signs of generalized parvovirus infection

Goloshchapov-fig02.jpg

Hematoxilin/eosin staining (A, C); immunohistochemical (IHC) labeling for parvovirus B19, DAB staining (B, D).

Macrofocal hemorrhage to the submucosal areas of jejunal, extended perimuscular myocardial hemorrhages (В). Expression of PVB19 antigens (brown staining) in stromal cells of the large intestinal mucosa and myocardium (arrows). The histological slices were prepared from the paraffin-embedded specimens. Immunohistochemistry was carried out with murine monoclonal antibodies to PVB19 (Novocastra, UK, 1:10 dilution). The cells were examined with Ultra Vision Quanto polymerization system, Thermo, USA).

We have performed a study of autoptic material by means of PVB19 antigen expression detected by immunohistochemistry. Real-time PCR of DNA extracted from tissues has revealed parvovirus B19 in jejunum at 6.7×103 МU/mL, in stomach, 3.5×103 МU/mL, in large bowel samples, at 1.3×103 МU/mL, for myocardium, 1.1×103 МU/mL, with negative results for blood samples.

Discussion

As mentioned above, the issues of parvovirus infection is especially important in immunocompromised patients who underwent hematopoietic stem cell transplantation [2, 11]. The endogenous virus reactivation may occur following immunosuppressive therapy. Requirements for multiple hemotransfusions may also significantly increase the infection risk [12, 13, 14, 15]. Moreover, an opportunity exists for a viral transmission from donors during allogeneic HSCT [13].

In the patients with pronounced immune deficiency, one may observe severe non-typical clinical condition affecting liver, kidney, myocardium, central nervous system being at high risk for lethal outcome [3, 8, 9, 10].

Affection of gastrointestinal tract (GIT) is not typical to HPVB19 infection. There are only two clinical cases reported in literature with intestinal detection of the virus. E.c., Loris Pironi, Francesca Bonvicini have revealed PVB19 in the intraepithelial intestinal T lymphocytes in a 52-year male patient with suggested nonspecific ulcerous colitis who developed severe symptoms during immunosuppressive therapy [16]. The second case of haemorrhagic enteritis caused by PVB19 was described by H. Koklu, В. Buyukeren in a 63-year old female patient with aplastic anemia in her history [17]. Both patients received therapy with intravenous immunoglobulins that yielded positive results, i.e., jugulation of symptoms and elimination of the virus [16, 17].

The reported clinical case is showing for the first time a case with atypical clinical course of parvovirus-associated infectious condition which proceeded as severe haemorrhagic enteritis in a patient treated with immunosuppressive drugs following allogeneic HSCT. Both donor and recipient of hematopoietic stem cells were not tested for PVD19 before transplant. Due to non-typical GIT affection in presence of parvovirus infection, our diagnostics did not initially include tests for PVB19. The patient underwent conventional examination for herpesvirus infection (CMV, EBV, HHV type 6, HSV), we have also excluded graft-versus-host disease (GvHD).

Upon the postmortem histological study of a myocardial sample, we have documented haemorrhagic myocarditis with perivascular lymphoid-cell infiltration, thus suggesting a parvovirus affection. Further on, PVD19 was detected by means of IHC and PCR in myocardium, stomach and intestinal tissues. Hence, distinct etiological verification of a lethal infectious pathology in the oncohematological patient was performed as late as by autopsy.

In conclusion, the reported clinical case demonstrates atypical clinical course of parvovirus infection proceeding as haemorrhagic enteritis in an immunocompromised patients after hematopoietic stem cell transplantation. GIT affection associated with parvovirus B19 seems to be a rather rare condition with severe clinical course, and it may result into serious complications including lethal outcome.

Conflict of interest

The authors report no conflicts of interest.

References

  1. Servant-Delmas A, Lefrère JJ, Morinet F, Pillet S. Advances in human B19 erythrovirus biology. J Virol. 2010; 84:9658-9665.
  2. Laudry ML. Parvovirus B19. Microbiol Spectrum. 2015; 4(3):1-13.
  3. Leon LA, Alves A, Garcia RC, Melgaço JG, de Paula VS, Pinto MA. Parvovirus infection in a fatal case of acute liver failure, Pediat Infect Dis J. 2017; 36(12):e355-e358.
  4. Kerr JR. Pathogenesis of parvovirus B19 infection: Host gene variability, and possible means and effects of virus persistence. J Vet Med (Ser.B). 2005; 52(7-8):335-339.
  5. Lotze U, Egerer R, Tresselt C, Gluck B Dannberg G, Stelzner A, Figulla HR. Frequent detection of parvovirus B19 genome in the myocardium of adult patients with idiopathic dilated cardiomyopathy, Med Microbiol Immunol, 2003; 193(2-3):75-82.
  6. Lamparter S, Schoppet M, Pankweit S, Maisch B. Acute parvovirus В19 infection associated with myocarditis in an immunocompetent adult. Hum Pathol.2003; 34(7):725-728.
  7. Nakamura Y, Ohsawa I, Goto Y, Namba H, Dodo Y, Tsuji M, Kiuchi Y, Inagaki M, Gotoh H. The impact of human parvovirus B19 infection on heart failure and anemia with reference to iron metabolism markers in an adult woman. Internal Medicine. 2018; 57(3):403-407.
  8. Spartalis M, Tzatzaki E, Spartalis E, Damaskos C, Mavrogeni S, Voudris V. Parvovirus B19 myocarditis of fulminant evolution, Cardiol Res. 2017; 8(4):172-175.
  9. Verdonschot J, Hazebroek M, Merken J, Debing Y, Dennert R, Brunner-La Rocca HP, Heymans S. Relevance of cardiac parvovirus B19 in myocarditis and dilated cardiomyopathy: review of the literature. Eur J Heart Failure. 2016; 18(12):1430-1441.
  10. Samanta D, Willis E. Focal seizure associated with human parvovirus B19 infection in a non-encephalopathic child. World J Pediat. 2016; 12(1): 118-120.
  11. Sedaghat AR, Rastegar DA, O`Connell K, Dinoso JB, Wilke CO, Blankson JN. Evaluation of parvovirus B19 infection in children with malignant or hematological disorders. Clin Infect Dis. 2010; 50(10):1425-1426.
  12. Khamitova I, Lavrentyeva I, Averyanova M, Chukhlovin A, Zubarovskaya L, Afanasyev B. Parvovirus B19 incidence, specific antibody response, and delayed hematopoietic recovery after allogeneic hematopoietic stem cell transplantation. Cell Ther Transplant. 2018; 7(1):36-43.
  13. Plentz A, Hahn J, Knoll A, Holler E, Jilg W, Modrow S. Exposure of hematologic patients to parvovirus B19 as a contaminant of blood cell preparations and blood products. Transfusion. 2005; 45: 1811-1815.
  14. Gahr M, Pekrun A, Eiffert H. Persistence of parvovirus B19-DNA in blood of a child with severe combined immunodeficiency associated with chronic pure red cell aplasia. Eur J Pediat. 1991; 150(7): 470-472.
  15. Trimble S, Parker C, Grant A, Soucie JM, Reyes N. Assessing emerging infectious threats to blood safety for the blood disorders community. J Prevent Med. 2010; 38 (Suppl 4): S468-S474.
  16. Pironi L, Bonvicini F, Gionchetti P, D'Errico A, Rizzello F, Corsini C, Foroni L, Gallinella G. Parvovirus B19 infection localized in the intestinal mucosa and associated with severe inflammatory bowel disease. J Clin Microbiol. 2009; 47(5): 1591-1595.
  17. Koklu H, Buyukeren B, Inkaya AC, Sokmensuer C, Kav T. An unexpected cause of acute enteritis in a patient with pure red cell aplasia parvovirus B19-associated acute enteritis. Am J Gastroenterol. 2018; 113(4): 630-632. 2018.
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Introduction

Incidence of parvovirus B19 (PVB19) infections is registered everywhere in the world, with specific antibodies detectable in 70-75% of adult population [1, 2]. In immunocompetent persons, the PVB19 infection typically manifests as infectious erythema or arthropathy [2, 3, 4]. In certain cohorts, however, this infection may proceed as a severe disorder, e.g., in hematological patients where it may cause aplastic crisis, in pregnant women, as well as in immunocopromised patients [2, 4, 5]. Clinical pattern in cases of pronounced immune deficiency is more variable, i.e., chronic persistent anemia, acute myocarditis, hepatitis, glomerulonephritis, neurological signs are observed [6, 7, 8, 9, 10].

In the present report, we describe for the first time a clinical case with atypical clinical course of a parvovirus-associated infection presenting as acute haemorrhagic enteritis which developed after hematopoietic stem cell transplantation (HSCT). The patient manifested with severe enteric bleeding resistant to common hemostatic therapy. Upon autopsy, the PVB19-specific antigens were detected, along with virus-specific nucleotide sequences revealed in gastric, enteric and myocardial samples.

Case report

A male patient, 52, was admitted to the clinic of R. Gorbacheva Memorial Institute with previously diagnosed chronic myeloid leukemia (Ph-). Standard virological examination of both donor and patient was performed before the HSCT, according to the institutional protocol. IgG antibodies to cytomegalovirus, Epstein-Barr virus, Herpes simples type 1 and 2 were detected in blood sera, along with negative serological tests for HBV, HCV and AIDS virus. Relatives of the patient has provided a written informed consent for the publication of his personal medical data.

The patient received Ruxolitinib therapy with evident clinical improvement. Therefore, a decision of allogeneic HSCT was approved. Upon admission, clinical blood analysis showed hypochromic anemia (ery, 3.3*1012/L; Hb, 86 g/L; platelets, 77*109/L). Myeloablative conditioning regimen was applied pre-transplant, i.e., Fludarabine (50 mg/d), Busulfan (344 mg/d), Ruxolitinib (45 mg/d). The patient tolerated well the therapy, and no signs of active infection were observed at the time of HSCT.

Hematopoietic transplantation from a related donor was performed on D0. The graft parameters were as follows: total volume of 352 mL containing 94.4×109 nucleated cells (10.9×108/kg body mass); CD34+ cells, 0.92% (10.0×106/kg); CD3+ cells, 21.9% (23.9×107/kg).

Since the day +1 (D+1), the first-line antibiotics were administered, due to ongoing febrile neutropenia (Cefoperazon + Sulbactam, 1 g + 1 g twice a day). Immunosuppressive therapy was also started: Cyclophosphfan 4500 mg/day (D+3 to D+4) followed by Ruxolitinib since D+5 (15 mg daily).

Since D+10, a negative clinical trend, i.e., development of grade 3 oral mucositis was observed, thus requiring administration of opioid analgetics (Fentanyl infused at 0.5 mg/kg/h). The signs of haemorrhagic syndrome appeared as petechial rush on skin and mucosae, along with periodical nasal bleedings. The patient was administered parenteral nutrition. Vancomycin (500 mg, 4× daily) was added to basic antibacterial therapy, due to increased serum C-reactive protein levels.

Clinically, the patient’s state remained moderately severe on D+11 to D+14, with persisting trilineage cytopenia, pronounced haemorrhagic signs on the skin and oral mucosa, and daily requirements for blood components. Mucositis symptoms were gradually resolved since D+15, thus allowing unaided peroral nutrition.

By the day +17, a febrile fever episode with chills was successfully cured with antipyretics. However, an increase in general fatigue was observed during subsequent hours accompanied by repeated fever attack with chills, followed by the bile vomiting with blood admixture. Therefore, Vancomycin treatment has been changed to Linezolid (600 mg twice daily); Cefoperazon + Sulbactam therapy was changed to Meropenem (1 g twice daily). Immunosuppressive treatment by Ruxolitinib was also discontinued.

On D+18, the body temperature was sub-febrile, pale skin, general fatigue, disorientation. Clinical blood analysis showed a decreased Hb by 20 g/L, despite erythrocyte mass transfusion (2 doses). Gastroabdominal bleeding was suspected. The patient was delivered to ICU due to instable hemodynamics (blood hypotension to 75/45 mm Hg), thus requiring sympathomimetic drugs at moderate doses, i.e., noradrenaline (0.04 mcg/kg/min). Urgent fibrogastrocopy has revealed erosive esophagitis and gastritis. We were unable to determine the source of bleeding. The signs of continuous bleeding were traceable on Day +19, i.e., dark, melena-like stool with blood clots, at a daily volume of 4 liters. Conservative hemostatic therapy (transfusion of blood components, fresh-frozen plasma, cryoprecipitate, Prothromplex (2400 U daily), antifibrinolytic drugs, aminomethylbenzoic acid (100 mg 3× daily), Terlipressine (1 mg 4× a day) was not effective, with blood Hb levels reaching 25 g/L without any changes. The patient was intubated in order to perform artificial lung ventilation.

Computer tomography of abdominal area with Optiray contrast was performed, yielding no evidence of gastrointestinal bleeding. Fibrocolonoscopy was also made, however, without any findings suggestive for hemorrhage sources: the colic walls along their entire length were covered with blood-impregnated mucinous secretions. Due to absence of evident colon bleeding accompanied by blood clots in the colon lumen and diffuse blood distribution, we suggested a small intestinal bleeding in this case.

By the D+20, the clinical state remained extremely severe and unstable, due to continuing hemorrhage treated with massive conservative hemostatic therapy and inotropic support (epinephrine infused at 0.05 mg/kg/min).

Despite high probability of surgical intervention, due to recurrent bleeding and anemia progression, we still decided to perform a laparotomy aiming or detection of the bleeding source and achieving surgical hemostasis. Upon revision of abdominal cavity, the small intestine in its upper third and more distal part was found to be filled with blood masses. No visible pathological changes were found during the inspection and palpatory revision of small intestine. After passing the Treitz ligament with fibrogastroscopic probe, a number of acute mucosal erosions have been revealed that were covered with hematin and sometimes with blood clots (Fig. 1). During this surgical intervention, 8 to 10 such loci were closed by sutures. The following conclusion was drawn after the laparotomy: Erosive esophagitis; acute erosive haemorrhagic gastritis; Continuous bleeding from the jejunal erosions.

Figure 1. Images obtained at surgical intervention of the patient with GIT bleeding

Goloshchapov-fig01.jpg

A – Macroscopic view of the small intestinal wall: multiple focal hemorrhages with distinct contours (0.2 to 0.8 cm in size) protruding to the lumen are visible in the intestinal wall, mucosae are also showing erosive defects up to 0.3-0.4 cm (shown by arrow). B – Closing of a bleeding source with single sutures when the gastroscope was passed behind the Treitz ligament.

On the D+21, no sufficient dynamics was observed and ALV was continued. Stable febrile fever persisted without any response to antipyretics; hemodynamics was supported by norepinehrine (0.06 mcg/kg/min). Stool was absent, with haemorrhagic secretion from the surgical wound (520 mL). Blood Hb level remained stably low. On day+22, the patient had dark stool with bloot clots. On day +24, the patient developed pronounced negative symptoms associated with continuing intestinal bleeding (blood admixture in stool, blood Hb drop by 35 g/L within 12 hours, followed by haemorrhagic shock that was refractory to vasopressor drugs, infusion therapy by salt solutions and substitution hemotransfusions. The patient entered terminal phase with arrested blood flow and no effect from resuscitation measures.

Upon postmortem pathological examination, large amounts of blood are seen in enteric and colonic lumen, along with numerous hemorrhages and erosions on the jejunal mucosa. Upon histological examination, the signs of altered blood flow in the large bowel were evident, i.e., macrofocal, partly confluent heporrhages to submucous layers of intestinal wall, as well as in myocardium as extended confluent perivascular and perimuscular hemorrhages without pronounced perifocal cellular infiltration (Fig. 2 A, С). Mucosal epithelium of the large bowel was desquamated along the whole length, mostly affecting superficial layers of mucosa, and its stroma showed extensive infiltration with polymorphic cells. In the myocardium, perivascular pathological cellular infiltration was weakly pronounced. Immunohistochemical studies have shown expression of parvovirus B19 antigen revealed in stromal elements of intestines and myocardium (Fig. 2, B, D).

Figure 2. Postmortem signs of generalized parvovirus infection

Goloshchapov-fig02.jpg

Hematoxilin/eosin staining (A, C); immunohistochemical (IHC) labeling for parvovirus B19, DAB staining (B, D).

Macrofocal hemorrhage to the submucosal areas of jejunal, extended perimuscular myocardial hemorrhages (В). Expression of PVB19 antigens (brown staining) in stromal cells of the large intestinal mucosa and myocardium (arrows). The histological slices were prepared from the paraffin-embedded specimens. Immunohistochemistry was carried out with murine monoclonal antibodies to PVB19 (Novocastra, UK, 1:10 dilution). The cells were examined with Ultra Vision Quanto polymerization system, Thermo, USA).

We have performed a study of autoptic material by means of PVB19 antigen expression detected by immunohistochemistry. Real-time PCR of DNA extracted from tissues has revealed parvovirus B19 in jejunum at 6.7×103 МU/mL, in stomach, 3.5×103 МU/mL, in large bowel samples, at 1.3×103 МU/mL, for myocardium, 1.1×103 МU/mL, with negative results for blood samples.

Discussion

As mentioned above, the issues of parvovirus infection is especially important in immunocompromised patients who underwent hematopoietic stem cell transplantation [2, 11]. The endogenous virus reactivation may occur following immunosuppressive therapy. Requirements for multiple hemotransfusions may also significantly increase the infection risk [12, 13, 14, 15]. Moreover, an opportunity exists for a viral transmission from donors during allogeneic HSCT [13].

In the patients with pronounced immune deficiency, one may observe severe non-typical clinical condition affecting liver, kidney, myocardium, central nervous system being at high risk for lethal outcome [3, 8, 9, 10].

Affection of gastrointestinal tract (GIT) is not typical to HPVB19 infection. There are only two clinical cases reported in literature with intestinal detection of the virus. E.c., Loris Pironi, Francesca Bonvicini have revealed PVB19 in the intraepithelial intestinal T lymphocytes in a 52-year male patient with suggested nonspecific ulcerous colitis who developed severe symptoms during immunosuppressive therapy [16]. The second case of haemorrhagic enteritis caused by PVB19 was described by H. Koklu, В. Buyukeren in a 63-year old female patient with aplastic anemia in her history [17]. Both patients received therapy with intravenous immunoglobulins that yielded positive results, i.e., jugulation of symptoms and elimination of the virus [16, 17].

The reported clinical case is showing for the first time a case with atypical clinical course of parvovirus-associated infectious condition which proceeded as severe haemorrhagic enteritis in a patient treated with immunosuppressive drugs following allogeneic HSCT. Both donor and recipient of hematopoietic stem cells were not tested for PVD19 before transplant. Due to non-typical GIT affection in presence of parvovirus infection, our diagnostics did not initially include tests for PVB19. The patient underwent conventional examination for herpesvirus infection (CMV, EBV, HHV type 6, HSV), we have also excluded graft-versus-host disease (GvHD).

Upon the postmortem histological study of a myocardial sample, we have documented haemorrhagic myocarditis with perivascular lymphoid-cell infiltration, thus suggesting a parvovirus affection. Further on, PVD19 was detected by means of IHC and PCR in myocardium, stomach and intestinal tissues. Hence, distinct etiological verification of a lethal infectious pathology in the oncohematological patient was performed as late as by autopsy.

In conclusion, the reported clinical case demonstrates atypical clinical course of parvovirus infection proceeding as haemorrhagic enteritis in an immunocompromised patients after hematopoietic stem cell transplantation. GIT affection associated with parvovirus B19 seems to be a rather rare condition with severe clinical course, and it may result into serious complications including lethal outcome.

Conflict of interest

The authors report no conflicts of interest.

References

  1. Servant-Delmas A, Lefrère JJ, Morinet F, Pillet S. Advances in human B19 erythrovirus biology. J Virol. 2010; 84:9658-9665.
  2. Laudry ML. Parvovirus B19. Microbiol Spectrum. 2015; 4(3):1-13.
  3. Leon LA, Alves A, Garcia RC, Melgaço JG, de Paula VS, Pinto MA. Parvovirus infection in a fatal case of acute liver failure, Pediat Infect Dis J. 2017; 36(12):e355-e358.
  4. Kerr JR. Pathogenesis of parvovirus B19 infection: Host gene variability, and possible means and effects of virus persistence. J Vet Med (Ser.B). 2005; 52(7-8):335-339.
  5. Lotze U, Egerer R, Tresselt C, Gluck B Dannberg G, Stelzner A, Figulla HR. Frequent detection of parvovirus B19 genome in the myocardium of adult patients with idiopathic dilated cardiomyopathy, Med Microbiol Immunol, 2003; 193(2-3):75-82.
  6. Lamparter S, Schoppet M, Pankweit S, Maisch B. Acute parvovirus В19 infection associated with myocarditis in an immunocompetent adult. Hum Pathol.2003; 34(7):725-728.
  7. Nakamura Y, Ohsawa I, Goto Y, Namba H, Dodo Y, Tsuji M, Kiuchi Y, Inagaki M, Gotoh H. The impact of human parvovirus B19 infection on heart failure and anemia with reference to iron metabolism markers in an adult woman. Internal Medicine. 2018; 57(3):403-407.
  8. Spartalis M, Tzatzaki E, Spartalis E, Damaskos C, Mavrogeni S, Voudris V. Parvovirus B19 myocarditis of fulminant evolution, Cardiol Res. 2017; 8(4):172-175.
  9. Verdonschot J, Hazebroek M, Merken J, Debing Y, Dennert R, Brunner-La Rocca HP, Heymans S. Relevance of cardiac parvovirus B19 in myocarditis and dilated cardiomyopathy: review of the literature. Eur J Heart Failure. 2016; 18(12):1430-1441.
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  12. Khamitova I, Lavrentyeva I, Averyanova M, Chukhlovin A, Zubarovskaya L, Afanasyev B. Parvovirus B19 incidence, specific antibody response, and delayed hematopoietic recovery after allogeneic hematopoietic stem cell transplantation. Cell Ther Transplant. 2018; 7(1):36-43.
  13. Plentz A, Hahn J, Knoll A, Holler E, Jilg W, Modrow S. Exposure of hematologic patients to parvovirus B19 as a contaminant of blood cell preparations and blood products. Transfusion. 2005; 45: 1811-1815.
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Целью нашего сообщения было описание редкого случая геморрагического энтерита, ассоциированного с ПВ В19 у пациента после аллогенной трансплантации гемопоэтических стволовых клеток (алло-ТГСК). Нами представлен клинический случай парвовирусной инфекции, протекавшей на фоне острого геморрагического энтерита у 52-летнего больного после ТГСК. Посредством иммуногистохимического тестирования выявлена экспрессия антигена ПВ В19- при аутопсии, а также с помощью ПЦР была обнаружена ДНК ПВ В19 в тканях желудка, тонкой кишки и образцах миокарда. </p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Парвовирус B19, аллогенная трансплантация гемопоэтических клеток, клиническая инфекция, геморрагический энтерит, миокардит, кишечное кровотечение. </p>" ["ELEMENT_PREVIEW_PICTURE_FILE_TITLE"]=> string(287) "Геморрагический энтерит, ассоциированный с парвовирусом В19 после трансплантации гемопоэтических стволовых клеток: клинический случай и данные литературы" ["ELEMENT_DETAIL_PICTURE_FILE_ALT"]=> string(287) "Геморрагический энтерит, ассоциированный с парвовирусом В19 после трансплантации гемопоэтических стволовых клеток: клинический случай и данные литературы" ["ELEMENT_DETAIL_PICTURE_FILE_TITLE"]=> string(287) "Геморрагический энтерит, ассоциированный с парвовирусом В19 после трансплантации гемопоэтических стволовых клеток: 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Голощапов<sup>1</sup>, Наталья Д. Венцловайте<sup>1</sup>, Руслана В. Клементьева<sup>1</sup>, Александр Н. Швецов<sup>1</sup>, Александр А. Щербаков<sup>1</sup>, Мария О. Голощапова<sup>1</sup>, Вадим Е. Карев<sup>2</sup>, Борис В. Афанасьев<sup>1</sup> </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(398) "

Олег В. Голощапов1, Наталья Д. Венцловайте1, Руслана В. Клементьева1, Александр Н. Швецов1, Александр А. Щербаков1, Мария О. Голощапова1, Вадим Е. Карев2, Борис В. Афанасьев1

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Федеральный детский научно-клинический центр инфекционных болезней, Санкт-Петербург, Россия

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Инфекция парвовирусом (ПВ) B19 весьма распространена в мире и проявляется рядом клинических симптомов. Целью нашего сообщения было описание редкого случая геморрагического энтерита, ассоциированного с ПВ В19 у пациента после аллогенной трансплантации гемопоэтических стволовых клеток (алло-ТГСК). Нами представлен клинический случай парвовирусной инфекции, протекавшей на фоне острого геморрагического энтерита у 52-летнего больного после ТГСК. Посредством иммуногистохимического тестирования выявлена экспрессия антигена ПВ В19- при аутопсии, а также с помощью ПЦР была обнаружена ДНК ПВ В19 в тканях желудка, тонкой кишки и образцах миокарда.

Ключевые слова

Парвовирус B19, аллогенная трансплантация гемопоэтических клеток, клиническая инфекция, геморрагический энтерит, миокардит, кишечное кровотечение.

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Oleg V. Goloshchapov1, Natalia D. Ventslovayte1, Ruslana V. Klementeva1, Alexander N. Shvetsov1, Aleksandr A. Shcherbakov1, Maria O. Goloshchapova1, Vadim E. Karev2, Boris V. Afanasyev1

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia
2 Federal Pediatric Research Center of Infectious Diseases, St. Petersburg, Russia

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Parvovirus (PV) B19 infection is rather spread worldwide and manifests with a range of clinical symptoms. The aim of our report was to demonstrate a rare case of haemorrhagic enteritis associated with parvovirus B19 in the patient after allogeneic hematopoietic stem cell transplantation (allo-HSCT).We present here a clinical case of PV infection which proceeded as acute haemorrhagic enteritis in 52-year male patient who underwent HSCT. Distinct expression of antigens specific for PV B19 was revealed on autopsy by means of immunohistochemical testing, along with PVB19 DNA found in stomach, small intestine tissues and myocardial samples by means of PCR technique.

Keywords

Parvovirus B19, allogeneic hematopoietic stem cell transplantation, clinical infection, haemorrhagic enteritis, myocarditis, intestinal bleeding.

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Goloshchapov<sup>1</sup>, Natalia D. Ventslovayte<sup>1</sup>, Ruslana V. Klementeva<sup>1</sup>, Alexander N. Shvetsov<sup>1</sup>, Aleksandr A. Shcherbakov<sup>1</sup>, Maria O. Goloshchapova<sup>1</sup>, Vadim E. Karev<sup>2</sup>, Boris V. Afanasyev<sup>1</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(280) "

Oleg V. Goloshchapov1, Natalia D. Ventslovayte1, Ruslana V. Klementeva1, Alexander N. Shvetsov1, Aleksandr A. Shcherbakov1, Maria O. Goloshchapova1, Vadim E. Karev2, Boris V. Afanasyev1

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Oleg V. Goloshchapov1, Natalia D. Ventslovayte1, Ruslana V. Klementeva1, Alexander N. Shvetsov1, Aleksandr A. Shcherbakov1, Maria O. Goloshchapova1, Vadim E. Karev2, Boris V. Afanasyev1

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Parvovirus (PV) B19 infection is rather spread worldwide and manifests with a range of clinical symptoms. The aim of our report was to demonstrate a rare case of haemorrhagic enteritis associated with parvovirus B19 in the patient after allogeneic hematopoietic stem cell transplantation (allo-HSCT).We present here a clinical case of PV infection which proceeded as acute haemorrhagic enteritis in 52-year male patient who underwent HSCT. Distinct expression of antigens specific for PV B19 was revealed on autopsy by means of immunohistochemical testing, along with PVB19 DNA found in stomach, small intestine tissues and myocardial samples by means of PCR technique.

Keywords

Parvovirus B19, allogeneic hematopoietic stem cell transplantation, clinical infection, haemorrhagic enteritis, myocarditis, intestinal bleeding.

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Parvovirus (PV) B19 infection is rather spread worldwide and manifests with a range of clinical symptoms. The aim of our report was to demonstrate a rare case of haemorrhagic enteritis associated with parvovirus B19 in the patient after allogeneic hematopoietic stem cell transplantation (allo-HSCT).We present here a clinical case of PV infection which proceeded as acute haemorrhagic enteritis in 52-year male patient who underwent HSCT. Distinct expression of antigens specific for PV B19 was revealed on autopsy by means of immunohistochemical testing, along with PVB19 DNA found in stomach, small intestine tissues and myocardial samples by means of PCR technique.

Keywords

Parvovirus B19, allogeneic hematopoietic stem cell transplantation, clinical infection, haemorrhagic enteritis, myocarditis, intestinal bleeding.

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia
2 Federal Pediatric Research Center of Infectious Diseases, St. Petersburg, Russia

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia
2 Federal Pediatric Research Center of Infectious Diseases, St. Petersburg, Russia

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Целью нашего сообщения было описание редкого случая геморрагического энтерита, ассоциированного с ПВ В19 у пациента после аллогенной трансплантации гемопоэтических стволовых клеток (алло-ТГСК). Нами представлен клинический случай парвовирусной инфекции, протекавшей на фоне острого геморрагического энтерита у 52-летнего больного после ТГСК. Посредством иммуногистохимического тестирования выявлена экспрессия антигена ПВ В19- при аутопсии, а также с помощью ПЦР была обнаружена ДНК ПВ В19 в тканях желудка, тонкой кишки и образцах миокарда. </p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Парвовирус B19, аллогенная трансплантация гемопоэтических клеток, клиническая инфекция, геморрагический энтерит, миокардит, кишечное кровотечение. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1571) "

Инфекция парвовирусом (ПВ) B19 весьма распространена в мире и проявляется рядом клинических симптомов. Целью нашего сообщения было описание редкого случая геморрагического энтерита, ассоциированного с ПВ В19 у пациента после аллогенной трансплантации гемопоэтических стволовых клеток (алло-ТГСК). Нами представлен клинический случай парвовирусной инфекции, протекавшей на фоне острого геморрагического энтерита у 52-летнего больного после ТГСК. Посредством иммуногистохимического тестирования выявлена экспрессия антигена ПВ В19- при аутопсии, а также с помощью ПЦР была обнаружена ДНК ПВ В19 в тканях желудка, тонкой кишки и образцах миокарда.

Ключевые слова

Парвовирус B19, аллогенная трансплантация гемопоэтических клеток, клиническая инфекция, геморрагический энтерит, миокардит, кишечное кровотечение.

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Инфекция парвовирусом (ПВ) B19 весьма распространена в мире и проявляется рядом клинических симптомов. Целью нашего сообщения было описание редкого случая геморрагического энтерита, ассоциированного с ПВ В19 у пациента после аллогенной трансплантации гемопоэтических стволовых клеток (алло-ТГСК). Нами представлен клинический случай парвовирусной инфекции, протекавшей на фоне острого геморрагического энтерита у 52-летнего больного после ТГСК. Посредством иммуногистохимического тестирования выявлена экспрессия антигена ПВ В19- при аутопсии, а также с помощью ПЦР была обнаружена ДНК ПВ В19 в тканях желудка, тонкой кишки и образцах миокарда.

Ключевые слова

Парвовирус B19, аллогенная трансплантация гемопоэтических клеток, клиническая инфекция, геморрагический энтерит, миокардит, кишечное кровотечение.

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Федеральный детский научно-клинический центр инфекционных болезней, Санкт-Петербург, Россия

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Федеральный детский научно-клинический центр инфекционных болезней, Санкт-Петербург, Россия

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Introduction

At the present time, a sufficient attention is paid to changing quality of life (QoL) during rehabilitation programs in young patients with tuberculosis and other chronic conditions [1, 2]. Life quality aspects in children and adults after hematopoietic stem cell transplantation is also in focus of current studies [3-7]. In this view, the effects of physical rehabilitation seems to exert positive effects upon quality of life in early posttransplant period.

QoL is a common category meaning an integrity of physical, psychological, emotional and social functioning. Determination of the QoL indexes is included into evaluation scoring of rehabilitation programs [8].

Over last years, a distinct trend for increased cancer morbidity worldwide, including children and adolescents [9]. 300,000 cases of cancer are registered yearly in children from 0 to 18 years old. In 2016, 24207 children were registered at oncological dispensaries in Russia, thus requiring appropriate rehabilitation programs following cancer therapy.

The effects of physical rehabilitation upon QoL of adolescents with cancer following HSCT is poorly studied so far. Our aim was to propose an original system of post-transplant physical rehabilitation and tools of appropriate QoL control.

Patients and methods

The study included twenty patients at the age of 12 to 17 years old. The study was performed at the base of R. Gorbacheva Research Institute of Children Onclogy, Hematology and Transplantology over a period of April 2017 to November 2018. Ten patients were in experimental group 1, and 10, in experimental group 2. The 1st group received a standard program of physical exercises, whereas 2nd group was subject to additional program of physical rehabilitation.

To resolve our clinical tasks, we have developed and tested a program of physical rehabilitation for adolescents with cancer diseases after HSCT procedure. This method is aimed for effective recovery of functional state, prevention of complications, QoL increase, psychophysical development of the patients subjected to HSCT at different rehabilitation stages.

This purpose was achieved by resolution of some educational and health-sparing health-promoting tasks at the 3 time stages of the program:
1. Pre-transplant;
2. During the early posttransplant period (over 30-40 days);
3. At the later posttransplant period (over D+100).

Educational tasks are obligatory for each phase of the physical rehabilitation. They include: developing positive attitude for physical exercises; development of physical abilities during the studies; education of aesthetic and moral personal properties (honesty, discipline, responsibility etc.). Posing the health-promoting tasks depends on the disease severity, secondary disturbances of different organs and systems as well as existing comorbidities.

At each stage of the program, certain specific tasks were perform, as follows:
1. Before transplantation:
- to prepare the organism for the ongoing therapeutic procedure;
- to promote sufficient levels of adaptational abilities in the patient;
- to educate positive attitude for the motor activity exercises.
2. Early posttransplant period:
- to promote recovery of the functional systems of the organism;
- to develop and restore motor abilities;
- to perform prevention of complications and concomitant diseases;
- to optimize psycho-emotional state of the patient.
3. Late posttransplant period:
- further promotion of physical abilities;
- development of functional systems in the patient;
- to foster volitional powers in the subjects’ personality;
- to increase the level of emotional state.

Design of the program was based on the following pedagogical principles: availability and individualization, gradually increasing duration and intensity of exercises, activity and consciousness of the subjects involved; continuity of pedagogical activity in the course of rehabilitation, differential approach to application of physical exercises. Organizational and methodical features of physical rehabilitation for adolescents with cancer diseases: keeping the treatment and general regimen at the clinical facility; taking into account the types and forms of physical exercises; engraftment degree; education and preparation for the next rehabilitation step, high-quality self-consistent performance of the physical exercises; prophylaxis of the complications caused by low motor activities.

The developed program of physical rehabilitation consists of the following components:
1) Active games, aimed for correction and development of sensory, perceptive, psychomotor, emotional and volitional properties, voluntary attention and memory, communicative skills, e.g., Just a Minute, Nose-Year, Mirror etc.
2) Active games aimed for development of fine motor skills, respiratory functions, restoration of motor skills, after long-term hypodynamy when staying in bed, games in order to improve physical characteristics of the patients, i.e., Balls in the basket, Rope-walker, Spinner.
3) Physical exercises should be health-promoting, with elements of extension and static tension, respiratory and corrective exercises with adaptive sport elements. Hockey on the floor, sitting volleyball.

The program includes 9 sets which were dependent on the rehabilitation stage and age of the patient. The exercise sets consisted of basic and variative parts. The basic part included obligatory exercises, whereas variative part consisted of games that could be chosen of a certain list, aiming for solution of distinct tasks for the given rehabilitation phase, as shown in Table 1.

Table 1. Variable exercise sets included into the physical rehabilitation program

Potapchuk-tab01.jpg

Contents of the exercise sets were variable, depending on age and rehabilitation period. I.e., exercises for the children of 12-13 years are more simple and require less repeats that those for adolescents in the age of 14-15 or 16-17 years.

Short description of the physical exercises applied includes the movement regimens, initial positions, amplitude and pace of the exercises, ratio of fitness gym and special exercises (respiratory, correcting exercises with adaptive sport elements). Short characteristics of their contents are presented in Table 2.

Table 2. Brief description of exercise sets for different posttransplant patients

Potapchuk-tab02.jpg

Recent publications on dosage of loads for physical rehabilitation of children after HSCT are controversial and methodologically different [10, 11, 12].

The authors propose individual dosage, depending on physical potential of the patients and terms posttransplant. E.g., Yildiz Kabak et al. suggest usage of the Borg scale despite its subjectivity based on pulse rates of adult persons [13]. To perform dosage for physical loads, some special devices are applied, e.g., Actiwatch-Score-type pulsometers, or a portable monitor for the pulse rate measurements. However, they are intended for routine screening, and it is difficult to perform effective scheduling of long-term programs [11, 14].

Some reports present dosage variants for physical loadings with its gradual increment, variability and adaptation, depending on the patients’ condition. Meanwhile, we did not find any data on dosage of physical loads for adolescents during the pre-transplant period. Therefore, we planned loadings based on the developed original regimens, general principles and requirements for age-adapted physical exercises [15, 16].

The physical load was optimal and corresponded to functional abilities for adolescents. A number of factors was considered when planning the dosage of physical load, aiming for its increase or reduction: initial laying or sitting caused reduced load; staying posture was associated with increased load; switching of small muscular groups (foot, hand) were connected with decreased loadings. Increased amplitude of the movements and repeat numbers did also increase physical loads. The exercises were performed slowly, at moderate rates, or rapidly; rhythmic exercises alleviated the loads. A demand for exact performance caused initial increase of physical load, while decreasing later, upon automation of movements. Complex exercises with motor coordination did enhance the load, thus having been excluded from initial first-stage classes, and were introduced gradually; the exercises for relaxation and static respiratory exercises caused a decreased load (the load became lesser, the more this exercise was repeated. The ratios between health-promoting and special exercises were 1:1; 1:2; 1:3; 1:4; 1:5, and positive emotions during the classes in the form of games helped to better tolerate physical loads. Different grade of the patient’s efforts when performing the exercises proved to promote variation of loadings. In order to manage physical loadings, we used a principle of the load spreading with alternative involvement of different muscle groups; usage of different apparatus influenced the intensity of physical load.

When performing this program of physical exercises, their general load depended on their intensity, duration, density and volume. The intensity corresponded to certain threshold level for given step of the program. Duration of the load was adequate to performance time for each distinct task. The total volume of loads and their density was distributed uniformly, with their intensity determined by individual features of the patient and stage of the program. The motion regimen, dosage, density and total volume of the loads depended on the patient’s age and stage of the given rehabilitation program.

When arranging content of the game complexes and physical exercise sets we followed the principle "from a simple to more complex", i.e., from minor muscular groups to major ones, depending on the patient’s age. The games were classified into four groups with increasing loads: 1) On-site passive games; 2) Less active games; 3) Active games; 4) Elements of sports games. The games allowed usage of selective effects, exact intensity dosage for differently directed game exercises.

To evaluate efficiency of the the program, we used the QoL assessment using the special questionnaire (PedsQL Stem Cell Transplant Module Version 1.0) [14, 17].

Statistical evaluation of the results was performed by the STATISTICA 7.0 (StatSoft, USA). At initial stage, we evaluated the type of distribution by means of Shapiro-Wilkes criterion. Since most indexes did not show a standard distribution, the non-parametric methods were used. Significance of appropriate differences between the median values was evaluated by the Mann-Whitney test, with p<0.05 taken as a value of significance.

Results

Potapchuk-fig01.jpg

Figure 1. Quality of life indexes at the 3 stages of study in the 2 experimental groups

The analysis of QoL in the children following HSCT has shown statistically significant differences between the groups 1 and 2 (p<0.05) by all the scales of Questionnaire. The indexes were registered at all 3 stages of the program. The PedsQL Stem Cell Transplant Module data are shown in Table 3 and Fig. 1.

Evaluation of QoL indexes in adolescents subjected to HSCT allowed us to assess a statistically significant improvement of QoL by all the questionnaire scales. The indexes regularly decreased at the 2nd rehabilitation stage after HSCT, and increased at the 3rd rehabilitation stage, showing improved QoL for most indexes in experimental group 2, as compared to the 1st group.

Table 3. Quality of life scores in posttransplant adolescents at different stages of rehabilitation program

Potapchuk-tab03.jpg

Note: The data are expressed as points of the QoL questionnaire scores *, p<0.05 means a statistically significant difference between group 1 and group 2.

When summarizing the data obtained, one may see that all the life quality indexes were substantially decreased after HSCT in both experimental groups. However, during the rehabilitation measures, implementing the proposed program, a normalization and increase of parameters were revealed in experimental groups, especially by the indexes of physical functioning (+14%), emotional functioning (+11%), and communication abilities (+33%), thus confirming efficiency of the proposed physical rehabilitation program with respect to quality of life in the patients.

The data obtained confirm a positive effect of motor activities upon quality of life in adolescents subjected to hematopoietic stem cell transplantation reported elsewhere [13, 16].

Conclusion

1. At the present time, a number of children with cancer is registered worldwide, thus often requiring severe chemotherapy and hematopoietic stem cell transplantation (HSCT).

2. We have proposed a program of physical rehabilitation in children with cancer diseases, including nine variative sets of exercises. The technique consists of game exercises, fitness, respiratory and corrective exercises as well elements of adaptive sport.

3. The quality of life was evaluated by means of a PedsQL Stem Cell Transplant Questionnaire. Following HSCT, all the QoL indexes were decreased in both groups, i.e., with standard program of physical exercises (Group 1), and group 2 subjected to additional physical programs.

4. The course of rehabilitation in the patients from group 2 who used the proposed additional program has resulted into physical normalization and more pronounced increase in QoL, when compared to the children receiving standard physical exercises.

References

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  2. Romanova LA, Kulishova TV, Nesina IA. Time dynamics of life quality in the children of school age with innate cervical spinal trauma following combined sanatory treatment, including manual therapy. Journal of Siberian Medical Sciences. 2014; No.4:180-187 (In Russian).
  3. Takken T, van der Torre P, Zwerink M, Hulzebos EH, Bierings M, Helders PJ, van der Net J. Development, feasibility and efficacy of a community-based exercise training program in pediatric cancer survivors. Psychooncology. 2009; 18(4):440-448.
  4. Parsons SK, Tighiouart H, Terrin N. Assessment of health-related quality of life in pediatric hematopoietic stem cell transplant recipients: progress, challenges and future directions. Expert Rev Pharmacoecon Outcomes Res. 2013; 13: 217-225.
  5. Lawitschka A, Güclü ED, Varni JW, Putz M, Wolff D, Pavletic S, Greinix H, Peters C, Felder-Puig R. Health-related quality of life in pediatric patients after allogeneic SCT: development of the PedsQL Stem Cell Transplant module and results of a pilot study. Bone Marrow Transplant. 2014; 49: 1093-1097.
  6. Hastings B, Patil C, Gallo AM. The experience and health-related quality of life after haploidentical stem cell transplantation for adults with sickle cell disease. West J Nurs Res. 2019;18:193945919870828. doi: 10.1177/0193945919870828.
  7. Zając-Spychała O, Pieczonka A, Barańska M, Wachowiak J. Long-term recipient health-related quality of life and donor-recipient relationship following sibling pediatric hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2019 pii: S1083-8791(19)30665-2/ doi: 10.1016/j.bbmt.2019.10.009.
  8. Ivannikova AS, Pochivalov AV. Quality of life in children with respiratory diseases associated with non-differentiated dysplasia of connective tissue. The BelGU Research Notes (Medical and Pharmaceutic Series). 2012; No.16(135):47-49 (In Russian).
  9. Kaprina AD, Starinsky VV, Petrova GV. State of oncological care for the population of Russia in 2016. P.Gerzen Research Institute of Oncology: Moscow, 2017, pp. 18-19 (In Russian).
  10. van Brussel M, Takken T, van der Net J, Engelbert RH, Bierings M, Schoenmakers MA, Helders PJ. Physical function and fitness in long-term survivors of childhood leukaemia. Pediatr Rehabil. 2006; 9(3):267-274.
  11. San Juan AF, Chamorro-Viña C, Moral S, Fernández del Valle M, Madero L, Ramírez M, Pérez M, Lucia A. Benefits of intrahospital exercise training after pediatric bone marrow transplantation. Int J Sports Med. 2008;29(5): 439-446.
  12. Norris JM, Moules NJ, Pelletier G, Culos-Reed SN. Families of young pediatric cancer survivors: a cross-sectional survey examining physical activity behavior and health-related quality of life. J Pediatr Oncol Nurs. 2010; 27(4):196-208.
  13. Yildiz Kabak V, Cetinkaya DU, Kuskonmaz B, Cetin N, Duger T. Effects of multimodal exercise on clinical status and patient-reported outcomes in children undergoing hematopoietic stem cell transplantation. Pediatr Hematol Oncol. (2019) 36(7):410-421.
  14. Danaher EH, Ferrans C, Verlen E, Ravandi F, van Besien K, Gelms J, Dieterle N. Fatigue and physical activity in patients undergoing hematopoietic stem cell transplant. Oncol Nurs Forum. 2006; 33:614-624.
  15. Rosenhagen A, Bernhörster M, Vogt L, Weiss B, Senn A, Arndt S, Siegler K, Jung M, Bader P, Banzer W. Implementation of structured physical activity in the pediatric stem cell transplantation. Klin Pädiatr. 2011;223(3):147-151.
  16. Yildiz Kabak V, Duger T, Cetinkaya D. Investigation of the effects of an exercise program on physical functions and activities of daily life in pediatric hematopoietic stem cell transplantation. Pediatr Blood Cancer. 2016;63 (9):1643-1648.
  17. Brice L, Weiss R, Wei Y, Satwani P, Bhatia M, George D, Garvin J, Morris E, Harrison L, Cairo MS, Sands SA. Health-related quality of life (HRQoL): the impact of medical and demographic variables upon pediatric recipients of hematopoietic stem cell transplantation. Pediatr Blood Cancer. 2011;57(7):1179-1185.
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Introduction

At the present time, a sufficient attention is paid to changing quality of life (QoL) during rehabilitation programs in young patients with tuberculosis and other chronic conditions [1, 2]. Life quality aspects in children and adults after hematopoietic stem cell transplantation is also in focus of current studies [3-7]. In this view, the effects of physical rehabilitation seems to exert positive effects upon quality of life in early posttransplant period.

QoL is a common category meaning an integrity of physical, psychological, emotional and social functioning. Determination of the QoL indexes is included into evaluation scoring of rehabilitation programs [8].

Over last years, a distinct trend for increased cancer morbidity worldwide, including children and adolescents [9]. 300,000 cases of cancer are registered yearly in children from 0 to 18 years old. In 2016, 24207 children were registered at oncological dispensaries in Russia, thus requiring appropriate rehabilitation programs following cancer therapy.

The effects of physical rehabilitation upon QoL of adolescents with cancer following HSCT is poorly studied so far. Our aim was to propose an original system of post-transplant physical rehabilitation and tools of appropriate QoL control.

Patients and methods

The study included twenty patients at the age of 12 to 17 years old. The study was performed at the base of R. Gorbacheva Research Institute of Children Onclogy, Hematology and Transplantology over a period of April 2017 to November 2018. Ten patients were in experimental group 1, and 10, in experimental group 2. The 1st group received a standard program of physical exercises, whereas 2nd group was subject to additional program of physical rehabilitation.

To resolve our clinical tasks, we have developed and tested a program of physical rehabilitation for adolescents with cancer diseases after HSCT procedure. This method is aimed for effective recovery of functional state, prevention of complications, QoL increase, psychophysical development of the patients subjected to HSCT at different rehabilitation stages.

This purpose was achieved by resolution of some educational and health-sparing health-promoting tasks at the 3 time stages of the program:
1. Pre-transplant;
2. During the early posttransplant period (over 30-40 days);
3. At the later posttransplant period (over D+100).

Educational tasks are obligatory for each phase of the physical rehabilitation. They include: developing positive attitude for physical exercises; development of physical abilities during the studies; education of aesthetic and moral personal properties (honesty, discipline, responsibility etc.). Posing the health-promoting tasks depends on the disease severity, secondary disturbances of different organs and systems as well as existing comorbidities.

At each stage of the program, certain specific tasks were perform, as follows:
1. Before transplantation:
- to prepare the organism for the ongoing therapeutic procedure;
- to promote sufficient levels of adaptational abilities in the patient;
- to educate positive attitude for the motor activity exercises.
2. Early posttransplant period:
- to promote recovery of the functional systems of the organism;
- to develop and restore motor abilities;
- to perform prevention of complications and concomitant diseases;
- to optimize psycho-emotional state of the patient.
3. Late posttransplant period:
- further promotion of physical abilities;
- development of functional systems in the patient;
- to foster volitional powers in the subjects’ personality;
- to increase the level of emotional state.

Design of the program was based on the following pedagogical principles: availability and individualization, gradually increasing duration and intensity of exercises, activity and consciousness of the subjects involved; continuity of pedagogical activity in the course of rehabilitation, differential approach to application of physical exercises. Organizational and methodical features of physical rehabilitation for adolescents with cancer diseases: keeping the treatment and general regimen at the clinical facility; taking into account the types and forms of physical exercises; engraftment degree; education and preparation for the next rehabilitation step, high-quality self-consistent performance of the physical exercises; prophylaxis of the complications caused by low motor activities.

The developed program of physical rehabilitation consists of the following components:
1) Active games, aimed for correction and development of sensory, perceptive, psychomotor, emotional and volitional properties, voluntary attention and memory, communicative skills, e.g., Just a Minute, Nose-Year, Mirror etc.
2) Active games aimed for development of fine motor skills, respiratory functions, restoration of motor skills, after long-term hypodynamy when staying in bed, games in order to improve physical characteristics of the patients, i.e., Balls in the basket, Rope-walker, Spinner.
3) Physical exercises should be health-promoting, with elements of extension and static tension, respiratory and corrective exercises with adaptive sport elements. Hockey on the floor, sitting volleyball.

The program includes 9 sets which were dependent on the rehabilitation stage and age of the patient. The exercise sets consisted of basic and variative parts. The basic part included obligatory exercises, whereas variative part consisted of games that could be chosen of a certain list, aiming for solution of distinct tasks for the given rehabilitation phase, as shown in Table 1.

Table 1. Variable exercise sets included into the physical rehabilitation program

Potapchuk-tab01.jpg

Contents of the exercise sets were variable, depending on age and rehabilitation period. I.e., exercises for the children of 12-13 years are more simple and require less repeats that those for adolescents in the age of 14-15 or 16-17 years.

Short description of the physical exercises applied includes the movement regimens, initial positions, amplitude and pace of the exercises, ratio of fitness gym and special exercises (respiratory, correcting exercises with adaptive sport elements). Short characteristics of their contents are presented in Table 2.

Table 2. Brief description of exercise sets for different posttransplant patients

Potapchuk-tab02.jpg

Recent publications on dosage of loads for physical rehabilitation of children after HSCT are controversial and methodologically different [10, 11, 12].

The authors propose individual dosage, depending on physical potential of the patients and terms posttransplant. E.g., Yildiz Kabak et al. suggest usage of the Borg scale despite its subjectivity based on pulse rates of adult persons [13]. To perform dosage for physical loads, some special devices are applied, e.g., Actiwatch-Score-type pulsometers, or a portable monitor for the pulse rate measurements. However, they are intended for routine screening, and it is difficult to perform effective scheduling of long-term programs [11, 14].

Some reports present dosage variants for physical loadings with its gradual increment, variability and adaptation, depending on the patients’ condition. Meanwhile, we did not find any data on dosage of physical loads for adolescents during the pre-transplant period. Therefore, we planned loadings based on the developed original regimens, general principles and requirements for age-adapted physical exercises [15, 16].

The physical load was optimal and corresponded to functional abilities for adolescents. A number of factors was considered when planning the dosage of physical load, aiming for its increase or reduction: initial laying or sitting caused reduced load; staying posture was associated with increased load; switching of small muscular groups (foot, hand) were connected with decreased loadings. Increased amplitude of the movements and repeat numbers did also increase physical loads. The exercises were performed slowly, at moderate rates, or rapidly; rhythmic exercises alleviated the loads. A demand for exact performance caused initial increase of physical load, while decreasing later, upon automation of movements. Complex exercises with motor coordination did enhance the load, thus having been excluded from initial first-stage classes, and were introduced gradually; the exercises for relaxation and static respiratory exercises caused a decreased load (the load became lesser, the more this exercise was repeated. The ratios between health-promoting and special exercises were 1:1; 1:2; 1:3; 1:4; 1:5, and positive emotions during the classes in the form of games helped to better tolerate physical loads. Different grade of the patient’s efforts when performing the exercises proved to promote variation of loadings. In order to manage physical loadings, we used a principle of the load spreading with alternative involvement of different muscle groups; usage of different apparatus influenced the intensity of physical load.

When performing this program of physical exercises, their general load depended on their intensity, duration, density and volume. The intensity corresponded to certain threshold level for given step of the program. Duration of the load was adequate to performance time for each distinct task. The total volume of loads and their density was distributed uniformly, with their intensity determined by individual features of the patient and stage of the program. The motion regimen, dosage, density and total volume of the loads depended on the patient’s age and stage of the given rehabilitation program.

When arranging content of the game complexes and physical exercise sets we followed the principle "from a simple to more complex", i.e., from minor muscular groups to major ones, depending on the patient’s age. The games were classified into four groups with increasing loads: 1) On-site passive games; 2) Less active games; 3) Active games; 4) Elements of sports games. The games allowed usage of selective effects, exact intensity dosage for differently directed game exercises.

To evaluate efficiency of the the program, we used the QoL assessment using the special questionnaire (PedsQL Stem Cell Transplant Module Version 1.0) [14, 17].

Statistical evaluation of the results was performed by the STATISTICA 7.0 (StatSoft, USA). At initial stage, we evaluated the type of distribution by means of Shapiro-Wilkes criterion. Since most indexes did not show a standard distribution, the non-parametric methods were used. Significance of appropriate differences between the median values was evaluated by the Mann-Whitney test, with p<0.05 taken as a value of significance.

Results

Potapchuk-fig01.jpg

Figure 1. Quality of life indexes at the 3 stages of study in the 2 experimental groups

The analysis of QoL in the children following HSCT has shown statistically significant differences between the groups 1 and 2 (p<0.05) by all the scales of Questionnaire. The indexes were registered at all 3 stages of the program. The PedsQL Stem Cell Transplant Module data are shown in Table 3 and Fig. 1.

Evaluation of QoL indexes in adolescents subjected to HSCT allowed us to assess a statistically significant improvement of QoL by all the questionnaire scales. The indexes regularly decreased at the 2nd rehabilitation stage after HSCT, and increased at the 3rd rehabilitation stage, showing improved QoL for most indexes in experimental group 2, as compared to the 1st group.

Table 3. Quality of life scores in posttransplant adolescents at different stages of rehabilitation program

Potapchuk-tab03.jpg

Note: The data are expressed as points of the QoL questionnaire scores *, p<0.05 means a statistically significant difference between group 1 and group 2.

When summarizing the data obtained, one may see that all the life quality indexes were substantially decreased after HSCT in both experimental groups. However, during the rehabilitation measures, implementing the proposed program, a normalization and increase of parameters were revealed in experimental groups, especially by the indexes of physical functioning (+14%), emotional functioning (+11%), and communication abilities (+33%), thus confirming efficiency of the proposed physical rehabilitation program with respect to quality of life in the patients.

The data obtained confirm a positive effect of motor activities upon quality of life in adolescents subjected to hematopoietic stem cell transplantation reported elsewhere [13, 16].

Conclusion

1. At the present time, a number of children with cancer is registered worldwide, thus often requiring severe chemotherapy and hematopoietic stem cell transplantation (HSCT).

2. We have proposed a program of physical rehabilitation in children with cancer diseases, including nine variative sets of exercises. The technique consists of game exercises, fitness, respiratory and corrective exercises as well elements of adaptive sport.

3. The quality of life was evaluated by means of a PedsQL Stem Cell Transplant Questionnaire. Following HSCT, all the QoL indexes were decreased in both groups, i.e., with standard program of physical exercises (Group 1), and group 2 subjected to additional physical programs.

4. The course of rehabilitation in the patients from group 2 who used the proposed additional program has resulted into physical normalization and more pronounced increase in QoL, when compared to the children receiving standard physical exercises.

References

  1. Solokhina LV, Dyachenko EI, Yarinchuk EI. Studies on quality of life in tuberculosis-affected children. Far-Eastern Medical Journal. 2010; No.1: 134-137 (In Russian).
  2. Romanova LA, Kulishova TV, Nesina IA. Time dynamics of life quality in the children of school age with innate cervical spinal trauma following combined sanatory treatment, including manual therapy. Journal of Siberian Medical Sciences. 2014; No.4:180-187 (In Russian).
  3. Takken T, van der Torre P, Zwerink M, Hulzebos EH, Bierings M, Helders PJ, van der Net J. Development, feasibility and efficacy of a community-based exercise training program in pediatric cancer survivors. Psychooncology. 2009; 18(4):440-448.
  4. Parsons SK, Tighiouart H, Terrin N. Assessment of health-related quality of life in pediatric hematopoietic stem cell transplant recipients: progress, challenges and future directions. Expert Rev Pharmacoecon Outcomes Res. 2013; 13: 217-225.
  5. Lawitschka A, Güclü ED, Varni JW, Putz M, Wolff D, Pavletic S, Greinix H, Peters C, Felder-Puig R. Health-related quality of life in pediatric patients after allogeneic SCT: development of the PedsQL Stem Cell Transplant module and results of a pilot study. Bone Marrow Transplant. 2014; 49: 1093-1097.
  6. Hastings B, Patil C, Gallo AM. The experience and health-related quality of life after haploidentical stem cell transplantation for adults with sickle cell disease. West J Nurs Res. 2019;18:193945919870828. doi: 10.1177/0193945919870828.
  7. Zając-Spychała O, Pieczonka A, Barańska M, Wachowiak J. Long-term recipient health-related quality of life and donor-recipient relationship following sibling pediatric hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2019 pii: S1083-8791(19)30665-2/ doi: 10.1016/j.bbmt.2019.10.009.
  8. Ivannikova AS, Pochivalov AV. Quality of life in children with respiratory diseases associated with non-differentiated dysplasia of connective tissue. The BelGU Research Notes (Medical and Pharmaceutic Series). 2012; No.16(135):47-49 (In Russian).
  9. Kaprina AD, Starinsky VV, Petrova GV. State of oncological care for the population of Russia in 2016. P.Gerzen Research Institute of Oncology: Moscow, 2017, pp. 18-19 (In Russian).
  10. van Brussel M, Takken T, van der Net J, Engelbert RH, Bierings M, Schoenmakers MA, Helders PJ. Physical function and fitness in long-term survivors of childhood leukaemia. Pediatr Rehabil. 2006; 9(3):267-274.
  11. San Juan AF, Chamorro-Viña C, Moral S, Fernández del Valle M, Madero L, Ramírez M, Pérez M, Lucia A. Benefits of intrahospital exercise training after pediatric bone marrow transplantation. Int J Sports Med. 2008;29(5): 439-446.
  12. Norris JM, Moules NJ, Pelletier G, Culos-Reed SN. Families of young pediatric cancer survivors: a cross-sectional survey examining physical activity behavior and health-related quality of life. J Pediatr Oncol Nurs. 2010; 27(4):196-208.
  13. Yildiz Kabak V, Cetinkaya DU, Kuskonmaz B, Cetin N, Duger T. Effects of multimodal exercise on clinical status and patient-reported outcomes in children undergoing hematopoietic stem cell transplantation. Pediatr Hematol Oncol. (2019) 36(7):410-421.
  14. Danaher EH, Ferrans C, Verlen E, Ravandi F, van Besien K, Gelms J, Dieterle N. Fatigue and physical activity in patients undergoing hematopoietic stem cell transplant. Oncol Nurs Forum. 2006; 33:614-624.
  15. Rosenhagen A, Bernhörster M, Vogt L, Weiss B, Senn A, Arndt S, Siegler K, Jung M, Bader P, Banzer W. Implementation of structured physical activity in the pediatric stem cell transplantation. Klin Pädiatr. 2011;223(3):147-151.
  16. Yildiz Kabak V, Duger T, Cetinkaya D. Investigation of the effects of an exercise program on physical functions and activities of daily life in pediatric hematopoietic stem cell transplantation. Pediatr Blood Cancer. 2016;63 (9):1643-1648.
  17. Brice L, Weiss R, Wei Y, Satwani P, Bhatia M, George D, Garvin J, Morris E, Harrison L, Cairo MS, Sands SA. Health-related quality of life (HRQoL): the impact of medical and demographic variables upon pediatric recipients of hematopoietic stem cell transplantation. Pediatr Blood Cancer. 2011;57(7):1179-1185.
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NULL ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25270" ["VALUE"]=> string(10) "21.10.2019" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(10) "21.10.2019" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(21) "Дата подачи" ["~DEFAULT_VALUE"]=> NULL } ["ACCEPTED"]=> array(36) { ["ID"]=> string(2) "21" ["TIMESTAMP_X"]=> string(19) "2015-09-02 17:21:42" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(25) "Дата принятия" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(8) "ACCEPTED" ["DEFAULT_VALUE"]=> NULL ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "21" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" 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string(5) "25279" ["VALUE"]=> array(2) { ["TEXT"]=> string(374) "<p>Алла А. Потапчук<sup>1</sup>, Алиса Г. Волкова<sup>1</sup>, Федор В. Терентьев<sup>2</sup>, Ирина Г. Терентьева<sup>2</sup>, Людмила С. Зубаровская<sup>1</sup>, Борис В. Афанасьев<sup>1</sup> </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(290) "

Алла А. Потапчук1, Алиса Г. Волкова1, Федор В. Терентьев2, Ирина Г. Терентьева2, Людмила С. Зубаровская1, Борис В. Афанасьев1

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Национальный государственный университет физической культуры, спорта и здоровья им. П. Ф. Лесгафта, Санкт-Петербург, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25281" ["VALUE"]=> array(2) { ["TEXT"]=> string(1831) "<p style="text-align: justify;">Данная статья посвящена анализу влияния физической реабилитации на показатели качества жизни подростков 12-17 лет с онкопатологией после трансплантации гемопоэтических стволовых клеток (ТГСК). Авторская методика физической реабилитации включает три этапа, включающие девять комплексов физических упражнений в зависимости от возраста и режима двигательной активности. Проводилась оценка качества жизни, оценивался уровень тревожно-депрессивных состояний подростков на трех этапах исследования: до проведения трансплантации, после трансплантации, после реабилитации. Полученные данные свидетельствуют о положительном влиянии физической реабилитации на качество жизни подростков с онкопатологией, перенесших трансплантацию гемопоэтических стволовых клеток.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Физическая реабилитация, онкология, дети, трансплантация гемопоэтических стволовых клеток, депрессия, тревога, эмоциональное состояние. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1775) "

Данная статья посвящена анализу влияния физической реабилитации на показатели качества жизни подростков 12-17 лет с онкопатологией после трансплантации гемопоэтических стволовых клеток (ТГСК). Авторская методика физической реабилитации включает три этапа, включающие девять комплексов физических упражнений в зависимости от возраста и режима двигательной активности. Проводилась оценка качества жизни, оценивался уровень тревожно-депрессивных состояний подростков на трех этапах исследования: до проведения трансплантации, после трансплантации, после реабилитации. Полученные данные свидетельствуют о положительном влиянии физической реабилитации на качество жизни подростков с онкопатологией, перенесших трансплантацию гемопоэтических стволовых клеток.

Ключевые слова

Физическая реабилитация, онкология, дети, трансплантация гемопоэтических стволовых клеток, депрессия, тревога, эмоциональное состояние.

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Alla A. Potapchuk1, Alisa G. Volkova1, Fedor V. Terentiev2, Irina G. Terentieva2, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University,
St. Petersburg, Russia
2 National State P. F. Lesgaft University of Physical Culture, Sports and Health, St. Petersburg, Russia

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The present article is evaluating the effects of physical rehabilitation upon the quality of life (QoL) indexes in adolescents (12 to 17 y.o.) with oncological diseases following hematopoietic stem cell transplantation (HSCT). The proprietary technique of physical rehabilitation includes 3 stages with nine complexes of physical exercises, dependent on their age and regimen of motor activities. We have evaluated QoL, and anxiety/depressive conditions in adolescents at three stages of the study: HSCT, after it, and following rehabilitation. The data obtained confirm a positive effect of the physical rehabilitation upon QoL in the adolescents with cancer subjected to hematopoietic stem cell transplantation.

Keywords

Physical rehabilitation, oncology, children, hematopoietic stem cell transplantation, depression, anxiety, emotional state.

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Potapchuk<sup>1</sup>, Alisa G. Volkova<sup>1</sup>, Fedor V. Terentiev<sup>2</sup>, Irina G. Terentieva<sup>2</sup>, Ludmila S. Zubarovskaya<sup>1</sup>, Boris V. Afanasyev<sup>1</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(200) "

Alla A. Potapchuk1, Alisa G. Volkova1, Fedor V. Terentiev2, Irina G. Terentieva2, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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Alla A. Potapchuk1, Alisa G. Volkova1, Fedor V. Terentiev2, Irina G. Terentieva2, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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The present article is evaluating the effects of physical rehabilitation upon the quality of life (QoL) indexes in adolescents (12 to 17 y.o.) with oncological diseases following hematopoietic stem cell transplantation (HSCT). The proprietary technique of physical rehabilitation includes 3 stages with nine complexes of physical exercises, dependent on their age and regimen of motor activities. We have evaluated QoL, and anxiety/depressive conditions in adolescents at three stages of the study: HSCT, after it, and following rehabilitation. The data obtained confirm a positive effect of the physical rehabilitation upon QoL in the adolescents with cancer subjected to hematopoietic stem cell transplantation.

Keywords

Physical rehabilitation, oncology, children, hematopoietic stem cell transplantation, depression, anxiety, emotional state.

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The present article is evaluating the effects of physical rehabilitation upon the quality of life (QoL) indexes in adolescents (12 to 17 y.o.) with oncological diseases following hematopoietic stem cell transplantation (HSCT). The proprietary technique of physical rehabilitation includes 3 stages with nine complexes of physical exercises, dependent on their age and regimen of motor activities. We have evaluated QoL, and anxiety/depressive conditions in adolescents at three stages of the study: HSCT, after it, and following rehabilitation. The data obtained confirm a positive effect of the physical rehabilitation upon QoL in the adolescents with cancer subjected to hematopoietic stem cell transplantation.

Keywords

Physical rehabilitation, oncology, children, hematopoietic stem cell transplantation, depression, anxiety, emotional state.

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University,
St. Petersburg, Russia
2 National State P. F. Lesgaft University of Physical Culture, Sports and Health, St. Petersburg, Russia

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University,
St. Petersburg, Russia
2 National State P. F. Lesgaft University of Physical Culture, Sports and Health, St. Petersburg, Russia

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Алла А. Потапчук1, Алиса Г. Волкова1, Федор В. Терентьев2, Ирина Г. Терентьева2, Людмила С. Зубаровская1, Борис В. Афанасьев1

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Алла А. Потапчук1, Алиса Г. Волкова1, Федор В. Терентьев2, Ирина Г. Терентьева2, Людмила С. Зубаровская1, Борис В. Афанасьев1

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Terentiev" ["LINK_ELEMENT_VALUE"]=> bool(false) } ["SUMMARY_RU"]=> array(37) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25281" ["VALUE"]=> array(2) { ["TEXT"]=> string(1831) "<p style="text-align: justify;">Данная статья посвящена анализу влияния физической реабилитации на показатели качества жизни подростков 12-17 лет с онкопатологией после трансплантации гемопоэтических стволовых клеток (ТГСК). Авторская методика физической реабилитации включает три этапа, включающие девять комплексов физических упражнений в зависимости от возраста и режима двигательной активности. Проводилась оценка качества жизни, оценивался уровень тревожно-депрессивных состояний подростков на трех этапах исследования: до проведения трансплантации, после трансплантации, после реабилитации. Полученные данные свидетельствуют о положительном влиянии физической реабилитации на качество жизни подростков с онкопатологией, перенесших трансплантацию гемопоэтических стволовых клеток.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Физическая реабилитация, онкология, дети, трансплантация гемопоэтических стволовых клеток, депрессия, тревога, эмоциональное состояние. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1775) "

Данная статья посвящена анализу влияния физической реабилитации на показатели качества жизни подростков 12-17 лет с онкопатологией после трансплантации гемопоэтических стволовых клеток (ТГСК). Авторская методика физической реабилитации включает три этапа, включающие девять комплексов физических упражнений в зависимости от возраста и режима двигательной активности. Проводилась оценка качества жизни, оценивался уровень тревожно-депрессивных состояний подростков на трех этапах исследования: до проведения трансплантации, после трансплантации, после реабилитации. Полученные данные свидетельствуют о положительном влиянии физической реабилитации на качество жизни подростков с онкопатологией, перенесших трансплантацию гемопоэтических стволовых клеток.

Ключевые слова

Физическая реабилитация, онкология, дети, трансплантация гемопоэтических стволовых клеток, депрессия, тревога, эмоциональное состояние.

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Данная статья посвящена анализу влияния физической реабилитации на показатели качества жизни подростков 12-17 лет с онкопатологией после трансплантации гемопоэтических стволовых клеток (ТГСК). Авторская методика физической реабилитации включает три этапа, включающие девять комплексов физических упражнений в зависимости от возраста и режима двигательной активности. Проводилась оценка качества жизни, оценивался уровень тревожно-депрессивных состояний подростков на трех этапах исследования: до проведения трансплантации, после трансплантации, после реабилитации. Полученные данные свидетельствуют о положительном влиянии физической реабилитации на качество жизни подростков с онкопатологией, перенесших трансплантацию гемопоэтических стволовых клеток.

Ключевые слова

Физическая реабилитация, онкология, дети, трансплантация гемопоэтических стволовых клеток, депрессия, тревога, эмоциональное состояние.

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Национальный государственный университет физической культуры, спорта и здоровья им. П. Ф. Лесгафта, Санкт-Петербург, Россия

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Национальный государственный университет физической культуры, спорта и здоровья им. П. Ф. Лесгафта, Санкт-Петербург, Россия

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Introduction

Disturbed postural resistance is a common finding among the patients treated for cancer diseases, regardless of their exact nosological forms. Researchers describe imbalances in children treated for brain tumors [1, 2] and leukemia [3], in adult people treated for lung cancer [4], breast cancer [5], leukemia, lymphomas and other solid tumors [6], etc. According to evidence-based studies meta-analyses, the percentage of leukemia survivors with disturbed postural equilibrium ranged from 27% to 69% during the treatment, being 7% to 65% at later observation terms (over 5 years) following the cytostatic therapy [6]. For children treated for medulloblastoma, the development of posterior cranial fossa syndrome is characteristic which may manifest with acute postural imbalance.

Damage of brain by the growing malignancy and surgical intervention are considered to be a cause of this phenomenon in the patients with tumors located at the posterior cranial fossa. However, imbalance signs in pediatric cancer patients without evident brain lesions suggest some other possible causes of postural instability. A number of researchers attribute postural imbalance to the late toxic effects of radiation therapy [6], or consequences of chemotherapy [7]. In the literature, we have encountered only a few studies on the mechanisms of impaired postural stability in the cancer patients. In particular, Gilchrist L.S. and Tanner L.R. (2018) examined the relationships of imbalance with manifestations of peripheral neuropathy [3].

In another study of adult cancer survivors treated in their childhood, it was shown that both the disease and treatment cause long-term disturbances of postural resistance in the position with open eyes. At the same time, the authors found a similar reaction of cancer survivors and healthy subjects to closing their eyes, which allowed them to confirm a preserved role of vision for postural resistance [8]. R. Leight and D. Zee (2015) showed that the brain tumors, including cerebellum, lead to serious oculomotor disturbances, in particular, saccadic dysmetry, occurence of disruptive micro- and macrosaccades, that may affect the body equilibrium [9]. Einarsson E.J. et al. (2016) showed sufficient oculomotor disorders in patients with oncological diseases which did not directly affect the central nervous system [10]. In their opinion, these disorders may be caused by toxic effects chemotherapeutic cytostatic drugs upon brain tissues after crossing the blood-brain barrier. In 2019, the same authors described increased visual dependence in people who survived childhood cancer under the age of 12 years, which is thought to explain the visual dizziness in adults who previously received chemotherapy.

The aim of our retrospective study was to clarify a relationship between the postural stability disorders in children treated for cancer, and oculomotor muscle dysfunction.

Patients and methods

The study was carried out during their rehabilitation course at the Medical Rehabilitation Research Center Russian Field. The study involved 291 children 5-18 years old who were previously treated for a brain tumor localized in the posterior cranial fossa: medulloblastoma – 58.11%, piloid astrocytoma – 22.50%, anaplastic ependymoma – 6.25%, diffuse stem tumors – 4.36%, anaplastic astrocytoma – 2.25% ganglioglioma – 2.25% and others with a frequency of <1% and were in remission (82.3%) or stabilization (17.7%). In the vast majority of cases, the disease was diagnosed at an early age: up to 6 years, in 63.9% of girls and 53.7% of boys, from 7 to 11 years – in 26.9% of girls and 34.2% of boys (Fig. 1).

Chechelnitskaia-fig01.jpg

Figure 1. Distribution of the children with malignancies by their gender and age of onset. Abscissa, age of the disease onset, years; ordinate, number of cases

79% of the examined children underwent radiation therapy, 75% chemotherapy, 64% received complex therapy, including surgical treatment, chemotherapy and radiation therapy.

According to the duration of remission at the time of examination, the patients were distributed as follows: up to 1 year – 15.6%, from 1 year to 3 years – 37.8%, from 4 to 7 years – 31.1%, over 8 years – 15.6%.

The control group included 182 children 6-18 years old, who were in the medical rehabilitation scientific center "Russian Field" with their siblings, and healthy children who were engaged in the group of general physical training for the first year.

The quality of the postural balance was evaluated by a stabilometric method using the computer-assisted Stabilan 01-2 device (manufacturing firm OKB RITM Russia). A stabilometric study is based on recording the parameters of the oscillations of the projection of the conditional center of mass of the person being examined on the plane of the stable platform.

Each individual test consisted of sequential trials with open and closed eyes (Romberg test) in a European installation (in heel position together, socks divorced at an angle of 30 degrees), the duration of each trial was 30 seconds [11]. The mark was stuck on the wall in front of the child. The subject should fix his eyes on it throughout the testing. We analyzed the stabilometric indicators of the displacement and dispersion of the center of human pressure in the area of support (on the reference plane, the lengths of the trajectories of the pressure center in the frontal and sagittal planes, the linear velocities of the movement of the pressure center on the reference plane, and the size of the area of the confidence ellipse of the statokinesiogram).

Chechelnitskaya-fig02.jpg

Figure 2. An example of a graphic image of a statokinesiogram. Actually, the statokinesiogram is the trajectory of pressure center oscillations during the study. The circle (a special case of an ellipse) represents a 95% confidence interval for the position of the pressure center

The center of a person’s pressure on the area of support is the projection of the general center of pressure of a person’s body on a horizontal plane. Displacements from the center of pressure are recorded as a statokinesiogram. The area of statokinesiogram forms an ellipse, which includes 95 percent of the fixed points, is called the area of the confidence ellipse. Figure 2 shows an example of a statokinesiogram with a confidence ellipse.

The patient’s data were compared with gender- and age-matched children from the control group. Postural balance indexes were registered in the Romberg test with open eyes. A test for fixing the gaze on a stimulus was used to evaluate the work of the saccadic system of eye movements [12], which allows one to characterize the degree of work of the oculomotor muscles, since the physiological fixation process requires establishing and maintaining fovea in one position. The required duration of fixation in the test (20 seconds) on each stimulus was selected, to prevent a sufficient loading of the oculomotor muscles. The test evaluates the spread and density of the gaze when fixing the patient on the stimulus.

The patient was sitting comfortably on the chair in front the monitor in the calm room for neurophysiological investigations. Eye movements were recorded by videoculography using an Arrington 60 Hz eye-tracker glasses. Patient`s head was fixed by a frontal chin support to minimize head movements. Functioning of the oculomotor muscles was evaluated by the gaze fixation test on the stimulus (Danilov et al., 2015) [12]. The stimulus were presented on a Samsung 23-inch screen (with a resolution of 1920×1080 pixels) at a distance of 60 cm from the subjects' eyes, while occupied about 45° horizontally and 26° vertically of their visual field. The stimulating object (a green dot on the screen) had a size of ~1°, having been sequentially moved in the left/right positions by 15°, and at the top/bottom direction, by 8° for 20 s for each position. Dispersion and density of the gaze fixation points on the every stimulus were evaluated. Raw dispersions of gaze fixation points were filtered in ±2σ of coordinates' distribution and fitted by ellipse Matlab function "fit_ellipse". Then the squares of the obtained ellipses were counted in deg2. Densities of the gaze fixation points were counted as a ratio of the number of fixation points to the ellipse square. The larger squares of the ellipses and the lower densities of the points reveal the more unstable gaze fixation.

Statistical evaluation of the results was performed with a modification of the Student t-test (Welch test), which suggests that the variances of the compared populations are not equal. To model relationships between of the analyzed indexes, regression analysis was used, which allowed us to analytically present the relationship models between appropriate indexes, and to quantify relative influence for distinct factors. In the course of statistical modeling of explicit asymmetric distributions, we used conversion of initial values to logarithmic form and the Box-Cox transformation.

Results

To assess the postural balance in patients treated for tumors of the posterior cranial fossa, we analyzed the stabilometric indicators of the displacement and dispersion of the fixation points of the pressure center on the reference plane, the length of the trajectories of the pressure center in the frontal and sagittal planes, the linear velocities of the pressure center on the reference plane and the magnitude areas of the confiding ellipse of the statokinesiogram. The results were compared with homologous children from the control group. Indicators of postural balance were recorded in the Romberg test with open eyes. The results are presented in Table 1.

Table 1. Indexes of postural balance in children treated for brain tumor, and in healthy children using Romberg test with open eyes

Chechelnitskaia-tab01.jpg

In our study, the average size of the estimated ellipse area in children of the main group in the position with open eyes was 673±1201.1 mm2, thus being significantly differed from the average values in the control group (258.9±162.5 mm2). To confirm the hypothesis about the relationship between the postural balance and the disease, a nonlinear (exponential) regression model was constructed for the Ellipse Area indicator:

log(Ells)=6.7 – 0.059full.year + 0.104gender – 0.57grp,
R2=0.103, p<0,05.
where log (Ells) is the logarithm (natural) of the area of the ellipse.
gender = 1 – boys, 0 – girls
grp = 1 – healthy controls; 0, treated patients.

Age of children (full_years), and disease state (grp) proved to be the statistically significant factors in this model. According to the model, the logarithm of ellipse area in healthy children was lower by 0.57 (p<0.000).

In order to study potential contribution of altered vision in the postural control, we analyzed the change in the Rom-berg test parameters when the patient changes the position with open eyes (EO) to the pose with closed eyes (EC). For analysis, the relative dynamics of indexes were calculated by the formula:

Chechelnitskaia-form01.jpg

where

Chechelnitskaia-form02.jpg

When evaluating the following indices: Assessment of movement and Quality of the equilibrium function, a minus sign was introduced before the formula, due to their special calculation modes:

Chechelnitskaia-form03.jpg

As a result, we have calculated the factors characterizing changes of stabilometric indexes when turning off the vision. The values of the coefficient equal to "0" and higher denoted the improvement of stabilometric values when closing the eyes, whereas a negative value meant their impairment (Table 2).

Table 2. Increases in the indicators of the postural balance of children treated for cancer and their healthy peers in the Romberg test when moving from the Open eyes to the Closed eyes position

Chechelnitskaia-tab02.jpg

More often, the shutdown of vision led to a positive change in the mentioned indexes. Assessment of movement and Displacement of the center of pressure along the sagittal axis (68.5%/61.1% of pediatric patients, and 30.8%/33.3% in the control group, respectively), as seen from Table 3.

Table 3. Frequencies of “atypical” reactions in the Romberg position with closed eyes, %

Chechelnitskaia-tab03.jpg

In the main group, the area of the confidence ellipse decreased in 43.2% of children by an average of 33.4%. Similar dynamics was noted in 20.5% of the examined children, the average decrease in area was 29.6% (Fig. 3). Moreover, the Romberg coefficient averaged 113% both in the main group and in the control group.

Chechelnitskaia-fig03.jpg

Figure 3. The allocation of growth rates of the indicator Ellipse area increments in the Romberg test during the transition from open to closed eyes in children of the main group

To test the hypothesis about the relationship between postural control and oculomotor activity, we analyzed the results of examination of children treated for tumors of the posterior cranial fossa, on an i-tracking. The oculomotor muscles perform fast saccadic eye movements necessary for fixing the gaze on the object, a point in space, etc., due to which the brain receives visual information. The saccadic system is a complex hierarchical system in which many brain structures are involved [19]. The variable measured in the i-tracking is the area of ellipses (deg2), in terms of the content and type of the calculation, it is related to the stabilometric parameter – the ellipse of the statokinesiogram. The larger is the area of the ellipse, the less stable the gaze is kept. Vice versa, the gaze fixation of the gaze is impaired due to various involuntary saccadic movements (disruptive, intrusive macro- and micro-amplitude involuntary saccades) and nystagmus. The second variable density of gaze fixation, with 95% of points fitting the ellipse area within a definite time period. It characterizes the presence or absence of large-amplitude movements, since with large-amplitude movements, the area of the ellipse increases when the gaze is fixed, and the density of the gaze positions, on the contrary, decreases.

We did not find any correlations between the absolute stabilometric indexes and saccadic activity. At the same time, we found a connection between saccadic activity indexes and increased stabilometry indexes in the Romberg test upon transition from open to closed eyes. Indicators of saccadic activity showed asymmetric distribution. Therefore, a power-law transformation of initial data by the Box-Cox method was performed, in order to identify their relationships with stabilometry indexes.

The simulation results showed that the mode of relationships between the saccadic activity indicators and incrementing stabilometric indices corresponded to linear regression. A moderate correlation between the conventional elliptic area during gaze fixation and increased stabilometry indices was shown by means of this model; the multiple correlation coefficient is in the range between 0.35 and 0.62. The contribution of explained variance (R2) was in the range of 13.2% to 38.0%.

The moderate correlation between the density of points in the ellipse during gaze fixation and the growth of stabilometry indicators was also demonstrable, with multiple correlation coefficients of 0.38 to 0.59. The impact of explained variance (R2) is in the range of 14.4-34.5%. The correlation coefficients of individual indicators are shown in Table 4.

Table 4. Matrix of paired correlation coefficients between the increment of stabilometry indicators and parameters of saccadic activity after the Box-Cox transformation

Chechelnitskaia-tab04.jpg

Note: *, correlation quotients are statistically significant at p <0.05

Discussion

The physical status of children who survived cancer, has become the subject of an active study in connection with the successes of modern medicine. The end of anti-cancer treatment does not mean complete recovery of the patient. Moreover, aggressive anti-cancer treatment leads to the development of multiple complications that worsen the quality of life and reduce the predicted life expectancy [13, 14, 7]. The data obtained by researchers indicate the need for physical activity programs aimed specifically at approaches to minimizing physical limitations. One of these limitations is a violation of the postural balance.

Imbalances in the body in works on children who have survived cancer, are usually detected by the Bruninks-Ozeretsky test, which allows you to study the whole range of motor qualities [8, 5, 1]. According to Gilchrist LS, Tanner LR (2018), 78% of children receiving chemotherapy courses for cancer showed reduced balance on treatment, 6 months after the end of treatment, the percentage of children with reduced rates decreased to 53% [3]. This means that more than half of the children still had difficulty holding their posture. In studies of Piscione PJ, Bouffet E et al. (2014), conducted with the participation of children with tumors of the posterior cranial fossa (cerebellar astrocytoma 43.3% and medulloblastoma 40%), a significant decrease in balance indicators was recorded in 70% of the examined [1].

We applied the method of stabilometry to assess the postural balance in children 5-18 years old. Differences between the indicators of children of the main and control groups reached the level of statistical significance, excluding the indicator, i.e., displacement length of the center of pressure in frontal plane. But at the same time, the difference in almost all parameters did not reach the level of physiological significance, since in both groups the spread of the numbers was very large.

Einarsson E-J, Patel M, et al. (2016) also described the absence of a significant difference between people who survived childhood cancer and healthy control in a calm stance [10]. But at the same time they found that former patients spend significantly more energy than healthy people to maintain vertical balance. In our further analysis, we plan to study the features of energy consumption for maintaining a vertical posture in children.

The area of confidence ellipse proved to be the most sensitive parameter in our study, since the average size of the area of the ellipse in children of the main group in the position with open eyes was 673±1201.1 mm2, and in the control group 258.9±162.5 mm2. The constructed model of nonlinear (exponential) regression for the Ellipse area indicator allowed us to confirm the relationship between the ellipse area and the disease. Consequently, a combination of not very physiologically significant deviations in the stabilometry indicators confirms the presence of postural disorders.

The leading role of vision in postural control in cancer survivors is confirmed by Einarsson E-J, Patel M, et al. (2016). According to them, vision significantly increased postural stability in both former patients and the control group. Both of them spent less energy on maintaining the posture in the position with open eyes. The authors found no evidence of dependence on chemotherapy [10].

The data given indicate that in the position with the eyes closed we are entitled to expect a significant deterioration in the main indicators of stabilometry. Perhaps even more significant than in healthy children. It is generally accepted that a healthy person has a normal reaction from the body balance control system to turning off the visual analyzer – an increase in the fluctuation of the center of pressure [15].

In our studies, we often encountered the opposite reaction – the postural balance in the position with the eyes closed improved.

The analysis of the coefficients of growth indicators obtained by us when closing the eyes showed that a positive reaction of the postural balance to turning off the vision occurs both among children treated for tumors of the posterior cranial fossa and among their healthy peers. In the group of treated children, this phenomenon occurred reliably and significantly more often. But at the same time, the values of the average coefficients of the indicators were comparable, their differences did not reach the level of statistical significance.

The most sensitive to eye closure were the indicators Assessment of movement and Displacement of the center of pressure along the sagittal. These results are consistent with the data of Andrea Berensci et al. (2005) [16] that the amplitudes of postural vibrations are greater when stimuli are presented for central vision than for peripheral vision conditions. Our study did not include children with clinically expressed central vision problems, as this was an exclusion criterion. Nevertheless, it cannot be ruled out that one of the reasons for improving the postural balance is subclinical visual acuity.

The indicator Assessment of movement should not be associated with the acuity of central vision, since it is calculated as the ratio of the indicators "Curve Length" and "Average Dispersion" and reflects the spread of fluctuations (tremor).

Earlier, a number of authors showed that patho-biomechanical changes in the structures richest in proprioreceptors (neck muscles, oculomotor muscles, chewing muscles) cause a mismatch between the real and perceived CNS position of the body parts [8, 16]. We tested the hypothesis about the role of oculomotor muscle dysfunction in disturbing postural balance in children treated for tumors of the posterior cranial fossa. Absolute indicators of stabilometry in an upright posture with open eyes were not associated with indicators of saccadic activity. At the same time, the relationship between the coefficients of change in the indicators of stabilometry when closing the eyes with the area of the ellipse of the fixation points of the gaze corresponded to linear regression and was stable in average. The share of the explained variance reached 38.0%. Equally expressed and stable was the relationship between the coefficients of change in the indicators of stabilometry and the density of the points of fixation of the gaze in the ellipse.

Since when closing the eyes there is not only a shutdown of visual afferentation, but also a decrease in the activity of the oculomotor muscles, the latter may explain the improvement in postural balance when closing the eyes. The validity of this conclusion is indirectly confirmed by a number of works.

Einarsson E-J, Patel M, et al. (2016) studied oculomotor activity in adults who received chemotherapy in childhood for a solid cancerous tumor that did not affect the central nervous system. According to them, the temporal control of smooth tracking speed (speed accuracy) was noticeably worse (p<0.001), and saccades had a disproportionately lower amplitude in survivors of childhood cancer compared with healthy subjects [10]. Patients treated before 12 years old had a more expressed oculomotor deficiency. Patients who survived childhood cancer experienced subjective symptoms of visual impairment (70%), sensations that things around them revolved or moved (87%). Several subjective symptoms were largely associated with a deficiency of oculomotor characteristics.

In our study, the phenomena of saccadic dysmetry, regardless of the direction of gaze, were associated with coefficients reflecting the change in the indicators of movement of the fixation points of the center of pressure of the body on the surface in the frontal plane and their derivatives, which is consistent with the statement of Andrea Berensci et al. [17] on the role of peripheral vision in postural stability. Changes in indicators in the sagittal plane were either not connected at all, or with a small number of variables, which indicates the absence of influence of central vision.

Conclusion

We have confirmed that, already early after the end of cytostatic treatment, the children who survived cancer develop postural balance disorders associated with the disease factor. We have revealed an improvement of postural control when closing eyes and its connection with saccadic dysmetria, thus allowing to consider this phenomenon to be a result of damage to oculomotor muscles and offering new tools and methods for rehabilitation of cancer patients.

Conflict of interest

None reported.

References

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  3. Gilchrist LS, Tanner LR. Short-term recovery of balance control: association with chemotherapy-induced peripheral neuropathy in pediatric oncology. Pediat Phys Ther. 2018; 30(2): 119-124.
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  5. Bahcaci U, Demirbuken I. Effects of chemotherapy process on postural balance control in patients with breast cancer. Indian J Cancer. 2019; 56(1):50-54.
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  7. Ness KK, Krull KR, Jones KE, Mulrooney DA, Armstrong GT, Green DM, Chemaitilly W, Smith WA, Wilson CL, Sklar CA, Shelton K, Srivastava DK, Ali S, Robison LL, Hudson MM. Physiologic frailty as a sign of accelerated aging among adult survivors of childhood cancer: A report from the St. Jude Lifetime Cohort study. J Clin Oncol. 2013; 31(36):4496-4503.
  8. Einarsson EJ, Patel M, Petersen H, Wiebe T, Fransson PA, Magnusson M, et al. Elevated visual dependency in young adults after chemotherapy in childhood. PLoS One. 2018; 13(2):e0173678.
  9. Leigh RJ, Zee DS. The Neurology of Eye Movements. 5th edition. New York, NY: Oxford University Press: 2015, 1075 p.
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  15. Lysenko VV, Mirzoeva EV, Ostrikov AP, Bozhkov AV. Interaction between disturbed statics and vision quality in sports. Molodoy Ucheny. 2016; 24: 565-568 (In Russian).
  16. Boulanger M, Giraudet G, Faubert J. Interaction between the oculomotor and postural systems during a dual-task: Compensatory reductions in head sway following visually-induced postural perturbations promote the production of accurate double-step saccades in standing human adults. PLoS One. 2017; 12(3): e0173678.
  17. Berensci A, Ishihara M, Imanaka K. The functional role of central and peripheral vision in the control of posture. Human Movement. 2005; 24(5-6):689-709.
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Introduction

Disturbed postural resistance is a common finding among the patients treated for cancer diseases, regardless of their exact nosological forms. Researchers describe imbalances in children treated for brain tumors [1, 2] and leukemia [3], in adult people treated for lung cancer [4], breast cancer [5], leukemia, lymphomas and other solid tumors [6], etc. According to evidence-based studies meta-analyses, the percentage of leukemia survivors with disturbed postural equilibrium ranged from 27% to 69% during the treatment, being 7% to 65% at later observation terms (over 5 years) following the cytostatic therapy [6]. For children treated for medulloblastoma, the development of posterior cranial fossa syndrome is characteristic which may manifest with acute postural imbalance.

Damage of brain by the growing malignancy and surgical intervention are considered to be a cause of this phenomenon in the patients with tumors located at the posterior cranial fossa. However, imbalance signs in pediatric cancer patients without evident brain lesions suggest some other possible causes of postural instability. A number of researchers attribute postural imbalance to the late toxic effects of radiation therapy [6], or consequences of chemotherapy [7]. In the literature, we have encountered only a few studies on the mechanisms of impaired postural stability in the cancer patients. In particular, Gilchrist L.S. and Tanner L.R. (2018) examined the relationships of imbalance with manifestations of peripheral neuropathy [3].

In another study of adult cancer survivors treated in their childhood, it was shown that both the disease and treatment cause long-term disturbances of postural resistance in the position with open eyes. At the same time, the authors found a similar reaction of cancer survivors and healthy subjects to closing their eyes, which allowed them to confirm a preserved role of vision for postural resistance [8]. R. Leight and D. Zee (2015) showed that the brain tumors, including cerebellum, lead to serious oculomotor disturbances, in particular, saccadic dysmetry, occurence of disruptive micro- and macrosaccades, that may affect the body equilibrium [9]. Einarsson E.J. et al. (2016) showed sufficient oculomotor disorders in patients with oncological diseases which did not directly affect the central nervous system [10]. In their opinion, these disorders may be caused by toxic effects chemotherapeutic cytostatic drugs upon brain tissues after crossing the blood-brain barrier. In 2019, the same authors described increased visual dependence in people who survived childhood cancer under the age of 12 years, which is thought to explain the visual dizziness in adults who previously received chemotherapy.

The aim of our retrospective study was to clarify a relationship between the postural stability disorders in children treated for cancer, and oculomotor muscle dysfunction.

Patients and methods

The study was carried out during their rehabilitation course at the Medical Rehabilitation Research Center Russian Field. The study involved 291 children 5-18 years old who were previously treated for a brain tumor localized in the posterior cranial fossa: medulloblastoma – 58.11%, piloid astrocytoma – 22.50%, anaplastic ependymoma – 6.25%, diffuse stem tumors – 4.36%, anaplastic astrocytoma – 2.25% ganglioglioma – 2.25% and others with a frequency of <1% and were in remission (82.3%) or stabilization (17.7%). In the vast majority of cases, the disease was diagnosed at an early age: up to 6 years, in 63.9% of girls and 53.7% of boys, from 7 to 11 years – in 26.9% of girls and 34.2% of boys (Fig. 1).

Chechelnitskaia-fig01.jpg

Figure 1. Distribution of the children with malignancies by their gender and age of onset. Abscissa, age of the disease onset, years; ordinate, number of cases

79% of the examined children underwent radiation therapy, 75% chemotherapy, 64% received complex therapy, including surgical treatment, chemotherapy and radiation therapy.

According to the duration of remission at the time of examination, the patients were distributed as follows: up to 1 year – 15.6%, from 1 year to 3 years – 37.8%, from 4 to 7 years – 31.1%, over 8 years – 15.6%.

The control group included 182 children 6-18 years old, who were in the medical rehabilitation scientific center "Russian Field" with their siblings, and healthy children who were engaged in the group of general physical training for the first year.

The quality of the postural balance was evaluated by a stabilometric method using the computer-assisted Stabilan 01-2 device (manufacturing firm OKB RITM Russia). A stabilometric study is based on recording the parameters of the oscillations of the projection of the conditional center of mass of the person being examined on the plane of the stable platform.

Each individual test consisted of sequential trials with open and closed eyes (Romberg test) in a European installation (in heel position together, socks divorced at an angle of 30 degrees), the duration of each trial was 30 seconds [11]. The mark was stuck on the wall in front of the child. The subject should fix his eyes on it throughout the testing. We analyzed the stabilometric indicators of the displacement and dispersion of the center of human pressure in the area of support (on the reference plane, the lengths of the trajectories of the pressure center in the frontal and sagittal planes, the linear velocities of the movement of the pressure center on the reference plane, and the size of the area of the confidence ellipse of the statokinesiogram).

Chechelnitskaya-fig02.jpg

Figure 2. An example of a graphic image of a statokinesiogram. Actually, the statokinesiogram is the trajectory of pressure center oscillations during the study. The circle (a special case of an ellipse) represents a 95% confidence interval for the position of the pressure center

The center of a person’s pressure on the area of support is the projection of the general center of pressure of a person’s body on a horizontal plane. Displacements from the center of pressure are recorded as a statokinesiogram. The area of statokinesiogram forms an ellipse, which includes 95 percent of the fixed points, is called the area of the confidence ellipse. Figure 2 shows an example of a statokinesiogram with a confidence ellipse.

The patient’s data were compared with gender- and age-matched children from the control group. Postural balance indexes were registered in the Romberg test with open eyes. A test for fixing the gaze on a stimulus was used to evaluate the work of the saccadic system of eye movements [12], which allows one to characterize the degree of work of the oculomotor muscles, since the physiological fixation process requires establishing and maintaining fovea in one position. The required duration of fixation in the test (20 seconds) on each stimulus was selected, to prevent a sufficient loading of the oculomotor muscles. The test evaluates the spread and density of the gaze when fixing the patient on the stimulus.

The patient was sitting comfortably on the chair in front the monitor in the calm room for neurophysiological investigations. Eye movements were recorded by videoculography using an Arrington 60 Hz eye-tracker glasses. Patient`s head was fixed by a frontal chin support to minimize head movements. Functioning of the oculomotor muscles was evaluated by the gaze fixation test on the stimulus (Danilov et al., 2015) [12]. The stimulus were presented on a Samsung 23-inch screen (with a resolution of 1920×1080 pixels) at a distance of 60 cm from the subjects' eyes, while occupied about 45° horizontally and 26° vertically of their visual field. The stimulating object (a green dot on the screen) had a size of ~1°, having been sequentially moved in the left/right positions by 15°, and at the top/bottom direction, by 8° for 20 s for each position. Dispersion and density of the gaze fixation points on the every stimulus were evaluated. Raw dispersions of gaze fixation points were filtered in ±2σ of coordinates' distribution and fitted by ellipse Matlab function "fit_ellipse". Then the squares of the obtained ellipses were counted in deg2. Densities of the gaze fixation points were counted as a ratio of the number of fixation points to the ellipse square. The larger squares of the ellipses and the lower densities of the points reveal the more unstable gaze fixation.

Statistical evaluation of the results was performed with a modification of the Student t-test (Welch test), which suggests that the variances of the compared populations are not equal. To model relationships between of the analyzed indexes, regression analysis was used, which allowed us to analytically present the relationship models between appropriate indexes, and to quantify relative influence for distinct factors. In the course of statistical modeling of explicit asymmetric distributions, we used conversion of initial values to logarithmic form and the Box-Cox transformation.

Results

To assess the postural balance in patients treated for tumors of the posterior cranial fossa, we analyzed the stabilometric indicators of the displacement and dispersion of the fixation points of the pressure center on the reference plane, the length of the trajectories of the pressure center in the frontal and sagittal planes, the linear velocities of the pressure center on the reference plane and the magnitude areas of the confiding ellipse of the statokinesiogram. The results were compared with homologous children from the control group. Indicators of postural balance were recorded in the Romberg test with open eyes. The results are presented in Table 1.

Table 1. Indexes of postural balance in children treated for brain tumor, and in healthy children using Romberg test with open eyes

Chechelnitskaia-tab01.jpg

In our study, the average size of the estimated ellipse area in children of the main group in the position with open eyes was 673±1201.1 mm2, thus being significantly differed from the average values in the control group (258.9±162.5 mm2). To confirm the hypothesis about the relationship between the postural balance and the disease, a nonlinear (exponential) regression model was constructed for the Ellipse Area indicator:

log(Ells)=6.7 – 0.059full.year + 0.104gender – 0.57grp,
R2=0.103, p<0,05.
where log (Ells) is the logarithm (natural) of the area of the ellipse.
gender = 1 – boys, 0 – girls
grp = 1 – healthy controls; 0, treated patients.

Age of children (full_years), and disease state (grp) proved to be the statistically significant factors in this model. According to the model, the logarithm of ellipse area in healthy children was lower by 0.57 (p<0.000).

In order to study potential contribution of altered vision in the postural control, we analyzed the change in the Rom-berg test parameters when the patient changes the position with open eyes (EO) to the pose with closed eyes (EC). For analysis, the relative dynamics of indexes were calculated by the formula:

Chechelnitskaia-form01.jpg

where

Chechelnitskaia-form02.jpg

When evaluating the following indices: Assessment of movement and Quality of the equilibrium function, a minus sign was introduced before the formula, due to their special calculation modes:

Chechelnitskaia-form03.jpg

As a result, we have calculated the factors characterizing changes of stabilometric indexes when turning off the vision. The values of the coefficient equal to "0" and higher denoted the improvement of stabilometric values when closing the eyes, whereas a negative value meant their impairment (Table 2).

Table 2. Increases in the indicators of the postural balance of children treated for cancer and their healthy peers in the Romberg test when moving from the Open eyes to the Closed eyes position

Chechelnitskaia-tab02.jpg

More often, the shutdown of vision led to a positive change in the mentioned indexes. Assessment of movement and Displacement of the center of pressure along the sagittal axis (68.5%/61.1% of pediatric patients, and 30.8%/33.3% in the control group, respectively), as seen from Table 3.

Table 3. Frequencies of “atypical” reactions in the Romberg position with closed eyes, %

Chechelnitskaia-tab03.jpg

In the main group, the area of the confidence ellipse decreased in 43.2% of children by an average of 33.4%. Similar dynamics was noted in 20.5% of the examined children, the average decrease in area was 29.6% (Fig. 3). Moreover, the Romberg coefficient averaged 113% both in the main group and in the control group.

Chechelnitskaia-fig03.jpg

Figure 3. The allocation of growth rates of the indicator Ellipse area increments in the Romberg test during the transition from open to closed eyes in children of the main group

To test the hypothesis about the relationship between postural control and oculomotor activity, we analyzed the results of examination of children treated for tumors of the posterior cranial fossa, on an i-tracking. The oculomotor muscles perform fast saccadic eye movements necessary for fixing the gaze on the object, a point in space, etc., due to which the brain receives visual information. The saccadic system is a complex hierarchical system in which many brain structures are involved [19]. The variable measured in the i-tracking is the area of ellipses (deg2), in terms of the content and type of the calculation, it is related to the stabilometric parameter – the ellipse of the statokinesiogram. The larger is the area of the ellipse, the less stable the gaze is kept. Vice versa, the gaze fixation of the gaze is impaired due to various involuntary saccadic movements (disruptive, intrusive macro- and micro-amplitude involuntary saccades) and nystagmus. The second variable density of gaze fixation, with 95% of points fitting the ellipse area within a definite time period. It characterizes the presence or absence of large-amplitude movements, since with large-amplitude movements, the area of the ellipse increases when the gaze is fixed, and the density of the gaze positions, on the contrary, decreases.

We did not find any correlations between the absolute stabilometric indexes and saccadic activity. At the same time, we found a connection between saccadic activity indexes and increased stabilometry indexes in the Romberg test upon transition from open to closed eyes. Indicators of saccadic activity showed asymmetric distribution. Therefore, a power-law transformation of initial data by the Box-Cox method was performed, in order to identify their relationships with stabilometry indexes.

The simulation results showed that the mode of relationships between the saccadic activity indicators and incrementing stabilometric indices corresponded to linear regression. A moderate correlation between the conventional elliptic area during gaze fixation and increased stabilometry indices was shown by means of this model; the multiple correlation coefficient is in the range between 0.35 and 0.62. The contribution of explained variance (R2) was in the range of 13.2% to 38.0%.

The moderate correlation between the density of points in the ellipse during gaze fixation and the growth of stabilometry indicators was also demonstrable, with multiple correlation coefficients of 0.38 to 0.59. The impact of explained variance (R2) is in the range of 14.4-34.5%. The correlation coefficients of individual indicators are shown in Table 4.

Table 4. Matrix of paired correlation coefficients between the increment of stabilometry indicators and parameters of saccadic activity after the Box-Cox transformation

Chechelnitskaia-tab04.jpg

Note: *, correlation quotients are statistically significant at p <0.05

Discussion

The physical status of children who survived cancer, has become the subject of an active study in connection with the successes of modern medicine. The end of anti-cancer treatment does not mean complete recovery of the patient. Moreover, aggressive anti-cancer treatment leads to the development of multiple complications that worsen the quality of life and reduce the predicted life expectancy [13, 14, 7]. The data obtained by researchers indicate the need for physical activity programs aimed specifically at approaches to minimizing physical limitations. One of these limitations is a violation of the postural balance.

Imbalances in the body in works on children who have survived cancer, are usually detected by the Bruninks-Ozeretsky test, which allows you to study the whole range of motor qualities [8, 5, 1]. According to Gilchrist LS, Tanner LR (2018), 78% of children receiving chemotherapy courses for cancer showed reduced balance on treatment, 6 months after the end of treatment, the percentage of children with reduced rates decreased to 53% [3]. This means that more than half of the children still had difficulty holding their posture. In studies of Piscione PJ, Bouffet E et al. (2014), conducted with the participation of children with tumors of the posterior cranial fossa (cerebellar astrocytoma 43.3% and medulloblastoma 40%), a significant decrease in balance indicators was recorded in 70% of the examined [1].

We applied the method of stabilometry to assess the postural balance in children 5-18 years old. Differences between the indicators of children of the main and control groups reached the level of statistical significance, excluding the indicator, i.e., displacement length of the center of pressure in frontal plane. But at the same time, the difference in almost all parameters did not reach the level of physiological significance, since in both groups the spread of the numbers was very large.

Einarsson E-J, Patel M, et al. (2016) also described the absence of a significant difference between people who survived childhood cancer and healthy control in a calm stance [10]. But at the same time they found that former patients spend significantly more energy than healthy people to maintain vertical balance. In our further analysis, we plan to study the features of energy consumption for maintaining a vertical posture in children.

The area of confidence ellipse proved to be the most sensitive parameter in our study, since the average size of the area of the ellipse in children of the main group in the position with open eyes was 673±1201.1 mm2, and in the control group 258.9±162.5 mm2. The constructed model of nonlinear (exponential) regression for the Ellipse area indicator allowed us to confirm the relationship between the ellipse area and the disease. Consequently, a combination of not very physiologically significant deviations in the stabilometry indicators confirms the presence of postural disorders.

The leading role of vision in postural control in cancer survivors is confirmed by Einarsson E-J, Patel M, et al. (2016). According to them, vision significantly increased postural stability in both former patients and the control group. Both of them spent less energy on maintaining the posture in the position with open eyes. The authors found no evidence of dependence on chemotherapy [10].

The data given indicate that in the position with the eyes closed we are entitled to expect a significant deterioration in the main indicators of stabilometry. Perhaps even more significant than in healthy children. It is generally accepted that a healthy person has a normal reaction from the body balance control system to turning off the visual analyzer – an increase in the fluctuation of the center of pressure [15].

In our studies, we often encountered the opposite reaction – the postural balance in the position with the eyes closed improved.

The analysis of the coefficients of growth indicators obtained by us when closing the eyes showed that a positive reaction of the postural balance to turning off the vision occurs both among children treated for tumors of the posterior cranial fossa and among their healthy peers. In the group of treated children, this phenomenon occurred reliably and significantly more often. But at the same time, the values of the average coefficients of the indicators were comparable, their differences did not reach the level of statistical significance.

The most sensitive to eye closure were the indicators Assessment of movement and Displacement of the center of pressure along the sagittal. These results are consistent with the data of Andrea Berensci et al. (2005) [16] that the amplitudes of postural vibrations are greater when stimuli are presented for central vision than for peripheral vision conditions. Our study did not include children with clinically expressed central vision problems, as this was an exclusion criterion. Nevertheless, it cannot be ruled out that one of the reasons for improving the postural balance is subclinical visual acuity.

The indicator Assessment of movement should not be associated with the acuity of central vision, since it is calculated as the ratio of the indicators "Curve Length" and "Average Dispersion" and reflects the spread of fluctuations (tremor).

Earlier, a number of authors showed that patho-biomechanical changes in the structures richest in proprioreceptors (neck muscles, oculomotor muscles, chewing muscles) cause a mismatch between the real and perceived CNS position of the body parts [8, 16]. We tested the hypothesis about the role of oculomotor muscle dysfunction in disturbing postural balance in children treated for tumors of the posterior cranial fossa. Absolute indicators of stabilometry in an upright posture with open eyes were not associated with indicators of saccadic activity. At the same time, the relationship between the coefficients of change in the indicators of stabilometry when closing the eyes with the area of the ellipse of the fixation points of the gaze corresponded to linear regression and was stable in average. The share of the explained variance reached 38.0%. Equally expressed and stable was the relationship between the coefficients of change in the indicators of stabilometry and the density of the points of fixation of the gaze in the ellipse.

Since when closing the eyes there is not only a shutdown of visual afferentation, but also a decrease in the activity of the oculomotor muscles, the latter may explain the improvement in postural balance when closing the eyes. The validity of this conclusion is indirectly confirmed by a number of works.

Einarsson E-J, Patel M, et al. (2016) studied oculomotor activity in adults who received chemotherapy in childhood for a solid cancerous tumor that did not affect the central nervous system. According to them, the temporal control of smooth tracking speed (speed accuracy) was noticeably worse (p<0.001), and saccades had a disproportionately lower amplitude in survivors of childhood cancer compared with healthy subjects [10]. Patients treated before 12 years old had a more expressed oculomotor deficiency. Patients who survived childhood cancer experienced subjective symptoms of visual impairment (70%), sensations that things around them revolved or moved (87%). Several subjective symptoms were largely associated with a deficiency of oculomotor characteristics.

In our study, the phenomena of saccadic dysmetry, regardless of the direction of gaze, were associated with coefficients reflecting the change in the indicators of movement of the fixation points of the center of pressure of the body on the surface in the frontal plane and their derivatives, which is consistent with the statement of Andrea Berensci et al. [17] on the role of peripheral vision in postural stability. Changes in indicators in the sagittal plane were either not connected at all, or with a small number of variables, which indicates the absence of influence of central vision.

Conclusion

We have confirmed that, already early after the end of cytostatic treatment, the children who survived cancer develop postural balance disorders associated with the disease factor. We have revealed an improvement of postural control when closing eyes and its connection with saccadic dysmetria, thus allowing to consider this phenomenon to be a result of damage to oculomotor muscles and offering new tools and methods for rehabilitation of cancer patients.

Conflict of interest

None reported.

References

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  3. Gilchrist LS, Tanner LR. Short-term recovery of balance control: association with chemotherapy-induced peripheral neuropathy in pediatric oncology. Pediat Phys Ther. 2018; 30(2): 119-124.
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Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation). </p> <p style="text-align: justify;"> Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц. </p> <h2>Ключевые слова</h2> <p style="text-align: justify;"> Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы. </p>" ["ELEMENT_PREVIEW_PICTURE_FILE_TITLE"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["ELEMENT_DETAIL_PICTURE_FILE_ALT"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["ELEMENT_DETAIL_PICTURE_FILE_TITLE"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["SECTION_META_TITLE"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["SECTION_META_KEYWORDS"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["SECTION_META_DESCRIPTION"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["SECTION_PICTURE_FILE_ALT"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["SECTION_PICTURE_FILE_TITLE"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["SECTION_PICTURE_FILE_NAME"]=> string(100) "sensornyy-konflikt-kak-vozmozhnaya-prichina-narusheniya-posturalnoy-ustoychivosti-detey-lechivshikhs" ["SECTION_DETAIL_PICTURE_FILE_ALT"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["SECTION_DETAIL_PICTURE_FILE_TITLE"]=> string(239) "«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний" ["SECTION_DETAIL_PICTURE_FILE_NAME"]=> string(100) "sensornyy-konflikt-kak-vozmozhnaya-prichina-narusheniya-posturalnoy-ustoychivosti-detey-lechivshikhs" ["ELEMENT_PREVIEW_PICTURE_FILE_NAME"]=> string(100) "sensornyy-konflikt-kak-vozmozhnaya-prichina-narusheniya-posturalnoy-ustoychivosti-detey-lechivshikhs" ["ELEMENT_DETAIL_PICTURE_FILE_NAME"]=> string(100) "sensornyy-konflikt-kak-vozmozhnaya-prichina-narusheniya-posturalnoy-ustoychivosti-detey-lechivshikhs" } ["FIELDS"]=> array(1) { ["IBLOCK_SECTION_ID"]=> string(3) "138" } ["PROPERTIES"]=> array(18) { ["KEYWORDS"]=> array(36) { ["ID"]=> string(2) "19" ["TIMESTAMP_X"]=> string(19) "2015-09-03 10:46:01" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(27) "Ключевые слова" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(8) 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["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(8) "DateTime" ["USER_TYPE_SETTINGS"]=> NULL ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> NULL ["VALUE"]=> string(0) "" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(0) "" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(29) "Дата публикации" ["~DEFAULT_VALUE"]=> NULL } ["CONTACT"]=> array(36) { ["ID"]=> string(2) "23" ["TIMESTAMP_X"]=> string(19) "2015-09-03 14:43:05" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(14) "Контакт" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(7) "CONTACT" ["DEFAULT_VALUE"]=> string(0) "" ["PROPERTY_TYPE"]=> string(1) "E" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "23" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "3" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "Y" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(13) "EAutocomplete" ["USER_TYPE_SETTINGS"]=> array(9) { ["VIEW"]=> string(1) "E" ["SHOW_ADD"]=> string(1) "Y" ["MAX_WIDTH"]=> int(0) ["MIN_HEIGHT"]=> int(24) ["MAX_HEIGHT"]=> int(1000) ["BAN_SYM"]=> string(2) ",;" ["REP_SYM"]=> string(1) " " ["OTHER_REP_SYM"]=> string(0) "" ["IBLOCK_MESS"]=> string(1) "N" } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25392" ["VALUE"]=> string(4) "1803" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(4) "1803" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(14) "Контакт" ["~DEFAULT_VALUE"]=> string(0) "" } ["AUTHORS"]=> 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["OTHER_REP_SYM"]=> string(0) "" ["IBLOCK_MESS"]=> string(1) "N" } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> array(10) { [0]=> string(5) "25523" [1]=> string(5) "25524" [2]=> string(5) "25525" [3]=> string(5) "25526" [4]=> string(5) "25527" [5]=> string(5) "25528" [6]=> string(5) "25529" [7]=> string(5) "25530" [8]=> string(5) "25531" [9]=> string(5) "25532" } ["VALUE"]=> array(10) { [0]=> string(4) "1803" [1]=> string(4) "1804" [2]=> string(4) "1805" [3]=> string(4) "1806" [4]=> string(4) "1807" [5]=> string(4) "1808" [6]=> string(4) "1809" [7]=> string(4) "1810" [8]=> string(4) "1811" [9]=> string(4) "1812" } ["DESCRIPTION"]=> array(10) { [0]=> string(0) "" [1]=> string(0) "" [2]=> string(0) "" [3]=> string(0) "" [4]=> string(0) "" [5]=> string(0) "" [6]=> string(0) "" [7]=> string(0) "" [8]=> string(0) "" [9]=> string(0) "" } ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(10) { [0]=> string(4) "1803" [1]=> string(4) "1804" [2]=> string(4) "1805" [3]=> string(4) "1806" [4]=> string(4) "1807" [5]=> string(4) "1808" [6]=> string(4) "1809" [7]=> string(4) "1810" [8]=> string(4) "1811" [9]=> string(4) "1812" } ["~DESCRIPTION"]=> array(10) { [0]=> string(0) "" [1]=> string(0) "" [2]=> string(0) "" [3]=> string(0) "" [4]=> string(0) "" [5]=> string(0) "" [6]=> string(0) "" [7]=> string(0) "" [8]=> string(0) "" [9]=> string(0) "" } ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> string(0) "" } ["AUTHOR_RU"]=> array(36) { ["ID"]=> string(2) "25" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Авторы" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(9) "AUTHOR_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "25" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25403" ["VALUE"]=> array(2) { ["TEXT"]=> string(386) "<p> Серафима М. Чечельницкая, Владимир Н. Касаткин, Марина А. Шурупова, Ирина Д. Бородина, Юрий В. Сарайкин, Александр Ф. Карелин, Дмитрий В. Скворцов, Александра В. Баербах, Дарья В. Жук, Владислав А. Никулин </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(374) "

Серафима М. Чечельницкая, Владимир Н. Касаткин, Марина А. Шурупова, Ирина Д. Бородина, Юрий В. Сарайкин, Александр Ф. Карелин, Дмитрий В. Скворцов, Александра В. Баербах, Дарья В. Жук, Владислав А. Никулин

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_RU"]=> array(36) { ["ID"]=> string(2) "26" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(22) "Организации" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "26" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25404" ["VALUE"]=> array(2) { ["TEXT"]=> string(370) "<p> Лечебно-реабилитационный научный центр «Русское поле», Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева, Москва, Россия </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(358) "

Лечебно-реабилитационный научный центр «Русское поле», Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева, Москва, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25405" ["VALUE"]=> array(2) { ["TEXT"]=> string(3305) "<p style="text-align: justify;"> Нарушения постуральной устойчивости широко распространено среди пациентов, лечившихся от онкологических заболеваний. Вопрос о механизмах этого явления находится на стадии изучения. Целью проведенного нами ретроспективного исследования было уточнение связи постуральной нестабильности онкологических пациентов с дисфункцией глазодвигательных мышц. В исследовании приняли участие 291 ребенок 5-18 лет, перенесших онкологическое заболевание и находящихся в стадии ремиссии или стабилизации. В контрольную группу вошли 182 здоровых ребенка. </p> <p style="text-align: justify;"> Качество постурального баланса оценивалось методом стабилометрии на компьютерном стабилоанализаторе «Стабилан 01-2». Регистрация движений глаз производилась методом видеокулографии с помощью айтрекера Arrington. Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation). </p> <p style="text-align: justify;"> Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц. </p> <h2>Ключевые слова</h2> <p style="text-align: justify;"> Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(3205) "

Нарушения постуральной устойчивости широко распространено среди пациентов, лечившихся от онкологических заболеваний. Вопрос о механизмах этого явления находится на стадии изучения. Целью проведенного нами ретроспективного исследования было уточнение связи постуральной нестабильности онкологических пациентов с дисфункцией глазодвигательных мышц. В исследовании приняли участие 291 ребенок 5-18 лет, перенесших онкологическое заболевание и находящихся в стадии ремиссии или стабилизации. В контрольную группу вошли 182 здоровых ребенка.

Качество постурального баланса оценивалось методом стабилометрии на компьютерном стабилоанализаторе «Стабилан 01-2». Регистрация движений глаз производилась методом видеокулографии с помощью айтрекера Arrington. Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation).

Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц.

Ключевые слова

Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы.

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Serafima M. Chechelnitskaia, Vladimir N. Kasatkin, Marina A. Shurupova, Irina D. Borodina, Yurij V. Sarajkin, Aleksandr F. Karelin, Dmitrij V. Skvorcov, Aleksandra V. Baerbakh, Daria V. Zhuk, Vladislav A. Nikulin

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Medical Rehabilitation Research Center "Russkoe Pole", Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia

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Disorders of postural resistance are widespread among the patients treated for cancer. The question of the mechanism of this phenomenon is under the study. The aim of our retrospective study was to clarify the relationship of postural instability in cancer patients with oculomotor muscle dysfunction.

Patients and methods

The study involved 291 children 5-18 years old who had cancer and were in remission state or stable clinical condition. The control group included 182 healthy children. The quality of postural balance was evaluated by stabilometric method using a computer-assisted stabilizer (Stabilan 01-2 model). The eye movements were recorded by videoculography using the Arrington eye-tracker. Regression analysis was used to assess relationships of the analyzed parameters. For explicit asymmetric distributions, we used conversion of initial values to logarithmic form and the Box-Cox transformation.

Results

The main stabilometric indicators in the position with open eyes confirmed impaired postural balance in the children who survived cancer. We have substantiated a high probability of correlation between the postural imbalance and disease factor. Improvement in stabilometric indexes with eyes closed was detected for both groups. However, this phenomenon proved to be significant and was more common among the children who survived cancer.

Conclusion

A stable relationship was found between the postural instability and altered functioning of oculomotor muscles.

Keywords

Childhood cancer, postural control, anticancer therapy, toxic effects, oculomotor muscles.

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Chechelnitskaia, Vladimir N. Kasatkin, Marina A. Shurupova, Irina D. Borodina, Yurij V. Sarajkin, Aleksandr F. Karelin, Dmitrij V. Skvorcov, Aleksandra V. Baerbakh, Daria V. Zhuk, Vladislav A. Nikulin </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(224) "

Serafima M. Chechelnitskaia, Vladimir N. Kasatkin, Marina A. Shurupova, Irina D. Borodina, Yurij V. Sarajkin, Aleksandr F. Karelin, Dmitrij V. Skvorcov, Aleksandra V. Baerbakh, Daria V. Zhuk, Vladislav A. Nikulin

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Serafima M. Chechelnitskaia, Vladimir N. Kasatkin, Marina A. Shurupova, Irina D. Borodina, Yurij V. Sarajkin, Aleksandr F. Karelin, Dmitrij V. Skvorcov, Aleksandra V. Baerbakh, Daria V. Zhuk, Vladislav A. Nikulin

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Disorders of postural resistance are widespread among the patients treated for cancer. The question of the mechanism of this phenomenon is under the study. The aim of our retrospective study was to clarify the relationship of postural instability in cancer patients with oculomotor muscle dysfunction.

Patients and methods

The study involved 291 children 5-18 years old who had cancer and were in remission state or stable clinical condition. The control group included 182 healthy children. The quality of postural balance was evaluated by stabilometric method using a computer-assisted stabilizer (Stabilan 01-2 model). The eye movements were recorded by videoculography using the Arrington eye-tracker. Regression analysis was used to assess relationships of the analyzed parameters. For explicit asymmetric distributions, we used conversion of initial values to logarithmic form and the Box-Cox transformation.

Results

The main stabilometric indicators in the position with open eyes confirmed impaired postural balance in the children who survived cancer. We have substantiated a high probability of correlation between the postural imbalance and disease factor. Improvement in stabilometric indexes with eyes closed was detected for both groups. However, this phenomenon proved to be significant and was more common among the children who survived cancer.

Conclusion

A stable relationship was found between the postural instability and altered functioning of oculomotor muscles.

Keywords

Childhood cancer, postural control, anticancer therapy, toxic effects, oculomotor muscles.

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Disorders of postural resistance are widespread among the patients treated for cancer. The question of the mechanism of this phenomenon is under the study. The aim of our retrospective study was to clarify the relationship of postural instability in cancer patients with oculomotor muscle dysfunction.

Patients and methods

The study involved 291 children 5-18 years old who had cancer and were in remission state or stable clinical condition. The control group included 182 healthy children. The quality of postural balance was evaluated by stabilometric method using a computer-assisted stabilizer (Stabilan 01-2 model). The eye movements were recorded by videoculography using the Arrington eye-tracker. Regression analysis was used to assess relationships of the analyzed parameters. For explicit asymmetric distributions, we used conversion of initial values to logarithmic form and the Box-Cox transformation.

Results

The main stabilometric indicators in the position with open eyes confirmed impaired postural balance in the children who survived cancer. We have substantiated a high probability of correlation between the postural imbalance and disease factor. Improvement in stabilometric indexes with eyes closed was detected for both groups. However, this phenomenon proved to be significant and was more common among the children who survived cancer.

Conclusion

A stable relationship was found between the postural instability and altered functioning of oculomotor muscles.

Keywords

Childhood cancer, postural control, anticancer therapy, toxic effects, oculomotor muscles.

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Medical Rehabilitation Research Center "Russkoe Pole", Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia

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Medical Rehabilitation Research Center "Russkoe Pole", Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia

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Серафима М. Чечельницкая, Владимир Н. Касаткин, Марина А. Шурупова, Ирина Д. Бородина, Юрий В. Сарайкин, Александр Ф. Карелин, Дмитрий В. Скворцов, Александра В. Баербах, Дарья В. Жук, Владислав А. Никулин

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Chechelnitskaia" ["LINK_ELEMENT_VALUE"]=> bool(false) } ["SUMMARY_RU"]=> array(37) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25405" ["VALUE"]=> array(2) { ["TEXT"]=> string(3305) "<p style="text-align: justify;"> Нарушения постуральной устойчивости широко распространено среди пациентов, лечившихся от онкологических заболеваний. Вопрос о механизмах этого явления находится на стадии изучения. Целью проведенного нами ретроспективного исследования было уточнение связи постуральной нестабильности онкологических пациентов с дисфункцией глазодвигательных мышц. В исследовании приняли участие 291 ребенок 5-18 лет, перенесших онкологическое заболевание и находящихся в стадии ремиссии или стабилизации. В контрольную группу вошли 182 здоровых ребенка. </p> <p style="text-align: justify;"> Качество постурального баланса оценивалось методом стабилометрии на компьютерном стабилоанализаторе «Стабилан 01-2». Регистрация движений глаз производилась методом видеокулографии с помощью айтрекера Arrington. Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation). </p> <p style="text-align: justify;"> Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц. </p> <h2>Ключевые слова</h2> <p style="text-align: justify;"> Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(3205) "

Нарушения постуральной устойчивости широко распространено среди пациентов, лечившихся от онкологических заболеваний. Вопрос о механизмах этого явления находится на стадии изучения. Целью проведенного нами ретроспективного исследования было уточнение связи постуральной нестабильности онкологических пациентов с дисфункцией глазодвигательных мышц. В исследовании приняли участие 291 ребенок 5-18 лет, перенесших онкологическое заболевание и находящихся в стадии ремиссии или стабилизации. В контрольную группу вошли 182 здоровых ребенка.

Качество постурального баланса оценивалось методом стабилометрии на компьютерном стабилоанализаторе «Стабилан 01-2». Регистрация движений глаз производилась методом видеокулографии с помощью айтрекера Arrington. Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation).

Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц.

Ключевые слова

Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы.

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Нарушения постуральной устойчивости широко распространено среди пациентов, лечившихся от онкологических заболеваний. Вопрос о механизмах этого явления находится на стадии изучения. Целью проведенного нами ретроспективного исследования было уточнение связи постуральной нестабильности онкологических пациентов с дисфункцией глазодвигательных мышц. В исследовании приняли участие 291 ребенок 5-18 лет, перенесших онкологическое заболевание и находящихся в стадии ремиссии или стабилизации. В контрольную группу вошли 182 здоровых ребенка.

Качество постурального баланса оценивалось методом стабилометрии на компьютерном стабилоанализаторе «Стабилан 01-2». Регистрация движений глаз производилась методом видеокулографии с помощью айтрекера Arrington. Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation).

Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц.

Ключевые слова

Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы.

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Лечебно-реабилитационный научный центр «Русское поле», Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева, Москва, Россия

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Лечебно-реабилитационный научный центр «Русское поле», Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева, Москва, Россия

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Beyond a certain point, there is no return.
This point has to be reached.
Franz Kafka

In 2017, the global cell and gene therapy market was valued at USD 6 billion, and it is expected to grow at 21.9% annually, exceeding USD 35 billion by 2026 [1]. North America comprises about one-half of this market.

Food and Drug Administration (FDA), the US regulatory authority, admits ‘a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications’ [2]. By the end of 2018, nearly 300 cell and gene therapy products had been in development for the treatment of more than 100 various diseases, mostly cancer [3]. The vast majority of these medicines are still in the early phases of clinical trials. Nevertheless, top market players are actively investing in R&D programs of cell and gene therapies. Since 2010, there have been 120 venture investments in gene therapy, with USD 5 billion raised, half of them have been disclosed since the beginning of 2018 [4]. Notably, unlike other fields of biopharmaceuticals, the vast majority of investments (over USD 3 billion) went to companies with only a platform technology or still at the preclinical stage with no clinical data available yet, showing the intensity of interest to this field.

FDA anticipates that by 2020 they will be receiving more than 200 cell-based or directly administered gene therapy IND applications annually. Current predictions based on the existing pipeline and the clinical success rates state that by 2025, FDA is expected to approve 10 to 20 novel cell and gene therapy products a year [2].

Today, many new technologies enter clinical trials, e.g., CRISPR-edited cells for cancer immunotherapy, new gene therapies for inherited and rare diseases. There’s a potential to expand indications to the more prevalent diseases, including cardiovascular, neurological, endocrine disorders.

Within the last 3 years, there have been several important first-time regulatory approvals, most of them in the USA and EU. In 2017, two approvals of CAR-T products opened access to a novel autologous T cell immunotherapy approach for pediatric and adult patients with B-cell malignancies. Kymriah (tisagenlecleucel) was approved by the FDA and European Medicines Agency (EMA) for the treatment of refractory or relapsed B-cell precursor acute lymphoblastic leukemia in children and for relapsed/refractory large B-cell lymphoma in adults [5]. It is currently sold in the US by Novartis at the price of up to USD 475.000. With additional expenses for hospitalization and supportive care, the costs would make it up to USD 1 million per patient [6]. Yescarta (axicabtagene ciloleucel) was approved by the FDA and EMA for the treatment of relapsed or refractory large В-cell lymphoma in adults [7], being currently sold in the USA for USD 373.000 per unit. This product was initially developed by Kite Pharma, which was eventually acquired by Gilead for USD 11.9 billion [8].

Despite that the clinical toxicity issues, such as cytokine release syndrome and neurological toxicities have been mostly resolved, the financial toxicity of these novel therapies remains an unmet problem for patients and healthcare systems. The recent study on cost-effectiveness of CAR T cell therapy in relapsed or refractory adult large B-cell lymphoma has demonstrated that, in an optimistic scenario with a 40% 5-year progression-free survival (PFS), axicabtagene ciloleucel increased life expectancy by 8.2 years at the cost of USD 129.000/quality-adjusted life year (QALY) gained. Similarly, tisagenlecleucel, with a 35% 5-year PFS, increased life expectancy by 4.6 years at USD 168.000 per QALY gained. If CAR-T cells will be tomorrow administered by therapeutic grounds to all the US patients, it would increase health care costs by approximately USD 10 billion over 5 years [9]. Therefore, only substantial price reductions, or alternative payment scenarios (e.g. based on initial complete response) would allow CAR T cell therapies to meet a less than USD 150.000/QALY threshold at more modest long-term clinical outcomes.

Manufacturing is another significant challenge in the field today. On the one hand, the FDA is working on improving appropriate guidelines, to ensure easier bridging to more efficient technologies safely and cost-effectively, without additional clinical investigations. On the other hand, the contract manufacturing organizations (CMO), i.e. of viral vectors, are being acquired by large industrial players to ensure quality control and the most efficient manufacturing process as well as to offer a wider range of the CMO services to their clients.

Among the latest approvals of gene therapies, the most disputed one was a novel Novartis drug, Zolgensma (onasemnogene abeparvovec-xioi), developed by AveXis for the treatment of pediatric patients with spinal muscular atrophy (SMA). This most expensive drug priced at USD 2.1 million caused a lot of discussions because of the unprecedented follow-up story of uncovered data inaccuracy submitted to FDA [10]. The long-term consequences of this story are yet to be expected.

Ethics around the cell and gene therapy is increasingly becoming another important element characterizing this field. The first gene-edited babies in China, followed by the statement from a Russian scientist [11] led to the worldwide attention of the scientific community and the call for a moratorium on clinical uses of germline gene editing.

In the meantime, the Nuffield Council on Bioethics published a report on the social and ethical issues raised by the use of genome editing ‘as a technology that could influence inherited characteristics in humans’ [12]. It concludes that "the potential use of heritable genome editing interventions to influence the characteristics of future generations could be ethically acceptable in some circumstances" as long as it is intended for the good of a person who will be born, and it does not increase disadvantage, discrimination, or division in society.

Many scientists and entrepreneurs believe that no matter how hard regulations are, technology advent cannot be stopped. However, only few patients, if any, would voluntarily agree to become a victim of unregulated research. Human history has already learned this lesson and came to the agreement to protect humanity and devote research to its welfare. The non-return point has been reached, and new technologies will definitely keep emerging. Our main task today is to make sure that the benefit-risk ratio remains positive on the patients’ side.

Conflict of interests

The author has no conflicts of interest to be declared.

References

  1. Cell and Gene Therapy Market. Coherent Market Insights Analysis (2018). Published Feb 2019; 164 pages.
  2. Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. January 15, 2019. FDA’s website: https://www.fda.gov.
  3. Medicines in Development for Cell Therapy and Gene Therapy. America’s Biopharmaceutical Companies 2018 Report. Published on the Pharmaceutical Research and Manufacturers of America’s website: https://www.phrma.org/.
  4. DealForma Database. June 2019. Reported by David H. Crean on 27.06.2019. Source: https://pharmaboardroom.com/.
  5. Kymriah. FDA Prescribing Information. FDA’s website: https://www.fda.gov.
  6. Cavallo J. Weighing the Cost and Value of CAR T-Cell Therapy. A Roundtable Discussion With Carl H. June, MD; Sagar Lonial, MD; David G. Maloney, MD, PhD; and Pascal Touchon. ASCO Post. May 25, 2018. Website: https://www.ascopost.com/.
  7. Yescarta. FDA Prescribing Information. FDA’s website: https://www.fda.gov.
  8. Gilead’s press release on August 28, 2017. Gilead’s website: https://www.gilead.com/.
  9. Lin JK, Muffly LS, Spinner MA, et al. Cost Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Multiply Relapsed or Refractory Adult Large B-Cell Lymphoma. J Clin Oncol. 2019; 37(24):2105-2119.
  10. FDA Statement on data accuracy issues with recently approved gene therapy. August 6, 2019. FDA website: https://www.fda.gov.
  11. David Cyranoski. Russian biologist plans more CRISPR-edited babies. Nature 570, 145-146 (2019).
  12. Nuffield Council on Bioethics (2018) Genome Editing and Human Reproduction: social and ethical issues (London: Nuffield Council on Bioethics), 183 pages.
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Beyond a certain point, there is no return.
This point has to be reached.
Franz Kafka

In 2017, the global cell and gene therapy market was valued at USD 6 billion, and it is expected to grow at 21.9% annually, exceeding USD 35 billion by 2026 [1]. North America comprises about one-half of this market.

Food and Drug Administration (FDA), the US regulatory authority, admits ‘a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications’ [2]. By the end of 2018, nearly 300 cell and gene therapy products had been in development for the treatment of more than 100 various diseases, mostly cancer [3]. The vast majority of these medicines are still in the early phases of clinical trials. Nevertheless, top market players are actively investing in R&D programs of cell and gene therapies. Since 2010, there have been 120 venture investments in gene therapy, with USD 5 billion raised, half of them have been disclosed since the beginning of 2018 [4]. Notably, unlike other fields of biopharmaceuticals, the vast majority of investments (over USD 3 billion) went to companies with only a platform technology or still at the preclinical stage with no clinical data available yet, showing the intensity of interest to this field.

FDA anticipates that by 2020 they will be receiving more than 200 cell-based or directly administered gene therapy IND applications annually. Current predictions based on the existing pipeline and the clinical success rates state that by 2025, FDA is expected to approve 10 to 20 novel cell and gene therapy products a year [2].

Today, many new technologies enter clinical trials, e.g., CRISPR-edited cells for cancer immunotherapy, new gene therapies for inherited and rare diseases. There’s a potential to expand indications to the more prevalent diseases, including cardiovascular, neurological, endocrine disorders.

Within the last 3 years, there have been several important first-time regulatory approvals, most of them in the USA and EU. In 2017, two approvals of CAR-T products opened access to a novel autologous T cell immunotherapy approach for pediatric and adult patients with B-cell malignancies. Kymriah (tisagenlecleucel) was approved by the FDA and European Medicines Agency (EMA) for the treatment of refractory or relapsed B-cell precursor acute lymphoblastic leukemia in children and for relapsed/refractory large B-cell lymphoma in adults [5]. It is currently sold in the US by Novartis at the price of up to USD 475.000. With additional expenses for hospitalization and supportive care, the costs would make it up to USD 1 million per patient [6]. Yescarta (axicabtagene ciloleucel) was approved by the FDA and EMA for the treatment of relapsed or refractory large В-cell lymphoma in adults [7], being currently sold in the USA for USD 373.000 per unit. This product was initially developed by Kite Pharma, which was eventually acquired by Gilead for USD 11.9 billion [8].

Despite that the clinical toxicity issues, such as cytokine release syndrome and neurological toxicities have been mostly resolved, the financial toxicity of these novel therapies remains an unmet problem for patients and healthcare systems. The recent study on cost-effectiveness of CAR T cell therapy in relapsed or refractory adult large B-cell lymphoma has demonstrated that, in an optimistic scenario with a 40% 5-year progression-free survival (PFS), axicabtagene ciloleucel increased life expectancy by 8.2 years at the cost of USD 129.000/quality-adjusted life year (QALY) gained. Similarly, tisagenlecleucel, with a 35% 5-year PFS, increased life expectancy by 4.6 years at USD 168.000 per QALY gained. If CAR-T cells will be tomorrow administered by therapeutic grounds to all the US patients, it would increase health care costs by approximately USD 10 billion over 5 years [9]. Therefore, only substantial price reductions, or alternative payment scenarios (e.g. based on initial complete response) would allow CAR T cell therapies to meet a less than USD 150.000/QALY threshold at more modest long-term clinical outcomes.

Manufacturing is another significant challenge in the field today. On the one hand, the FDA is working on improving appropriate guidelines, to ensure easier bridging to more efficient technologies safely and cost-effectively, without additional clinical investigations. On the other hand, the contract manufacturing organizations (CMO), i.e. of viral vectors, are being acquired by large industrial players to ensure quality control and the most efficient manufacturing process as well as to offer a wider range of the CMO services to their clients.

Among the latest approvals of gene therapies, the most disputed one was a novel Novartis drug, Zolgensma (onasemnogene abeparvovec-xioi), developed by AveXis for the treatment of pediatric patients with spinal muscular atrophy (SMA). This most expensive drug priced at USD 2.1 million caused a lot of discussions because of the unprecedented follow-up story of uncovered data inaccuracy submitted to FDA [10]. The long-term consequences of this story are yet to be expected.

Ethics around the cell and gene therapy is increasingly becoming another important element characterizing this field. The first gene-edited babies in China, followed by the statement from a Russian scientist [11] led to the worldwide attention of the scientific community and the call for a moratorium on clinical uses of germline gene editing.

In the meantime, the Nuffield Council on Bioethics published a report on the social and ethical issues raised by the use of genome editing ‘as a technology that could influence inherited characteristics in humans’ [12]. It concludes that "the potential use of heritable genome editing interventions to influence the characteristics of future generations could be ethically acceptable in some circumstances" as long as it is intended for the good of a person who will be born, and it does not increase disadvantage, discrimination, or division in society.

Many scientists and entrepreneurs believe that no matter how hard regulations are, technology advent cannot be stopped. However, only few patients, if any, would voluntarily agree to become a victim of unregulated research. Human history has already learned this lesson and came to the agreement to protect humanity and devote research to its welfare. The non-return point has been reached, and new technologies will definitely keep emerging. Our main task today is to make sure that the benefit-risk ratio remains positive on the patients’ side.

Conflict of interests

The author has no conflicts of interest to be declared.

References

  1. Cell and Gene Therapy Market. Coherent Market Insights Analysis (2018). Published Feb 2019; 164 pages.
  2. Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. January 15, 2019. FDA’s website: https://www.fda.gov.
  3. Medicines in Development for Cell Therapy and Gene Therapy. America’s Biopharmaceutical Companies 2018 Report. Published on the Pharmaceutical Research and Manufacturers of America’s website: https://www.phrma.org/.
  4. DealForma Database. June 2019. Reported by David H. Crean on 27.06.2019. Source: https://pharmaboardroom.com/.
  5. Kymriah. FDA Prescribing Information. FDA’s website: https://www.fda.gov.
  6. Cavallo J. Weighing the Cost and Value of CAR T-Cell Therapy. A Roundtable Discussion With Carl H. June, MD; Sagar Lonial, MD; David G. Maloney, MD, PhD; and Pascal Touchon. ASCO Post. May 25, 2018. Website: https://www.ascopost.com/.
  7. Yescarta. FDA Prescribing Information. FDA’s website: https://www.fda.gov.
  8. Gilead’s press release on August 28, 2017. Gilead’s website: https://www.gilead.com/.
  9. Lin JK, Muffly LS, Spinner MA, et al. Cost Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Multiply Relapsed or Refractory Adult Large B-Cell Lymphoma. J Clin Oncol. 2019; 37(24):2105-2119.
  10. FDA Statement on data accuracy issues with recently approved gene therapy. August 6, 2019. FDA website: https://www.fda.gov.
  11. David Cyranoski. Russian biologist plans more CRISPR-edited babies. Nature 570, 145-146 (2019).
  12. Nuffield Council on Bioethics (2018) Genome Editing and Human Reproduction: social and ethical issues (London: Nuffield Council on Bioethics), 183 pages.
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Фонд поддержки научных исследований в онкологии (РакФонд), Москва, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25904" ["VALUE"]=> array(2) { ["TEXT"]=> string(2185) "<p style="text-align: justify;">За последние пять лет область редактирования генома кардинально изменилась и трансформировалась из научных идей и лабораторных исследований в многочисленные клинические применения, меняющие жизнь пациентов, новые коммерческие возможности с существенными инвестициями в области и заметными сделками и социальные дилеммы, поднимающие множество вопросов перед медицинским сообществом и широкой общественностью. Сегодня многие из самых передовых исследований и разработок, инвестиций, регуляторных инициатив и этических дискуссий происходят именно в этой области. Итак, могут ли рынок и общество идти в ногу с последними научными открытиями, и что будет дальше?</p> <p style="text-align: justify;">В этом эссе будут обсуждаться возможности и трудности современного рынка клеточной и генной терапии, последние одобрения и их клинические и экономические последствия, новые технологии, которые транслируются в клинические исследования, и этические вопросы, которые вызывают некоторые из этих технологий и/или их применение.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Редактирование генома, инвестиции, рынок, исследования и разработки, этика.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2107) "

За последние пять лет область редактирования генома кардинально изменилась и трансформировалась из научных идей и лабораторных исследований в многочисленные клинические применения, меняющие жизнь пациентов, новые коммерческие возможности с существенными инвестициями в области и заметными сделками и социальные дилеммы, поднимающие множество вопросов перед медицинским сообществом и широкой общественностью. Сегодня многие из самых передовых исследований и разработок, инвестиций, регуляторных инициатив и этических дискуссий происходят именно в этой области. Итак, могут ли рынок и общество идти в ногу с последними научными открытиями, и что будет дальше?

В этом эссе будут обсуждаться возможности и трудности современного рынка клеточной и генной терапии, последние одобрения и их клинические и экономические последствия, новые технологии, которые транслируются в клинические исследования, и этические вопросы, которые вызывают некоторые из этих технологий и/или их применение.

Ключевые слова

Редактирование генома, инвестиции, рынок, исследования и разработки, этика.

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Kristina A. Zakurdaeva

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Foundation for Cancer Research Support (RakFond), Moscow, Russia

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Organization" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_EN"]=> array(36) { ["ID"]=> string(2) "39" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(21) "Description / Summary" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "39" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25908" ["VALUE"]=> array(2) { ["TEXT"]=> string(1241) "<p style="text-align: justify;">The landscape of genome editing has dramatically changed over the recent five years, and evolved from scientific ideas and laboratory research to multiple clinical applications changing patients’ lives, creating new commercial opportunities with substantial investments in the field and notable deals, and societal dilemmas raising many discussion items for the medical community and general public. Today, many of the cutting-edge R&D efforts, investments, regulatory initiatives, and ethical discussions occur in this field. In what way can the market and society keep up with the latest scientific discoveries, and what is the next big thing to come? </p> <p style="text-align: justify;">In this essay, I will discuss the opportunities and challenges of current cell and gene therapy market, recent approvals and their clinical and economic impact, novel technologies that are entering clinical trials, and ethical considerations that some of these technologies and/or their applications provoke.</p> <h2>Keywords</h2> <p style="text-align: justify;">Genome editing, investments, market, research & development, ethics.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1163) "

The landscape of genome editing has dramatically changed over the recent five years, and evolved from scientific ideas and laboratory research to multiple clinical applications changing patients’ lives, creating new commercial opportunities with substantial investments in the field and notable deals, and societal dilemmas raising many discussion items for the medical community and general public. Today, many of the cutting-edge R&D efforts, investments, regulatory initiatives, and ethical discussions occur in this field. In what way can the market and society keep up with the latest scientific discoveries, and what is the next big thing to come?

In this essay, I will discuss the opportunities and challenges of current cell and gene therapy market, recent approvals and their clinical and economic impact, novel technologies that are entering clinical trials, and ethical considerations that some of these technologies and/or their applications provoke.

Keywords

Genome editing, investments, market, research & development, ethics.

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Zakurdaeva</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(29) "

Kristina A. Zakurdaeva

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Kristina A. Zakurdaeva

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The landscape of genome editing has dramatically changed over the recent five years, and evolved from scientific ideas and laboratory research to multiple clinical applications changing patients’ lives, creating new commercial opportunities with substantial investments in the field and notable deals, and societal dilemmas raising many discussion items for the medical community and general public. Today, many of the cutting-edge R&D efforts, investments, regulatory initiatives, and ethical discussions occur in this field. In what way can the market and society keep up with the latest scientific discoveries, and what is the next big thing to come?

In this essay, I will discuss the opportunities and challenges of current cell and gene therapy market, recent approvals and their clinical and economic impact, novel technologies that are entering clinical trials, and ethical considerations that some of these technologies and/or their applications provoke.

Keywords

Genome editing, investments, market, research & development, ethics.

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The landscape of genome editing has dramatically changed over the recent five years, and evolved from scientific ideas and laboratory research to multiple clinical applications changing patients’ lives, creating new commercial opportunities with substantial investments in the field and notable deals, and societal dilemmas raising many discussion items for the medical community and general public. Today, many of the cutting-edge R&D efforts, investments, regulatory initiatives, and ethical discussions occur in this field. In what way can the market and society keep up with the latest scientific discoveries, and what is the next big thing to come?

In this essay, I will discuss the opportunities and challenges of current cell and gene therapy market, recent approvals and their clinical and economic impact, novel technologies that are entering clinical trials, and ethical considerations that some of these technologies and/or their applications provoke.

Keywords

Genome editing, investments, market, research & development, ethics.

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Foundation for Cancer Research Support (RakFond), Moscow, Russia

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Foundation for Cancer Research Support (RakFond), Moscow, Russia

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Кристина А. Закурдаева

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Кристина А. Закурдаева

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Zakurdaeva" ["LINK_ELEMENT_VALUE"]=> bool(false) } ["SUMMARY_RU"]=> array(37) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25904" ["VALUE"]=> array(2) { ["TEXT"]=> string(2185) "<p style="text-align: justify;">За последние пять лет область редактирования генома кардинально изменилась и трансформировалась из научных идей и лабораторных исследований в многочисленные клинические применения, меняющие жизнь пациентов, новые коммерческие возможности с существенными инвестициями в области и заметными сделками и социальные дилеммы, поднимающие множество вопросов перед медицинским сообществом и широкой общественностью. Сегодня многие из самых передовых исследований и разработок, инвестиций, регуляторных инициатив и этических дискуссий происходят именно в этой области. Итак, могут ли рынок и общество идти в ногу с последними научными открытиями, и что будет дальше?</p> <p style="text-align: justify;">В этом эссе будут обсуждаться возможности и трудности современного рынка клеточной и генной терапии, последние одобрения и их клинические и экономические последствия, новые технологии, которые транслируются в клинические исследования, и этические вопросы, которые вызывают некоторые из этих технологий и/или их применение.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Редактирование генома, инвестиции, рынок, исследования и разработки, этика.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2107) "

За последние пять лет область редактирования генома кардинально изменилась и трансформировалась из научных идей и лабораторных исследований в многочисленные клинические применения, меняющие жизнь пациентов, новые коммерческие возможности с существенными инвестициями в области и заметными сделками и социальные дилеммы, поднимающие множество вопросов перед медицинским сообществом и широкой общественностью. Сегодня многие из самых передовых исследований и разработок, инвестиций, регуляторных инициатив и этических дискуссий происходят именно в этой области. Итак, могут ли рынок и общество идти в ногу с последними научными открытиями, и что будет дальше?

В этом эссе будут обсуждаться возможности и трудности современного рынка клеточной и генной терапии, последние одобрения и их клинические и экономические последствия, новые технологии, которые транслируются в клинические исследования, и этические вопросы, которые вызывают некоторые из этих технологий и/или их применение.

Ключевые слова

Редактирование генома, инвестиции, рынок, исследования и разработки, этика.

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За последние пять лет область редактирования генома кардинально изменилась и трансформировалась из научных идей и лабораторных исследований в многочисленные клинические применения, меняющие жизнь пациентов, новые коммерческие возможности с существенными инвестициями в области и заметными сделками и социальные дилеммы, поднимающие множество вопросов перед медицинским сообществом и широкой общественностью. Сегодня многие из самых передовых исследований и разработок, инвестиций, регуляторных инициатив и этических дискуссий происходят именно в этой области. Итак, могут ли рынок и общество идти в ногу с последними научными открытиями, и что будет дальше?

В этом эссе будут обсуждаться возможности и трудности современного рынка клеточной и генной терапии, последние одобрения и их клинические и экономические последствия, новые технологии, которые транслируются в клинические исследования, и этические вопросы, которые вызывают некоторые из этих технологий и/или их применение.

Ключевые слова

Редактирование генома, инвестиции, рынок, исследования и разработки, этика.

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Фонд поддержки научных исследований в онкологии (РакФонд), Москва, Россия

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Фонд поддержки научных исследований в онкологии (РакФонд), Москва, Россия

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Introduction

Anosmia is a Greek word meaning the inability to perceive odor or loss of the sense of smell. It is a major olfactory disorder that greatly impairs an individual’s quality of life. Several etiologies such as sinonasal disorders, including inflammatory disease like rhinosinusitis, nasal fracture, obstructive conditions of the upper respiratory tract, viral infections, brain trauma, and congenital and neurologic diseases may induce an olfactory dysfunction [1, 2]. Olfactory disorders are also caused by reduction of olfactory receptor neurons in neuroepithelium and olfactory bulb area. The olfactory neuroepithelium covers the ethmoturbinate structure that contains the olfactory receptor neurons and is located in posterior region of the nasal cavity. Olfactory neuronal damage is mainly caused by loss of olfactory receptor neurons [3, 4, 5], and regeneration of these receptors is associated with the function and presence of neural stem cells. Therefore, application of stem cells may have benefits for the treatment of olfactory dysfunction. In previous animal model studies, the olfactory function of anosmic mice was improved after transplantation of stem cells [4, 6]. Such studies suggested a correlation between olfactory dysfunction and a decrease in the neuronal olfactory population, which can be replaced or repaired by using neural stem cells.

Mesenchymal stem cells (MSCs) are among the most interesting types of adult stem cells that could be isolated from different tissues, such as bone marrow, adipose tissue, umbilical cord blood, placental and amniotic fluid, and menstrual blood. These cells can be ex vivo manipulated and successfully applied for treatment clinical conditions, like coronary artery disease and vascular ischemia, bone and cartilage defects, and graft versus host disease (GVHD) [7, 8]. These effects are caused by the immunomodulatory properties of MSCs [8, 9], or differentiation ability of these cells into various mesodermal cell lineages [10-12]. Previous reports have also demonstrated the transdifferentiation ability of MSCs into endodermal and ectodermal lineages [13-15], including neural, epithelial, and islet-like cells. Adipose tissue is one of the most prominent sources of MSCs owing to the fact that this tissue is the most available and easy to harvest for extracting MSCs.

Hence, the aim of present study was to see how adipose-derived mesenchymal stem cells (ASCs) can contribute to the improvement of anosmia in rats.

Materials and methods

Adipose-derived mesenchymal stem cells (ASCs) isolation, culture and characterization

This case-control study in animal model was approved by the Research Animal Care Committee of Laboratory Animals of Shiraz University of Medical Sciences. Twenty-five Sprague Dawley female rats weighing 200 g each were divided into the case (N=15, 10 rats for autologous and 5 rats for allogenic transplantation) and control (N=10) groups. ASCs were isolated from periuterine fat tissue of the case group, washed with phosphate-buffered saline (PBS), sliced into small pieces, and then incubated with 0.2% collagenase type I (Gibco, USA) at 37°C in a shaker for two hours. Following routine cell centrifugation, the resulting pellet was incubated for 10 minutes in RBC lysis buffer and centrifuged again. The cell pellet was obtained for the separation of the stromal vascular fraction (SVF) using Ficoll-Paque density gradient (Biosera, UK). The SVF pellet was re-suspended in DMEM culture medium (Gibco, USA) containing 10% fetal bovine serum (FBS, Gibco, USA) and 1% penicillin/streptomycin (Biosera, UK). Non-adherent cells were discarded and adherent cells were cultured by changing the medium every three to four days and harvested on passage 3 for further experiments.

The third-passaged rat ASCs were examined by flow cytometry. Briefly, 5×105 trypsinized cells were separately stained with allophycocyanin (APC)-conjugated anti-rat CD90 or CD73 (BD Biosciences, USA) and fluorescein isothiocyanate (FITC)-conjugated anti-rat CD14 (BD Biosciences, USA). Isotype-matched irrelevant monoclonal antibodies (BD Biosciences, USA) were used to exclude non-specific staining of the cells (BD Biosciences, USA). Flow cytometric analysis was performed using FlowJo software version 7.6.

Standard functional olfactory ability evaluation

Before starting the experiments, olfactory function of the rats was evaluated, and then all the animals were put in the new environment, Maze apparatus (Suppl. Fig. 1), for adapting them to find food for 2 weeks. All the rats were fed routinely before the test, and then underwent fasting, except for water, for three days. Each rat was evaluated every 20 minutes for one hour to find the food, using the standard Maze test (food-finding test) [16]. The average time taken to find the food was between 12 and 19 seconds for all rats. Anosmia was induced by intraperitoneal injection of 3-methylindole (Sigma, USA) (30 μg/kg) which was applied elsewhere for induction of anosmia [17, 18]. On the next day, 500000 ASCs/100μl culture media were injected intranasally five times, 10 μl in each nasal cavity every time. Autologous cells were used in 10 rats, and allogeneic, in five other rats. For the control group, culture medium without ASCs was similarly used for 10 rats. Evaluation of anosmia and the effects of injected ASCs were examined at four and eight weeks after induction of anosmia by means of standard Maze test and immunohistochemistry for olfactory bulb and olfactory neuroepithelium specimens.

Histological study

Rats were sacrificed with high dose of ketamine followed by harvesting of olfactory bulb and olfactory neuroepithelium and formalin fixation. The samples were then embedded in paraffin. Tissue sections were prepared, the slides were generated, and evaluation of the slides was done histologically using Hematoxylin staining.

Statistical evaluation

The data were analyzed with a Statistical Package for Social Science (SPSS) version 17 for windows (IBM, USA) using Student's t test to determine statistical significance between the control and case groups. Results were expressed as mean ± SD and a p-value <0.05 was considered significant.

Results

The average time for food finding was significantly different between the case and control groups

Adipose-derived mesenchymal stem cells were recognized by their spindle-shaped appearance in culture (Fig. 1a). These cells were positive for the expression of MSC specific markers, CD73 and CD90, but were negative for CD14 expression (Fig. 1b).

Khademi-fig01.jpg

Figure 1. (a) Microscopic appearance of ASCs in culture in passage 3. Cultured ASCs were observed as spindle-shaped cell population. (b) Flow cytometric analysis of MSC-specific markers. Expression of CD73 and CD90 and absence of CD14 were shown on the surface of ASCs

Khademi-fig02.jpg

Figure 2. Comparison of the food finding mean time between the rats injected with autologous and allogeneic ASC (case group) and control group by 4 and 8 weeks after evaluation of olfactory function using the food-finding test. The differences between case and control groups were statistically significant. *: P-value <0.05 means a significant difference.

Olfactory function of rats was evaluated using the food-finding test. After four weeks, the mean ± SD of the food-finding time were 13.8±4.1 sec., 14.6±8.6 sec., and 99.2±44.6 sec. in the rats after autologous injections, in rats subjected to allogeneic injections, and in anosmic controls, respectively. Thus, the injection of ASCs caused about a seven-fold statistically significant reduction in food-finding time in our case group of rats (P-value=0.00, Fig. 2). A six-fold statistically significant reduction in the food-finding time was observed in the case group of rats compared to the control group eight weeks after injection of ASCs. Accordingly, the food-finding time was 12.25±1.7 sec. in the case group, comparing with 73.6±29.3 sec. in the control group (P-value=0.035, Fig. 2). The mean food-finding time was not statistically different between the groups with autologous and allogeneic transplants (P-value >0.05).

Histological evaluation

Histological evaluations of the brain and ethmoturbinate of the stem-cell transplanted rats showed that olfactory neuroepithelium and olfactory bulbs were revealed, respectively, in 14 rats (93%) (Fig. 3b) and nine rats (60%) (Fig. 4b) out of 15 ASC-treated animals. No significant difference was found between autologous and allogeneic ASC-injected groups. In the control group, olfactory epithelium (Fig. 3a) and olfactory bulb (Fig. 4a) were seen in five rats (50%) and two rats (20%) of all 10 control rats, respectively. As depicted in Fig. 3a, olfactory epithelium in the control group showed severe infiltration with lymphocytes and neutrophils that penetrated the surface layers.

Khademi-fig03.jpg

Figure 3. Olfactory epithelium in the non ASC-injected (control) and ASC-injected (case) groups. a: Olfactory epithelium in the control group with severe infiltration of lymphocytes and neutrophils penetrating surface layers. H&E X250. b. Olfactory epithelium in the case group without inflammation. H&E X250.

Khademi-fig4.jpg

Figure 4. Olfactory bulb in the control group (a), and case group (b) with intact architecture and cells, however, without inflammation after ASC injection. H&E X100.

Discussion

MSCs are renowned mostly because of their unparalleled effects in regenerative medicine, which is caused by their outstanding ability to differentiate into various cell types, such as chondrocytes, osteocytes, and neural cells [7, 8, 14]. Recently, MSCs have been reported as promising therapeutic cell sources for restoring the function of neurons in neurodegenerative disorders, including stroke, Batten disease, Parkinson’s, Alzheimer’s disease, and spinal cord injury [19, 20].

Olfactory disorders represent a common health problem, and their incidence has recently increased by 4-25% [21]. Impairment of sensory neural system is the main cause of olfactory dysfunction. Despite several therapeutic options, including medical and surgical procedures, the patients still suffer from recurrent anosmia. Since anosmia can be caused by degeneration of olfactory neuron receptors, Lee and colleagues suggested that transplantation of the neural stem cells stimulates regeneration of damaged olfactory cells [4]. Previous studies have demonstrated that other types of stem cells may effectively restore olfactory functions in various olfactory disorders. Jo et al. reported that the bone marrow mesenchymal stem cell (BMSCs) transplantation influences regeneration of olfactory epithelium and olfaction by expression of the nerve growth factor (NGF) and the brain-derived neurotrophic factor (BDNF) [22]. Ochi et al. reported migration of BMSCs to olfactory epithelium and higher engraftment rates in mice, and showed differentiation of these cells to premature olfactory receptor neurons in mice [23]. Human cord blood stem cells also showed promising results because it has been previously shown that BDNF-expressing hUCB-MSCs have great ability to differentiate into astrocytes and olfactory bulb in mice [24]. Furthermore, adipose tissue, an important source for stem cells, can be considered for differentiation towards a neuronal lineage and olfactory restoration [25-28]. As shown by Kokai and colleagues, ASCs may differentiate into different cell types, like neural stem cells [25]. Transplantation of ASCs in mice showed convincing results for restoration of neuroepithelium in the damaged olfactory region [29]. In the present study, anosmia was induced in a group of rats using 3-methylindole; then olfactory function of the anosmic rats was evaluated after injection of ASCs. The transplantation was performed either with allogeneic, or autologous ASCs, in order to compare any possible difference between the results, and to show whether autologous source of ASCs have any preference to allogeneic ones. Based on our results, a statistically significant reduction was observed in the food-finding time in anosmia-induced rats by four and eight weeks post injection of ASCs. Histological evaluation confirmed the effects of ASCs, since olfactory neuroepithelium and olfactory bulb of the brain and ethmoturbinate were detected in the stem cell-transplanted rats but not in the control group. No difference between autologous and allogeneic groups was found either in the mean duration of food-finding, or in histological evaluation. Accordingly, our findings are consistent with other reports showing the effects of stem cell transplantation in the recovery from anosmia, because the rats transplanted with ASCs after anosmia induction and destruction of the olfactory region, could find the food more rapidly than the animals from control group. This finding showed a faster functional recovery of olfactory system following ASCs treatment. Compared to other studies, the present survey was more preferential, due to safer and less invasive way for isolating stem cells and minimizing probable differentiation of the stem cells to other lineages by transnasal delivery of ASCs.

Conclusion

In summary, the present study provides the in vivo experimental evidence indicating that the administration of ASCs obtained from periuterine fat tissue may improve olfactory function. Studies with larger numbers of animals over longer periods of time can provide more confirmation of the efficacy of this approach as a therapeutic intervention for anosmic patients in the future. Adipose tissue represents an abundant and easily available cell source from which stem cells can be obtained by a less invasive method. Accordingly, this tissue may be considered the most promising alternative to the other sources of stem cells to these purposes.

Acknowledgments

This work was financially supported by grants from Shiraz University of Medical Sciences and Shiraz Institute for Cancer Research [Grant No. 91-01-01-5210 and ICR-100-504]. This research was done as a requirement for the special Ear, Nose, and Throat thesis defended by Dr. Zohreh Zandifar. We are grateful to Mr. Omid Koohi and Mr. Aziz Abbaspoor for doing the laboratory experiments and sampling.

The authors declare that they have no conflict of interest concerning this article.

References

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  23. Ochi N, Doi K, Uranagase M, Nishikawa T, Katsunuma S, Nibu K. Bone marrow stem cell transplantation to olfactory epithelium. Ann Otol Rhinol Laryngol. 2010;119:535-540.
  24. Lim JY, Park SI, Kim SM, Jun JA, Oh JH, Ryu CH, Jeong CH, Park SH, Park SA, Oh W, Chang JW, Jeun SS. Neural differentiation of brain-derived neurotrophic factor-expressing human umbilical cord blood-derived mesenchymal stem cells in culture via TrkB-mediated ERK and β-catenin phosphorylation and following transplantation into the developing brain. Cell Transplant. 2011;20(11-12):1855-1866.
  25. Kokai LE, Rubin JP, Marra KG. The potential of adipose-derived adult stem cells as a source of neuronal progenitor cells. Plast Reconstr Surg. 2005;116:1453-1460.
  26. Goudarzi F, Tayebinia H, Karimi J, Habibitabar E, Khodadadi I. Calcium: A novel and efficient inducer of differentiation of adipose-derived stem cells into neuron-like cells. J Cell Physiol. 2018; 233(11):8940-8951.
  27. Moon MY, Kim HJ, Choi BY, Sohn M, Chung TN, Suh SW. Zinc Promotes Adipose-Derived Mesenchymal Stem Cell Proliferation and Differentiation towards a Neuronal Fate. Stem Cells Int. 2018;2018:5736535.
  28. Fesharaki M, Razavi S, Ghasemi-Mobarakeh L, Behjati M, Yarahmadian R, Kazemi M, Hejazi H. Differentiation of human scalp adipose-derived mesenchymal stem cells into mature neural cells on electrospun nanofibrous scaffolds for nerve tissue engineering applications. Cell J. 2018; 20(2): 168-176.
  29. Franceschini V, Bettini S, Pifferi S, Menini A, Siciliano G, Ognio E, Brini AT, Di Oto E, Revoltella RP. Transplanted human adipose tissue-derived stem cells engraft and induce regeneration in mice olfactory neuroepithelium in response to dichlobenilsubministration. Chem Senses. 2014;39:617-629.
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Introduction

Anosmia is a Greek word meaning the inability to perceive odor or loss of the sense of smell. It is a major olfactory disorder that greatly impairs an individual’s quality of life. Several etiologies such as sinonasal disorders, including inflammatory disease like rhinosinusitis, nasal fracture, obstructive conditions of the upper respiratory tract, viral infections, brain trauma, and congenital and neurologic diseases may induce an olfactory dysfunction [1, 2]. Olfactory disorders are also caused by reduction of olfactory receptor neurons in neuroepithelium and olfactory bulb area. The olfactory neuroepithelium covers the ethmoturbinate structure that contains the olfactory receptor neurons and is located in posterior region of the nasal cavity. Olfactory neuronal damage is mainly caused by loss of olfactory receptor neurons [3, 4, 5], and regeneration of these receptors is associated with the function and presence of neural stem cells. Therefore, application of stem cells may have benefits for the treatment of olfactory dysfunction. In previous animal model studies, the olfactory function of anosmic mice was improved after transplantation of stem cells [4, 6]. Such studies suggested a correlation between olfactory dysfunction and a decrease in the neuronal olfactory population, which can be replaced or repaired by using neural stem cells.

Mesenchymal stem cells (MSCs) are among the most interesting types of adult stem cells that could be isolated from different tissues, such as bone marrow, adipose tissue, umbilical cord blood, placental and amniotic fluid, and menstrual blood. These cells can be ex vivo manipulated and successfully applied for treatment clinical conditions, like coronary artery disease and vascular ischemia, bone and cartilage defects, and graft versus host disease (GVHD) [7, 8]. These effects are caused by the immunomodulatory properties of MSCs [8, 9], or differentiation ability of these cells into various mesodermal cell lineages [10-12]. Previous reports have also demonstrated the transdifferentiation ability of MSCs into endodermal and ectodermal lineages [13-15], including neural, epithelial, and islet-like cells. Adipose tissue is one of the most prominent sources of MSCs owing to the fact that this tissue is the most available and easy to harvest for extracting MSCs.

Hence, the aim of present study was to see how adipose-derived mesenchymal stem cells (ASCs) can contribute to the improvement of anosmia in rats.

Materials and methods

Adipose-derived mesenchymal stem cells (ASCs) isolation, culture and characterization

This case-control study in animal model was approved by the Research Animal Care Committee of Laboratory Animals of Shiraz University of Medical Sciences. Twenty-five Sprague Dawley female rats weighing 200 g each were divided into the case (N=15, 10 rats for autologous and 5 rats for allogenic transplantation) and control (N=10) groups. ASCs were isolated from periuterine fat tissue of the case group, washed with phosphate-buffered saline (PBS), sliced into small pieces, and then incubated with 0.2% collagenase type I (Gibco, USA) at 37°C in a shaker for two hours. Following routine cell centrifugation, the resulting pellet was incubated for 10 minutes in RBC lysis buffer and centrifuged again. The cell pellet was obtained for the separation of the stromal vascular fraction (SVF) using Ficoll-Paque density gradient (Biosera, UK). The SVF pellet was re-suspended in DMEM culture medium (Gibco, USA) containing 10% fetal bovine serum (FBS, Gibco, USA) and 1% penicillin/streptomycin (Biosera, UK). Non-adherent cells were discarded and adherent cells were cultured by changing the medium every three to four days and harvested on passage 3 for further experiments.

The third-passaged rat ASCs were examined by flow cytometry. Briefly, 5×105 trypsinized cells were separately stained with allophycocyanin (APC)-conjugated anti-rat CD90 or CD73 (BD Biosciences, USA) and fluorescein isothiocyanate (FITC)-conjugated anti-rat CD14 (BD Biosciences, USA). Isotype-matched irrelevant monoclonal antibodies (BD Biosciences, USA) were used to exclude non-specific staining of the cells (BD Biosciences, USA). Flow cytometric analysis was performed using FlowJo software version 7.6.

Standard functional olfactory ability evaluation

Before starting the experiments, olfactory function of the rats was evaluated, and then all the animals were put in the new environment, Maze apparatus (Suppl. Fig. 1), for adapting them to find food for 2 weeks. All the rats were fed routinely before the test, and then underwent fasting, except for water, for three days. Each rat was evaluated every 20 minutes for one hour to find the food, using the standard Maze test (food-finding test) [16]. The average time taken to find the food was between 12 and 19 seconds for all rats. Anosmia was induced by intraperitoneal injection of 3-methylindole (Sigma, USA) (30 μg/kg) which was applied elsewhere for induction of anosmia [17, 18]. On the next day, 500000 ASCs/100μl culture media were injected intranasally five times, 10 μl in each nasal cavity every time. Autologous cells were used in 10 rats, and allogeneic, in five other rats. For the control group, culture medium without ASCs was similarly used for 10 rats. Evaluation of anosmia and the effects of injected ASCs were examined at four and eight weeks after induction of anosmia by means of standard Maze test and immunohistochemistry for olfactory bulb and olfactory neuroepithelium specimens.

Histological study

Rats were sacrificed with high dose of ketamine followed by harvesting of olfactory bulb and olfactory neuroepithelium and formalin fixation. The samples were then embedded in paraffin. Tissue sections were prepared, the slides were generated, and evaluation of the slides was done histologically using Hematoxylin staining.

Statistical evaluation

The data were analyzed with a Statistical Package for Social Science (SPSS) version 17 for windows (IBM, USA) using Student's t test to determine statistical significance between the control and case groups. Results were expressed as mean ± SD and a p-value <0.05 was considered significant.

Results

The average time for food finding was significantly different between the case and control groups

Adipose-derived mesenchymal stem cells were recognized by their spindle-shaped appearance in culture (Fig. 1a). These cells were positive for the expression of MSC specific markers, CD73 and CD90, but were negative for CD14 expression (Fig. 1b).

Khademi-fig01.jpg

Figure 1. (a) Microscopic appearance of ASCs in culture in passage 3. Cultured ASCs were observed as spindle-shaped cell population. (b) Flow cytometric analysis of MSC-specific markers. Expression of CD73 and CD90 and absence of CD14 were shown on the surface of ASCs

Khademi-fig02.jpg

Figure 2. Comparison of the food finding mean time between the rats injected with autologous and allogeneic ASC (case group) and control group by 4 and 8 weeks after evaluation of olfactory function using the food-finding test. The differences between case and control groups were statistically significant. *: P-value <0.05 means a significant difference.

Olfactory function of rats was evaluated using the food-finding test. After four weeks, the mean ± SD of the food-finding time were 13.8±4.1 sec., 14.6±8.6 sec., and 99.2±44.6 sec. in the rats after autologous injections, in rats subjected to allogeneic injections, and in anosmic controls, respectively. Thus, the injection of ASCs caused about a seven-fold statistically significant reduction in food-finding time in our case group of rats (P-value=0.00, Fig. 2). A six-fold statistically significant reduction in the food-finding time was observed in the case group of rats compared to the control group eight weeks after injection of ASCs. Accordingly, the food-finding time was 12.25±1.7 sec. in the case group, comparing with 73.6±29.3 sec. in the control group (P-value=0.035, Fig. 2). The mean food-finding time was not statistically different between the groups with autologous and allogeneic transplants (P-value >0.05).

Histological evaluation

Histological evaluations of the brain and ethmoturbinate of the stem-cell transplanted rats showed that olfactory neuroepithelium and olfactory bulbs were revealed, respectively, in 14 rats (93%) (Fig. 3b) and nine rats (60%) (Fig. 4b) out of 15 ASC-treated animals. No significant difference was found between autologous and allogeneic ASC-injected groups. In the control group, olfactory epithelium (Fig. 3a) and olfactory bulb (Fig. 4a) were seen in five rats (50%) and two rats (20%) of all 10 control rats, respectively. As depicted in Fig. 3a, olfactory epithelium in the control group showed severe infiltration with lymphocytes and neutrophils that penetrated the surface layers.

Khademi-fig03.jpg

Figure 3. Olfactory epithelium in the non ASC-injected (control) and ASC-injected (case) groups. a: Olfactory epithelium in the control group with severe infiltration of lymphocytes and neutrophils penetrating surface layers. H&E X250. b. Olfactory epithelium in the case group without inflammation. H&E X250.

Khademi-fig4.jpg

Figure 4. Olfactory bulb in the control group (a), and case group (b) with intact architecture and cells, however, without inflammation after ASC injection. H&E X100.

Discussion

MSCs are renowned mostly because of their unparalleled effects in regenerative medicine, which is caused by their outstanding ability to differentiate into various cell types, such as chondrocytes, osteocytes, and neural cells [7, 8, 14]. Recently, MSCs have been reported as promising therapeutic cell sources for restoring the function of neurons in neurodegenerative disorders, including stroke, Batten disease, Parkinson’s, Alzheimer’s disease, and spinal cord injury [19, 20].

Olfactory disorders represent a common health problem, and their incidence has recently increased by 4-25% [21]. Impairment of sensory neural system is the main cause of olfactory dysfunction. Despite several therapeutic options, including medical and surgical procedures, the patients still suffer from recurrent anosmia. Since anosmia can be caused by degeneration of olfactory neuron receptors, Lee and colleagues suggested that transplantation of the neural stem cells stimulates regeneration of damaged olfactory cells [4]. Previous studies have demonstrated that other types of stem cells may effectively restore olfactory functions in various olfactory disorders. Jo et al. reported that the bone marrow mesenchymal stem cell (BMSCs) transplantation influences regeneration of olfactory epithelium and olfaction by expression of the nerve growth factor (NGF) and the brain-derived neurotrophic factor (BDNF) [22]. Ochi et al. reported migration of BMSCs to olfactory epithelium and higher engraftment rates in mice, and showed differentiation of these cells to premature olfactory receptor neurons in mice [23]. Human cord blood stem cells also showed promising results because it has been previously shown that BDNF-expressing hUCB-MSCs have great ability to differentiate into astrocytes and olfactory bulb in mice [24]. Furthermore, adipose tissue, an important source for stem cells, can be considered for differentiation towards a neuronal lineage and olfactory restoration [25-28]. As shown by Kokai and colleagues, ASCs may differentiate into different cell types, like neural stem cells [25]. Transplantation of ASCs in mice showed convincing results for restoration of neuroepithelium in the damaged olfactory region [29]. In the present study, anosmia was induced in a group of rats using 3-methylindole; then olfactory function of the anosmic rats was evaluated after injection of ASCs. The transplantation was performed either with allogeneic, or autologous ASCs, in order to compare any possible difference between the results, and to show whether autologous source of ASCs have any preference to allogeneic ones. Based on our results, a statistically significant reduction was observed in the food-finding time in anosmia-induced rats by four and eight weeks post injection of ASCs. Histological evaluation confirmed the effects of ASCs, since olfactory neuroepithelium and olfactory bulb of the brain and ethmoturbinate were detected in the stem cell-transplanted rats but not in the control group. No difference between autologous and allogeneic groups was found either in the mean duration of food-finding, or in histological evaluation. Accordingly, our findings are consistent with other reports showing the effects of stem cell transplantation in the recovery from anosmia, because the rats transplanted with ASCs after anosmia induction and destruction of the olfactory region, could find the food more rapidly than the animals from control group. This finding showed a faster functional recovery of olfactory system following ASCs treatment. Compared to other studies, the present survey was more preferential, due to safer and less invasive way for isolating stem cells and minimizing probable differentiation of the stem cells to other lineages by transnasal delivery of ASCs.

Conclusion

In summary, the present study provides the in vivo experimental evidence indicating that the administration of ASCs obtained from periuterine fat tissue may improve olfactory function. Studies with larger numbers of animals over longer periods of time can provide more confirmation of the efficacy of this approach as a therapeutic intervention for anosmic patients in the future. Adipose tissue represents an abundant and easily available cell source from which stem cells can be obtained by a less invasive method. Accordingly, this tissue may be considered the most promising alternative to the other sources of stem cells to these purposes.

Acknowledgments

This work was financially supported by grants from Shiraz University of Medical Sciences and Shiraz Institute for Cancer Research [Grant No. 91-01-01-5210 and ICR-100-504]. This research was done as a requirement for the special Ear, Nose, and Throat thesis defended by Dr. Zohreh Zandifar. We are grateful to Mr. Omid Koohi and Mr. Aziz Abbaspoor for doing the laboratory experiments and sampling.

The authors declare that they have no conflict of interest concerning this article.

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NULL ["LINK_IBLOCK_ID"]=> string(1) "3" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "Y" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(13) "EAutocomplete" ["USER_TYPE_SETTINGS"]=> array(9) { ["VIEW"]=> string(1) "E" ["SHOW_ADD"]=> string(1) "Y" ["MAX_WIDTH"]=> int(0) ["MIN_HEIGHT"]=> int(24) ["MAX_HEIGHT"]=> int(1000) ["BAN_SYM"]=> string(2) ",;" ["REP_SYM"]=> string(1) " " ["OTHER_REP_SYM"]=> string(0) "" ["IBLOCK_MESS"]=> string(1) "N" } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25847" ["VALUE"]=> string(4) "1827" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(4) "1827" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(14) "Контакт" ["~DEFAULT_VALUE"]=> string(0) "" } ["AUTHORS"]=> array(36) { ["ID"]=> string(2) "24" ["TIMESTAMP_X"]=> string(19) "2015-09-03 10:45:07" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> 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"25882" [1]=> string(5) "25883" [2]=> string(5) "25884" [3]=> string(5) "25885" [4]=> string(5) "25886" [5]=> string(5) "25887" } ["VALUE"]=> array(6) { [0]=> string(4) "1822" [1]=> string(4) "1823" [2]=> string(4) "1824" [3]=> string(4) "1825" [4]=> string(4) "1826" [5]=> string(4) "1827" } ["DESCRIPTION"]=> array(6) { [0]=> string(0) "" [1]=> string(0) "" [2]=> string(0) "" [3]=> string(0) "" [4]=> string(0) "" [5]=> string(0) "" } ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(6) { [0]=> string(4) "1822" [1]=> string(4) "1823" [2]=> string(4) "1824" [3]=> string(4) "1825" [4]=> string(4) "1826" [5]=> string(4) "1827" } ["~DESCRIPTION"]=> array(6) { [0]=> string(0) "" [1]=> string(0) "" [2]=> string(0) "" [3]=> string(0) "" [4]=> string(0) "" [5]=> string(0) "" } ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> string(0) "" } ["AUTHOR_RU"]=> array(36) { ["ID"]=> string(2) "25" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Авторы" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(9) "AUTHOR_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "25" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25854" ["VALUE"]=> array(2) { ["TEXT"]=> string(337) "<p>Биджан Хадеми<sup>1,2</sup>, Зохре Зандифар<sup>2</sup>, Ахмад Монабати<sup>3</sup>, Нушафарин Ченари<sup>4</sup>, Аббас Гадери<sup>4,5</sup>, Мабубе Размха<sup>4</sup> </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(253) "

Биджан Хадеми1,2, Зохре Зандифар2, Ахмад Монабати3, Нушафарин Ченари4, Аббас Гадери4,5, Мабубе Размха4

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1 Научный центр ЛОР-хирургии области головы и шеи, Ширазский университет медицинских наук, Шираз, Иран
2 Департамент оториноларингологии, Ширазский медицинский университет, Шираз, Иран
3 Департамент патологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран
4 Ширазский институт раковых исследований, Школа медицины, Ширазский медицинский университет, Шираз, Иран
5 Департамент иммунологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25856" ["VALUE"]=> array(2) { ["TEXT"]=> string(3732) "<p style="text-align: justify;">Нарушения обонятельной функции являются большой проблемой медицины, и нет радикального лечения больных с аносмией. Мезенхимные стволовые клетки, полученные из жировой ткани (АМСК) являются мультипонтентными клетками, способными к дифференцировке в несколько клеточных ростков. Целью настоящего исследования была оценка эффектов АМСК на восстановление обонятельной функции у крыс с аносмией.</p> <h3>Материалы и методы</h3> <p style="text-align: justify;">АМСК изолировали из околоматочной жировой ткани крыс с применением коллагеназы типа 1. Аносмию индуцировали путем интраперитонеального введения 3-метилиндола. Затем через 1 сут. после индукции аносмии, вводили 5×105 АМСК трансназально животным опытной группы. В контрольной группе были крысы с аносмией, которым вводили культуральную среду без АМСК. Обонятельную функцию оценивали еженедельно с помощью теста нахождения пищи. Обонятельный нейроэпителий и луковицу забирали для гистопатологического исследования в сроки 4 и 8 недель.</p> <h3>Результаты</h3> <p style="text-align: justify;">После инъекции АМСК наблюдалось примерно 6-7 кратное снижение времени нахождения пищи в опытной группе крыс по сравнению с контрольной группой. Различие было достоверным при P=0,00 и Р=0,035, соответственно, через 4 и 8 недель после инъекции АМСК. Результаты гистопатологического исследования показали реконструкцию обонятельного нейроэпителия в 93% случаев в опытной группе, и в 50% – у контрольных крыс. Обонятельная луковица выявлялась у 60% крыс в опыте, по сравнению с 20% в контроле.</p> <h3>Выводы</h3> <p style="text-align: justify;">Полученные нами результаты показывают, что регенерация обонятельного эпителия может быть ускорена при использовании локального введения АМСК. Эти данные предполагают, что АМСК в будущем могут быть перспективным источником лечения дисфункции обоняния.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Аносмия, экспериментальная, мезенхимные стволовые клетки, жировая ткань, дифференцировка, нейрональные клетки.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(3574) "

Нарушения обонятельной функции являются большой проблемой медицины, и нет радикального лечения больных с аносмией. Мезенхимные стволовые клетки, полученные из жировой ткани (АМСК) являются мультипонтентными клетками, способными к дифференцировке в несколько клеточных ростков. Целью настоящего исследования была оценка эффектов АМСК на восстановление обонятельной функции у крыс с аносмией.

Материалы и методы

АМСК изолировали из околоматочной жировой ткани крыс с применением коллагеназы типа 1. Аносмию индуцировали путем интраперитонеального введения 3-метилиндола. Затем через 1 сут. после индукции аносмии, вводили 5×105 АМСК трансназально животным опытной группы. В контрольной группе были крысы с аносмией, которым вводили культуральную среду без АМСК. Обонятельную функцию оценивали еженедельно с помощью теста нахождения пищи. Обонятельный нейроэпителий и луковицу забирали для гистопатологического исследования в сроки 4 и 8 недель.

Результаты

После инъекции АМСК наблюдалось примерно 6-7 кратное снижение времени нахождения пищи в опытной группе крыс по сравнению с контрольной группой. Различие было достоверным при P=0,00 и Р=0,035, соответственно, через 4 и 8 недель после инъекции АМСК. Результаты гистопатологического исследования показали реконструкцию обонятельного нейроэпителия в 93% случаев в опытной группе, и в 50% – у контрольных крыс. Обонятельная луковица выявлялась у 60% крыс в опыте, по сравнению с 20% в контроле.

Выводы

Полученные нами результаты показывают, что регенерация обонятельного эпителия может быть ускорена при использовании локального введения АМСК. Эти данные предполагают, что АМСК в будущем могут быть перспективным источником лечения дисфункции обоняния.

Ключевые слова

Аносмия, экспериментальная, мезенхимные стволовые клетки, жировая ткань, дифференцировка, нейрональные клетки.

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Bijan Khademi1,2, Zohreh Zandifar2, Ahmad Monabati3, Nooshafarin Chenari4, Abbas Ghaderi4,5, Mahboobeh Razmkhah4

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(6) "Author" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_EN"]=> array(36) { ["ID"]=> string(2) "38" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Organization" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "38" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25859" ["VALUE"]=> array(2) { ["TEXT"]=> string(688) "<p><sup>1</sup> Research Center of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran<br> <sup>2</sup> Department of Otorhinolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran<br> <sup>3</sup> Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran<br> <sup>4</sup> Shiraz Institute for Cancer Research, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran<br> <sup>5</sup> Department of Immunology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(592) "

1 Research Center of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran
2 Department of Otorhinolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran
3 Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
4 Shiraz Institute for Cancer Research, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
5 Department of Immunology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

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Olfactory dysfunction is a major challenge in medicine and there is no absolute treatment for anosmic patients. Adipose-derived mesenchymal stem cells (ASCs) are multipotent cells capable of differentiating into several cell lineages. The aim of present study was to assess effects of ASCs upon restoration of the olfactory function in anosmic rats.

Materials and methods

ASCs were isolated from the periuterine fat tissue of rats using collagenase type I. Anosmia was induced by intraperitoneal injection of 3-methylindole. Further on, 5×105 ASCs were transnasally transferred into the case group one day after the induction of anosmia. The control group included anosmic rats that were injected with culture media without ASCs. The olfactory function was evaluated weekly by a food-finding test. Olfactory neuroepithelium and bulb were harvested for histopathologic study at 4 and 8 weeks.

Results

Injection of ASCs caused about seven- and six-fold statistically significant reduction in the food-finding time in the case group of rats when compared to the control group tested, respectively, 4 and 8 weeks after injection of ASCs (P-value= 0.00 and =0.035, respectively). Histopathological findings showed reconstruction of olfactory neuroepithelium in 93% of the cases while it was detected in 50% of control rats. The olfactory bulb was detectable in 60% of the case group rats, compared with 20% of the control rats.

Conclusion

Our present results show that regeneration of olfactory epithelium may be accelerated using local ASCs treatment. These data suggest that ASCs might be a promising source for the treatment of olfactory dysfunction in the future.

Keywords

Anosmia, experimental, mesenchymal stem cells, adipose-derived, differentiation, neural cells.

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Bijan Khademi1,2, Zohreh Zandifar2, Ahmad Monabati3, Nooshafarin Chenari4, Abbas Ghaderi4,5, Mahboobeh Razmkhah4

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Bijan Khademi1,2, Zohreh Zandifar2, Ahmad Monabati3, Nooshafarin Chenari4, Abbas Ghaderi4,5, Mahboobeh Razmkhah4

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Olfactory dysfunction is a major challenge in medicine and there is no absolute treatment for anosmic patients. Adipose-derived mesenchymal stem cells (ASCs) are multipotent cells capable of differentiating into several cell lineages. The aim of present study was to assess effects of ASCs upon restoration of the olfactory function in anosmic rats.

Materials and methods

ASCs were isolated from the periuterine fat tissue of rats using collagenase type I. Anosmia was induced by intraperitoneal injection of 3-methylindole. Further on, 5×105 ASCs were transnasally transferred into the case group one day after the induction of anosmia. The control group included anosmic rats that were injected with culture media without ASCs. The olfactory function was evaluated weekly by a food-finding test. Olfactory neuroepithelium and bulb were harvested for histopathologic study at 4 and 8 weeks.

Results

Injection of ASCs caused about seven- and six-fold statistically significant reduction in the food-finding time in the case group of rats when compared to the control group tested, respectively, 4 and 8 weeks after injection of ASCs (P-value= 0.00 and =0.035, respectively). Histopathological findings showed reconstruction of olfactory neuroepithelium in 93% of the cases while it was detected in 50% of control rats. The olfactory bulb was detectable in 60% of the case group rats, compared with 20% of the control rats.

Conclusion

Our present results show that regeneration of olfactory epithelium may be accelerated using local ASCs treatment. These data suggest that ASCs might be a promising source for the treatment of olfactory dysfunction in the future.

Keywords

Anosmia, experimental, mesenchymal stem cells, adipose-derived, differentiation, neural cells.

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Olfactory dysfunction is a major challenge in medicine and there is no absolute treatment for anosmic patients. Adipose-derived mesenchymal stem cells (ASCs) are multipotent cells capable of differentiating into several cell lineages. The aim of present study was to assess effects of ASCs upon restoration of the olfactory function in anosmic rats.

Materials and methods

ASCs were isolated from the periuterine fat tissue of rats using collagenase type I. Anosmia was induced by intraperitoneal injection of 3-methylindole. Further on, 5×105 ASCs were transnasally transferred into the case group one day after the induction of anosmia. The control group included anosmic rats that were injected with culture media without ASCs. The olfactory function was evaluated weekly by a food-finding test. Olfactory neuroepithelium and bulb were harvested for histopathologic study at 4 and 8 weeks.

Results

Injection of ASCs caused about seven- and six-fold statistically significant reduction in the food-finding time in the case group of rats when compared to the control group tested, respectively, 4 and 8 weeks after injection of ASCs (P-value= 0.00 and =0.035, respectively). Histopathological findings showed reconstruction of olfactory neuroepithelium in 93% of the cases while it was detected in 50% of control rats. The olfactory bulb was detectable in 60% of the case group rats, compared with 20% of the control rats.

Conclusion

Our present results show that regeneration of olfactory epithelium may be accelerated using local ASCs treatment. These data suggest that ASCs might be a promising source for the treatment of olfactory dysfunction in the future.

Keywords

Anosmia, experimental, mesenchymal stem cells, adipose-derived, differentiation, neural cells.

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1 Research Center of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran
2 Department of Otorhinolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran
3 Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
4 Shiraz Institute for Cancer Research, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
5 Department of Immunology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

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1 Research Center of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran
2 Department of Otorhinolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran
3 Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
4 Shiraz Institute for Cancer Research, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
5 Department of Immunology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

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Биджан Хадеми1,2, Зохре Зандифар2, Ахмад Монабати3, Нушафарин Ченари4, Аббас Гадери4,5, Мабубе Размха4

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Биджан Хадеми1,2, Зохре Зандифар2, Ахмад Монабати3, Нушафарин Ченари4, Аббас Гадери4,5, Мабубе Размха4

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["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25856" ["VALUE"]=> array(2) { ["TEXT"]=> string(3732) "<p style="text-align: justify;">Нарушения обонятельной функции являются большой проблемой медицины, и нет радикального лечения больных с аносмией. Мезенхимные стволовые клетки, полученные из жировой ткани (АМСК) являются мультипонтентными клетками, способными к дифференцировке в несколько клеточных ростков. Целью настоящего исследования была оценка эффектов АМСК на восстановление обонятельной функции у крыс с аносмией.</p> <h3>Материалы и методы</h3> <p style="text-align: justify;">АМСК изолировали из околоматочной жировой ткани крыс с применением коллагеназы типа 1. Аносмию индуцировали путем интраперитонеального введения 3-метилиндола. Затем через 1 сут. после индукции аносмии, вводили 5×105 АМСК трансназально животным опытной группы. В контрольной группе были крысы с аносмией, которым вводили культуральную среду без АМСК. Обонятельную функцию оценивали еженедельно с помощью теста нахождения пищи. Обонятельный нейроэпителий и луковицу забирали для гистопатологического исследования в сроки 4 и 8 недель.</p> <h3>Результаты</h3> <p style="text-align: justify;">После инъекции АМСК наблюдалось примерно 6-7 кратное снижение времени нахождения пищи в опытной группе крыс по сравнению с контрольной группой. Различие было достоверным при P=0,00 и Р=0,035, соответственно, через 4 и 8 недель после инъекции АМСК. Результаты гистопатологического исследования показали реконструкцию обонятельного нейроэпителия в 93% случаев в опытной группе, и в 50% – у контрольных крыс. Обонятельная луковица выявлялась у 60% крыс в опыте, по сравнению с 20% в контроле.</p> <h3>Выводы</h3> <p style="text-align: justify;">Полученные нами результаты показывают, что регенерация обонятельного эпителия может быть ускорена при использовании локального введения АМСК. Эти данные предполагают, что АМСК в будущем могут быть перспективным источником лечения дисфункции обоняния.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Аносмия, экспериментальная, мезенхимные стволовые клетки, жировая ткань, дифференцировка, нейрональные клетки.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(3574) "

Нарушения обонятельной функции являются большой проблемой медицины, и нет радикального лечения больных с аносмией. Мезенхимные стволовые клетки, полученные из жировой ткани (АМСК) являются мультипонтентными клетками, способными к дифференцировке в несколько клеточных ростков. Целью настоящего исследования была оценка эффектов АМСК на восстановление обонятельной функции у крыс с аносмией.

Материалы и методы

АМСК изолировали из околоматочной жировой ткани крыс с применением коллагеназы типа 1. Аносмию индуцировали путем интраперитонеального введения 3-метилиндола. Затем через 1 сут. после индукции аносмии, вводили 5×105 АМСК трансназально животным опытной группы. В контрольной группе были крысы с аносмией, которым вводили культуральную среду без АМСК. Обонятельную функцию оценивали еженедельно с помощью теста нахождения пищи. Обонятельный нейроэпителий и луковицу забирали для гистопатологического исследования в сроки 4 и 8 недель.

Результаты

После инъекции АМСК наблюдалось примерно 6-7 кратное снижение времени нахождения пищи в опытной группе крыс по сравнению с контрольной группой. Различие было достоверным при P=0,00 и Р=0,035, соответственно, через 4 и 8 недель после инъекции АМСК. Результаты гистопатологического исследования показали реконструкцию обонятельного нейроэпителия в 93% случаев в опытной группе, и в 50% – у контрольных крыс. Обонятельная луковица выявлялась у 60% крыс в опыте, по сравнению с 20% в контроле.

Выводы

Полученные нами результаты показывают, что регенерация обонятельного эпителия может быть ускорена при использовании локального введения АМСК. Эти данные предполагают, что АМСК в будущем могут быть перспективным источником лечения дисфункции обоняния.

Ключевые слова

Аносмия, экспериментальная, мезенхимные стволовые клетки, жировая ткань, дифференцировка, нейрональные клетки.

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Нарушения обонятельной функции являются большой проблемой медицины, и нет радикального лечения больных с аносмией. Мезенхимные стволовые клетки, полученные из жировой ткани (АМСК) являются мультипонтентными клетками, способными к дифференцировке в несколько клеточных ростков. Целью настоящего исследования была оценка эффектов АМСК на восстановление обонятельной функции у крыс с аносмией.

Материалы и методы

АМСК изолировали из околоматочной жировой ткани крыс с применением коллагеназы типа 1. Аносмию индуцировали путем интраперитонеального введения 3-метилиндола. Затем через 1 сут. после индукции аносмии, вводили 5×105 АМСК трансназально животным опытной группы. В контрольной группе были крысы с аносмией, которым вводили культуральную среду без АМСК. Обонятельную функцию оценивали еженедельно с помощью теста нахождения пищи. Обонятельный нейроэпителий и луковицу забирали для гистопатологического исследования в сроки 4 и 8 недель.

Результаты

После инъекции АМСК наблюдалось примерно 6-7 кратное снижение времени нахождения пищи в опытной группе крыс по сравнению с контрольной группой. Различие было достоверным при P=0,00 и Р=0,035, соответственно, через 4 и 8 недель после инъекции АМСК. Результаты гистопатологического исследования показали реконструкцию обонятельного нейроэпителия в 93% случаев в опытной группе, и в 50% – у контрольных крыс. Обонятельная луковица выявлялась у 60% крыс в опыте, по сравнению с 20% в контроле.

Выводы

Полученные нами результаты показывают, что регенерация обонятельного эпителия может быть ускорена при использовании локального введения АМСК. Эти данные предполагают, что АМСК в будущем могут быть перспективным источником лечения дисфункции обоняния.

Ключевые слова

Аносмия, экспериментальная, мезенхимные стволовые клетки, жировая ткань, дифференцировка, нейрональные клетки.

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1 Научный центр ЛОР-хирургии области головы и шеи, Ширазский университет медицинских наук, Шираз, Иран
2 Департамент оториноларингологии, Ширазский медицинский университет, Шираз, Иран
3 Департамент патологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран
4 Ширазский институт раковых исследований, Школа медицины, Ширазский медицинский университет, Шираз, Иран
5 Департамент иммунологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран

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3 Департамент патологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран
4 Ширазский институт раковых исследований, Школа медицины, Ширазский медицинский университет, Шираз, Иран
5 Департамент иммунологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран

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Introduction

Maxillary sinusitis is one of the most common diseases of paranasal sinuses [1]. According to latest statistics, the prevalence of sinusitis in Russia is growing to 1.420 cases per 100.000 adult population [2]. Odontogenic maxillary sinusitis, comprises 4 to 7% of all cases of this morbidity, and its incidence also continues to grow [3]. Oroantral communication (OAC) takes a sufficient place in pathogenesis of odontogenic sinusitis [4]. OAC occurs most often when the upper molars are removed, and the frequency of such forms of sinusitis is 41-92% [5].

Bone tissue regeneration in the area of OAC defect can be achieved not only by structural replacement of such defect, but also by stimulating the regeneration of surrounding bony tissues [6]. To this purpose, biocompatible polymer scaffolds can be used [7]. Appropriate matrices or scaffold systems represent an artificial tissue equivalent with three-dimensional structure that form a substrate for the tissue regeneration [8]. An ideal scaffold should promote tissue restoration, being, however, resorbed afterwards. Moreover, the scaffold should have a pore size optimal for uniform cell distribution, an adhesive surface that promotes cell proliferation and differentiation, and be biocompatible [9].

Synthetic and natural polymer matrices are discerned. According to several authors, synthetic fibrous matrices are the most promising for bone tissue regeneration [10]. The matrices obtained by electrospinning method are of greatest interest. It allows to produce matrices with specified structural and biomechanical properties. The scaffold systems made with this technique have good elasticity and mechanical strength [11]. Polycaprolactone nonwoven fabric is most often used in electrospinning technology. The results of experimental studies indicate to successful use of polycaprolactone-based matrices for replacement of skin and bone defects [12].

The 3D porous scaffolds can maintain the physical space necessary for bone regeneration, thus preventing invasion of undesired cells, along with anchoring endogenous osteogenic cells, in order to induce cell ingrowth and promoting molecular microenvironment for osteoblastic differentiation [13]. Due to its biodegradability and biocompatibility, PCL can be employed as a bone substitute to reconstruct the alveolar bone in the oral cavity. In addition, PCL is a safe material approved by the FDA for use in drug delivery devices and implantation scaffolds [14]. Proven biocompatibility and optimal physico-chemical characteristics make it possible to use PCL as a matrix for closing the OAC defect [15].

The aim of our study was to test potential effects of PCL-based matrices upon closure of oroantral defect in experimental animals. The results show effective in vivo regeneration of maxillar bone with the local PCL implants.

Materials and methods

We have performed an in vivo experimental study to assess the opportunity of OAC treatment by means of PCL-based scaffold systems. The study was carried out at the Research Center of First St. Petersburg State I. Pavlov Medical University. The polycaprolactone matrices were manufactured at the Tomsk Polytechnic University using the electrospinning technique (Fig. 1).

To prepare pure polycaprolactone-based scaffolds, the polymer was dissolved in chloroform at a concentration of 9% and 6%. A syringe pump was used to supply solutions through an extension tube covered with blunt 21 gauge needles (inner diameter 0.51 mm). A voltage of 6.5 kV was applied using a high voltage power source. During the electrospinning process, a special collector needle (8 cm) was used, with a deposition time of 60 min and a fixed injection rate of 1.5 mL/h. The prepared samples were separated from the collector and used for further experiments. The square-shaped specimens (5×5 mm) were produced, then being sterilized and placed into a sterile medium (Fig. 2).

Yaremenko-fig01.jpg

Figure 1. Micrograph. 200x magnification. Cross section of spongy cylindrical matrix samples based on polycaprolactone

Yaremenko-fig02.jpg

Figure 2. Polycaprolactone Scaffold Samples

The male rabbits were used (Soviet Chinchilla) at the age of 1 year, weighing from 3 kg. A total of 9 laboratory animals were used in the study. Surgery was made under general anesthesia with using ketamine. The experimental animals were subject to extraction of the right anterior chewing tooth using surgical forceps (Fig. 3). Thereafter, a hole was penetrated with a metal probe to the lumen of the maxillary sinus, thereby establishing an OAC condition. A matrix of polycaprolactone was introduced into the hole of the extracted tooth. Upon perforation, the matrix was impregnated with blood, but it did not change its volume. Therefore, additional fixation of the matrix was carried out using two metal pins to the edges of the defect (Fig. 4). The wound was sutured tightly with overlapping of the defect area with a mucoperiosteal flap.

Yaremenko-fig03.jpg

Figure 3. The experimental animal after the extraction of the anterior masticatory tooth (the hole is marked with an arrow)

Yaremenko-fig04.jpg

Figure 4. The matrix of polycaprolactone is fixed in the area of the hole of the extracted tooth with two pins

The animals were sacrificed from the experiment according to the schedule at the following observation terms: 1 month, 2 months, and 6 months after surgery. The rabbits were anaesthesized, decapitated, and a fragment of the upper jaw 2×2 cm was separated using a drill, 1 cm around the site of matrix installation, while maintaining the oral mucosa. The preparations were fixed in formalin, decalcified, and embedded into paraffin blocks. Then, 5 μm-thick sections were sliced, that were stained with hematoxylin and eosin (H&E), and a histochemical reaction for connective tissue elements was performed with Mallory staining using the BioVitrum kit (Russia). The photos were obtained with Leica DM750 microscope (Germany) using a 10×10 eyepiece, 40× lenses, and the ICC50 digital camera (Leica, Germany).

Results

Yaremenko-fig05.jpg

Figure 5. 400x magnification. The capsule surrounding the polycaprolactone matrix 1 month after implantation. H&E staining

1 – matrix, 2 – connective tissue capsule surrounding the matrix, 3 – bone wall of the tooth alveole.

One month after implantation, a connective tissue capsule is detected around the matrix (Fig. 5). The cellular composition of the matrix is represented mainly by fibroblasts, macrophages and a small number of leukocytes. Giant multinuclear cells are located on the matrix fibers. Between the fibers are seen macrophages and fibroblasts, which actively synthesize collagen fibers. Hence, the experimental area was completely penetrated by thin collagen fibers within 1 month. No signs of inflammatory cellular response were detectable on affected bone fragment (Fig. 6), thus resulting into growth of connective tissue which sprouted into the matrix, along with single blood vessels and multinuclear giant cells of foreign bodies in small amounts (Fig. 7).

At two months of observation, there were no signs of inflammatory reaction in the capsule surrounding the matrix. Mucosa lining the maxillary sinus and at the root of the tooth was immediately adjacent to the matrix (Fig. 8). The severity degree of matrix sprouting by connective tissue elements has become significantly greater over this time. In addition to fibroblasts, giant multinuclear cells of foreign bodies, and macrophages, a small number of leukocytes was visualized between the matrix fibers (Fig. 9). Neoangiogenesis and PCL matrix resorption were also in progress (Fig. 10).

After 6 months of our experiment, the matrix was completely penetrated by thick bundles of collagen fibers, whereas any sufficient signs of an inflammatory tissue reaction were not revealed in the implantation area. Bony wall of the tooth well was covered with osteoblasts and single osteoclasts (Fig. 11).

A significant decrease of polycaprolactone amounts was noted in the matrix volume by 6 months of experiment. This event may be caused by active destruction of the synthetic matrix fibers and indicates a high rate of its resorption. At the same time period, its structure was almost completely replaced by well-vascularized connective tissue (Fig. 12).

Yaremenko-fig06.jpg

Figure 6. Micrograph. 100x magnification. Fragment of the maxilla of the rabbit 1 month after the installation of the matrix of polycaprolactone (A – H&E staining, B – staining Mallory method)

1 – matrix, 2 – collagen fibers sprouting into the matrix, 3 – connective tissue capsule surrounding the matrix, 4 – bone wall of the tooth alveole.

Yaremenko-fig07.jpg

Figure 7. Micrograph. 400x magnification. Fragment of the maxilla of the rabbit 1 month after the installation of the matrix of polycaprolactone. H&E staining

1 – blood vessels in the structure of the matrix, 2 – multinuclear giant cells.

Yaremenko-fig08.jpg

Figure 8. Micrograph. 40x magnification. Fragment of the maxilla of the rabbit 2 months after the installation of the matrix of polycaprolactone. H&E staining

1 – matrix, 2 – connective tissue capsule surrounding the matrix, 3 – dentin of the tooth root, 4 – bone wall of the tooth alveole.

Yaremenko-fig09.jpg

Figure 9. Micrograph. 100x magnification. Fragment of the maxilla of the rabbit 2 months after the installation of the matrix of polycaprolactone (stained by the method of Mallory)

1 – matrix penetrated by collagen fibers, 2 – connective tissue capsule surrounding the matrix, 3 – maxillary sinus lumen filled with mucus.

Yaremenko-fig10.jpg

Figure 10. Micrograph. 400x magnification. Fragment of the maxilla of the rabbit 2 months after the installation of the matrix of polycaprolactone. H&E staining

1 – blood vessels, 2 multinuclear giant cells, 3 – fibers of loose connective tissue.



Yaremenko-fig11.jpg

Figure 11. Micrograph. 100x magnification. Fragment of the maxilla of the rabbit 6 months after the installation of the matrix of polycaprolactone. H&E staining

1 – matrix penetrated by collagen fibers, 2 – connective tissue capsule surrounding the matrix, 3 – bone wall of the tooth alveole.

Yaremenko-fig12.jpg

Figure 12. Micrograph. 400x magnification. Six months after installing the polycaprolactone matrix (stained by the method of Mallory)

1 – blood vessels, 2 – multinuclear giant cells, 3 – fibers of loose connective tissue.

Discussion and conclusion

In an in vivo pilot study, there were no cases of PCL-scaffolds rejection. The matrix is flexible and durable, it was not loosening during fixation in the wound. However, it does not change its volume when contacting with blood, therefore, its additional on-site fixation is necessary to avoid synthetic matrix migration to the lumen of maxillary sinus.

According to the results of a morphological study, as soon as a month after implantation, there are signs of connective tissue penetration to the matrix structure. The surrounding capsule is thin and shows only minimal signs of inflammation, which completely disappeared by the 2nd month after the intervention. Over next 4 months, the capsule becomes thinner, the matrix is totally penetrated by connective tissue and blood vessels. It helps to maintain the height of the alveolar process of the upper jaw at the site of the extracted tooth.

Other works also confirm good tolerability of PCL in various experimental settings [16, 17, 18, 19].

Conclusion

The scaffolds based on polycaprolactone are biocompatible, do not cause a pronounced inflammatory reaction in surrounding tissues and demonstrate a good potential for their use for closing the OAC lesions.

The proposed method for eliminating the oroantral communication using a scaffold system ensures volume maintenance of the deficient maxillary bone fragment for up to 6 months, and moreover, it may stimulate local osteogenesis, as shown in the animal model.

In the future, we plan to continue studies on the polymer constructs in order to repair OAC and to conduct a comparative in vivo experimental study of natural and synthetic bioengineered materials.

References

  1. Yildirim TT, Güncü GN, Göksülük D, Tözüm MD, Colak M, Tözüm TF. The effect of demographic and disease variables on Schneiderian membrane thickness and appearance. Oral Surg Oral Med Oral Pathol. Oral Radiol.2017;124(6): 568-576.
  2. Baydik OD, Sysolyatin PG, Gurin AA, Ilenok OV. Modern approaches to diagnostics and treatment of chronic odontogenic maxillary sinusitis. Russian Journal of Dentistry. 2015;19(4):14-18 (In Russian).
  3. Little RE, Long CM, Loehrl TA, Poetker DM. Odontogenic sinusitis: A review of the current literature. Invest Otolaryngol. 2018; 3(2):110-114.
  4. Troeltzsch M, Pache C. Etiology and clinical characteristics of symptomatic unilateral maxillary sinusitis: A review of 174 cases. J Cranio-Maxillofac Surg. 2015; 43(8):1522-1529.
  5. Akhlaghi F, Esmaeelinejad M, Safai P. Etiologies and treatments of odontogenic maxillary sinusitis: A systematic review. Iran Red Crescent Med J. 2015;7(12): e25536.
  6. Yakushiji N. Treatment for oroantral communications of 170 cases. Oral Maxillofac Surg. 2014; 72(9, Suppl): e82.
  7. Dreifke MB, Ebraheim NA, Jayasuriya AC. Investigation of potential injectable polymeric biomaterials for bone regeneration. J Biomed Mater Res A. 2013; 101: 2436-2447.
  8. Park SH, Park DS, Shin JW, Kang YG, Kim HK, Yoon TR, Shin JW. Scaffolds for bone tissue engineering fabricated from two different materials by the rapid prototyping technique: PCL versus PLGA. J Mater Sci Mater Med. 2012; 23:2671-2678.
  9. Sheikh Z, Hamdan N, Ikeda Y, Grynpas M, Ganss B, Glogauer M. Natural graft tissues and synthetic biomaterials for periodontal and alveolar bone reconstructive applications: A review. Biomater. Res. 2017; 21: 9.
  10. Williams JM, Adewunmi A, Schek RM, Flanagan CL, Krebsbach PH, Feinberg SE, Hollister SJ, Das S. Bone tissue engineering using polycaprolactone scaffolds fabricated via selective laser sintering. Biomaterials. 2005, 26:4817-4827.
  11. Karimi A, Karbasi S, Razavi S, Zargar EN. Poly(hydroxybutyrate)/chitosan aligned electrospun scaffold as a novel substrate for nerve tissue engineering. Adv Biomed Res. 2018:7(1):44-50.
  12. Kretlow JD, Klouda L, Mikos AG, Injectable matrices and scaffolds for drug delivery in tissue engineering. Adv Drug Deliv Rev. 2007;59: 263-273.
  13. Mckee MD. Extracellular matrix and mineralization of craniofacial bone. In: Mineralized Tissues in Oral and Craniofacial Science: Biological Principle. 2012. J Wiley & Sons Inc. Hoboken, NY, USA.
  14. Yaremenko AI, Lysenko AV, Ivanova EA, Vilesov AD, Galibin OV, Petrov NL, Kirillov PA. Prospectives for using artificial scaffolds in oral and craniofacial surgery: literature review. Cell Ther Transplant. 2018;7;1(22): 20-26.
  15. Ye P, Yu B, Deng J, She RF, Huang WL. Application of silk fibroin/chitosan/nano-hydroxyapatite composite scaffold in the repair of rabbit radial bone defect. Exp Ther Med. 2017;14;6: 5547-5553.
  16. Islas-Arteaga NC, Rivera AR, Esquiliano Rendon DR, Morales-Corona J, Ontiveros-Nevares PG, Flores Sánchez MG, Mojica-Cardoso C, Olay R. Electrospun scaffolds with surfaces modified by plasma for regeneration of articular cartilage tissue: a pilot study in rabbit. Int J Polym Mater Polym Biomater. 2019;68:18:1089-1098.
  17. Zheng P, Hu X, Lou Y, Tang K. A Rabbit Model of osteochondral regeneration using three-dimensional printed polycaprolactone-hydroxyapatite scaffolds coated with umbilical cord blood mesenchymal stem cells and chondrocytes. Med Sci Monit. 2019;25:7361-7369.
  18. Liao W, Xu L, Wangrao K, Du Y, Xiong Q, Yao Y. 2019. Three-dimensional printing with biomaterials in craniofacial and dental tissue engineering. Peer J 7:e7271.
  19. Yaremenko AI, Zubareva AA, Lysenko AV, Chibisova MA, Udin VE, Popriaduchin PV, Ukina GU, Ivanova EA. Application of chitosan matrix for closure maxillary sinus perforation: future prospects. Experimental work. The Dental Institute. 2017; 2 (75):62-63.
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Introduction

Maxillary sinusitis is one of the most common diseases of paranasal sinuses [1]. According to latest statistics, the prevalence of sinusitis in Russia is growing to 1.420 cases per 100.000 adult population [2]. Odontogenic maxillary sinusitis, comprises 4 to 7% of all cases of this morbidity, and its incidence also continues to grow [3]. Oroantral communication (OAC) takes a sufficient place in pathogenesis of odontogenic sinusitis [4]. OAC occurs most often when the upper molars are removed, and the frequency of such forms of sinusitis is 41-92% [5].

Bone tissue regeneration in the area of OAC defect can be achieved not only by structural replacement of such defect, but also by stimulating the regeneration of surrounding bony tissues [6]. To this purpose, biocompatible polymer scaffolds can be used [7]. Appropriate matrices or scaffold systems represent an artificial tissue equivalent with three-dimensional structure that form a substrate for the tissue regeneration [8]. An ideal scaffold should promote tissue restoration, being, however, resorbed afterwards. Moreover, the scaffold should have a pore size optimal for uniform cell distribution, an adhesive surface that promotes cell proliferation and differentiation, and be biocompatible [9].

Synthetic and natural polymer matrices are discerned. According to several authors, synthetic fibrous matrices are the most promising for bone tissue regeneration [10]. The matrices obtained by electrospinning method are of greatest interest. It allows to produce matrices with specified structural and biomechanical properties. The scaffold systems made with this technique have good elasticity and mechanical strength [11]. Polycaprolactone nonwoven fabric is most often used in electrospinning technology. The results of experimental studies indicate to successful use of polycaprolactone-based matrices for replacement of skin and bone defects [12].

The 3D porous scaffolds can maintain the physical space necessary for bone regeneration, thus preventing invasion of undesired cells, along with anchoring endogenous osteogenic cells, in order to induce cell ingrowth and promoting molecular microenvironment for osteoblastic differentiation [13]. Due to its biodegradability and biocompatibility, PCL can be employed as a bone substitute to reconstruct the alveolar bone in the oral cavity. In addition, PCL is a safe material approved by the FDA for use in drug delivery devices and implantation scaffolds [14]. Proven biocompatibility and optimal physico-chemical characteristics make it possible to use PCL as a matrix for closing the OAC defect [15].

The aim of our study was to test potential effects of PCL-based matrices upon closure of oroantral defect in experimental animals. The results show effective in vivo regeneration of maxillar bone with the local PCL implants.

Materials and methods

We have performed an in vivo experimental study to assess the opportunity of OAC treatment by means of PCL-based scaffold systems. The study was carried out at the Research Center of First St. Petersburg State I. Pavlov Medical University. The polycaprolactone matrices were manufactured at the Tomsk Polytechnic University using the electrospinning technique (Fig. 1).

To prepare pure polycaprolactone-based scaffolds, the polymer was dissolved in chloroform at a concentration of 9% and 6%. A syringe pump was used to supply solutions through an extension tube covered with blunt 21 gauge needles (inner diameter 0.51 mm). A voltage of 6.5 kV was applied using a high voltage power source. During the electrospinning process, a special collector needle (8 cm) was used, with a deposition time of 60 min and a fixed injection rate of 1.5 mL/h. The prepared samples were separated from the collector and used for further experiments. The square-shaped specimens (5×5 mm) were produced, then being sterilized and placed into a sterile medium (Fig. 2).

Yaremenko-fig01.jpg

Figure 1. Micrograph. 200x magnification. Cross section of spongy cylindrical matrix samples based on polycaprolactone

Yaremenko-fig02.jpg

Figure 2. Polycaprolactone Scaffold Samples

The male rabbits were used (Soviet Chinchilla) at the age of 1 year, weighing from 3 kg. A total of 9 laboratory animals were used in the study. Surgery was made under general anesthesia with using ketamine. The experimental animals were subject to extraction of the right anterior chewing tooth using surgical forceps (Fig. 3). Thereafter, a hole was penetrated with a metal probe to the lumen of the maxillary sinus, thereby establishing an OAC condition. A matrix of polycaprolactone was introduced into the hole of the extracted tooth. Upon perforation, the matrix was impregnated with blood, but it did not change its volume. Therefore, additional fixation of the matrix was carried out using two metal pins to the edges of the defect (Fig. 4). The wound was sutured tightly with overlapping of the defect area with a mucoperiosteal flap.

Yaremenko-fig03.jpg

Figure 3. The experimental animal after the extraction of the anterior masticatory tooth (the hole is marked with an arrow)

Yaremenko-fig04.jpg

Figure 4. The matrix of polycaprolactone is fixed in the area of the hole of the extracted tooth with two pins

The animals were sacrificed from the experiment according to the schedule at the following observation terms: 1 month, 2 months, and 6 months after surgery. The rabbits were anaesthesized, decapitated, and a fragment of the upper jaw 2×2 cm was separated using a drill, 1 cm around the site of matrix installation, while maintaining the oral mucosa. The preparations were fixed in formalin, decalcified, and embedded into paraffin blocks. Then, 5 μm-thick sections were sliced, that were stained with hematoxylin and eosin (H&E), and a histochemical reaction for connective tissue elements was performed with Mallory staining using the BioVitrum kit (Russia). The photos were obtained with Leica DM750 microscope (Germany) using a 10×10 eyepiece, 40× lenses, and the ICC50 digital camera (Leica, Germany).

Results

Yaremenko-fig05.jpg

Figure 5. 400x magnification. The capsule surrounding the polycaprolactone matrix 1 month after implantation. H&E staining

1 – matrix, 2 – connective tissue capsule surrounding the matrix, 3 – bone wall of the tooth alveole.

One month after implantation, a connective tissue capsule is detected around the matrix (Fig. 5). The cellular composition of the matrix is represented mainly by fibroblasts, macrophages and a small number of leukocytes. Giant multinuclear cells are located on the matrix fibers. Between the fibers are seen macrophages and fibroblasts, which actively synthesize collagen fibers. Hence, the experimental area was completely penetrated by thin collagen fibers within 1 month. No signs of inflammatory cellular response were detectable on affected bone fragment (Fig. 6), thus resulting into growth of connective tissue which sprouted into the matrix, along with single blood vessels and multinuclear giant cells of foreign bodies in small amounts (Fig. 7).

At two months of observation, there were no signs of inflammatory reaction in the capsule surrounding the matrix. Mucosa lining the maxillary sinus and at the root of the tooth was immediately adjacent to the matrix (Fig. 8). The severity degree of matrix sprouting by connective tissue elements has become significantly greater over this time. In addition to fibroblasts, giant multinuclear cells of foreign bodies, and macrophages, a small number of leukocytes was visualized between the matrix fibers (Fig. 9). Neoangiogenesis and PCL matrix resorption were also in progress (Fig. 10).

After 6 months of our experiment, the matrix was completely penetrated by thick bundles of collagen fibers, whereas any sufficient signs of an inflammatory tissue reaction were not revealed in the implantation area. Bony wall of the tooth well was covered with osteoblasts and single osteoclasts (Fig. 11).

A significant decrease of polycaprolactone amounts was noted in the matrix volume by 6 months of experiment. This event may be caused by active destruction of the synthetic matrix fibers and indicates a high rate of its resorption. At the same time period, its structure was almost completely replaced by well-vascularized connective tissue (Fig. 12).

Yaremenko-fig06.jpg

Figure 6. Micrograph. 100x magnification. Fragment of the maxilla of the rabbit 1 month after the installation of the matrix of polycaprolactone (A – H&E staining, B – staining Mallory method)

1 – matrix, 2 – collagen fibers sprouting into the matrix, 3 – connective tissue capsule surrounding the matrix, 4 – bone wall of the tooth alveole.

Yaremenko-fig07.jpg

Figure 7. Micrograph. 400x magnification. Fragment of the maxilla of the rabbit 1 month after the installation of the matrix of polycaprolactone. H&E staining

1 – blood vessels in the structure of the matrix, 2 – multinuclear giant cells.

Yaremenko-fig08.jpg

Figure 8. Micrograph. 40x magnification. Fragment of the maxilla of the rabbit 2 months after the installation of the matrix of polycaprolactone. H&E staining

1 – matrix, 2 – connective tissue capsule surrounding the matrix, 3 – dentin of the tooth root, 4 – bone wall of the tooth alveole.

Yaremenko-fig09.jpg

Figure 9. Micrograph. 100x magnification. Fragment of the maxilla of the rabbit 2 months after the installation of the matrix of polycaprolactone (stained by the method of Mallory)

1 – matrix penetrated by collagen fibers, 2 – connective tissue capsule surrounding the matrix, 3 – maxillary sinus lumen filled with mucus.

Yaremenko-fig10.jpg

Figure 10. Micrograph. 400x magnification. Fragment of the maxilla of the rabbit 2 months after the installation of the matrix of polycaprolactone. H&E staining

1 – blood vessels, 2 multinuclear giant cells, 3 – fibers of loose connective tissue.



Yaremenko-fig11.jpg

Figure 11. Micrograph. 100x magnification. Fragment of the maxilla of the rabbit 6 months after the installation of the matrix of polycaprolactone. H&E staining

1 – matrix penetrated by collagen fibers, 2 – connective tissue capsule surrounding the matrix, 3 – bone wall of the tooth alveole.

Yaremenko-fig12.jpg

Figure 12. Micrograph. 400x magnification. Six months after installing the polycaprolactone matrix (stained by the method of Mallory)

1 – blood vessels, 2 – multinuclear giant cells, 3 – fibers of loose connective tissue.

Discussion and conclusion

In an in vivo pilot study, there were no cases of PCL-scaffolds rejection. The matrix is flexible and durable, it was not loosening during fixation in the wound. However, it does not change its volume when contacting with blood, therefore, its additional on-site fixation is necessary to avoid synthetic matrix migration to the lumen of maxillary sinus.

According to the results of a morphological study, as soon as a month after implantation, there are signs of connective tissue penetration to the matrix structure. The surrounding capsule is thin and shows only minimal signs of inflammation, which completely disappeared by the 2nd month after the intervention. Over next 4 months, the capsule becomes thinner, the matrix is totally penetrated by connective tissue and blood vessels. It helps to maintain the height of the alveolar process of the upper jaw at the site of the extracted tooth.

Other works also confirm good tolerability of PCL in various experimental settings [16, 17, 18, 19].

Conclusion

The scaffolds based on polycaprolactone are biocompatible, do not cause a pronounced inflammatory reaction in surrounding tissues and demonstrate a good potential for their use for closing the OAC lesions.

The proposed method for eliminating the oroantral communication using a scaffold system ensures volume maintenance of the deficient maxillary bone fragment for up to 6 months, and moreover, it may stimulate local osteogenesis, as shown in the animal model.

In the future, we plan to continue studies on the polymer constructs in order to repair OAC and to conduct a comparative in vivo experimental study of natural and synthetic bioengineered materials.

References

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  10. Williams JM, Adewunmi A, Schek RM, Flanagan CL, Krebsbach PH, Feinberg SE, Hollister SJ, Das S. Bone tissue engineering using polycaprolactone scaffolds fabricated via selective laser sintering. Biomaterials. 2005, 26:4817-4827.
  11. Karimi A, Karbasi S, Razavi S, Zargar EN. Poly(hydroxybutyrate)/chitosan aligned electrospun scaffold as a novel substrate for nerve tissue engineering. Adv Biomed Res. 2018:7(1):44-50.
  12. Kretlow JD, Klouda L, Mikos AG, Injectable matrices and scaffolds for drug delivery in tissue engineering. Adv Drug Deliv Rev. 2007;59: 263-273.
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  15. Ye P, Yu B, Deng J, She RF, Huang WL. Application of silk fibroin/chitosan/nano-hydroxyapatite composite scaffold in the repair of rabbit radial bone defect. Exp Ther Med. 2017;14;6: 5547-5553.
  16. Islas-Arteaga NC, Rivera AR, Esquiliano Rendon DR, Morales-Corona J, Ontiveros-Nevares PG, Flores Sánchez MG, Mojica-Cardoso C, Olay R. Electrospun scaffolds with surfaces modified by plasma for regeneration of articular cartilage tissue: a pilot study in rabbit. Int J Polym Mater Polym Biomater. 2019;68:18:1089-1098.
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По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели <i>in vivo</i>. 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["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25603" ["VALUE"]=> array(2) { ["TEXT"]=> string(475) "<p>Андрей И. Яременко<sup>1</sup>, Анна В. Лысенко<sup>1</sup>, Елизавета А. Иванова<sup>1</sup>, Александр Д. Вилесов<sup>3</sup>, Галина Ю. Юкина<sup>4</sup>, Марина А. Чибисова<sup>5</sup>, Анна А. Зубарева<sup>2</sup>, Олег В. Галибин<sup>3</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(367) "

Андрей И. Яременко1, Анна В. Лысенко1, Елизавета А. Иванова1, Александр Д. Вилесов3, Галина Ю. Юкина4, Марина А. Чибисова5, Анна А. Зубарева2, Олег В. Галибин3

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_RU"]=> array(36) { ["ID"]=> string(2) "26" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(22) "Организации" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "26" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25604" ["VALUE"]=> array(2) { ["TEXT"]=> string(1433) "<p> <sup>1</sup> Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет <br> им. акад. И. П. Павлова, Санкт-Петербург, Россия<br> <sup>2</sup> Кафедра оториноларингологии, Первый Санкт-Петербургский государственный медицинский университет <br> им. акад. И. П. Павлова, Санкт-Петербург, Россия<br> <sup>3</sup> НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия<br> <sup>4</sup> Научно-исследовательский центр Первого Санкт-Петербургского государственного медицинского университета <br> им. акад. И. П. Павлова, Санкт-Петербург, Россия<br> <sup>5</sup> Санкт-Петербургский стоматологический институт последипломного образования, Санкт-Петербург, Россия </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1319) "

1 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Кафедра оториноларингологии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
4 Научно-исследовательский центр Первого Санкт-Петербургского государственного медицинского университета
им. акад. И. П. Павлова, Санкт-Петербург, Россия
5 Санкт-Петербургский стоматологический институт последипломного образования, Санкт-Петербург, Россия

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25605" ["VALUE"]=> array(2) { ["TEXT"]=> string(6161) "<p style="text-align: justify;">Одонтогенный максиллярный синусит (ОМС) занимает одно из первых мест по заболеваемости среди болезней параназального синуса. По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели <i>in vivo</i>. В данном экспериментальном исследовании, проводилась ксеногенная трансплантация поликапролактонового матрикса в нижнюю стенку максиллярного синуса после развития ОАК у кроликов. Девять животных исследовали в сроки 4, 8 и 24 недели. Проводили рассечение костей верхней челюсти, резали на меньшие блоки и помещали образцы в формалин. Серийные гистологические препараты окрашивали и исследовали методами световой микроскопии. Морфологический анализ показал, наличие ранних признаков врастания соединительной ткани в сетку матрикса уже через 1 мес. после ее имплантации. Окружающая капсула была тонкой, с минимальными признаками воспаления, которое полностью исчезало к 2 мес. после вмешательства. В течение последующих 4 мес. капсула становилась тоньше, синтетический матрикс полностью прорастал соединительной тканью и кровеносными сосудами. Это помогало сохранить высоту альвеолярного отростка верхней челюсти в месте экстракции зуба.</p> <h3>Выводы</h3> <p style="text-align: justify;">Предложенный метод закрытия ороантральной коммуникации с применением системы ПКЛ-скаффолда может сохранить объем утраченного костного фрагмента на срок до 6 мес. и может стимулировать остеогенез, как показано нашими экспериментами на животных.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Ороантральная коммуникация, максиллярный синус, поликапролактон, полимерные матрицы, костная регенерация.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(6059) "

Одонтогенный максиллярный синусит (ОМС) занимает одно из первых мест по заболеваемости среди болезней параназального синуса. По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели in vivo. В данном экспериментальном исследовании, проводилась ксеногенная трансплантация поликапролактонового матрикса в нижнюю стенку максиллярного синуса после развития ОАК у кроликов. Девять животных исследовали в сроки 4, 8 и 24 недели. Проводили рассечение костей верхней челюсти, резали на меньшие блоки и помещали образцы в формалин. Серийные гистологические препараты окрашивали и исследовали методами световой микроскопии. Морфологический анализ показал, наличие ранних признаков врастания соединительной ткани в сетку матрикса уже через 1 мес. после ее имплантации. Окружающая капсула была тонкой, с минимальными признаками воспаления, которое полностью исчезало к 2 мес. после вмешательства. В течение последующих 4 мес. капсула становилась тоньше, синтетический матрикс полностью прорастал соединительной тканью и кровеносными сосудами. Это помогало сохранить высоту альвеолярного отростка верхней челюсти в месте экстракции зуба.

Выводы

Предложенный метод закрытия ороантральной коммуникации с применением системы ПКЛ-скаффолда может сохранить объем утраченного костного фрагмента на срок до 6 мес. и может стимулировать остеогенез, как показано нашими экспериментами на животных.

Ключевые слова

Ороантральная коммуникация, максиллярный синус, поликапролактон, полимерные матрицы, костная регенерация.

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Аndrey I. Yaremenko1, Anna V. Lysenko1, Elizaveta A. Ivanova1, Galina U. Ukina4, Alexander D. Vilesov3, Marina A. Chibisova5, Anna A. Zubareva2, Оleg V. Galibin3

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1 Department of Maxillofacial Surgery, Pavlov University, St. Petersburg, Russia
2 Department of Otorhinolaryngology, Pavlov University, St. Petersburg, Russia
3 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia
4 Research Center, Pavlov University, St. Petersburg, Russia
5 Saint Petersburg Stomatology Institute of Postgraduate Education, St. Petersburg, Russia

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Odontogenic maxillary sinusitis (OMS) takes one of the leading position among the paranasal sinus diseases. According to current reviews, the number of patients with OMS is increasing every year, and makes up from 4 to 7% of the maxillofacial diseases. Recently, a perforating form of OMS becomes more common in practice of maxillofacial surgery. Perforative sinusitis occurs due to break of mucoperiosteum in response to some pathological conditions, most frequently, following extraction of a superior tooth. Therefore, improvement of existing approaches and development of new affordable and less traumatic methods for treatment of sinusitis remains quite relevant. Over last years, usage of polymer materials (both natural and artificial products) has become increasingly popular in maxillofacial and dental surgery. Such materials should have several favorable properties: lack of cytotoxicity, biocompatibility, resorbability and good handling characteristics. The synthetic polymer polycaprolactone (PCL) meets these requirements to a greater extent. Due to its three-dimensional porous structure, these polymers are actively used in tissue engineering. Available data on the opportunity of bone tissue regeneration by the polymer structures suggest that they can be used to stimulate osteogenesis and maintain the height of the alveolar process of the upper jaw in cases of oroantral communication (OAC) occurring after tooth extraction. Of note, PCL is a safe material approved by the FDA for use in drug delivery devices and implantation scaffolds. Considering these data, it is of great interest to evaluate the opportunity of its application in the sites of inflammation, e.c., for elimination of OAC defect in presence of developing sinusitis. The aim of our study was to evaluate the opportunity of using a PCL matrix in order to close the OAC using an in vivo experimental model.

Materials and methods

In an experimental study, xenogeneic transplantation of polycaprolactone matrix was performed into the lower wall of maxillary sinus after the OAC development in rabbits. Nine animals were sacrificed after 4, 8 and 24 weeks. The maxillary bones were dissected, cut into smaller blocks, and the specimens were immediately placed in formalin. Serial sections were stained and examined using light microscope.

Results

The morphological study showed that there are early signs of connective tissue ingrowth to the matrix mesh 1 month after implantation. The surrounding capsule was thin and showed minimal signs of inflammation, which completely disappeared by the second month after the intervention. Over the next 4 months, the capsule becomes thinner, the matrix was totally penetrated by connective tissue and blood vessels. It helped to retain the height of alveolar process in the upper jaw at the site of tooth extraction. In conclusion, the proposed method for OAC closure by means of the PCL scaffold system can retain the space of the lost maxillary bone fragment for up to 6 months being able to stimulate osteogenesis, as shown by our animal experiments.

Keywords

Oroantral communication, maxillary sinus, polycaprolactone, polymer scaffolds, bone regeneration.

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Yaremenko<sup>1</sup>, Anna V. Lysenko<sup>1</sup>, Elizaveta A. Ivanova<sup>1</sup>, Galina U. Ukina<sup>4</sup>, Alexander D. Vilesov<sup>3</sup>, Marina A. Chibisova<sup>5</sup>, Anna A. Zubareva<sup>2</sup>, Оleg V. Galibin<sup>3</sup></p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(258) "

Аndrey I. Yaremenko1, Anna V. Lysenko1, Elizaveta A. Ivanova1, Galina U. Ukina4, Alexander D. Vilesov3, Marina A. Chibisova5, Anna A. Zubareva2, Оleg V. Galibin3

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Аndrey I. Yaremenko1, Anna V. Lysenko1, Elizaveta A. Ivanova1, Galina U. Ukina4, Alexander D. Vilesov3, Marina A. Chibisova5, Anna A. Zubareva2, Оleg V. Galibin3

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Odontogenic maxillary sinusitis (OMS) takes one of the leading position among the paranasal sinus diseases. According to current reviews, the number of patients with OMS is increasing every year, and makes up from 4 to 7% of the maxillofacial diseases. Recently, a perforating form of OMS becomes more common in practice of maxillofacial surgery. Perforative sinusitis occurs due to break of mucoperiosteum in response to some pathological conditions, most frequently, following extraction of a superior tooth. Therefore, improvement of existing approaches and development of new affordable and less traumatic methods for treatment of sinusitis remains quite relevant. Over last years, usage of polymer materials (both natural and artificial products) has become increasingly popular in maxillofacial and dental surgery. Such materials should have several favorable properties: lack of cytotoxicity, biocompatibility, resorbability and good handling characteristics. The synthetic polymer polycaprolactone (PCL) meets these requirements to a greater extent. Due to its three-dimensional porous structure, these polymers are actively used in tissue engineering. Available data on the opportunity of bone tissue regeneration by the polymer structures suggest that they can be used to stimulate osteogenesis and maintain the height of the alveolar process of the upper jaw in cases of oroantral communication (OAC) occurring after tooth extraction. Of note, PCL is a safe material approved by the FDA for use in drug delivery devices and implantation scaffolds. Considering these data, it is of great interest to evaluate the opportunity of its application in the sites of inflammation, e.c., for elimination of OAC defect in presence of developing sinusitis. The aim of our study was to evaluate the opportunity of using a PCL matrix in order to close the OAC using an in vivo experimental model.

Materials and methods

In an experimental study, xenogeneic transplantation of polycaprolactone matrix was performed into the lower wall of maxillary sinus after the OAC development in rabbits. Nine animals were sacrificed after 4, 8 and 24 weeks. The maxillary bones were dissected, cut into smaller blocks, and the specimens were immediately placed in formalin. Serial sections were stained and examined using light microscope.

Results

The morphological study showed that there are early signs of connective tissue ingrowth to the matrix mesh 1 month after implantation. The surrounding capsule was thin and showed minimal signs of inflammation, which completely disappeared by the second month after the intervention. Over the next 4 months, the capsule becomes thinner, the matrix was totally penetrated by connective tissue and blood vessels. It helped to retain the height of alveolar process in the upper jaw at the site of tooth extraction. In conclusion, the proposed method for OAC closure by means of the PCL scaffold system can retain the space of the lost maxillary bone fragment for up to 6 months being able to stimulate osteogenesis, as shown by our animal experiments.

Keywords

Oroantral communication, maxillary sinus, polycaprolactone, polymer scaffolds, bone regeneration.

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Odontogenic maxillary sinusitis (OMS) takes one of the leading position among the paranasal sinus diseases. According to current reviews, the number of patients with OMS is increasing every year, and makes up from 4 to 7% of the maxillofacial diseases. Recently, a perforating form of OMS becomes more common in practice of maxillofacial surgery. Perforative sinusitis occurs due to break of mucoperiosteum in response to some pathological conditions, most frequently, following extraction of a superior tooth. Therefore, improvement of existing approaches and development of new affordable and less traumatic methods for treatment of sinusitis remains quite relevant. Over last years, usage of polymer materials (both natural and artificial products) has become increasingly popular in maxillofacial and dental surgery. Such materials should have several favorable properties: lack of cytotoxicity, biocompatibility, resorbability and good handling characteristics. The synthetic polymer polycaprolactone (PCL) meets these requirements to a greater extent. Due to its three-dimensional porous structure, these polymers are actively used in tissue engineering. Available data on the opportunity of bone tissue regeneration by the polymer structures suggest that they can be used to stimulate osteogenesis and maintain the height of the alveolar process of the upper jaw in cases of oroantral communication (OAC) occurring after tooth extraction. Of note, PCL is a safe material approved by the FDA for use in drug delivery devices and implantation scaffolds. Considering these data, it is of great interest to evaluate the opportunity of its application in the sites of inflammation, e.c., for elimination of OAC defect in presence of developing sinusitis. The aim of our study was to evaluate the opportunity of using a PCL matrix in order to close the OAC using an in vivo experimental model.

Materials and methods

In an experimental study, xenogeneic transplantation of polycaprolactone matrix was performed into the lower wall of maxillary sinus after the OAC development in rabbits. Nine animals were sacrificed after 4, 8 and 24 weeks. The maxillary bones were dissected, cut into smaller blocks, and the specimens were immediately placed in formalin. Serial sections were stained and examined using light microscope.

Results

The morphological study showed that there are early signs of connective tissue ingrowth to the matrix mesh 1 month after implantation. The surrounding capsule was thin and showed minimal signs of inflammation, which completely disappeared by the second month after the intervention. Over the next 4 months, the capsule becomes thinner, the matrix was totally penetrated by connective tissue and blood vessels. It helped to retain the height of alveolar process in the upper jaw at the site of tooth extraction. In conclusion, the proposed method for OAC closure by means of the PCL scaffold system can retain the space of the lost maxillary bone fragment for up to 6 months being able to stimulate osteogenesis, as shown by our animal experiments.

Keywords

Oroantral communication, maxillary sinus, polycaprolactone, polymer scaffolds, bone regeneration.

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1 Department of Maxillofacial Surgery, Pavlov University, St. Petersburg, Russia
2 Department of Otorhinolaryngology, Pavlov University, St. Petersburg, Russia
3 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia
4 Research Center, Pavlov University, St. Petersburg, Russia
5 Saint Petersburg Stomatology Institute of Postgraduate Education, St. Petersburg, Russia

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1 Department of Maxillofacial Surgery, Pavlov University, St. Petersburg, Russia
2 Department of Otorhinolaryngology, Pavlov University, St. Petersburg, Russia
3 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia
4 Research Center, Pavlov University, St. Petersburg, Russia
5 Saint Petersburg Stomatology Institute of Postgraduate Education, St. Petersburg, Russia

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Андрей И. Яременко1, Анна В. Лысенко1, Елизавета А. Иванова1, Александр Д. Вилесов3, Галина Ю. Юкина4, Марина А. Чибисова5, Анна А. Зубарева2, Олег В. Галибин3

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Андрей И. Яременко1, Анна В. Лысенко1, Елизавета А. Иванова1, Александр Д. Вилесов3, Галина Ю. Юкина4, Марина А. Чибисова5, Анна А. Зубарева2, Олег В. Галибин3

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Ivanova" ["LINK_ELEMENT_VALUE"]=> bool(false) } ["SUMMARY_RU"]=> array(37) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25605" ["VALUE"]=> array(2) { ["TEXT"]=> string(6161) "<p style="text-align: justify;">Одонтогенный максиллярный синусит (ОМС) занимает одно из первых мест по заболеваемости среди болезней параназального синуса. По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели <i>in vivo</i>. В данном экспериментальном исследовании, проводилась ксеногенная трансплантация поликапролактонового матрикса в нижнюю стенку максиллярного синуса после развития ОАК у кроликов. Девять животных исследовали в сроки 4, 8 и 24 недели. Проводили рассечение костей верхней челюсти, резали на меньшие блоки и помещали образцы в формалин. Серийные гистологические препараты окрашивали и исследовали методами световой микроскопии. Морфологический анализ показал, наличие ранних признаков врастания соединительной ткани в сетку матрикса уже через 1 мес. после ее имплантации. Окружающая капсула была тонкой, с минимальными признаками воспаления, которое полностью исчезало к 2 мес. после вмешательства. В течение последующих 4 мес. капсула становилась тоньше, синтетический матрикс полностью прорастал соединительной тканью и кровеносными сосудами. Это помогало сохранить высоту альвеолярного отростка верхней челюсти в месте экстракции зуба.</p> <h3>Выводы</h3> <p style="text-align: justify;">Предложенный метод закрытия ороантральной коммуникации с применением системы ПКЛ-скаффолда может сохранить объем утраченного костного фрагмента на срок до 6 мес. и может стимулировать остеогенез, как показано нашими экспериментами на животных.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Ороантральная коммуникация, максиллярный синус, поликапролактон, полимерные матрицы, костная регенерация.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(6059) "

Одонтогенный максиллярный синусит (ОМС) занимает одно из первых мест по заболеваемости среди болезней параназального синуса. По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели in vivo. В данном экспериментальном исследовании, проводилась ксеногенная трансплантация поликапролактонового матрикса в нижнюю стенку максиллярного синуса после развития ОАК у кроликов. Девять животных исследовали в сроки 4, 8 и 24 недели. Проводили рассечение костей верхней челюсти, резали на меньшие блоки и помещали образцы в формалин. Серийные гистологические препараты окрашивали и исследовали методами световой микроскопии. Морфологический анализ показал, наличие ранних признаков врастания соединительной ткани в сетку матрикса уже через 1 мес. после ее имплантации. Окружающая капсула была тонкой, с минимальными признаками воспаления, которое полностью исчезало к 2 мес. после вмешательства. В течение последующих 4 мес. капсула становилась тоньше, синтетический матрикс полностью прорастал соединительной тканью и кровеносными сосудами. Это помогало сохранить высоту альвеолярного отростка верхней челюсти в месте экстракции зуба.

Выводы

Предложенный метод закрытия ороантральной коммуникации с применением системы ПКЛ-скаффолда может сохранить объем утраченного костного фрагмента на срок до 6 мес. и может стимулировать остеогенез, как показано нашими экспериментами на животных.

Ключевые слова

Ороантральная коммуникация, максиллярный синус, поликапролактон, полимерные матрицы, костная регенерация.

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Одонтогенный максиллярный синусит (ОМС) занимает одно из первых мест по заболеваемости среди болезней параназального синуса. По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели in vivo. В данном экспериментальном исследовании, проводилась ксеногенная трансплантация поликапролактонового матрикса в нижнюю стенку максиллярного синуса после развития ОАК у кроликов. Девять животных исследовали в сроки 4, 8 и 24 недели. Проводили рассечение костей верхней челюсти, резали на меньшие блоки и помещали образцы в формалин. Серийные гистологические препараты окрашивали и исследовали методами световой микроскопии. Морфологический анализ показал, наличие ранних признаков врастания соединительной ткани в сетку матрикса уже через 1 мес. после ее имплантации. Окружающая капсула была тонкой, с минимальными признаками воспаления, которое полностью исчезало к 2 мес. после вмешательства. В течение последующих 4 мес. капсула становилась тоньше, синтетический матрикс полностью прорастал соединительной тканью и кровеносными сосудами. Это помогало сохранить высоту альвеолярного отростка верхней челюсти в месте экстракции зуба.

Выводы

Предложенный метод закрытия ороантральной коммуникации с применением системы ПКЛ-скаффолда может сохранить объем утраченного костного фрагмента на срок до 6 мес. и может стимулировать остеогенез, как показано нашими экспериментами на животных.

Ключевые слова

Ороантральная коммуникация, максиллярный синус, поликапролактон, полимерные матрицы, костная регенерация.

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1 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Кафедра оториноларингологии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
4 Научно-исследовательский центр Первого Санкт-Петербургского государственного медицинского университета
им. акад. И. П. Павлова, Санкт-Петербург, Россия
5 Санкт-Петербургский стоматологический институт последипломного образования, Санкт-Петербург, Россия

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1 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Кафедра оториноларингологии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
4 Научно-исследовательский центр Первого Санкт-Петербургского государственного медицинского университета
им. акад. И. П. Павлова, Санкт-Петербург, Россия
5 Санкт-Петербургский стоматологический институт последипломного образования, Санкт-Петербург, Россия

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Генная и клеточная терапия» в Санкт-Петербурге.</p> <p style="text-align: justify;">Ежегодно наш форум собирает специалистов, в фокусе научных и практических интересов которых находятся вопросы трансплантации гемопоэтических стволовых клеток. Лекции ведущих экспертов, новейшие данные в области клинических исследований, дискуссии и обмен опытом помогают повысить уровень знаний и расширить профессиональный кругозор специалистов, принимающих участие в работе Симпозиума.</p> <p style="text-align: justify;">С информационной, образовательной целью предлагаем вашему вниманию второе издание брошюры «Показания к ТГСК-2019», в которой изложены основные показания к трансплантации гемопоэтических стволовых клеток в соответствии с современными рекомендациями европейского сообщества по трансплантации костного мозга (EBMT) 2019, опубликованными в официальном журнале EBMT Bone Marrow Transplantation 5 апреля 2019 года: Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2. </p> <p>Мы надеемся, что данное издание будет полезным и удобным в использовании.</p> <p>Профессор АФАНАСЬЕВ Борис Владимирович<br> Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. 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Бориса В. Афанасьева</p> <p>Ксения С. Афанасьева, Мария В. Барабанщикова, Сергей Н. Бондаренко, Татьяна А. Быкова, Юлия Ю. Власова, Асмик Г. Геворгян, Ирина К. Голубовская, Елена И. Дарская, Юрий Р. Залялов, Дарья А. Звягинцева, Людмила С. Зубаровская, Мария О. Иванова, Илья В. Казанцев, Ольга Б. Калашникова, Андрей В. Козлов, Елена В. Кондакова, Владислав О. Короленко, Ольга В. Кудяшева, Александр Д. Кулагин, Елена Е. Лепик, Кирилл В. Лепик, Инна В. Маркова, Ирина А. Михайлова, Наталья Б. Михайлова, Иван С. Моисеев, Елена В. Морозова, Анна А. Осипова, Олеся В. Паина, Ольга В. Пирогова, Алексей Ю. Полушин, Марина О. Попова, Валентина В. Порунова, Юрий А. Пунанов, Елена В. Семенова, Анна Г. Смирнова, Олеся В. Смыкова, Полина С. Толкунова, Людмила В. Федорова, Николай Ю. Цветков, Иван В. Цыганков, Татьяна В. Юхта</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1474) "

Под редакцией проф. Бориса В. Афанасьева

Ксения С. Афанасьева, Мария В. Барабанщикова, Сергей Н. Бондаренко, Татьяна А. Быкова, Юлия Ю. Власова, Асмик Г. Геворгян, Ирина К. Голубовская, Елена И. Дарская, Юрий Р. Залялов, Дарья А. Звягинцева, Людмила С. Зубаровская, Мария О. Иванова, Илья В. Казанцев, Ольга Б. Калашникова, Андрей В. Козлов, Елена В. Кондакова, Владислав О. Короленко, Ольга В. Кудяшева, Александр Д. Кулагин, Елена Е. Лепик, Кирилл В. Лепик, Инна В. Маркова, Ирина А. Михайлова, Наталья Б. Михайлова, Иван С. Моисеев, Елена В. Морозова, Анна А. Осипова, Олеся В. Паина, Ольга В. Пирогова, Алексей Ю. Полушин, Марина О. Попова, Валентина В. Порунова, Юрий А. Пунанов, Елена В. Семенова, Анна Г. Смирнова, Олеся В. Смыкова, Полина С. Толкунова, Людмила В. Федорова, Николай Ю. Цветков, Иван В. Цыганков, Татьяна В. Юхта

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Глубокоуважаемые коллеги!
Мы вновь рады приветствовать вас – участников XIII Международного симпозиума памяти Раисы Максимовны Горбачевой «Трансплантация стволовых гемопоэтических клеток. Генная и клеточная терапия» в Санкт-Петербурге.

Ежегодно наш форум собирает специалистов, в фокусе научных и практических интересов которых находятся вопросы трансплантации гемопоэтических стволовых клеток. Лекции ведущих экспертов, новейшие данные в области клинических исследований, дискуссии и обмен опытом помогают повысить уровень знаний и расширить профессиональный кругозор специалистов, принимающих участие в работе Симпозиума.

С информационной, образовательной целью предлагаем вашему вниманию второе издание брошюры «Показания к ТГСК-2019», в которой изложены основные показания к трансплантации гемопоэтических стволовых клеток в соответствии с современными рекомендациями европейского сообщества по трансплантации костного мозга (EBMT) 2019, опубликованными в официальном журнале EBMT Bone Marrow Transplantation 5 апреля 2019 года: Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

Мы надеемся, что данное издание будет полезным и удобным в использовании.

Профессор АФАНАСЬЕВ Борис Владимирович
Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова

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Editor: Prof. Dr. Boris V. Afanasyev

Ksenia S. Afanasyeva, Maria V. Barabanshchikova, Sergey N. Bondarenko, Tatyana A. Bykova, Julia Yu. Vlasova, Asmik G. Gevorgian, Irina K. Golubovskaya, Elena I. Darskaya, Yury R. Zalyalov, Darya A. Zvyagintseva, Ludmila S. Zubarovskaya, Maria O. Ivanova, Ilya V. Kazantsev, Olga B. Kalashnikova, Andrey V. Kozlov, Elena V. Kondakova, Vladislav O. Korolenko, Olga V. Kudyasheva, Alexander D. Kulagin, Elena E. Lepik, Kirill V. Lepik, Inna V. Markova, Irina A. Mikhailova, Natalya B. Mikhailova, Ivan S. Moiseev, Elena V. Morozova, Anna A. Osipova, Olesya V. Paina, Olga V. Pirogova, Alexey Yu. Polushin, Marina O. Popova, Valentina V. Porunova, Yury A. Punanov, Elena V. Semenova, Anna G. Smirnova, Olesya V. Smykova, Polina S. Tolkunova, Lyudmila V. Fedorova, Nikolay Yu. Tcvetkov, Ivan V. Tsygankov, Tatyana V. Yukhta

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Dear colleagues,
We are glad to welcome you again at the XIII R. Gorbacheva Memorial Symposium Hematopoietic Stem Cell Transplantation. Gene and Cellular Therapy in Saint Petersburg.

Our annual forum invites specialists who are focused on scientific and practical issues of hematopoietic stem cell transplantation (HSCT). The lectures presented by leading experts, quite recent data in the field of clinical studies, discussions and sharing experience in this area allow to extend knowledge and to increase professional level of the specialists participating at the Symposium.

Intending for better information in the field and pursuing educational aims, we are bringing to your notice the second edition of our booklet Indications for Hematopoietic Stem Cell Transplantation which contains the main indications for HSCT, brought into compliance with updated guidelines from European Society for Blood and Marrow Transplantation (EBMT) published in the official journal Bone Marrow Transplantation (published April 5, 2019): Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

We express a hope that this publication will be manageable and user-friendly to Russian-speaking readers.

Professor Boris V. AFANASYEV
Pavlov University, St. Petersburg, Russia

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Afanasyev</p> <p>Ksenia S. Afanasyeva, Maria V. Barabanshchikova, Sergey N. Bondarenko, Tatyana A. Bykova, Julia Yu. Vlasova, Asmik G. Gevorgian, Irina K. Golubovskaya, Elena I. Darskaya, Yury R. Zalyalov, Darya A. Zvyagintseva, Ludmila S. Zubarovskaya, Maria O. Ivanova, Ilya V. Kazantsev, Olga B. Kalashnikova, Andrey V. Kozlov, Elena V. Kondakova, Vladislav O. Korolenko, Olga V. Kudyasheva, Alexander D. Kulagin, Elena E. Lepik, Kirill V. Lepik, Inna V. Markova, Irina A. Mikhailova, Natalya B. Mikhailova, Ivan S. Moiseev, Elena V. Morozova, Anna A. Osipova, Olesya V. Paina, Olga V. Pirogova, Alexey Yu. Polushin, Marina O. Popova, Valentina V. Porunova, Yury A. Punanov, Elena V. Semenova, Anna G. Smirnova, Olesya V. Smykova, Polina S. Tolkunova, Lyudmila V. Fedorova, Nikolay Yu. Tcvetkov, Ivan V. Tsygankov, Tatyana V. 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Editor: Prof. Dr. Boris V. Afanasyev

Ksenia S. Afanasyeva, Maria V. Barabanshchikova, Sergey N. Bondarenko, Tatyana A. Bykova, Julia Yu. Vlasova, Asmik G. Gevorgian, Irina K. Golubovskaya, Elena I. Darskaya, Yury R. Zalyalov, Darya A. Zvyagintseva, Ludmila S. Zubarovskaya, Maria O. Ivanova, Ilya V. Kazantsev, Olga B. Kalashnikova, Andrey V. Kozlov, Elena V. Kondakova, Vladislav O. Korolenko, Olga V. Kudyasheva, Alexander D. Kulagin, Elena E. Lepik, Kirill V. Lepik, Inna V. Markova, Irina A. Mikhailova, Natalya B. Mikhailova, Ivan S. Moiseev, Elena V. Morozova, Anna A. Osipova, Olesya V. Paina, Olga V. Pirogova, Alexey Yu. Polushin, Marina O. Popova, Valentina V. Porunova, Yury A. Punanov, Elena V. Semenova, Anna G. Smirnova, Olesya V. Smykova, Polina S. Tolkunova, Lyudmila V. Fedorova, Nikolay Yu. Tcvetkov, Ivan V. Tsygankov, Tatyana V. Yukhta

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Editor: Prof. Dr. Boris V. Afanasyev

Ksenia S. Afanasyeva, Maria V. Barabanshchikova, Sergey N. Bondarenko, Tatyana A. Bykova, Julia Yu. Vlasova, Asmik G. Gevorgian, Irina K. Golubovskaya, Elena I. Darskaya, Yury R. Zalyalov, Darya A. Zvyagintseva, Ludmila S. Zubarovskaya, Maria O. Ivanova, Ilya V. Kazantsev, Olga B. Kalashnikova, Andrey V. Kozlov, Elena V. Kondakova, Vladislav O. Korolenko, Olga V. Kudyasheva, Alexander D. Kulagin, Elena E. Lepik, Kirill V. Lepik, Inna V. Markova, Irina A. Mikhailova, Natalya B. Mikhailova, Ivan S. Moiseev, Elena V. Morozova, Anna A. Osipova, Olesya V. Paina, Olga V. Pirogova, Alexey Yu. Polushin, Marina O. Popova, Valentina V. Porunova, Yury A. Punanov, Elena V. Semenova, Anna G. Smirnova, Olesya V. Smykova, Polina S. Tolkunova, Lyudmila V. Fedorova, Nikolay Yu. Tcvetkov, Ivan V. Tsygankov, Tatyana V. Yukhta

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Dear colleagues,
We are glad to welcome you again at the XIII R. Gorbacheva Memorial Symposium Hematopoietic Stem Cell Transplantation. Gene and Cellular Therapy in Saint Petersburg.

Our annual forum invites specialists who are focused on scientific and practical issues of hematopoietic stem cell transplantation (HSCT). The lectures presented by leading experts, quite recent data in the field of clinical studies, discussions and sharing experience in this area allow to extend knowledge and to increase professional level of the specialists participating at the Symposium.

Intending for better information in the field and pursuing educational aims, we are bringing to your notice the second edition of our booklet Indications for Hematopoietic Stem Cell Transplantation which contains the main indications for HSCT, brought into compliance with updated guidelines from European Society for Blood and Marrow Transplantation (EBMT) published in the official journal Bone Marrow Transplantation (published April 5, 2019): Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

We express a hope that this publication will be manageable and user-friendly to Russian-speaking readers.

Professor Boris V. AFANASYEV
Pavlov University, St. Petersburg, Russia

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(21) "Description / Summary" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(1931) "

Dear colleagues,
We are glad to welcome you again at the XIII R. Gorbacheva Memorial Symposium Hematopoietic Stem Cell Transplantation. Gene and Cellular Therapy in Saint Petersburg.

Our annual forum invites specialists who are focused on scientific and practical issues of hematopoietic stem cell transplantation (HSCT). The lectures presented by leading experts, quite recent data in the field of clinical studies, discussions and sharing experience in this area allow to extend knowledge and to increase professional level of the specialists participating at the Symposium.

Intending for better information in the field and pursuing educational aims, we are bringing to your notice the second edition of our booklet Indications for Hematopoietic Stem Cell Transplantation which contains the main indications for HSCT, brought into compliance with updated guidelines from European Society for Blood and Marrow Transplantation (EBMT) published in the official journal Bone Marrow Transplantation (published April 5, 2019): Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

We express a hope that this publication will be manageable and user-friendly to Russian-speaking readers.

Professor Boris V. AFANASYEV
Pavlov University, St. Petersburg, Russia

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Под редакцией проф. Бориса В. Афанасьева

Ксения С. Афанасьева, Мария В. Барабанщикова, Сергей Н. Бондаренко, Татьяна А. Быкова, Юлия Ю. Власова, Асмик Г. Геворгян, Ирина К. Голубовская, Елена И. Дарская, Юрий Р. Залялов, Дарья А. Звягинцева, Людмила С. Зубаровская, Мария О. Иванова, Илья В. Казанцев, Ольга Б. Калашникова, Андрей В. Козлов, Елена В. Кондакова, Владислав О. Короленко, Ольга В. Кудяшева, Александр Д. Кулагин, Елена Е. Лепик, Кирилл В. Лепик, Инна В. Маркова, Ирина А. Михайлова, Наталья Б. Михайлова, Иван С. Моисеев, Елена В. Морозова, Анна А. Осипова, Олеся В. Паина, Ольга В. Пирогова, Алексей Ю. Полушин, Марина О. Попова, Валентина В. Порунова, Юрий А. Пунанов, Елена В. Семенова, Анна Г. Смирнова, Олеся В. Смыкова, Полина С. Толкунова, Людмила В. Федорова, Николай Ю. Цветков, Иван В. Цыганков, Татьяна В. Юхта

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Под редакцией проф. Бориса В. Афанасьева

Ксения С. Афанасьева, Мария В. Барабанщикова, Сергей Н. Бондаренко, Татьяна А. Быкова, Юлия Ю. Власова, Асмик Г. Геворгян, Ирина К. Голубовская, Елена И. Дарская, Юрий Р. Залялов, Дарья А. Звягинцева, Людмила С. Зубаровская, Мария О. Иванова, Илья В. Казанцев, Ольга Б. Калашникова, Андрей В. Козлов, Елена В. Кондакова, Владислав О. Короленко, Ольга В. Кудяшева, Александр Д. Кулагин, Елена Е. Лепик, Кирилл В. Лепик, Инна В. Маркова, Ирина А. Михайлова, Наталья Б. Михайлова, Иван С. Моисеев, Елена В. Морозова, Анна А. Осипова, Олеся В. Паина, Ольга В. Пирогова, Алексей Ю. Полушин, Марина О. Попова, Валентина В. Порунова, Юрий А. Пунанов, Елена В. Семенова, Анна Г. Смирнова, Олеся В. Смыкова, Полина С. Толкунова, Людмила В. Федорова, Николай Ю. Цветков, Иван В. Цыганков, Татьяна В. Юхта

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Глубокоуважаемые коллеги!
Мы вновь рады приветствовать вас – участников XIII Международного симпозиума памяти Раисы Максимовны Горбачевой «Трансплантация стволовых гемопоэтических клеток. Генная и клеточная терапия» в Санкт-Петербурге.

Ежегодно наш форум собирает специалистов, в фокусе научных и практических интересов которых находятся вопросы трансплантации гемопоэтических стволовых клеток. Лекции ведущих экспертов, новейшие данные в области клинических исследований, дискуссии и обмен опытом помогают повысить уровень знаний и расширить профессиональный кругозор специалистов, принимающих участие в работе Симпозиума.

С информационной, образовательной целью предлагаем вашему вниманию второе издание брошюры «Показания к ТГСК-2019», в которой изложены основные показания к трансплантации гемопоэтических стволовых клеток в соответствии с современными рекомендациями европейского сообщества по трансплантации костного мозга (EBMT) 2019, опубликованными в официальном журнале EBMT Bone Marrow Transplantation 5 апреля 2019 года: Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

Мы надеемся, что данное издание будет полезным и удобным в использовании.

Профессор АФАНАСЬЕВ Борис Владимирович
Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова

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Глубокоуважаемые коллеги!
Мы вновь рады приветствовать вас – участников XIII Международного симпозиума памяти Раисы Максимовны Горбачевой «Трансплантация стволовых гемопоэтических клеток. Генная и клеточная терапия» в Санкт-Петербурге.

Ежегодно наш форум собирает специалистов, в фокусе научных и практических интересов которых находятся вопросы трансплантации гемопоэтических стволовых клеток. Лекции ведущих экспертов, новейшие данные в области клинических исследований, дискуссии и обмен опытом помогают повысить уровень знаний и расширить профессиональный кругозор специалистов, принимающих участие в работе Симпозиума.

С информационной, образовательной целью предлагаем вашему вниманию второе издание брошюры «Показания к ТГСК-2019», в которой изложены основные показания к трансплантации гемопоэтических стволовых клеток в соответствии с современными рекомендациями европейского сообщества по трансплантации костного мозга (EBMT) 2019, опубликованными в официальном журнале EBMT Bone Marrow Transplantation 5 апреля 2019 года: Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

Мы надеемся, что данное издание будет полезным и удобным в использовании.

Профессор АФАНАСЬЕВ Борис Владимирович
Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова

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Том 8, Номер 4
23.12.2019
Том 8, Номер 4
Главный редактор
Афанасьев Б. В. (Санкт-Петербург, Россия)
Со-редакторы
Вагемакер Г. (Роттердам, Нидерланды)
Цандер А. Р. (Гамбург, Германия)
Заместитель главного редактора
Фезе Б. (Гамбург, Германия)
Ответственный редактор
Чухловин А. Б. (Санкт-Петербург, Россия)
Редакционная коллегия
Алейникова О. В. (Минск, Республика Беларусь)
Борсет М. (Трондхейм, Норвегия)
Галибин О. В. (Санкт-Петербург, Россия)
Зубаровская Л. С. (Санкт-Петербург, Россия)
Климко Н. Н. (Санкт-Петербург, Россия)
Кольб Х. (Мюнхен, Германия)
Крегер Н. (Гамбург, Германия)
Кулагин А. Д. (Санкт-Петербург, Россия)
Ланге К. (Гамбург, Германия)
Мамаев Н. Н. (Санкт-Петербург, Россия)
Михайлова Н. Б. (Санкт-Петербург, Россия)
Моисеев И. С. (Санкт-Петербург, Россия)
Наглер А. (Тель-Авив, Израиль)
Немков А. С. (Санкт-Петербург, Россия)
Парамонов И. В. (Киров, Россия)
Румянцев А. Г. (Москва, Россия)
Савченко В. Г. (Москва, Россия)
Смирнов А. В. (Санкт-Петербург, Россия)
Усс А. Л. (Минск, Республика Беларусь)
Фиббе В. (Лейден, Нидерланды)
Хельтцер Д. (Франкфурт-на-Майне, Германия)
Чечеткин А. В. (Санкт-Петербург, Россия)
Обзор выпуска
Статья М. Хрусталева и соавт. касается данных по наукометрии для 5 основных российских центров, проводящих трансплантацию гемопоэтических стволовых клеток (ТГСК). Общепринятые параметры, в т.ч. определяли показатели цитирования и и коллективный индекс Хирша. Платформа SciVal рекомендована для лучшего сравнения с работой ведущих центров ТГСК в мире.

Компетентный мини-обзор проф. А. Цандера содержит новые данные о мезенхимных стволовых клетках (МСК), в плане их приложения в практической медицине, доказанной эффективности при различных заболеваниях и перспектив их широкого использования в дальнейшем.

Другая обзорная работа д-ра С. Кулемзина и соавт. касается потенциальных антигенных мишеней на клетках рака простаты для последующей CAR T-клеточной терапии. Авторы ранжировали их по специфичности для опухолей простаты и степени экспрессии.

Проф. А. Кольшюттер сообщил о своем опыте заместительной энзимотерапии при наследственной болезни CLN2 – смертельном заболевании, связанном с накоплением липидов. Клиническое течение заболевания может существенно корригироваться при введении нормального энзима в желудочки головного мозга.

Клинически значимая статья д-ра П. Кожокарь и соавт. касается эффективности повторных ТГСК после неудачного приживления первого трансплантата и при рецидивах опухоли. Авторы показали ряд позитивных эффектов такого подхода в плане общей и безрецидивной выживаемости.

Клиническая эффективность ингибиторов иммунных контрольных точек при лимфоме Ходжкина определена в педиатрической клинике д-ром А. Козловым и соавт. Они показали высокую частоту клинических ремиссий после терапии ниволумабом в рефрактерных/резистентных случаях.

Проблемы, связанные с нарушениями микробиоты, вызванными массивной антибиотикотерапией в период после ТГСК обсуждались д-ром A. Спиридоновой, в частности – деплецией комменсальных микробов в течение 1-го мес. после трансплантации и экспансией Klebsiella в более поздние сроки.

Летальный случай тяжелого геморрагического энтерита, ассоциированного с парвовирусом, у септического пациента после ТГСК представил О. Голощапов и соавт. Случай описан подробно, хотя парвовирус не прослежен от начала развития заболевания.

В разделе «Реабилитация» мы публикуем статью Ф. Терентьева и соавт., которые предлагают рациональную и индивидуализированную программу физических упражнений для детей после ТГСК. Эти тренировочные программы позволяют добиться лучшего качества жизни в этой группе больных детей.

Фундаментальный подход был использован проф. С. Чечельницкой и соавт. Они обнаружили ряд нарушений постуральной устойчивости у детей, леченных по поводу злокачественных неоплазий головного мозга. Эти функциональные изменения движений глаз оказались связанными с дисфункцией глазодвигательных мышц.

Профессор А. Яременко и соавт. описали экспериментальные результаты, показывающие высокую эффективность поликапролактоновых материалов, использованных для закрытия и ускоренного заживления максиллярных дефектов, возникающих при удалении зубов.

Благоприятные эффекты мезенхимных стволовых клеток (МСК) сообщаются д-ром Хадеми и соавт., которые показали значительное улучшение аносмии в эксперименте и восстановление обонятельных клеток после инъекции МСК из жировой ткани.

Статья-эссе д-ра К. Закурдаевой касается ближайших перспектив генного редактирования и терапии. Она отслеживает проблемы, связанные с разработкой и юридическими вопросами внедрения соответствующих коммерческих генно-инженерных продуктов.

Общие вопросы

Обзорные статьи

Метастатический рак простаты в эпоху CAR T-клеточной терапии: «Полцарства за мишень!»

Сергей В. Кулемзин1, Андрей А. Горчаков1,2, Александр В. Таранин1,2

Клинические работы

Применение ниволумаба у детей с лимфомой Ходжкина

Андрей В. Козлов, Илья В. Казанцев, Татьяна В. Юхта, Полина С. Толкунова, Дарья А. Звягинцева, Асмик Г. Геворгян, Антон В. Малородов, Кирилл В. Лепик, Юрий Р. Залялов, Александр Н. Швецов, Анна В. Ботина, Вадим В. Байков, Елена В. Морозова, Юрий А. Пунанов, Наталья Б. Михайлова, Людмила С. Зубаровская, Борис В. Афанасьев

Эффективность повторной аллогенной ТГСК у детей с острыми лейкозами при рецидиве после первой трансплантации

Полина В. Кожокарь1, Олеся В. Паина1, Анастасия С. Фролова1, Джемал З. Рахманова1, Анастасия C. Боровкова1, Елена В. Семенова1, Анна А. Осипова1, Кирилл А. Екушов1, Ольга А. Слесарчук1, Варвара Н. Овечкина1, Елена В. Бабенко1, Алина А. Витрищак1, Борис И. Смирнов2, Людмила С. Зубаровская1, Борис В. Афанасьев1

Высеваемость бактерий со слизистой ротовой полости после трансплантации гемопоэтических стволовых клеток: зависимость от характеристик пациента и терапевтических факторов

Алексей Б. Чухловин1, Анна А. Спиридонова2, Ирина Б. Баранова3, Артур П. Григорьянц3, Мария Д. Владовская1, Людмила С. Зубаровская1, Борис В. Афанасьев1

Клинический случай

Геморрагический энтерит, ассоциированный с парвовирусом В19 после трансплантации гемопоэтических стволовых клеток: клинический случай и данные литературы

Олег В. Голощапов1, Наталья Д. Венцловайте1, Руслана В. Клементьева1, Александр Н. Швецов1, Александр А. Щербаков1, Мария О. Голощапова1, Вадим Е. Карев2, Борис В. Афанасьев1

Реабилитация

Влияние двигательной активности на качество жизни подростков, перенесших трансплантацию гемопоэтических стволовых клеток

Алла А. Потапчук1, Алиса Г. Волкова1, Федор В. Терентьев2, Ирина Г. Терентьева2, Людмила С. Зубаровская1, Борис В. Афанасьев1

«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний

Серафима М. Чечельницкая, Владимир Н. Касаткин, Марина А. Шурупова, Ирина Д. Бородина, Юрий В. Сарайкин, Александр Ф. Карелин, Дмитрий В. Скворцов, Александра В. Баербах, Дарья В. Жук, Владислав А. Никулин

Экспериментальные исследования

Трансплантация жировых мезенхимальных стволовых клеток (жМСК) восстанавливает обонятельную функцию у крыс с аносмией

Биджан Хадеми1,2, Зохре Зандифар2, Ахмад Монабати3, Нушафарин Ченари4, Аббас Гадери4,5, Мабубе Размха4

Экспериментальное изучение полимерных матриц, способствующих репарации костной ткани при ороантральном дефекте

Андрей И. Яременко1, Анна В. Лысенко1, Елизавета А. Иванова1, Александр Д. Вилесов3, Галина Ю. Юкина4, Марина А. Чибисова5, Анна А. Зубарева2, Олег В. Галибин3

Приложение 1

Показания к трансплантации гемопоэтических стволовых клеток

Под редакцией проф. Бориса В. Афанасьева

Ксения С. Афанасьева, Мария В. Барабанщикова, Сергей Н. Бондаренко, Татьяна А. Быкова, Юлия Ю. Власова, Асмик Г. Геворгян, Ирина К. Голубовская, Елена И. Дарская, Юрий Р. Залялов, Дарья А. Звягинцева, Людмила С. Зубаровская, Мария О. Иванова, Илья В. Казанцев, Ольга Б. Калашникова, Андрей В. Козлов, Елена В. Кондакова, Владислав О. Короленко, Ольга В. Кудяшева, Александр Д. Кулагин, Елена Е. Лепик, Кирилл В. Лепик, Инна В. Маркова, Ирина А. Михайлова, Наталья Б. Михайлова, Иван С. Моисеев, Елена В. Морозова, Анна А. Осипова, Олеся В. Паина, Ольга В. Пирогова, Алексей Ю. Полушин, Марина О. Попова, Валентина В. Порунова, Юрий А. Пунанов, Елена В. Семенова, Анна Г. Смирнова, Олеся В. Смыкова, Полина С. Толкунова, Людмила В. Федорова, Николай Ю. Цветков, Иван В. Цыганков, Татьяна В. Юхта

Общие вопросы

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Максим Б. Хрусталев, Артем В. Тишков, Наталья Ю. Турбина, Анна А. Максимова

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Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Организации [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [SUMMARY_RU] => Array ( [ID] => 27 [TIMESTAMP_X] => 2015-09-02 18:01:20 [IBLOCK_ID] => 2 [NAME] => Описание/Резюме [ACTIVE] => Y [SORT] => 500 [CODE] => SUMMARY_RU [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 27 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 24365 [VALUE] => Array ( [TEXT] => <p style="text-align: justify;">Цель работы – дать наукометрическую характеристику основных российских организаций, проводящих исследования в области онкологии и гематологии, опираясь, прежде всего, на показатели качества и влияния результатов научных исследований, оценить их позиции в тематических научных кластерах по данным международных баз цитирования.</p> <h3>Материалы и методы</h3> <p style="text-align: justify;">Проведено сравнение наукометрических показателей (количество публикаций, цитируемость, индекс Хирша организации) пяти организаций, проводящих исследования в области онкологии и гематологии: четыре НМИЦ и НИИ детской онкологии, гематологии и трансплантологии им. Р. Горбачевой (НИИДОГиТ) в составе Первого Санкт-Петербургского государственного медицинского университета им. И. Павлова. Оценена также продуктивность научной работы НИИДОГиТ, количество публикаций в соответствующих научных тематических кластерах (ТК), средневзвешенное цитирование по данным SciVal и доля среди мировых публикаций. Перечень публикаций был ограничен ключевыми словами, определяющими область исследований этих организаций.</p> <h3>Результаты</h3> <p style="text-align: justify;">Анализ научных публикаций выявил, что показатели научной работы НИИДОГиТ, не входящего в сеть национальных медицинских исследовательских центров, находятся на лидирующих позициях, лишь немного уступая показателям центров онкологии имени Н. Н. Петрова и им. Н. Н. Блохина. Показатели научной работы НИИДОГиТ на основании данных SciVal находятся на уровне по сравнению с показателями мировых публикаций в выбранных ТК.</p> <h3>Выводы</h3> <p style="text-align: justify;">Результативность научных исследований, которая косвенно отражается в количестве высокоцитируемых публикаций в образовательном учреждении оказывается на уровне не ниже, а иногда и выше, чем в специализированных научных учреждениях. Изучение публикационной активности с помощью системы SciVal показало, что спонсирующие организации могут рассматривать НИИДОГиТ им. Р. М. Горбачевой, как перспективную площадку для проведения исследований в соответствующих областях наравне с существующими специализированными научными учреждениями.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Гематология, онкология, национальные медицинские исследовательские центры, медицинский университет, наукометрические показатели, анализ цитирования, библиометрия.</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

Цель работы – дать наукометрическую характеристику основных российских организаций, проводящих исследования в области онкологии и гематологии, опираясь, прежде всего, на показатели качества и влияния результатов научных исследований, оценить их позиции в тематических научных кластерах по данным международных баз цитирования.

Материалы и методы

Проведено сравнение наукометрических показателей (количество публикаций, цитируемость, индекс Хирша организации) пяти организаций, проводящих исследования в области онкологии и гематологии: четыре НМИЦ и НИИ детской онкологии, гематологии и трансплантологии им. Р. Горбачевой (НИИДОГиТ) в составе Первого Санкт-Петербургского государственного медицинского университета им. И. Павлова. Оценена также продуктивность научной работы НИИДОГиТ, количество публикаций в соответствующих научных тематических кластерах (ТК), средневзвешенное цитирование по данным SciVal и доля среди мировых публикаций. Перечень публикаций был ограничен ключевыми словами, определяющими область исследований этих организаций.

Результаты

Анализ научных публикаций выявил, что показатели научной работы НИИДОГиТ, не входящего в сеть национальных медицинских исследовательских центров, находятся на лидирующих позициях, лишь немного уступая показателям центров онкологии имени Н. Н. Петрова и им. Н. Н. Блохина. Показатели научной работы НИИДОГиТ на основании данных SciVal находятся на уровне по сравнению с показателями мировых публикаций в выбранных ТК.

Выводы

Результативность научных исследований, которая косвенно отражается в количестве высокоцитируемых публикаций в образовательном учреждении оказывается на уровне не ниже, а иногда и выше, чем в специализированных научных учреждениях. Изучение публикационной активности с помощью системы SciVal показало, что спонсирующие организации могут рассматривать НИИДОГиТ им. Р. М. Горбачевой, как перспективную площадку для проведения исследований в соответствующих областях наравне с существующими специализированными научными учреждениями.

Ключевые слова

Гематология, онкология, национальные медицинские исследовательские центры, медицинский университет, наукометрические показатели, анализ цитирования, библиометрия.

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Maksim B. Khrustalev, Artem V. Tishkov, Natalia Yu. Turbina, Anna A. Maksimova

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The aim of this survey was to perform scientometric evaluation of the major Russian institutions conducting research in the field of oncology and hematology, relying primarily on the common quality indicators and impact of the research results, to аssess their position in the scientific topic clusters (TC) according to international citation databases.

Materials and methods

A comparison was made between five organizations conducting research in the field of oncology and hematology, i.e., four National Medical Research Centers (NMRCs), and Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation (R. Gorbacheva Institute) which is a part of I. Pavlov St. Petersburg State Medical University, using the following scientometric indices: citation, collective Hirsch index, as well as the productivity of research determined as relative share of publications in the scientific TC, as well as Field-weighted Citation Impact, using the SciVal platform. The list of publications was limited to keywords defining the field of research of these organizations.

Results

Comparative evaluation of research publication activity in oncohematology has shown the leading position of R. Gorbacheva Institute, as a part of I. Pavlov St. Petersburg State Medical University, which was not included into the NMRCs network. Its rating was only slightly lower than the indices of N. Petrov National Medical Research Center of Oncology and N. Blokhin National Medical Research Center of Oncology. The overall indices of the citation impact based on SciVal analytic platform assessed for R. Gorbacheva Institute are at a level compared to the figures for world publications in the selected topic clusters.

Conclusion

Efficiency of clinical research at an educational institution, evaluated as the number of highly cited publications proved to be not lower, but sometimes even higher than in specialized research institutions working in the field. Appropriate publishing activity evaluated by the SciVal system showed that the funding authorities providing research financiation should recognize R. Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation at the Pavlov University as a perspective university-based platform for research in relevant areas, along with existing specialized scientific institutions.

Keywords

Hematology, oncology, national medical research centers, medical university, scientometric indexes, bibliometry, citation analysis.

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Оценка наукометрических показателей ряда российских организаций, выполняющих исследования в области онкологии и гематологии

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Максим Б. Хрусталев, Артем В. Тишков, Наталья Ю. Турбина, Анна А. Максимова

Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия

Цель работы – дать наукометрическую характеристику основных российских организаций, проводящих исследования в области онкологии и гематологии, опираясь, прежде всего, на показатели качества и влияния результатов научных исследований, оценить их позиции в тематических научных кластерах по данным международных баз цитирования.

Материалы и методы

Проведено сравнение наукометрических показателей (количество публикаций, цитируемость, индекс Хирша организации) пяти организаций, проводящих исследования в области онкологии и гематологии: четыре НМИЦ и НИИ детской онкологии, гематологии и трансплантологии им. Р. Горбачевой (НИИДОГиТ) в составе Первого Санкт-Петербургского государственного медицинского университета им. И. Павлова. Оценена также продуктивность научной работы НИИДОГиТ, количество публикаций в соответствующих научных тематических кластерах (ТК), средневзвешенное цитирование по данным SciVal и доля среди мировых публикаций. Перечень публикаций был ограничен ключевыми словами, определяющими область исследований этих организаций.

Результаты

Анализ научных публикаций выявил, что показатели научной работы НИИДОГиТ, не входящего в сеть национальных медицинских исследовательских центров, находятся на лидирующих позициях, лишь немного уступая показателям центров онкологии имени Н. Н. Петрова и им. Н. Н. Блохина. Показатели научной работы НИИДОГиТ на основании данных SciVal находятся на уровне по сравнению с показателями мировых публикаций в выбранных ТК.

Выводы

Результативность научных исследований, которая косвенно отражается в количестве высокоцитируемых публикаций в образовательном учреждении оказывается на уровне не ниже, а иногда и выше, чем в специализированных научных учреждениях. Изучение публикационной активности с помощью системы SciVal показало, что спонсирующие организации могут рассматривать НИИДОГиТ им. Р. М. Горбачевой, как перспективную площадку для проведения исследований в соответствующих областях наравне с существующими специализированными научными учреждениями.

Ключевые слова

Гематология, онкология, национальные медицинские исследовательские центры, медицинский университет, наукометрические показатели, анализ цитирования, библиометрия.

Обзорные статьи

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Аксель Р. Цандер

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Гамбургский университет, Гамбург, Германия

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Мезенхимные стромальные клетки (МСК) проявляют противовоспалительные, анти-апоптотические и иммуномодулирующие свойства. Поэтому их исследовали на предмет лечения аутоиммунных и хронических воспалительных заболеваний на протяжении последних двух десятилетий. МСК получили одобрение надзорных органов в нескольких странах на лечение ими острой реакции «трансплантат против хозяина» и болезни Крона. Обещающие результаты получены при их применении для лечения некоторых других болезней, таких, как системная красная волчанка, множественный склероз, амиотрофический боковой склероз и при травмах спинного мозга. При некритичном подходе прямая продажа частными предпринимателями неразрешенных стволовых клеток для лечения вносит беспорядок в область исследований МСК и угрожают внедрению МСК в арсенал медицинских методов. Необходимы еще несколько лет для полной оценки этого нового подхода к лечению по нескольким показаниям.

Ключевые слова

Мезенхимные стромальные клетки, иммунные эффекты, медицинское применение.

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Axel R. Zander

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University of Hamburg, Germany

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Mesenchymal stroma cells (MSCs) have anti-inflammatory, anti-apoptotic and immunomodulating properties, and they have, therefore, been explored in the treatment of autoimmune and chronic inflammatory diseases during the last two decades. MSCs have reached regulatory approval in several countries for the treatment of Acute Graft-versus-Host Disease and for Crohn’s disease. Results in several other diseases like Lupus, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and Spinal cord injury look promising.

Uncritical, direct to consumer sales of unapproved stem cell treatments by private entrepreneurs cloud the field of MSC research and jeopardize the establishment of MSC treatment in the armamentarium of Medicine. Several more years are necessary for a full evaluation of this new treatment modality in several indications.

Keywords

Mesenchymal stromal cells, immune effects, medical applications.

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Мезенхимные стромальные клетки в регенеративной медицине: обновленная версия

Загрузить версию в PDF

Аксель Р. Цандер

Гамбургский университет, Гамбург, Германия

Мезенхимные стромальные клетки (МСК) проявляют противовоспалительные, анти-апоптотические и иммуномодулирующие свойства. Поэтому их исследовали на предмет лечения аутоиммунных и хронических воспалительных заболеваний на протяжении последних двух десятилетий. МСК получили одобрение надзорных органов в нескольких странах на лечение ими острой реакции «трансплантат против хозяина» и болезни Крона. Обещающие результаты получены при их применении для лечения некоторых других болезней, таких, как системная красная волчанка, множественный склероз, амиотрофический боковой склероз и при травмах спинного мозга. При некритичном подходе прямая продажа частными предпринимателями неразрешенных стволовых клеток для лечения вносит беспорядок в область исследований МСК и угрожают внедрению МСК в арсенал медицинских методов. Необходимы еще несколько лет для полной оценки этого нового подхода к лечению по нескольким показаниям.

Ключевые слова

Мезенхимные стромальные клетки, иммунные эффекты, медицинское применение.

Обзорные статьи

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Сергей В. Кулемзин1, Андрей А. Горчаков1,2, Александр В. Таранин1,2

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1 Институт молекулярной и клеточной биологии СО РАН, Новосибирск, Россия
2 Новосибирский государственный университет, Новосибирск, Россия

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Несмотря на значительный прогресс в области таргетной, химио- и радиотерапии, количество вариантов для пациентов с метастатическим кастрационно-резистентным раком предстательной железы остается невысоким. Большие надежды возлагались на дендритно-клеточные вакцины, в частности на sipuleucel-T, однако не все пациенты отвечают на этот тип терапии. Учитывая впечатляющий успех CAR T-клеток для лечения онкогематологических заболеваний, многие исследовательские группы начали разработку подходов CAR T-клеточной терапии кастрационно-резистентного рака предстательной железы. Из-за этого особенно актуальным стал вопрос об уникальных белках-мишенях рака простаты для CAR Т-клеточной терапии. В идеале такие белки должны отсутствовать на поверхности нормальных клеток, экспрессироваться на всех раковых клетках у всех пациентов и быть незаменимыми для выживания раковой клетки. На практике, однако, ни один из описанных к настоящему моменту поверхностных белков-маркеров рака простаты не отвечает всем указанным требованиям. В настоящем обзоре рассмотрены основные белки-мишени для CAR T-клеточной терапии рака простаты, обсуждается их безопасность и потенциальная эффективность.

Ключевые слова

Метастатический рак предстательной железы, иммунотерапия, химерные антигенные рецепторы, CAR T-клетки.

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Sergey V. Kulemzin1, Andrey A. Gorchakov1,2, Aleksandr V. Taranin1,2

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1 Institute of Molecular and Cellular Biology, Siberian Branch of the Russian Academy of Sciences, Novosibirsk, Russia
2 Novosibirsk State University, Novosibirsk, Russia

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Despite the progress achieved in target, chemo-, and radiotherapy, treatment options for patients with late-stage metastatic castration-resistant prostate cancer are presently very limited. Use of dendritic cell-based vaccines exemplified by sipuleucel-T appears is rarely curative and is effective in only a fraction of such patients. Given the success of CAR T cell therapy in the field of B cell malignancies, significant efforts have been made to adapt this powerful technology to the problem of metastatic prostate cancer. Availability of unique prostate cancer surface targets for CAR T cells has thereby become a pressing issue in the field of CAR design. Ideally, such targets should be absent from normal cells or tissues, be present on all prostate cancer cells across all patients, and be indispensable for the survival of cancer cells. In reality, however, none of the prostate cancer-associated surface markers described to date are matching such description. Here, we catalogue the list of tested as well as prospective surface antigens to be used as targets for CAR T cell therapy, and discuss the aspects of their safety and potential efficacy.

Keywords

Metastatic prostate cancer, immunotherapy, chimeric antigen receptor, CAR T cells.

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Метастатический рак простаты в эпоху CAR T-клеточной терапии: «Полцарства за мишень!»

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Сергей В. Кулемзин1, Андрей А. Горчаков1,2, Александр В. Таранин1,2

1 Институт молекулярной и клеточной биологии СО РАН, Новосибирск, Россия
2 Новосибирский государственный университет, Новосибирск, Россия

Несмотря на значительный прогресс в области таргетной, химио- и радиотерапии, количество вариантов для пациентов с метастатическим кастрационно-резистентным раком предстательной железы остается невысоким. Большие надежды возлагались на дендритно-клеточные вакцины, в частности на sipuleucel-T, однако не все пациенты отвечают на этот тип терапии. Учитывая впечатляющий успех CAR T-клеток для лечения онкогематологических заболеваний, многие исследовательские группы начали разработку подходов CAR T-клеточной терапии кастрационно-резистентного рака предстательной железы. Из-за этого особенно актуальным стал вопрос об уникальных белках-мишенях рака простаты для CAR Т-клеточной терапии. В идеале такие белки должны отсутствовать на поверхности нормальных клеток, экспрессироваться на всех раковых клетках у всех пациентов и быть незаменимыми для выживания раковой клетки. На практике, однако, ни один из описанных к настоящему моменту поверхностных белков-маркеров рака простаты не отвечает всем указанным требованиям. В настоящем обзоре рассмотрены основные белки-мишени для CAR T-клеточной терапии рака простаты, обсуждается их безопасность и потенциальная эффективность.

Ключевые слова

Метастатический рак предстательной железы, иммунотерапия, химерные антигенные рецепторы, CAR T-клетки.

Клинические работы

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Андрей В. Козлов, Илья В. Казанцев, Татьяна В. Юхта, Полина С. Толкунова, Дарья А. Звягинцева, Асмик Г. Геворгян, Антон В. Малородов, Кирилл В. Лепик, Юрий Р. Залялов, Александр Н. Швецов, Анна В. Ботина, Вадим В. Байков, Елена В. Морозова, Юрий А. Пунанов, Наталья Б. Михайлова, Людмила С. Зубаровская, Борис В. Афанасьев

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НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

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Ингибиторы контрольных точек показали высокую эффективность в лечении классической лимфомы Ходжкина (кЛХ). Пембролизумаб одобрен для применения у детей. Назначение данного препарата приводит к высокой частоте ответа на терапию и является относительно безопасным. Роль ниволумаба у детей с кЛХ еще только предстоит определить. Целями представленной работы были оценка эффективности и оценка побочных эффектов у детей с рецидивирующим и рефрактерным течением кЛХ. Терапия на основе ниволумаба была проведена у 21-го предлеченного пациента (9-18 лет) с кЛХ. Общий ответ отмечался у 86 % (полный ответ – 57% и частичный ответ – 29%). Трехлетняя общая выживаемость и выживаемость без прогрессирования составили 95% и 29%, соответственно. Отмечалось только одно клинически значимое осложнение ниволумаба (аутоиммунный тиреоидит). Не было зарегистрировано тяжелых побочных явлений проводимой терапии.

Ключевые слова

Лимфома Ходжкина, рецидивирующая, рефрактерное течение, дети, ниволумаб.

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Andrey V. Kozlov, Ilya V. Kazantzev, Tatyana V. Iukhta, Polina S. Tolkunova, Darya A. Zvyagintseva, Asmik G. Gevorgian, Anton V. Malorodov, Kirill V. Lepik, Yury R. Zalyalov, Alexander N. Shvetsov, Anna V. Botina, Vadim V. Baykov, Elena V. Morozova, Yury A. Punanov, Natalya B. Mikhailova, Ludmila S. Zubarovskaya, Boris V. Afanasyev

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Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia

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Immune checkpoint inhibitors (ICIs) are rather efficient in classical Hodgkin's lymphoma (cHL). Pembrolizumab (pembro) is approved in children and demonstrates high response rates with acceptable toxicity. The role of nivolumab (nivo) in pediatric cHL is only to be elucidated. The aim of the presented study was to assess safety and efficiency of nivo in this age group with relapsed or refractory (R-R) cHL. Twenty-one pediatric heavily pre-treated patients 9-18 years old received nivo-based therapy. Overall response was registered in 86% (complete response – 57% and partial response – 29%). Three-year overall survival (OS) and progression free survival (PFS) were 95% and 29%, respectively. Only 1 clinically significant adverse effect (AE) of nivo was registered in the study (autoimmune thyroiditis). We did not observe any unacceptable toxicity of nivo.

Keywords

Children, Hodgkin's lymphoma, relapsed, refractory, nivolumab.

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Применение ниволумаба у детей с лимфомой Ходжкина

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Андрей В. Козлов, Илья В. Казанцев, Татьяна В. Юхта, Полина С. Толкунова, Дарья А. Звягинцева, Асмик Г. Геворгян, Антон В. Малородов, Кирилл В. Лепик, Юрий Р. Залялов, Александр Н. Швецов, Анна В. Ботина, Вадим В. Байков, Елена В. Морозова, Юрий А. Пунанов, Наталья Б. Михайлова, Людмила С. Зубаровская, Борис В. Афанасьев

НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

Ингибиторы контрольных точек показали высокую эффективность в лечении классической лимфомы Ходжкина (кЛХ). Пембролизумаб одобрен для применения у детей. Назначение данного препарата приводит к высокой частоте ответа на терапию и является относительно безопасным. Роль ниволумаба у детей с кЛХ еще только предстоит определить. Целями представленной работы были оценка эффективности и оценка побочных эффектов у детей с рецидивирующим и рефрактерным течением кЛХ. Терапия на основе ниволумаба была проведена у 21-го предлеченного пациента (9-18 лет) с кЛХ. Общий ответ отмечался у 86 % (полный ответ – 57% и частичный ответ – 29%). Трехлетняя общая выживаемость и выживаемость без прогрессирования составили 95% и 29%, соответственно. Отмечалось только одно клинически значимое осложнение ниволумаба (аутоиммунный тиреоидит). Не было зарегистрировано тяжелых побочных явлений проводимой терапии.

Ключевые слова

Лимфома Ходжкина, рецидивирующая, рефрактерное течение, дети, ниволумаб.

Клинические работы

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия
2 Санкт-Петербургский государственный электротехнический университет, Санкт-Петербург, Россия

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Аллогенная трансплантация гемопоэтических стволовых клеток (алло-ТГСК) является стандартом терапии в группе высокого риска онкогематологических заболеваний. Несмотря на это, уровень рецидивов варьирует от 10 до 70%. До сих пор отсутствует оптимальный подход к терапии рецидива после алло-ТГСК. Возможные терапевтические опции включают в себя реиндукцию, иммуноадоптивную терапию, таргетную терапию, иммунотерапию (CAR T-клеточную терапию), повторную трансплантацию. В данной публикации представлено ретроспективное исследование пациентов с рефрактерным течением онкогематологических заболеваний, а также отторжением трансплантата в группе высокого риска, в связи с чем выполнялась повторная алло-ТГСК. Целью нашей работы был анализ результатов повторной алло-ТГСК у 50 детей с различными онкогематологическими заболеваниями: ОЛЛ – 24, ОМЛ – 15, МДС и ХМПЗ – 11 пациентов. Общая выживаемость (ОВ) по методу Каплан-Майер во всей группе составила 48%, безрецидивная выживаемость (БРВ) – 60%. Медиана наблюдения составила 3 года 7 мес. Пятилетняя ОВ в группе ОЛЛ была 46,2%, в группе ОМЛ – 53,3%, в группе МДС и МПЗ – 44,4%. Причины летальности: рецидив/прогрессия в 17 случаях (65%).Трансплантационная летальность составила 18% (95% ДИ, 8,8%-29,8%). Кумулятивная частота рецидива составила 34% (95% ДИ, 21,6%-48%).

Заключение

Повторная алло-ТГСК – эффективный метод терапии у пациентов с рецидивом заболевания после первой ТГСК. Пациенты, достигшие ремиссии или циторедукции перед алло-ТГСК, имеют статистически достоверный лучший прогноз. Развитие хронической РТПХ легкой и средней степени статистически улучшает ОВ. Не получено достоверной разницы между РИК и МАК. Посттрансплантационная терапия может улучшить результаты повторной алло-ТГСК.

Ключевые слова

Рецидив острого лейкоза, повторная алло-ТГСК, посттрансплантационная терапия, дети.

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Polina V. Kozhokar1, Olesya V. Paina1, Anastasia S. Frolova1, Zhemal Z. Rakhmanova1, Anastasia S. Borovkova1, Elena V. Semenova1, Anna A. Osipova1, Kirill A. Ekushov1, Olga A. Slesarchuk1, Varvara N. Ovechkina1, Elena V. Babenko1, Alina A. Vitrishchak1, Boris I. Smirnov2, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia
2 Saint Petersburg State Electrotechnical University, St. Petersburg, Russia

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is effective treatment in high risk hematological malignancies. Nevertheless, the relapse rates after allo-HSCT range from 10% to 70%.There is no optimal strategy of the relapse therapy after allo-HSCT. Possible therapeutic options include re-induction chemotherapy, immunoadoptive therapy (DLI), target drugs, immunotherapy (CAR-T) and second allo-HSCT. The presented study is a retrospective single-institution experience of second allo-HSCT in the patients (pts) with acute leukemia relapses or graft failure in high-risk cases. The aim of our study was to analyze the outcomes after second allo-HSCT in 50 children with hematological malignancies, i.e., ALL (n=24), AML (n=15), MPDs/MDS (n=11).

Results

Forty-four patients achieved engraftment, with median neutrophil engraftment time of 21 days (12 to 41). Remission was achieved in 44 pts (88%). Median follow-up period was 3 years 7 months. Overall survival (OS), according to Kaplan-Meier method, was 48% in the whole group. Relapse-free survival (RFS) was 60%. The five-year OS in ALL group was 46.2%; in AML group, 53.3%; in MPDs/MDS, 44.4%. Causes of death were as follows: relapse/progression in 65% (n=17), transplant-related mortality (TRM), in 18% (n=9; 95%CI, 8.8%-29.8%); cumulative relapse rate was 34% (95% CI, 21.6%-48%).

Conclusion

Second allo-HSCT is an effective treatment option in cases of relapse after 1st allo-HSCT. The patients that achieved remission or even blast cytoreduction prior to 2nd allo-HSCT had better outcome. Clinical manifestations of acute and chronic GVHD can significantly improve the OS. Results of 2nd allo-HSCT were comparable when using RIC or MAC conditioning regimens. Posttransplant therapy is required to improve results after 2nd HSCT.

Keywords

Leukemia relapse, second allogeneic HSCT, posttransplant therapy, children.

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Эффективность повторной аллогенной ТГСК у детей с острыми лейкозами при рецидиве после первой трансплантации

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Полина В. Кожокарь1, Олеся В. Паина1, Анастасия С. Фролова1, Джемал З. Рахманова1, Анастасия C. Боровкова1, Елена В. Семенова1, Анна А. Осипова1, Кирилл А. Екушов1, Ольга А. Слесарчук1, Варвара Н. Овечкина1, Елена В. Бабенко1, Алина А. Витрищак1, Борис И. Смирнов2, Людмила С. Зубаровская1, Борис В. Афанасьев1

1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова, Санкт-Петербург, Россия
2 Санкт-Петербургский государственный электротехнический университет, Санкт-Петербург, Россия

Аллогенная трансплантация гемопоэтических стволовых клеток (алло-ТГСК) является стандартом терапии в группе высокого риска онкогематологических заболеваний. Несмотря на это, уровень рецидивов варьирует от 10 до 70%. До сих пор отсутствует оптимальный подход к терапии рецидива после алло-ТГСК. Возможные терапевтические опции включают в себя реиндукцию, иммуноадоптивную терапию, таргетную терапию, иммунотерапию (CAR T-клеточную терапию), повторную трансплантацию. В данной публикации представлено ретроспективное исследование пациентов с рефрактерным течением онкогематологических заболеваний, а также отторжением трансплантата в группе высокого риска, в связи с чем выполнялась повторная алло-ТГСК. Целью нашей работы был анализ результатов повторной алло-ТГСК у 50 детей с различными онкогематологическими заболеваниями: ОЛЛ – 24, ОМЛ – 15, МДС и ХМПЗ – 11 пациентов. Общая выживаемость (ОВ) по методу Каплан-Майер во всей группе составила 48%, безрецидивная выживаемость (БРВ) – 60%. Медиана наблюдения составила 3 года 7 мес. Пятилетняя ОВ в группе ОЛЛ была 46,2%, в группе ОМЛ – 53,3%, в группе МДС и МПЗ – 44,4%. Причины летальности: рецидив/прогрессия в 17 случаях (65%).Трансплантационная летальность составила 18% (95% ДИ, 8,8%-29,8%). Кумулятивная частота рецидива составила 34% (95% ДИ, 21,6%-48%).

Заключение

Повторная алло-ТГСК – эффективный метод терапии у пациентов с рецидивом заболевания после первой ТГСК. Пациенты, достигшие ремиссии или циторедукции перед алло-ТГСК, имеют статистически достоверный лучший прогноз. Развитие хронической РТПХ легкой и средней степени статистически улучшает ОВ. Не получено достоверной разницы между РИК и МАК. Посттрансплантационная терапия может улучшить результаты повторной алло-ТГСК.

Ключевые слова

Рецидив острого лейкоза, повторная алло-ТГСК, посттрансплантационная терапия, дети.

Клинические работы

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Альфред Кольшюттер

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Университетский медицинский центр Гамбург-Эппендорф, Гамбург, Германия

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Нейрональный цероидный липофусциноз (CLN2) является наследственным, быстро прогрессирующим заболеванием раннего возраста, ведущим к деменции, резкой утрате всех навыков и ранней гибели пациента. Оно вызывается дефицитом лизосомного фермента трипептидил-пептидазы 1 (ТРР1) в нервной системе. Настоящая статья является обзором разработок по замещению дефектного энзима посредством повторных инфузий рекомбинантного ТРР1 в желудочки головного мозга. Показана эффективность метода в плане сдерживания быстрой прогрессии заболевания.

Ключевые слова

Нейрональный цероидный липофусциноз 2, трипептидил-пептидаза 1, дефицит, деменция, рекомбинантный энзим, локальная инфузия, клинический эффект.

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Alfried Kohlschütter

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University Medical Center Hamburg-Eppendorf, Hamburg, Germany

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Neuronal сeroid-lipofuscinosis 2 (CLN2) is a genetic, rapidly progressive brain disorder of young humans. It leads to dementia, dramatic loss of all abilities and early death. It is caused by the deficiency of the lysosomal enzyme tripeptidyl peptidase 1 (TPP1) in the nervous system. This article is an overview of the development of replacing the deficient enzyme by repeated infusion of recombinant TPP1 in a brain ventricle, shown to be effective in halting the rapid progression of the disease.

Keywords

Neuronal сeroid-lipofuscinosis 2, tripeptidyl peptidase 1, deficiency, dementia, recombinant enzyme, local infusion, clinical effect.

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Интратекальная заместительная энзимотерапия нейронального цероидного липофусциноза

Загрузить версию в PDF

Альфред Кольшюттер

Университетский медицинский центр Гамбург-Эппендорф, Гамбург, Германия

Нейрональный цероидный липофусциноз (CLN2) является наследственным, быстро прогрессирующим заболеванием раннего возраста, ведущим к деменции, резкой утрате всех навыков и ранней гибели пациента. Оно вызывается дефицитом лизосомного фермента трипептидил-пептидазы 1 (ТРР1) в нервной системе. Настоящая статья является обзором разработок по замещению дефектного энзима посредством повторных инфузий рекомбинантного ТРР1 в желудочки головного мозга. Показана эффективность метода в плане сдерживания быстрой прогрессии заболевания.

Ключевые слова

Нейрональный цероидный липофусциноз 2, трипептидил-пептидаза 1, дефицит, деменция, рекомбинантный энзим, локальная инфузия, клинический эффект.

Клинические работы

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Алексей Б. Чухловин1, Анна А. Спиридонова2, Ирина Б. Баранова3, Артур П. Григорьянц3, Мария Д. Владовская1, Людмила С. Зубаровская1, Борис В. Афанасьев1

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
2 Отделение клинической микробиологии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Организации [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [SUMMARY_RU] => Array ( [ID] => 27 [TIMESTAMP_X] => 2015-09-02 18:01:20 [IBLOCK_ID] => 2 [NAME] => Описание/Резюме [ACTIVE] => Y [SORT] => 500 [CODE] => SUMMARY_RU [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 27 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25085 [VALUE] => Array ( [TEXT] => <p style="text-align: justify;">Нормальная аэробная и факультативно-анаэробная микробиота, колонизирующая слизистую оболочку рта, часто выявляется в клинических лабораториях. Ее состав может быть важным показателем иммунокомпромиссных состояний. Данные параметры мало изучены у пациентов после трансплантации гемопоэтических клеток (ТГСК). Целью настоящей работы была оценка выявляемости обычной аэробной и факультативно-анаэробной микробиоты, культивированной из биоматериала полости рта до ТГСК и, по клиническим показаниям, в течение 4 мес. после этого лечения.</p> <h3>Пациенты и методы</h3> <p style="text-align: justify;">Мы оценили результаты посевов образцов, взятых из ротовой полости у 202 больных с онкогематологическими и врожденными заболеваниями в возрасте от 1 до 69 лет, которым была проведена аллогенная ТГСК. Анализ проводился для 3 возрастных групп: 1-5, 6-14, 15-21 и >22 лет.</p> <h3>Результаты</h3> <p style="text-align: justify;">После 630 проведенных бактериологических исследований, позитивные результаты культивирования получены в 61.8% образцов. Наиболее частыми микроорганизмами были следующие: <i>S.viridans</i> 245/630 (38.9%); <i>K.pneumoniae</i> 42/630 (6.7%); <i>S.epidermidis</i> 120/630 (19.1%); <i>Neisseria spp.</i> 66/630 (10.5%); <i>Corynebacterium spp.</i> 78/630 (12.4%). Частота выявления микроорганизмов зависела от времени после ТГСК, а именно отмечено снижение высеваемости <i>S.epidermidis, Corynebacterium spp.</i> и <i>Klebsiella spp.</i> в течение 1-го месяца после ТГСК, что можно объяснить эффективной ранней антибактериальной деконтаминацией пациентов, начиная с момента кондиционирования. Нами показано, что частота высеваемости <i>S.viridans</i> и <i>K.pneumoniae</i> в этих образцах была различной для отдельных возрастных групп, будучи существенно повышенной у детей самого младшего возраста (до 5 лет) и у взрослых пациентов (>22 лет), по сравнению со старшими детьми и подростками. Высеваемость <i>K.pneumoniae</i> в образцах из полости рта оказалась существенно повышенной через 2-3 месяца после ТГСК, что сопровождалось тяжелыми инфекционными осложнениями и наличием резистентности клинических изолятов <i>Klebsiella</i> к большинству антибиотиков. По клиническим показаниям проведена экстракция зубов в 10 случаях в течение 1-го мес. после ТГСК. Посевы раневого отделяемого из десен показали наличие <i>Pseudomonas aeruginosa</i> в 3 образцах, <i>S.viridans</i> – в 2 случаях.</p> <h3>Выводы</h3> <p style="text-align: justify;">Иммунотоксические эффекты цитостатической терапии и анализ микробиоты после ТГСК заслуживают дальнейших исследований, в том числе – анализ биологического разнообразия микробиоты полости рта посредством секвенирования гена 16S rRNA. Эти результаты могут стать основой для рациональной антибактериальной терапии при ТГСК.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Онкогематология, дети, химиотерапия, трансплантация гемопоэтических стволовых клеток, бактериальные культуры, факторы риска.</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

Нормальная аэробная и факультативно-анаэробная микробиота, колонизирующая слизистую оболочку рта, часто выявляется в клинических лабораториях. Ее состав может быть важным показателем иммунокомпромиссных состояний. Данные параметры мало изучены у пациентов после трансплантации гемопоэтических клеток (ТГСК). Целью настоящей работы была оценка выявляемости обычной аэробной и факультативно-анаэробной микробиоты, культивированной из биоматериала полости рта до ТГСК и, по клиническим показаниям, в течение 4 мес. после этого лечения.

Пациенты и методы

Мы оценили результаты посевов образцов, взятых из ротовой полости у 202 больных с онкогематологическими и врожденными заболеваниями в возрасте от 1 до 69 лет, которым была проведена аллогенная ТГСК. Анализ проводился для 3 возрастных групп: 1-5, 6-14, 15-21 и >22 лет.

Результаты

После 630 проведенных бактериологических исследований, позитивные результаты культивирования получены в 61.8% образцов. Наиболее частыми микроорганизмами были следующие: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). Частота выявления микроорганизмов зависела от времени после ТГСК, а именно отмечено снижение высеваемости S.epidermidis, Corynebacterium spp. и Klebsiella spp. в течение 1-го месяца после ТГСК, что можно объяснить эффективной ранней антибактериальной деконтаминацией пациентов, начиная с момента кондиционирования. Нами показано, что частота высеваемости S.viridans и K.pneumoniae в этих образцах была различной для отдельных возрастных групп, будучи существенно повышенной у детей самого младшего возраста (до 5 лет) и у взрослых пациентов (>22 лет), по сравнению со старшими детьми и подростками. Высеваемость K.pneumoniae в образцах из полости рта оказалась существенно повышенной через 2-3 месяца после ТГСК, что сопровождалось тяжелыми инфекционными осложнениями и наличием резистентности клинических изолятов Klebsiella к большинству антибиотиков. По клиническим показаниям проведена экстракция зубов в 10 случаях в течение 1-го мес. после ТГСК. Посевы раневого отделяемого из десен показали наличие Pseudomonas aeruginosa в 3 образцах, S.viridans – в 2 случаях.

Выводы

Иммунотоксические эффекты цитостатической терапии и анализ микробиоты после ТГСК заслуживают дальнейших исследований, в том числе – анализ биологического разнообразия микробиоты полости рта посредством секвенирования гена 16S rRNA. Эти результаты могут стать основой для рациональной антибактериальной терапии при ТГСК.

Ключевые слова

Онкогематология, дети, химиотерапия, трансплантация гемопоэтических стволовых клеток, бактериальные культуры, факторы риска.

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Alexei B. Chukhlovin1, Anna A. Spiridonova2, Irina B. Baranova3, Artur P. Grigoriants3, Maria D. Vladovskaya1, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Author [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [ORGANIZATION_EN] => Array ( [ID] => 38 [TIMESTAMP_X] => 2015-09-02 18:02:59 [IBLOCK_ID] => 2 [NAME] => Organization [ACTIVE] => Y [SORT] => 500 [CODE] => ORGANIZATION_EN [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 38 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25097 [VALUE] => Array ( [TEXT] => <p><sup>1</sup> Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia<br> <sup>2</sup> Department of Clinical Microbiology, Pavlov University, St. Petersburg, Russia<br> <sup>3</sup> Department of Orofacial Surgery, Pavlov University, St. Petersburg, Russia</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia
2 Department of Clinical Microbiology, Pavlov University, St. Petersburg, Russia
3 Department of Orofacial Surgery, Pavlov University, St. Petersburg, Russia

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Organization [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [SUMMARY_EN] => Array ( [ID] => 39 [TIMESTAMP_X] => 2015-09-02 18:02:59 [IBLOCK_ID] => 2 [NAME] => Description / Summary [ACTIVE] => Y [SORT] => 500 [CODE] => SUMMARY_EN [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 39 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25098 [VALUE] => Array ( [TEXT] => <p style="text-align: justify;">Normal aerobic and facultative anaerobic microbiota colonizing oral mucosa is usually identified at clinical laboratories. Its composition may be important index of immunocompromised conditions. These parameters are scarcely studied in patients undergoing hematopoietic stem cell transplantation (HSCT). The aim of this work was to evaluate incidence of common aerobic and facultative anaerobic microbiota cultured from oral samples taken before HSCT and, by clinical indications, within 4 months after the treatment.</p> <h3>Patients and methods</h3> <p style="text-align: justify;">We evaluated results of bacterial cultures from oral smears taken in 202 patients with oncohematological and inborn diseases at the age ranging from 1 to 69 years subjected to allogeneic HSCT. The analysis was performed for 3 age groups: 1-5, 6-14, 15-21, and >22 years old. </p> <h3>Results</h3> <p style="text-align: justify;">In total observation group of 630 oral samples, the bacterial cultures proved to be positive in 61.8% of specimens. The most common microorganisms were as follows: <i>S.viridans</i> 245/630 (38.9%); <i>K.pneumoniae</i> 42/630 (6.7%); <i>S.epidermidis</i> 120/630 (19.1%); <i>Neisseria spp.</i> 66/630 (10.5%); <i>Corynebacterium spp.</i> 78/630 (12.4%). The incidence of microbial detection was time-dependent, with significant decrease in <i>S.epidermidis, Corynebacterium spp.</i> and <i>Klebsiella spp.</i> during 1st month posttransplant which could be explained by early effective antibacterial decontamination since the time of conditioning in early posttransplant period. We have shown that the frequency of positive tests for <i>S.viridans</i> and <i>K.pneumoniae</i> in these samples were different for distinct age groups, i.e., the positivity rates were significantly higher in youngest children (up to 5 years old) and in adult patients (>22 years old), as compared with elder children and adolesсents. Incidence of <i>K.pneumoniae</i> in oral samples was found to be sufficiently increased 2-3 months after HSCT, being associated with severe infectious complications, with broad antibiotic resistance in most culturable <i>Klebsiella</i> isolates from the patients. For clinical indications, teeth extraction was made in 10 cases during 1<sup>st</sup> month after HSCT, with <i>Pseudomonas aeruginosa</i> in 3 samples, <i>S.viridans</i> in 2 cases isolated from the local gum wounds. In conclusion, the immunotoxic effects of cytostatic therapy and microbiota analysis post-HSCT deserve further studies, including biodiversity analysis of oral microbiota by means of 16S rRNA gene sequencing. These results may represent a basis for rational antibacterial therapy in HSCT. </p> <h2>Keywords</h2> <p style="text-align: justify;">Oncohematology, children, chemotherapy, hematopoietic stem cell transplantation, bacterial cultures, risk factors. </p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

Normal aerobic and facultative anaerobic microbiota colonizing oral mucosa is usually identified at clinical laboratories. Its composition may be important index of immunocompromised conditions. These parameters are scarcely studied in patients undergoing hematopoietic stem cell transplantation (HSCT). The aim of this work was to evaluate incidence of common aerobic and facultative anaerobic microbiota cultured from oral samples taken before HSCT and, by clinical indications, within 4 months after the treatment.

Patients and methods

We evaluated results of bacterial cultures from oral smears taken in 202 patients with oncohematological and inborn diseases at the age ranging from 1 to 69 years subjected to allogeneic HSCT. The analysis was performed for 3 age groups: 1-5, 6-14, 15-21, and >22 years old.

Results

In total observation group of 630 oral samples, the bacterial cultures proved to be positive in 61.8% of specimens. The most common microorganisms were as follows: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). The incidence of microbial detection was time-dependent, with significant decrease in S.epidermidis, Corynebacterium spp. and Klebsiella spp. during 1st month posttransplant which could be explained by early effective antibacterial decontamination since the time of conditioning in early posttransplant period. We have shown that the frequency of positive tests for S.viridans and K.pneumoniae in these samples were different for distinct age groups, i.e., the positivity rates were significantly higher in youngest children (up to 5 years old) and in adult patients (>22 years old), as compared with elder children and adolesсents. Incidence of K.pneumoniae in oral samples was found to be sufficiently increased 2-3 months after HSCT, being associated with severe infectious complications, with broad antibiotic resistance in most culturable Klebsiella isolates from the patients. For clinical indications, teeth extraction was made in 10 cases during 1st month after HSCT, with Pseudomonas aeruginosa in 3 samples, S.viridans in 2 cases isolated from the local gum wounds. In conclusion, the immunotoxic effects of cytostatic therapy and microbiota analysis post-HSCT deserve further studies, including biodiversity analysis of oral microbiota by means of 16S rRNA gene sequencing. These results may represent a basis for rational antibacterial therapy in HSCT.

Keywords

Oncohematology, children, chemotherapy, hematopoietic stem cell transplantation, bacterial cultures, risk factors.

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Высеваемость бактерий со слизистой ротовой полости после трансплантации гемопоэтических стволовых клеток: зависимость от характеристик пациента и терапевтических факторов

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Алексей Б. Чухловин1, Анна А. Спиридонова2, Ирина Б. Баранова3, Артур П. Григорьянц3, Мария Д. Владовская1, Людмила С. Зубаровская1, Борис В. Афанасьев1

1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
2 Отделение клинической микробиологии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия

Нормальная аэробная и факультативно-анаэробная микробиота, колонизирующая слизистую оболочку рта, часто выявляется в клинических лабораториях. Ее состав может быть важным показателем иммунокомпромиссных состояний. Данные параметры мало изучены у пациентов после трансплантации гемопоэтических клеток (ТГСК). Целью настоящей работы была оценка выявляемости обычной аэробной и факультативно-анаэробной микробиоты, культивированной из биоматериала полости рта до ТГСК и, по клиническим показаниям, в течение 4 мес. после этого лечения.

Пациенты и методы

Мы оценили результаты посевов образцов, взятых из ротовой полости у 202 больных с онкогематологическими и врожденными заболеваниями в возрасте от 1 до 69 лет, которым была проведена аллогенная ТГСК. Анализ проводился для 3 возрастных групп: 1-5, 6-14, 15-21 и >22 лет.

Результаты

После 630 проведенных бактериологических исследований, позитивные результаты культивирования получены в 61.8% образцов. Наиболее частыми микроорганизмами были следующие: S.viridans 245/630 (38.9%); K.pneumoniae 42/630 (6.7%); S.epidermidis 120/630 (19.1%); Neisseria spp. 66/630 (10.5%); Corynebacterium spp. 78/630 (12.4%). Частота выявления микроорганизмов зависела от времени после ТГСК, а именно отмечено снижение высеваемости S.epidermidis, Corynebacterium spp. и Klebsiella spp. в течение 1-го месяца после ТГСК, что можно объяснить эффективной ранней антибактериальной деконтаминацией пациентов, начиная с момента кондиционирования. Нами показано, что частота высеваемости S.viridans и K.pneumoniae в этих образцах была различной для отдельных возрастных групп, будучи существенно повышенной у детей самого младшего возраста (до 5 лет) и у взрослых пациентов (>22 лет), по сравнению со старшими детьми и подростками. Высеваемость K.pneumoniae в образцах из полости рта оказалась существенно повышенной через 2-3 месяца после ТГСК, что сопровождалось тяжелыми инфекционными осложнениями и наличием резистентности клинических изолятов Klebsiella к большинству антибиотиков. По клиническим показаниям проведена экстракция зубов в 10 случаях в течение 1-го мес. после ТГСК. Посевы раневого отделяемого из десен показали наличие Pseudomonas aeruginosa в 3 образцах, S.viridans – в 2 случаях.

Выводы

Иммунотоксические эффекты цитостатической терапии и анализ микробиоты после ТГСК заслуживают дальнейших исследований, в том числе – анализ биологического разнообразия микробиоты полости рта посредством секвенирования гена 16S rRNA. Эти результаты могут стать основой для рациональной антибактериальной терапии при ТГСК.

Ключевые слова

Онкогематология, дети, химиотерапия, трансплантация гемопоэтических стволовых клеток, бактериальные культуры, факторы риска.

Клинический случай

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Федеральный детский научно-клинический центр инфекционных болезней, Санкт-Петербург, Россия

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Инфекция парвовирусом (ПВ) B19 весьма распространена в мире и проявляется рядом клинических симптомов. Целью нашего сообщения было описание редкого случая геморрагического энтерита, ассоциированного с ПВ В19 у пациента после аллогенной трансплантации гемопоэтических стволовых клеток (алло-ТГСК). Нами представлен клинический случай парвовирусной инфекции, протекавшей на фоне острого геморрагического энтерита у 52-летнего больного после ТГСК. Посредством иммуногистохимического тестирования выявлена экспрессия антигена ПВ В19- при аутопсии, а также с помощью ПЦР была обнаружена ДНК ПВ В19 в тканях желудка, тонкой кишки и образцах миокарда.

Ключевые слова

Парвовирус B19, аллогенная трансплантация гемопоэтических клеток, клиническая инфекция, геморрагический энтерит, миокардит, кишечное кровотечение.

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Oleg V. Goloshchapov1, Natalia D. Ventslovayte1, Ruslana V. Klementeva1, Alexander N. Shvetsov1, Aleksandr A. Shcherbakov1, Maria O. Goloshchapova1, Vadim E. Karev2, Boris V. Afanasyev1

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, St. Petersburg, Russia
2 Federal Pediatric Research Center of Infectious Diseases, St. Petersburg, Russia

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Parvovirus (PV) B19 infection is rather spread worldwide and manifests with a range of clinical symptoms. The aim of our report was to demonstrate a rare case of haemorrhagic enteritis associated with parvovirus B19 in the patient after allogeneic hematopoietic stem cell transplantation (allo-HSCT).We present here a clinical case of PV infection which proceeded as acute haemorrhagic enteritis in 52-year male patient who underwent HSCT. Distinct expression of antigens specific for PV B19 was revealed on autopsy by means of immunohistochemical testing, along with PVB19 DNA found in stomach, small intestine tissues and myocardial samples by means of PCR technique.

Keywords

Parvovirus B19, allogeneic hematopoietic stem cell transplantation, clinical infection, haemorrhagic enteritis, myocarditis, intestinal bleeding.

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Геморрагический энтерит, ассоциированный с парвовирусом В19 после трансплантации гемопоэтических стволовых клеток: клинический случай и данные литературы

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Олег В. Голощапов1, Наталья Д. Венцловайте1, Руслана В. Клементьева1, Александр Н. Швецов1, Александр А. Щербаков1, Мария О. Голощапова1, Вадим Е. Карев2, Борис В. Афанасьев1

1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Федеральный детский научно-клинический центр инфекционных болезней, Санкт-Петербург, Россия

Инфекция парвовирусом (ПВ) B19 весьма распространена в мире и проявляется рядом клинических симптомов. Целью нашего сообщения было описание редкого случая геморрагического энтерита, ассоциированного с ПВ В19 у пациента после аллогенной трансплантации гемопоэтических стволовых клеток (алло-ТГСК). Нами представлен клинический случай парвовирусной инфекции, протекавшей на фоне острого геморрагического энтерита у 52-летнего больного после ТГСК. Посредством иммуногистохимического тестирования выявлена экспрессия антигена ПВ В19- при аутопсии, а также с помощью ПЦР была обнаружена ДНК ПВ В19 в тканях желудка, тонкой кишки и образцах миокарда.

Ключевые слова

Парвовирус B19, аллогенная трансплантация гемопоэтических клеток, клиническая инфекция, геморрагический энтерит, миокардит, кишечное кровотечение.

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Алла А. Потапчук1, Алиса Г. Волкова1, Федор В. Терентьев2, Ирина Г. Терентьева2, Людмила С. Зубаровская1, Борис В. Афанасьев1

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1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Национальный государственный университет физической культуры, спорта и здоровья им. П. Ф. Лесгафта, Санкт-Петербург, Россия

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Данная статья посвящена анализу влияния физической реабилитации на показатели качества жизни подростков 12-17 лет с онкопатологией после трансплантации гемопоэтических стволовых клеток (ТГСК). Авторская методика физической реабилитации включает три этапа, включающие девять комплексов физических упражнений в зависимости от возраста и режима двигательной активности. Проводилась оценка качества жизни, оценивался уровень тревожно-депрессивных состояний подростков на трех этапах исследования: до проведения трансплантации, после трансплантации, после реабилитации. Полученные данные свидетельствуют о положительном влиянии физической реабилитации на качество жизни подростков с онкопатологией, перенесших трансплантацию гемопоэтических стволовых клеток.

Ключевые слова

Физическая реабилитация, онкология, дети, трансплантация гемопоэтических стволовых клеток, депрессия, тревога, эмоциональное состояние.

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Alla A. Potapchuk1, Alisa G. Volkova1, Fedor V. Terentiev2, Irina G. Terentieva2, Ludmila S. Zubarovskaya1, Boris V. Afanasyev1

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1 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University,
St. Petersburg, Russia
2 National State P. F. Lesgaft University of Physical Culture, Sports and Health, St. Petersburg, Russia

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The present article is evaluating the effects of physical rehabilitation upon the quality of life (QoL) indexes in adolescents (12 to 17 y.o.) with oncological diseases following hematopoietic stem cell transplantation (HSCT). The proprietary technique of physical rehabilitation includes 3 stages with nine complexes of physical exercises, dependent on their age and regimen of motor activities. We have evaluated QoL, and anxiety/depressive conditions in adolescents at three stages of the study: HSCT, after it, and following rehabilitation. The data obtained confirm a positive effect of the physical rehabilitation upon QoL in the adolescents with cancer subjected to hematopoietic stem cell transplantation.

Keywords

Physical rehabilitation, oncology, children, hematopoietic stem cell transplantation, depression, anxiety, emotional state.

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Влияние двигательной активности на качество жизни подростков, перенесших трансплантацию гемопоэтических стволовых клеток

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Алла А. Потапчук1, Алиса Г. Волкова1, Федор В. Терентьев2, Ирина Г. Терентьева2, Людмила С. Зубаровская1, Борис В. Афанасьев1

1 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Национальный государственный университет физической культуры, спорта и здоровья им. П. Ф. Лесгафта, Санкт-Петербург, Россия

Данная статья посвящена анализу влияния физической реабилитации на показатели качества жизни подростков 12-17 лет с онкопатологией после трансплантации гемопоэтических стволовых клеток (ТГСК). Авторская методика физической реабилитации включает три этапа, включающие девять комплексов физических упражнений в зависимости от возраста и режима двигательной активности. Проводилась оценка качества жизни, оценивался уровень тревожно-депрессивных состояний подростков на трех этапах исследования: до проведения трансплантации, после трансплантации, после реабилитации. Полученные данные свидетельствуют о положительном влиянии физической реабилитации на качество жизни подростков с онкопатологией, перенесших трансплантацию гемопоэтических стволовых клеток.

Ключевые слова

Физическая реабилитация, онкология, дети, трансплантация гемопоэтических стволовых клеток, депрессия, тревога, эмоциональное состояние.

Реабилитация

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	Серафима М. Чечельницкая, Владимир Н. Касаткин, Марина А. Шурупова, Ирина Д. Бородина, Юрий В. Сарайкин, Александр Ф. Карелин, Дмитрий В. Скворцов, Александра В. Баербах, Дарья В. Жук, Владислав А. Никулин
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Серафима М. Чечельницкая, Владимир Н. Касаткин, Марина А. Шурупова, Ирина Д. Бородина, Юрий В. Сарайкин, Александр Ф. Карелин, Дмитрий В. Скворцов, Александра В. Баербах, Дарья В. Жук, Владислав А. Никулин

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Лечебно-реабилитационный научный центр «Русское поле», Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева, Москва, Россия

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Организации [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [SUMMARY_RU] => Array ( [ID] => 27 [TIMESTAMP_X] => 2015-09-02 18:01:20 [IBLOCK_ID] => 2 [NAME] => Описание/Резюме [ACTIVE] => Y [SORT] => 500 [CODE] => SUMMARY_RU [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 27 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25405 [VALUE] => Array ( [TEXT] => <p style="text-align: justify;"> Нарушения постуральной устойчивости широко распространено среди пациентов, лечившихся от онкологических заболеваний. Вопрос о механизмах этого явления находится на стадии изучения. Целью проведенного нами ретроспективного исследования было уточнение связи постуральной нестабильности онкологических пациентов с дисфункцией глазодвигательных мышц. В исследовании приняли участие 291 ребенок 5-18 лет, перенесших онкологическое заболевание и находящихся в стадии ремиссии или стабилизации. В контрольную группу вошли 182 здоровых ребенка. </p> <p style="text-align: justify;"> Качество постурального баланса оценивалось методом стабилометрии на компьютерном стабилоанализаторе «Стабилан 01-2». Регистрация движений глаз производилась методом видеокулографии с помощью айтрекера Arrington. Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation). </p> <p style="text-align: justify;"> Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц. </p> <h2>Ключевые слова</h2> <p style="text-align: justify;"> Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы. </p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

Нарушения постуральной устойчивости широко распространено среди пациентов, лечившихся от онкологических заболеваний. Вопрос о механизмах этого явления находится на стадии изучения. Целью проведенного нами ретроспективного исследования было уточнение связи постуральной нестабильности онкологических пациентов с дисфункцией глазодвигательных мышц. В исследовании приняли участие 291 ребенок 5-18 лет, перенесших онкологическое заболевание и находящихся в стадии ремиссии или стабилизации. В контрольную группу вошли 182 здоровых ребенка.

Качество постурального баланса оценивалось методом стабилометрии на компьютерном стабилоанализаторе «Стабилан 01-2». Регистрация движений глаз производилась методом видеокулографии с помощью айтрекера Arrington. Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation).

Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц.

Ключевые слова

Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы.

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Serafima M. Chechelnitskaia, Vladimir N. Kasatkin, Marina A. Shurupova, Irina D. Borodina, Yurij V. Sarajkin, Aleksandr F. Karelin, Dmitrij V. Skvorcov, Aleksandra V. Baerbakh, Daria V. Zhuk, Vladislav A. Nikulin

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Medical Rehabilitation Research Center "Russkoe Pole", Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia

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Disorders of postural resistance are widespread among the patients treated for cancer. The question of the mechanism of this phenomenon is under the study. The aim of our retrospective study was to clarify the relationship of postural instability in cancer patients with oculomotor muscle dysfunction.

Patients and methods

The study involved 291 children 5-18 years old who had cancer and were in remission state or stable clinical condition. The control group included 182 healthy children. The quality of postural balance was evaluated by stabilometric method using a computer-assisted stabilizer (Stabilan 01-2 model). The eye movements were recorded by videoculography using the Arrington eye-tracker. Regression analysis was used to assess relationships of the analyzed parameters. For explicit asymmetric distributions, we used conversion of initial values to logarithmic form and the Box-Cox transformation.

Results

The main stabilometric indicators in the position with open eyes confirmed impaired postural balance in the children who survived cancer. We have substantiated a high probability of correlation between the postural imbalance and disease factor. Improvement in stabilometric indexes with eyes closed was detected for both groups. However, this phenomenon proved to be significant and was more common among the children who survived cancer.

Conclusion

A stable relationship was found between the postural instability and altered functioning of oculomotor muscles.

Keywords

Childhood cancer, postural control, anticancer therapy, toxic effects, oculomotor muscles.

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«Сенсорный конфликт» как возможная причина нарушения постуральной устойчивости детей, лечившихся от онкологических заболеваний

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Серафима М. Чечельницкая, Владимир Н. Касаткин, Марина А. Шурупова, Ирина Д. Бородина, Юрий В. Сарайкин, Александр Ф. Карелин, Дмитрий В. Скворцов, Александра В. Баербах, Дарья В. Жук, Владислав А. Никулин

Лечебно-реабилитационный научный центр «Русское поле», Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева, Москва, Россия

Нарушения постуральной устойчивости широко распространено среди пациентов, лечившихся от онкологических заболеваний. Вопрос о механизмах этого явления находится на стадии изучения. Целью проведенного нами ретроспективного исследования было уточнение связи постуральной нестабильности онкологических пациентов с дисфункцией глазодвигательных мышц. В исследовании приняли участие 291 ребенок 5-18 лет, перенесших онкологическое заболевание и находящихся в стадии ремиссии или стабилизации. В контрольную группу вошли 182 здоровых ребенка.

Качество постурального баланса оценивалось методом стабилометрии на компьютерном стабилоанализаторе «Стабилан 01-2». Регистрация движений глаз производилась методом видеокулографии с помощью айтрекера Arrington. Для моделирования взаимосвязи анализируемых показателей использовался регрессионный анализ, для явно выраженных асимметричных распределений применялось преобразование исходных значений в виде логарифмирования и степенного преобразование Бокса-Кокса (Box-Cox transformation).

Основные показатели стабилометрии в позе с открытыми глазами подтвердили нарушения постурального баланса у детей, переживших рак. Математически была обоснована высокая вероятность связи дисбаланса с фактором заболевания. Улучшение показателей стабилометрии при закрывании глаз выявлено в обеих группах, но среди детей, переживших рак, этот феномен выявлялся достоверно и значимо чаще. Обнаружена устойчивая связь между постуральной нестабильностью и нарушением работы глазодвигательных мышц.

Ключевые слова

Рак у детей, постуральный контроль, противоопухолевая терапия, токсические эффекты, глазодвигательные мышцы.

Экспериментальные исследования

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Кристина А. Закурдаева

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Фонд поддержки научных исследований в онкологии (РакФонд), Москва, Россия

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За последние пять лет область редактирования генома кардинально изменилась и трансформировалась из научных идей и лабораторных исследований в многочисленные клинические применения, меняющие жизнь пациентов, новые коммерческие возможности с существенными инвестициями в области и заметными сделками и социальные дилеммы, поднимающие множество вопросов перед медицинским сообществом и широкой общественностью. Сегодня многие из самых передовых исследований и разработок, инвестиций, регуляторных инициатив и этических дискуссий происходят именно в этой области. Итак, могут ли рынок и общество идти в ногу с последними научными открытиями, и что будет дальше?

В этом эссе будут обсуждаться возможности и трудности современного рынка клеточной и генной терапии, последние одобрения и их клинические и экономические последствия, новые технологии, которые транслируются в клинические исследования, и этические вопросы, которые вызывают некоторые из этих технологий и/или их применение.

Ключевые слова

Редактирование генома, инвестиции, рынок, исследования и разработки, этика.

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Kristina A. Zakurdaeva

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Foundation for Cancer Research Support (RakFond), Moscow, Russia

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The landscape of genome editing has dramatically changed over the recent five years, and evolved from scientific ideas and laboratory research to multiple clinical applications changing patients’ lives, creating new commercial opportunities with substantial investments in the field and notable deals, and societal dilemmas raising many discussion items for the medical community and general public. Today, many of the cutting-edge R&D efforts, investments, regulatory initiatives, and ethical discussions occur in this field. In what way can the market and society keep up with the latest scientific discoveries, and what is the next big thing to come?

In this essay, I will discuss the opportunities and challenges of current cell and gene therapy market, recent approvals and their clinical and economic impact, novel technologies that are entering clinical trials, and ethical considerations that some of these technologies and/or their applications provoke.

Keywords

Genome editing, investments, market, research & development, ethics.

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Игра геномов: продолжение следует

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Кристина А. Закурдаева

Фонд поддержки научных исследований в онкологии (РакФонд), Москва, Россия

За последние пять лет область редактирования генома кардинально изменилась и трансформировалась из научных идей и лабораторных исследований в многочисленные клинические применения, меняющие жизнь пациентов, новые коммерческие возможности с существенными инвестициями в области и заметными сделками и социальные дилеммы, поднимающие множество вопросов перед медицинским сообществом и широкой общественностью. Сегодня многие из самых передовых исследований и разработок, инвестиций, регуляторных инициатив и этических дискуссий происходят именно в этой области. Итак, могут ли рынок и общество идти в ногу с последними научными открытиями, и что будет дальше?

В этом эссе будут обсуждаться возможности и трудности современного рынка клеточной и генной терапии, последние одобрения и их клинические и экономические последствия, новые технологии, которые транслируются в клинические исследования, и этические вопросы, которые вызывают некоторые из этих технологий и/или их применение.

Ключевые слова

Редактирование генома, инвестиции, рынок, исследования и разработки, этика.

Экспериментальные исследования

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Биджан Хадеми1,2, Зохре Зандифар2, Ахмад Монабати3, Нушафарин Ченари4, Аббас Гадери4,5, Мабубе Размха4

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Авторы [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [ORGANIZATION_RU] => Array ( [ID] => 26 [TIMESTAMP_X] => 2015-09-02 18:01:20 [IBLOCK_ID] => 2 [NAME] => Организации [ACTIVE] => Y [SORT] => 500 [CODE] => ORGANIZATION_RU [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 26 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25855 [VALUE] => Array ( [TEXT] => <p><sup>1</sup> Научный центр ЛОР-хирургии области головы и шеи, Ширазский университет медицинских наук, Шираз, Иран<br> <sup>2</sup> Департамент оториноларингологии, Ширазский медицинский университет, Шираз, Иран<br> <sup>3</sup> Департамент патологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран<br> <sup>4</sup> Ширазский институт раковых исследований, Школа медицины, Ширазский медицинский университет, Шираз, Иран<br> <sup>5</sup> Департамент иммунологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

1 Научный центр ЛОР-хирургии области головы и шеи, Ширазский университет медицинских наук, Шираз, Иран
2 Департамент оториноларингологии, Ширазский медицинский университет, Шираз, Иран
3 Департамент патологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран
4 Ширазский институт раковых исследований, Школа медицины, Ширазский медицинский университет, Шираз, Иран
5 Департамент иммунологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Организации [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [SUMMARY_RU] => Array ( [ID] => 27 [TIMESTAMP_X] => 2015-09-02 18:01:20 [IBLOCK_ID] => 2 [NAME] => Описание/Резюме [ACTIVE] => Y [SORT] => 500 [CODE] => SUMMARY_RU [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 27 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25856 [VALUE] => Array ( [TEXT] => <p style="text-align: justify;">Нарушения обонятельной функции являются большой проблемой медицины, и нет радикального лечения больных с аносмией. Мезенхимные стволовые клетки, полученные из жировой ткани (АМСК) являются мультипонтентными клетками, способными к дифференцировке в несколько клеточных ростков. Целью настоящего исследования была оценка эффектов АМСК на восстановление обонятельной функции у крыс с аносмией.</p> <h3>Материалы и методы</h3> <p style="text-align: justify;">АМСК изолировали из околоматочной жировой ткани крыс с применением коллагеназы типа 1. Аносмию индуцировали путем интраперитонеального введения 3-метилиндола. Затем через 1 сут. после индукции аносмии, вводили 5×105 АМСК трансназально животным опытной группы. В контрольной группе были крысы с аносмией, которым вводили культуральную среду без АМСК. Обонятельную функцию оценивали еженедельно с помощью теста нахождения пищи. Обонятельный нейроэпителий и луковицу забирали для гистопатологического исследования в сроки 4 и 8 недель.</p> <h3>Результаты</h3> <p style="text-align: justify;">После инъекции АМСК наблюдалось примерно 6-7 кратное снижение времени нахождения пищи в опытной группе крыс по сравнению с контрольной группой. Различие было достоверным при P=0,00 и Р=0,035, соответственно, через 4 и 8 недель после инъекции АМСК. Результаты гистопатологического исследования показали реконструкцию обонятельного нейроэпителия в 93% случаев в опытной группе, и в 50% – у контрольных крыс. Обонятельная луковица выявлялась у 60% крыс в опыте, по сравнению с 20% в контроле.</p> <h3>Выводы</h3> <p style="text-align: justify;">Полученные нами результаты показывают, что регенерация обонятельного эпителия может быть ускорена при использовании локального введения АМСК. Эти данные предполагают, что АМСК в будущем могут быть перспективным источником лечения дисфункции обоняния.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Аносмия, экспериментальная, мезенхимные стволовые клетки, жировая ткань, дифференцировка, нейрональные клетки.</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

Нарушения обонятельной функции являются большой проблемой медицины, и нет радикального лечения больных с аносмией. Мезенхимные стволовые клетки, полученные из жировой ткани (АМСК) являются мультипонтентными клетками, способными к дифференцировке в несколько клеточных ростков. Целью настоящего исследования была оценка эффектов АМСК на восстановление обонятельной функции у крыс с аносмией.

Материалы и методы

АМСК изолировали из околоматочной жировой ткани крыс с применением коллагеназы типа 1. Аносмию индуцировали путем интраперитонеального введения 3-метилиндола. Затем через 1 сут. после индукции аносмии, вводили 5×105 АМСК трансназально животным опытной группы. В контрольной группе были крысы с аносмией, которым вводили культуральную среду без АМСК. Обонятельную функцию оценивали еженедельно с помощью теста нахождения пищи. Обонятельный нейроэпителий и луковицу забирали для гистопатологического исследования в сроки 4 и 8 недель.

Результаты

После инъекции АМСК наблюдалось примерно 6-7 кратное снижение времени нахождения пищи в опытной группе крыс по сравнению с контрольной группой. Различие было достоверным при P=0,00 и Р=0,035, соответственно, через 4 и 8 недель после инъекции АМСК. Результаты гистопатологического исследования показали реконструкцию обонятельного нейроэпителия в 93% случаев в опытной группе, и в 50% – у контрольных крыс. Обонятельная луковица выявлялась у 60% крыс в опыте, по сравнению с 20% в контроле.

Выводы

Полученные нами результаты показывают, что регенерация обонятельного эпителия может быть ускорена при использовании локального введения АМСК. Эти данные предполагают, что АМСК в будущем могут быть перспективным источником лечения дисфункции обоняния.

Ключевые слова

Аносмия, экспериментальная, мезенхимные стволовые клетки, жировая ткань, дифференцировка, нейрональные клетки.

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Bijan Khademi1,2, Zohreh Zandifar2, Ahmad Monabati3, Nooshafarin Chenari4, Abbas Ghaderi4,5, Mahboobeh Razmkhah4

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Author [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [ORGANIZATION_EN] => Array ( [ID] => 38 [TIMESTAMP_X] => 2015-09-02 18:02:59 [IBLOCK_ID] => 2 [NAME] => Organization [ACTIVE] => Y [SORT] => 500 [CODE] => ORGANIZATION_EN [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 38 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25859 [VALUE] => Array ( [TEXT] => <p><sup>1</sup> Research Center of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran<br> <sup>2</sup> Department of Otorhinolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran<br> <sup>3</sup> Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran<br> <sup>4</sup> Shiraz Institute for Cancer Research, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran<br> <sup>5</sup> Department of Immunology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

1 Research Center of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran
2 Department of Otorhinolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran
3 Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
4 Shiraz Institute for Cancer Research, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
5 Department of Immunology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Organization [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [SUMMARY_EN] => Array ( [ID] => 39 [TIMESTAMP_X] => 2015-09-02 18:02:59 [IBLOCK_ID] => 2 [NAME] => Description / Summary [ACTIVE] => Y [SORT] => 500 [CODE] => SUMMARY_EN [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 39 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25860 [VALUE] => Array ( [TEXT] => <p style="text-align: justify;">Olfactory dysfunction is a major challenge in medicine and there is no absolute treatment for anosmic patients. Adipose-derived mesenchymal stem cells (ASCs) are multipotent cells capable of differentiating into several cell lineages. The aim of present study was to assess effects of ASCs upon restoration of the olfactory function in anosmic rats.</p> <h3>Materials and methods</h3> <p style="text-align: justify;">ASCs were isolated from the periuterine fat tissue of rats using collagenase type I. Anosmia was induced by intraperitoneal injection of 3-methylindole. Further on, 5×105 ASCs were transnasally transferred into the case group one day after the induction of anosmia. The control group included anosmic rats that were injected with culture media without ASCs. The olfactory function was evaluated weekly by a food-finding test. Olfactory neuroepithelium and bulb were harvested for histopathologic study at 4 and 8 weeks.</p> <h3>Results</h3> <p style="text-align: justify;">Injection of ASCs caused about seven- and six-fold statistically significant reduction in the food-finding time in the case group of rats when compared to the control group tested, respectively, 4 and 8 weeks after injection of ASCs (P-value= 0.00 and =0.035, respectively). Histopathological findings showed reconstruction of olfactory neuroepithelium in 93% of the cases while it was detected in 50% of control rats. The olfactory bulb was detectable in 60% of the case group rats, compared with 20% of the control rats.</p> <h3>Conclusion</h3> <p style="text-align: justify;">Our present results show that regeneration of olfactory epithelium may be accelerated using local ASCs treatment. These data suggest that ASCs might be a promising source for the treatment of olfactory dysfunction in the future. </p> <h2>Keywords</h2> <p style="text-align: justify;">Anosmia, experimental, mesenchymal stem cells, adipose-derived, differentiation, neural cells.</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

Olfactory dysfunction is a major challenge in medicine and there is no absolute treatment for anosmic patients. Adipose-derived mesenchymal stem cells (ASCs) are multipotent cells capable of differentiating into several cell lineages. The aim of present study was to assess effects of ASCs upon restoration of the olfactory function in anosmic rats.

Materials and methods

ASCs were isolated from the periuterine fat tissue of rats using collagenase type I. Anosmia was induced by intraperitoneal injection of 3-methylindole. Further on, 5×105 ASCs were transnasally transferred into the case group one day after the induction of anosmia. The control group included anosmic rats that were injected with culture media without ASCs. The olfactory function was evaluated weekly by a food-finding test. Olfactory neuroepithelium and bulb were harvested for histopathologic study at 4 and 8 weeks.

Results

Injection of ASCs caused about seven- and six-fold statistically significant reduction in the food-finding time in the case group of rats when compared to the control group tested, respectively, 4 and 8 weeks after injection of ASCs (P-value= 0.00 and =0.035, respectively). Histopathological findings showed reconstruction of olfactory neuroepithelium in 93% of the cases while it was detected in 50% of control rats. The olfactory bulb was detectable in 60% of the case group rats, compared with 20% of the control rats.

Conclusion

Our present results show that regeneration of olfactory epithelium may be accelerated using local ASCs treatment. These data suggest that ASCs might be a promising source for the treatment of olfactory dysfunction in the future.

Keywords

Anosmia, experimental, mesenchymal stem cells, adipose-derived, differentiation, neural cells.

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Трансплантация жировых мезенхимальных стволовых клеток (жМСК) восстанавливает обонятельную функцию у крыс с аносмией

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Биджан Хадеми1,2, Зохре Зандифар2, Ахмад Монабати3, Нушафарин Ченари4, Аббас Гадери4,5, Мабубе Размха4

1 Научный центр ЛОР-хирургии области головы и шеи, Ширазский университет медицинских наук, Шираз, Иран
2 Департамент оториноларингологии, Ширазский медицинский университет, Шираз, Иран
3 Департамент патологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран
4 Ширазский институт раковых исследований, Школа медицины, Ширазский медицинский университет, Шираз, Иран
5 Департамент иммунологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран

Нарушения обонятельной функции являются большой проблемой медицины, и нет радикального лечения больных с аносмией. Мезенхимные стволовые клетки, полученные из жировой ткани (АМСК) являются мультипонтентными клетками, способными к дифференцировке в несколько клеточных ростков. Целью настоящего исследования была оценка эффектов АМСК на восстановление обонятельной функции у крыс с аносмией.

Материалы и методы

АМСК изолировали из околоматочной жировой ткани крыс с применением коллагеназы типа 1. Аносмию индуцировали путем интраперитонеального введения 3-метилиндола. Затем через 1 сут. после индукции аносмии, вводили 5×105 АМСК трансназально животным опытной группы. В контрольной группе были крысы с аносмией, которым вводили культуральную среду без АМСК. Обонятельную функцию оценивали еженедельно с помощью теста нахождения пищи. Обонятельный нейроэпителий и луковицу забирали для гистопатологического исследования в сроки 4 и 8 недель.

Результаты

После инъекции АМСК наблюдалось примерно 6-7 кратное снижение времени нахождения пищи в опытной группе крыс по сравнению с контрольной группой. Различие было достоверным при P=0,00 и Р=0,035, соответственно, через 4 и 8 недель после инъекции АМСК. Результаты гистопатологического исследования показали реконструкцию обонятельного нейроэпителия в 93% случаев в опытной группе, и в 50% – у контрольных крыс. Обонятельная луковица выявлялась у 60% крыс в опыте, по сравнению с 20% в контроле.

Выводы

Полученные нами результаты показывают, что регенерация обонятельного эпителия может быть ускорена при использовании локального введения АМСК. Эти данные предполагают, что АМСК в будущем могут быть перспективным источником лечения дисфункции обоняния.

Ключевые слова

Аносмия, экспериментальная, мезенхимные стволовые клетки, жировая ткань, дифференцировка, нейрональные клетки.

Экспериментальные исследования

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Андрей И. Яременко1, Анна В. Лысенко1, Елизавета А. Иванова1, Александр Д. Вилесов3, Галина Ю. Юкина4, Марина А. Чибисова5, Анна А. Зубарева2, Олег В. Галибин3

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1 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Кафедра оториноларингологии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
4 Научно-исследовательский центр Первого Санкт-Петербургского государственного медицинского университета
им. акад. И. П. Павлова, Санкт-Петербург, Россия
5 Санкт-Петербургский стоматологический институт последипломного образования, Санкт-Петербург, Россия

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Организации [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [SUMMARY_RU] => Array ( [ID] => 27 [TIMESTAMP_X] => 2015-09-02 18:01:20 [IBLOCK_ID] => 2 [NAME] => Описание/Резюме [ACTIVE] => Y [SORT] => 500 [CODE] => SUMMARY_RU [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 27 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25605 [VALUE] => Array ( [TEXT] => <p style="text-align: justify;">Одонтогенный максиллярный синусит (ОМС) занимает одно из первых мест по заболеваемости среди болезней параназального синуса. По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели <i>in vivo</i>. В данном экспериментальном исследовании, проводилась ксеногенная трансплантация поликапролактонового матрикса в нижнюю стенку максиллярного синуса после развития ОАК у кроликов. Девять животных исследовали в сроки 4, 8 и 24 недели. Проводили рассечение костей верхней челюсти, резали на меньшие блоки и помещали образцы в формалин. Серийные гистологические препараты окрашивали и исследовали методами световой микроскопии. Морфологический анализ показал, наличие ранних признаков врастания соединительной ткани в сетку матрикса уже через 1 мес. после ее имплантации. Окружающая капсула была тонкой, с минимальными признаками воспаления, которое полностью исчезало к 2 мес. после вмешательства. В течение последующих 4 мес. капсула становилась тоньше, синтетический матрикс полностью прорастал соединительной тканью и кровеносными сосудами. Это помогало сохранить высоту альвеолярного отростка верхней челюсти в месте экстракции зуба.</p> <h3>Выводы</h3> <p style="text-align: justify;">Предложенный метод закрытия ороантральной коммуникации с применением системы ПКЛ-скаффолда может сохранить объем утраченного костного фрагмента на срок до 6 мес. и может стимулировать остеогенез, как показано нашими экспериментами на животных.</p> <h2>Ключевые слова</h2> <p style="text-align: justify;">Ороантральная коммуникация, максиллярный синус, поликапролактон, полимерные матрицы, костная регенерация.</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

Одонтогенный максиллярный синусит (ОМС) занимает одно из первых мест по заболеваемости среди болезней параназального синуса. По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели in vivo. В данном экспериментальном исследовании, проводилась ксеногенная трансплантация поликапролактонового матрикса в нижнюю стенку максиллярного синуса после развития ОАК у кроликов. Девять животных исследовали в сроки 4, 8 и 24 недели. Проводили рассечение костей верхней челюсти, резали на меньшие блоки и помещали образцы в формалин. Серийные гистологические препараты окрашивали и исследовали методами световой микроскопии. Морфологический анализ показал, наличие ранних признаков врастания соединительной ткани в сетку матрикса уже через 1 мес. после ее имплантации. Окружающая капсула была тонкой, с минимальными признаками воспаления, которое полностью исчезало к 2 мес. после вмешательства. В течение последующих 4 мес. капсула становилась тоньше, синтетический матрикс полностью прорастал соединительной тканью и кровеносными сосудами. Это помогало сохранить высоту альвеолярного отростка верхней челюсти в месте экстракции зуба.

Выводы

Предложенный метод закрытия ороантральной коммуникации с применением системы ПКЛ-скаффолда может сохранить объем утраченного костного фрагмента на срок до 6 мес. и может стимулировать остеогенез, как показано нашими экспериментами на животных.

Ключевые слова

Ороантральная коммуникация, максиллярный синус, поликапролактон, полимерные матрицы, костная регенерация.

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Аndrey I. Yaremenko1, Anna V. Lysenko1, Elizaveta A. Ivanova1, Galina U. Ukina4, Alexander D. Vilesov3, Marina A. Chibisova5, Anna A. Zubareva2, Оleg V. Galibin3

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Author [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [ORGANIZATION_EN] => Array ( [ID] => 38 [TIMESTAMP_X] => 2015-09-02 18:02:59 [IBLOCK_ID] => 2 [NAME] => Organization [ACTIVE] => Y [SORT] => 500 [CODE] => ORGANIZATION_EN [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 38 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25608 [VALUE] => Array ( [TEXT] => <p><sup>1</sup> Department of Maxillofacial Surgery, Pavlov University, St. Petersburg, Russia<br> <sup>2</sup> Department of Otorhinolaryngology, Pavlov University, St. Petersburg, Russia<br> <sup>3</sup> Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia<br> <sup>4</sup> Research Center, Pavlov University, St. Petersburg, Russia<br> <sup>5</sup> Saint Petersburg Stomatology Institute of Postgraduate Education, St. Petersburg, Russia</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

1 Department of Maxillofacial Surgery, Pavlov University, St. Petersburg, Russia
2 Department of Otorhinolaryngology, Pavlov University, St. Petersburg, Russia
3 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg, Russia
4 Research Center, Pavlov University, St. Petersburg, Russia
5 Saint Petersburg Stomatology Institute of Postgraduate Education, St. Petersburg, Russia

[TYPE] => HTML ) [~DESCRIPTION] => [~NAME] => Organization [~DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) ) [SUMMARY_EN] => Array ( [ID] => 39 [TIMESTAMP_X] => 2015-09-02 18:02:59 [IBLOCK_ID] => 2 [NAME] => Description / Summary [ACTIVE] => Y [SORT] => 500 [CODE] => SUMMARY_EN [DEFAULT_VALUE] => Array ( [TEXT] => [TYPE] => HTML ) [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => 39 [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => HTML [USER_TYPE_SETTINGS] => Array ( [height] => 200 ) [HINT] => [PROPERTY_VALUE_ID] => 25609 [VALUE] => Array ( [TEXT] => <p style="text-align: justify;">Odontogenic maxillary sinusitis (OMS) takes one of the leading position among the paranasal sinus diseases. According to current reviews, the number of patients with OMS is increasing every year, and makes up from 4 to 7% of the maxillofacial diseases. Recently, a perforating form of OMS becomes more common in practice of maxillofacial surgery. Perforative sinusitis occurs due to break of mucoperiosteum in response to some pathological conditions, most frequently, following extraction of a superior tooth. Therefore, improvement of existing approaches and development of new affordable and less traumatic methods for treatment of sinusitis remains quite relevant. Over last years, usage of polymer materials (both natural and artificial products) has become increasingly popular in maxillofacial and dental surgery. Such materials should have several favorable properties: lack of cytotoxicity, biocompatibility, resorbability and good handling characteristics. The synthetic polymer polycaprolactone (PCL) meets these requirements to a greater extent. Due to its three-dimensional porous structure, these polymers are actively used in tissue engineering. Available data on the opportunity of bone tissue regeneration by the polymer structures suggest that they can be used to stimulate osteogenesis and maintain the height of the alveolar process of the upper jaw in cases of oroantral communication (OAC) occurring after tooth extraction. Of note, PCL is a safe material approved by the FDA for use in drug delivery devices and implantation scaffolds. Considering these data, it is of great interest to evaluate the opportunity of its application in the sites of inflammation, e.c., for elimination of OAC defect in presence of developing sinusitis. The aim of our study was to evaluate the opportunity of using a PCL matrix in order to close the OAC using an <i>in vivo</i> experimental model.</p> <h3>Materials and methods</h3> <p style="text-align: justify;">In an experimental study, xenogeneic transplantation of polycaprolactone matrix was performed into the lower wall of maxillary sinus after the OAC development in rabbits. Nine animals were sacrificed after 4, 8 and 24 weeks. The maxillary bones were dissected, cut into smaller blocks, and the specimens were immediately placed in formalin. Serial sections were stained and examined using light microscope.</p> <h3>Results</h3> <p style="text-align: justify;">The morphological study showed that there are early signs of connective tissue ingrowth to the matrix mesh 1 month after implantation. The surrounding capsule was thin and showed minimal signs of inflammation, which completely disappeared by the second month after the intervention. Over the next 4 months, the capsule becomes thinner, the matrix was totally penetrated by connective tissue and blood vessels. It helped to retain the height of alveolar process in the upper jaw at the site of tooth extraction. In conclusion, the proposed method for OAC closure by means of the PCL scaffold system can retain the space of the lost maxillary bone fragment for up to 6 months being able to stimulate osteogenesis, as shown by our animal experiments.</p> <h2>Keywords</h2> <p style="text-align: justify;">Oroantral communication, maxillary sinus, polycaprolactone, polymer scaffolds, bone regeneration.</p> [TYPE] => HTML ) [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [TEXT] =>

Odontogenic maxillary sinusitis (OMS) takes one of the leading position among the paranasal sinus diseases. According to current reviews, the number of patients with OMS is increasing every year, and makes up from 4 to 7% of the maxillofacial diseases. Recently, a perforating form of OMS becomes more common in practice of maxillofacial surgery. Perforative sinusitis occurs due to break of mucoperiosteum in response to some pathological conditions, most frequently, following extraction of a superior tooth. Therefore, improvement of existing approaches and development of new affordable and less traumatic methods for treatment of sinusitis remains quite relevant. Over last years, usage of polymer materials (both natural and artificial products) has become increasingly popular in maxillofacial and dental surgery. Such materials should have several favorable properties: lack of cytotoxicity, biocompatibility, resorbability and good handling characteristics. The synthetic polymer polycaprolactone (PCL) meets these requirements to a greater extent. Due to its three-dimensional porous structure, these polymers are actively used in tissue engineering. Available data on the opportunity of bone tissue regeneration by the polymer structures suggest that they can be used to stimulate osteogenesis and maintain the height of the alveolar process of the upper jaw in cases of oroantral communication (OAC) occurring after tooth extraction. Of note, PCL is a safe material approved by the FDA for use in drug delivery devices and implantation scaffolds. Considering these data, it is of great interest to evaluate the opportunity of its application in the sites of inflammation, e.c., for elimination of OAC defect in presence of developing sinusitis. The aim of our study was to evaluate the opportunity of using a PCL matrix in order to close the OAC using an in vivo experimental model.

Materials and methods

In an experimental study, xenogeneic transplantation of polycaprolactone matrix was performed into the lower wall of maxillary sinus after the OAC development in rabbits. Nine animals were sacrificed after 4, 8 and 24 weeks. The maxillary bones were dissected, cut into smaller blocks, and the specimens were immediately placed in formalin. Serial sections were stained and examined using light microscope.

Results

The morphological study showed that there are early signs of connective tissue ingrowth to the matrix mesh 1 month after implantation. The surrounding capsule was thin and showed minimal signs of inflammation, which completely disappeared by the second month after the intervention. Over the next 4 months, the capsule becomes thinner, the matrix was totally penetrated by connective tissue and blood vessels. It helped to retain the height of alveolar process in the upper jaw at the site of tooth extraction. In conclusion, the proposed method for OAC closure by means of the PCL scaffold system can retain the space of the lost maxillary bone fragment for up to 6 months being able to stimulate osteogenesis, as shown by our animal experiments.

Keywords

Oroantral communication, maxillary sinus, polycaprolactone, polymer scaffolds, bone regeneration.

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Экспериментальное изучение полимерных матриц, способствующих репарации костной ткани при ороантральном дефекте

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Андрей И. Яременко1, Анна В. Лысенко1, Елизавета А. Иванова1, Александр Д. Вилесов3, Галина Ю. Юкина4, Марина А. Чибисова5, Анна А. Зубарева2, Олег В. Галибин3

1 Кафедра челюстно-лицевой хирургии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
2 Кафедра оториноларингологии, Первый Санкт-Петербургский государственный медицинский университет
им. акад. И. П. Павлова, Санкт-Петербург, Россия
3 НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Санкт-Петербург, Россия
4 Научно-исследовательский центр Первого Санкт-Петербургского государственного медицинского университета
им. акад. И. П. Павлова, Санкт-Петербург, Россия
5 Санкт-Петербургский стоматологический институт последипломного образования, Санкт-Петербург, Россия

Одонтогенный максиллярный синусит (ОМС) занимает одно из первых мест по заболеваемости среди болезней параназального синуса. По современным обзорам, число пациентов с ОМС возрастает каждый год и составляет 4-7% всех заболеваний верхней челюсти. В настоящее время в практике челюстно-лицевой хирургии все чаще встречается перфоративная форма ОМС. Перфоративный синусит возникает из-за разрушения периоста при некоторых патологических состояниях, наиболее часто – после экстракции верхнего зуба. Поэтому улучшение существующих подходов и разработка новых доступных и менее травматичных методов лечения синусита пока остается актуальным. В течение последних лет применение полимерных материалов (как естественных, так и синтетических продуктов) стало весьма популярным в челюстно-лицевой хирургии. Такие материалы должны иметь ряд существенных преимуществ: отсутствие цитотоксичности, биосовместимость, резорбируемость и возможность удобной обработки. Синтетический полимер поликапролактон (ПКЛ) соответствует этим требованиям в большой мере. Благодаря своей трехмерной пористой структуре, эти полимеры активно применяются в тканевой инженерии. Имеющиеся данные о возможности регенерации костной ткани в полимерных структурах предполагают, что они могут быть использованы для стимуляции остеогенеза и поддерживать высоту альвеолярного отростка верхней челюсти в случаях ороантральной коммуникации (ОАК), возникающей после удаления зуба. Следует отметить, что полимер ПКЛ – безопасный материал, одобренный FDA (США) для применения в устройствах для доставки препаратов и основ-скаффолдов для имплантации. С учетом этих данных, представляет большой интерес оценка их использования в зонах воспаления, например, для устранения дефекта при ОАК при развитии синусита. Целью нашего исследования была оценка возможности применения матриц ПКЛ для закрытия дефекта ОАК, в экспериментальной модели in vivo. В данном экспериментальном исследовании, проводилась ксеногенная трансплантация поликапролактонового матрикса в нижнюю стенку максиллярного синуса после развития ОАК у кроликов. Девять животных исследовали в сроки 4, 8 и 24 недели. Проводили рассечение костей верхней челюсти, резали на меньшие блоки и помещали образцы в формалин. Серийные гистологические препараты окрашивали и исследовали методами световой микроскопии. Морфологический анализ показал, наличие ранних признаков врастания соединительной ткани в сетку матрикса уже через 1 мес. после ее имплантации. Окружающая капсула была тонкой, с минимальными признаками воспаления, которое полностью исчезало к 2 мес. после вмешательства. В течение последующих 4 мес. капсула становилась тоньше, синтетический матрикс полностью прорастал соединительной тканью и кровеносными сосудами. Это помогало сохранить высоту альвеолярного отростка верхней челюсти в месте экстракции зуба.

Выводы

Предложенный метод закрытия ороантральной коммуникации с применением системы ПКЛ-скаффолда может сохранить объем утраченного костного фрагмента на срок до 6 мес. и может стимулировать остеогенез, как показано нашими экспериментами на животных.

Ключевые слова

Ороантральная коммуникация, максиллярный синус, поликапролактон, полимерные матрицы, костная регенерация.

Приложение 1

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Под редакцией проф. Бориса В. Афанасьева

Ксения С. Афанасьева, Мария В. Барабанщикова, Сергей Н. Бондаренко, Татьяна А. Быкова, Юлия Ю. Власова, Асмик Г. Геворгян, Ирина К. Голубовская, Елена И. Дарская, Юрий Р. Залялов, Дарья А. Звягинцева, Людмила С. Зубаровская, Мария О. Иванова, Илья В. Казанцев, Ольга Б. Калашникова, Андрей В. Козлов, Елена В. Кондакова, Владислав О. Короленко, Ольга В. Кудяшева, Александр Д. Кулагин, Елена Е. Лепик, Кирилл В. Лепик, Инна В. Маркова, Ирина А. Михайлова, Наталья Б. Михайлова, Иван С. Моисеев, Елена В. Морозова, Анна А. Осипова, Олеся В. Паина, Ольга В. Пирогова, Алексей Ю. Полушин, Марина О. Попова, Валентина В. Порунова, Юрий А. Пунанов, Елена В. Семенова, Анна Г. Смирнова, Олеся В. Смыкова, Полина С. Толкунова, Людмила В. Федорова, Николай Ю. Цветков, Иван В. Цыганков, Татьяна В. Юхта

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Глубокоуважаемые коллеги!
Мы вновь рады приветствовать вас – участников XIII Международного симпозиума памяти Раисы Максимовны Горбачевой «Трансплантация стволовых гемопоэтических клеток. Генная и клеточная терапия» в Санкт-Петербурге.

Ежегодно наш форум собирает специалистов, в фокусе научных и практических интересов которых находятся вопросы трансплантации гемопоэтических стволовых клеток. Лекции ведущих экспертов, новейшие данные в области клинических исследований, дискуссии и обмен опытом помогают повысить уровень знаний и расширить профессиональный кругозор специалистов, принимающих участие в работе Симпозиума.

С информационной, образовательной целью предлагаем вашему вниманию второе издание брошюры «Показания к ТГСК-2019», в которой изложены основные показания к трансплантации гемопоэтических стволовых клеток в соответствии с современными рекомендациями европейского сообщества по трансплантации костного мозга (EBMT) 2019, опубликованными в официальном журнале EBMT Bone Marrow Transplantation 5 апреля 2019 года: Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

Мы надеемся, что данное издание будет полезным и удобным в использовании.

Профессор АФАНАСЬЕВ Борис Владимирович
Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова

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Editor: Prof. Dr. Boris V. Afanasyev

Ksenia S. Afanasyeva, Maria V. Barabanshchikova, Sergey N. Bondarenko, Tatyana A. Bykova, Julia Yu. Vlasova, Asmik G. Gevorgian, Irina K. Golubovskaya, Elena I. Darskaya, Yury R. Zalyalov, Darya A. Zvyagintseva, Ludmila S. Zubarovskaya, Maria O. Ivanova, Ilya V. Kazantsev, Olga B. Kalashnikova, Andrey V. Kozlov, Elena V. Kondakova, Vladislav O. Korolenko, Olga V. Kudyasheva, Alexander D. Kulagin, Elena E. Lepik, Kirill V. Lepik, Inna V. Markova, Irina A. Mikhailova, Natalya B. Mikhailova, Ivan S. Moiseev, Elena V. Morozova, Anna A. Osipova, Olesya V. Paina, Olga V. Pirogova, Alexey Yu. Polushin, Marina O. Popova, Valentina V. Porunova, Yury A. Punanov, Elena V. Semenova, Anna G. Smirnova, Olesya V. Smykova, Polina S. Tolkunova, Lyudmila V. Fedorova, Nikolay Yu. Tcvetkov, Ivan V. Tsygankov, Tatyana V. Yukhta

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Dear colleagues,
We are glad to welcome you again at the XIII R. Gorbacheva Memorial Symposium Hematopoietic Stem Cell Transplantation. Gene and Cellular Therapy in Saint Petersburg.

Our annual forum invites specialists who are focused on scientific and practical issues of hematopoietic stem cell transplantation (HSCT). The lectures presented by leading experts, quite recent data in the field of clinical studies, discussions and sharing experience in this area allow to extend knowledge and to increase professional level of the specialists participating at the Symposium.

Intending for better information in the field and pursuing educational aims, we are bringing to your notice the second edition of our booklet Indications for Hematopoietic Stem Cell Transplantation which contains the main indications for HSCT, brought into compliance with updated guidelines from European Society for Blood and Marrow Transplantation (EBMT) published in the official journal Bone Marrow Transplantation (published April 5, 2019): Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

We express a hope that this publication will be manageable and user-friendly to Russian-speaking readers.

Professor Boris V. AFANASYEV
Pavlov University, St. Petersburg, Russia

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Показания к трансплантации гемопоэтических стволовых клеток

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Под редакцией проф. Бориса В. Афанасьева

Ксения С. Афанасьева, Мария В. Барабанщикова, Сергей Н. Бондаренко, Татьяна А. Быкова, Юлия Ю. Власова, Асмик Г. Геворгян, Ирина К. Голубовская, Елена И. Дарская, Юрий Р. Залялов, Дарья А. Звягинцева, Людмила С. Зубаровская, Мария О. Иванова, Илья В. Казанцев, Ольга Б. Калашникова, Андрей В. Козлов, Елена В. Кондакова, Владислав О. Короленко, Ольга В. Кудяшева, Александр Д. Кулагин, Елена Е. Лепик, Кирилл В. Лепик, Инна В. Маркова, Ирина А. Михайлова, Наталья Б. Михайлова, Иван С. Моисеев, Елена В. Морозова, Анна А. Осипова, Олеся В. Паина, Ольга В. Пирогова, Алексей Ю. Полушин, Марина О. Попова, Валентина В. Порунова, Юрий А. Пунанов, Елена В. Семенова, Анна Г. Смирнова, Олеся В. Смыкова, Полина С. Толкунова, Людмила В. Федорова, Николай Ю. Цветков, Иван В. Цыганков, Татьяна В. Юхта

Глубокоуважаемые коллеги!
Мы вновь рады приветствовать вас – участников XIII Международного симпозиума памяти Раисы Максимовны Горбачевой «Трансплантация стволовых гемопоэтических клеток. Генная и клеточная терапия» в Санкт-Петербурге.

Ежегодно наш форум собирает специалистов, в фокусе научных и практических интересов которых находятся вопросы трансплантации гемопоэтических стволовых клеток. Лекции ведущих экспертов, новейшие данные в области клинических исследований, дискуссии и обмен опытом помогают повысить уровень знаний и расширить профессиональный кругозор специалистов, принимающих участие в работе Симпозиума.

С информационной, образовательной целью предлагаем вашему вниманию второе издание брошюры «Показания к ТГСК-2019», в которой изложены основные показания к трансплантации гемопоэтических стволовых клеток в соответствии с современными рекомендациями европейского сообщества по трансплантации костного мозга (EBMT) 2019, опубликованными в официальном журнале EBMT Bone Marrow Transplantation 5 апреля 2019 года: Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kröger N, Mohty M; for the European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. (2019). 10.1038/s41409-019-0516-2.

Мы надеемся, что данное издание будет полезным и удобным в использовании.

Профессор АФАНАСЬЕВ Борис Владимирович
Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова