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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).

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.

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

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).

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.

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 2^nd 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).

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.

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

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).

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.

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 2^nd 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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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>" ["ELEMENT_PREVIEW_PICTURE_FILE_TITLE"]=> string(209) "Экспериментальное изучение полимерных матриц, способствующих репарации костной ткани при ороантральном дефекте" ["ELEMENT_DETAIL_PICTURE_FILE_ALT"]=> string(209) "Экспериментальное изучение полимерных матриц, способствующих репарации костной ткани при ороантральном дефекте" ["ELEMENT_DETAIL_PICTURE_FILE_TITLE"]=> string(209) "Экспериментальное изучение полимерных матриц, 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Яременко¹, Анна В. Лысенко¹, Елизавета А. Иванова¹, Александр Д. Вилесов³, Галина Ю. Юкина⁴, Марина А. Чибисова⁵, Анна А. Зубарева², Олег В. Галибин³</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

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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"]=> 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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Yaremenko¹, Anna V. Lysenko¹, Elizaveta A. Ivanova¹, Galina U. Ukina⁴, Alexander D. Vilesov³, Marina A. Chibisova⁵, Anna A. Zubareva², Оleg V. Galibin³</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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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).

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

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.

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.

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

1. Holbrook EH, Leopold DA. Anosmia: diagnosis and management. Curr Opin Otolaryngol Head Neck Surg. 2003;11(1):54-60.
2. Kern RC. Chronic sinusitis and anosmia: pathologic changes in the olfactory mucosa. Laryngoscope 2000; 110(7):1071-1077.
3. Franceschini V, Bettini S, Pifferi S, Rosellini A, Menini A, Saccardi R, Ognio E, Jeffery R, Poulsom R, Revoltella RP. Human cord blood CD133+ stem cells transplanted to nod-scid mice provide conditions for regeneration of olfactory neuroepithelium after permanent damage induced by dichlobenil. Stem Cells. 2009;27(4):825-835.
4. Lee CH, Jeon SW, Seo BS, Mo JH, Jeon EH, Choi AR, Kim JW. Transplantation of neural stem cells in anosmic mice. Clin Exp Otorhinolaryngol. 2010; 3:84–90.
5. Pagano SF, Impagnatiello F, Girelli M, Cova L, Grioni E, Onofri M, Cavallaro M, Etteri S, Vitello F, Giombini S, Solero CL, Parati EA. Isolation and characterization of neural stem cells from the adult human olfactory bulb. Stem Cell 2000;18(4):295-300.
6. Kim JW, Hong SL, Lee CH, Jeon EH, Choi AR. Relationship between olfactory function and olfactory neuronal population in C57BL6 mice injected intraperitoneally with 3-methylindole. Otolaryngol Head Neck Surg. 2010;143:837-842.
7. Murphy MB, Moncivais K, Caplan AI. Mesenchymal stem cells: environmentally responsive therapeutics for regenerative medicine. ExpMol Med. 2013;45:e54.
8. Kim N, Cho SG. Clinical applications of mesenchymal stem cells. Korean J Intern Med 2013; 28:387-402.
9. Beyer Nardi N, da Silva Meirelles L. Mesenchymal stem cells: isolation, in vitro expansion and characterization. Handb Exp Pharmacol. 2006; 174:249-282.
10. Chamberlain G, Fox J, Ashton B, Middleton J. Concise review: mesenchymal stem cells: their phenotype, differentiation capacity, immunological features, and potential for homing. Stem Cells 2007; 25: 2739-2749.
11. Mareschi K, Ferrero I, Rustichelli D, Aschero S, Gammaitoni L, Aglietta M, Madon E, Fagioli F. Expansion of mesenchymal stem cells isolated from pediatric and adult donor bone marrow. J Cell Biochem. 2006; 97(4):744-754.
12. Mitchell KE, Weiss ML, Mitchell BM, Martin P, Davis D, Morales L, Helwig B, Beerenstrauch M, Abou-Easa K, Hildreth T, Troyer D, Medicetty S. Matrix cells from Wharton’s jelly form neurons and glia. Stem Cells 2003; 21:50-60.
13. Pokrywczynska M, Lewandowska MA, Krzyzanowska S, Jundzill A, Rasmus M, Warda K., Gagat M, Deptula A, Helmin-Basa A, Holysz M, Nowacki M, Buchholz L, Bodnar M, Marszalek A, Grzanka A, Jozwicki W, Michalkiewicz J, Drewa T. Transdifferentiation of Bone Marrow Mesenchymal Stem Cells into the Islet-Like Cells: the Role of Extracellular Matrix Proteins. Arch Immunol Ther Exp. 2015;63(5):377-384.
14. Manochantr S, Marupanthorn K, Tantrawatpan C, Kheolamai P. The expression of neurogenic markers after neuronal induction of chorion-derived mesenchymal stromal cells. Neurol Res. 2015;37:545-552.
15. Liang L, Wang J, Zhang Y, Shen Z, Zheng J, Li J, Su Z, Cai J, Jiang W, Sun M. Transdifferentiation of bone marrow-derived mesenchymal stem cells into salivary gland-like cells using a novel culture method. Biotechnol Lett. 2015;37(7):1505-1513.
16. Tolman EC, Nyswander DB. The reliability and validity of maze measures for rats. J Comp Psychol.1927;7:425-460.
17. Kim HY, Kim JH, Dhong HJ, Kim KR, Chung SK, Chung SC, Kang JM, Jung YG, Jang SY, Hong SD. Effects of statins on the recovery of olfactory function in a 3-methylindole-induced anosmia mouse model. Am J Rhinol Allergy. 2012;26(2):e81-84.
18. Peele DB, Allison SD, Bolon B, Prah JD, Jensen KF, Morgan KT. Functional deficits produced by 3-methylindole-induced olfactory mucosal damage revealed by a simple olfactory learning task. Toxicol Appl Pharmacol. 1991;107:191-202.
19. Kim SU, de Villis J. Stem cell-based therapy in neurological diseases: a review, J Neurosci Res 2009;87:2183-2200.
20. Ul Hassan A, Hassan G, Rasool Z. Role of stem cells in treatment of neurological disorder. Int J Health Sci (Qassim). 2009;3:227-233.
21. Dalton P. Olfaction and anosmia in rhinosinusitis. Curr Allergy Asthma Rep. 2004; 4(3):230-236.
22. Jo H, Jung M, Seo DJ, Park DJ. The effect of rat bone marrow derived mesenchymal stem cells transplantation for restoration of olfactory disorder. Biochem Biophys Res Commun. 2015;467:395-399.
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).

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

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.

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.

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

1. Holbrook EH, Leopold DA. Anosmia: diagnosis and management. Curr Opin Otolaryngol Head Neck Surg. 2003;11(1):54-60.
2. Kern RC. Chronic sinusitis and anosmia: pathologic changes in the olfactory mucosa. Laryngoscope 2000; 110(7):1071-1077.
3. Franceschini V, Bettini S, Pifferi S, Rosellini A, Menini A, Saccardi R, Ognio E, Jeffery R, Poulsom R, Revoltella RP. Human cord blood CD133+ stem cells transplanted to nod-scid mice provide conditions for regeneration of olfactory neuroepithelium after permanent damage induced by dichlobenil. Stem Cells. 2009;27(4):825-835.
4. Lee CH, Jeon SW, Seo BS, Mo JH, Jeon EH, Choi AR, Kim JW. Transplantation of neural stem cells in anosmic mice. Clin Exp Otorhinolaryngol. 2010; 3:84–90.
5. Pagano SF, Impagnatiello F, Girelli M, Cova L, Grioni E, Onofri M, Cavallaro M, Etteri S, Vitello F, Giombini S, Solero CL, Parati EA. Isolation and characterization of neural stem cells from the adult human olfactory bulb. Stem Cell 2000;18(4):295-300.
6. Kim JW, Hong SL, Lee CH, Jeon EH, Choi AR. Relationship between olfactory function and olfactory neuronal population in C57BL6 mice injected intraperitoneally with 3-methylindole. Otolaryngol Head Neck Surg. 2010;143:837-842.
7. Murphy MB, Moncivais K, Caplan AI. Mesenchymal stem cells: environmentally responsive therapeutics for regenerative medicine. ExpMol Med. 2013;45:e54.
8. Kim N, Cho SG. Clinical applications of mesenchymal stem cells. Korean J Intern Med 2013; 28:387-402.
9. Beyer Nardi N, da Silva Meirelles L. Mesenchymal stem cells: isolation, in vitro expansion and characterization. Handb Exp Pharmacol. 2006; 174:249-282.
10. Chamberlain G, Fox J, Ashton B, Middleton J. Concise review: mesenchymal stem cells: their phenotype, differentiation capacity, immunological features, and potential for homing. Stem Cells 2007; 25: 2739-2749.
11. Mareschi K, Ferrero I, Rustichelli D, Aschero S, Gammaitoni L, Aglietta M, Madon E, Fagioli F. Expansion of mesenchymal stem cells isolated from pediatric and adult donor bone marrow. J Cell Biochem. 2006; 97(4):744-754.
12. Mitchell KE, Weiss ML, Mitchell BM, Martin P, Davis D, Morales L, Helwig B, Beerenstrauch M, Abou-Easa K, Hildreth T, Troyer D, Medicetty S. Matrix cells from Wharton’s jelly form neurons and glia. Stem Cells 2003; 21:50-60.
13. Pokrywczynska M, Lewandowska MA, Krzyzanowska S, Jundzill A, Rasmus M, Warda K., Gagat M, Deptula A, Helmin-Basa A, Holysz M, Nowacki M, Buchholz L, Bodnar M, Marszalek A, Grzanka A, Jozwicki W, Michalkiewicz J, Drewa T. Transdifferentiation of Bone Marrow Mesenchymal Stem Cells into the Islet-Like Cells: the Role of Extracellular Matrix Proteins. Arch Immunol Ther Exp. 2015;63(5):377-384.
14. Manochantr S, Marupanthorn K, Tantrawatpan C, Kheolamai P. The expression of neurogenic markers after neuronal induction of chorion-derived mesenchymal stromal cells. Neurol Res. 2015;37:545-552.
15. Liang L, Wang J, Zhang Y, Shen Z, Zheng J, Li J, Su Z, Cai J, Jiang W, Sun M. Transdifferentiation of bone marrow-derived mesenchymal stem cells into salivary gland-like cells using a novel culture method. Biotechnol Lett. 2015;37(7):1505-1513.
16. Tolman EC, Nyswander DB. The reliability and validity of maze measures for rats. J Comp Psychol.1927;7:425-460.
17. Kim HY, Kim JH, Dhong HJ, Kim KR, Chung SK, Chung SC, Kang JM, Jung YG, Jang SY, Hong SD. Effects of statins on the recovery of olfactory function in a 3-methylindole-induced anosmia mouse model. Am J Rhinol Allergy. 2012;26(2):e81-84.
18. Peele DB, Allison SD, Bolon B, Prah JD, Jensen KF, Morgan KT. Functional deficits produced by 3-methylindole-induced olfactory mucosal damage revealed by a simple olfactory learning task. Toxicol Appl Pharmacol. 1991;107:191-202.
19. Kim SU, de Villis J. Stem cell-based therapy in neurological diseases: a review, J Neurosci Res 2009;87:2183-2200.
20. Ul Hassan A, Hassan G, Rasool Z. Role of stem cells in treatment of neurological disorder. Int J Health Sci (Qassim). 2009;3:227-233.
21. Dalton P. Olfaction and anosmia in rhinosinusitis. Curr Allergy Asthma Rep. 2004; 4(3):230-236.
22. Jo H, Jung M, Seo DJ, Park DJ. The effect of rat bone marrow derived mesenchymal stem cells transplantation for restoration of olfactory disorder. Biochem Biophys Res Commun. 2015;467:395-399.
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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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>" ["ELEMENT_PREVIEW_PICTURE_FILE_TITLE"]=> string(218) "Трансплантация жировых мезенхимальных стволовых клеток (жМСК) восстанавливает обонятельную функцию у крыс с аносмией" ["ELEMENT_DETAIL_PICTURE_FILE_ALT"]=> string(218) "Трансплантация жировых мезенхимальных стволовых клеток (жМСК) восстанавливает обонятельную функцию у крыс с аносмией" ["ELEMENT_DETAIL_PICTURE_FILE_TITLE"]=> string(218) "Трансплантация жировых мезенхимальных стволовых клеток (жМСК) восстанавливает обонятельную функцию у крыс с аносмией" ["SECTION_META_TITLE"]=> string(218) "Трансплантация жировых мезенхимальных стволовых клеток (жМСК) восстанавливает обонятельную функцию у крыс с аносмией" ["SECTION_META_KEYWORDS"]=> string(218) 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Нушафарин Ченари⁴, Аббас Гадери^4,5, Мабубе Размха⁴ </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 Хадеми^1,2, Зохре Зандифар², Ахмад Монабати³, Нушафарин Ченари⁴, Аббас Гадери^4,5, 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 Khademi^1,2, Zohreh Zandifar², Ahmad Monabati³, Nooshafarin Chenari⁴, Abbas Ghaderi^4,5, Mahboobeh Razmkhah⁴

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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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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 Khademi^1,2, Zohreh Zandifar², Ahmad Monabati³, Nooshafarin Chenari⁴, Abbas Ghaderi^4,5, Mahboobeh Razmkhah⁴

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Bijan Khademi^1,2, Zohreh Zandifar², Ahmad Monabati³, Nooshafarin Chenari⁴, Abbas Ghaderi^4,5, 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.

" ["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(1992) "

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

" } ["AUTHORS"]=> array(38) { ["ID"]=> string(2) "24" ["TIMESTAMP_X"]=> 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" } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> array(6) { [0]=> string(5) "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) "" ["DISPLAY_VALUE"]=> array(6) { [0]=> string(57) "Bijan Khademi" [1]=> string(59) "Zohreh Zandifar" [2]=> string(58) "Ahmad Monabati" [3]=> string(63) "Nooshafarin Chenari" [4]=> string(57) "Abbas Ghaderi" [5]=> string(62) "Mahboobeh Razmkhah" } ["LINK_ELEMENT_VALUE"]=> bool(false) } ["AUTHOR_RU"]=> array(37) { ["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^1,2, Зохре Зандифар², Ахмад Монабати³, Нушафарин Ченари⁴, Аббас Гадери^4,5, Мабубе Размха⁴ </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 Хадеми^1,2, Зохре Зандифар², Ахмад Монабати³, Нушафарин Ченари⁴, Аббас Гадери^4,5, Мабубе Размха⁴

" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(253) "

Биджан Хадеми^1,2, Зохре Зандифар², Ахмад Монабати³, Нушафарин Ченари⁴, Аббас Гадери^4,5, Мабубе Размха⁴

" } ["SUBMITTED"]=> array(37) { ["ID"]=> string(2) "20" ["TIMESTAMP_X"]=> string(19) "2015-09-02 17:21:42" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(21) "Дата подачи" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(9) "SUBMITTED" ["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) "20" ["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(8) "DateTime" ["USER_TYPE_SETTINGS"]=> NULL ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "25845" ["VALUE"]=> string(22) "09/22/2019 12:00:00 am" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(22) "09/22/2019 12:00:00 am" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(21) "Дата подачи" ["~DEFAULT_VALUE"]=> NULL ["DISPLAY_VALUE"]=> string(32) "09/22/2019 12:00:00 am" } ["ACCEPTED"]=> array(37) { ["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" ["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"]=> string(5) "25846" ["VALUE"]=> string(22) "11/14/2019 12:00:00 am" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(22) "11/14/2019 12:00:00 am" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(25) "Дата принятия" ["~DEFAULT_VALUE"]=> NULL ["DISPLAY_VALUE"]=> string(32) "11/14/2019 12:00:00 am" } ["CONTACT"]=> array(38) { ["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) "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) "" ["DISPLAY_VALUE"]=> string(62) "Mahboobeh Razmkhah" ["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) "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.

" ["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(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.

" } ["ORGANIZATION_RU"]=> array(37) { ["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) "25855" ["VALUE"]=> array(2) { ["TEXT"]=> string(1037) "<p>¹ Научный центр ЛОР-хирургии области головы и шеи, Ширазский университет медицинских наук, Шираз, Иран<br> ² Департамент оториноларингологии, Ширазский медицинский университет, Шираз, Иран<br> ³ Департамент патологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран<br> ⁴ Ширазский институт раковых исследований, Школа медицины, Ширазский медицинский университет, Шираз, Иран<br> ⁵ Департамент иммунологии, Школа медицины, Ширазский медицинский университет, Шираз, Иран</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(941) "

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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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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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.

" ["~DETAIL_TEXT"]=> string(10274) "

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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Кристина А. Закурдаева

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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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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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 <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
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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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                    [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>
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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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<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>
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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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                    [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>
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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 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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                    [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>
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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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                    [TEXT] => <p>Bijan Khademi<sup>1,2</sup>, Zohreh Zandifar<sup>2</sup>, Ahmad Monabati<sup>3</sup>, Nooshafarin Chenari<sup>4</sup>, Abbas Ghaderi<sup>4,5</sup>, Mahboobeh Razmkhah<sup>4</sup></p>
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Bijan Khademi1,2, Zohreh Zandifar2, Ahmad Monabati3, Nooshafarin Chenari4, Abbas Ghaderi4,5, Mahboobeh Razmkhah4
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                    [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>
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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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                    [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>
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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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                    [TEXT] => <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>
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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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Foundation for Cancer Research Support (RakFond), Moscow, Russia
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                    [TEXT] => <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>
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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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            [TIMESTAMP_X] => 2015-09-03 10:49:47
            [IBLOCK_ID] => 2
            [NAME] => Name
            [ACTIVE] => Y
            [SORT] => 500
            [CODE] => NAME_EN
            [DEFAULT_VALUE] => 
            [PROPERTY_TYPE] => S
            [ROW_COUNT] => 1
            [COL_COUNT] => 80
            [LIST_TYPE] => L
            [MULTIPLE] => N
            [XML_ID] => 40
            [FILE_TYPE] => 
            [MULTIPLE_CNT] => 5
            [TMP_ID] => 
            [LINK_IBLOCK_ID] => 0
            [WITH_DESCRIPTION] => N
            [SEARCHABLE] => N
            [FILTRABLE] => N
            [IS_REQUIRED] => Y
            [VERSION] => 1
            [USER_TYPE] => 
            [USER_TYPE_SETTINGS] => 
            [HINT] => 
            [PROPERTY_VALUE_ID] => 25909
            [VALUE] => Game of genomes: to be continued
            [DESCRIPTION] => 
            [VALUE_ENUM] => 
            [VALUE_XML_ID] => 
            [VALUE_SORT] => 
            [~VALUE] => Game of genomes: to be continued
            [~DESCRIPTION] => 
            [~NAME] => Name
            [~DEFAULT_VALUE] => 
        )

    [FULL_TEXT_RU] => Array
        (
            [ID] => 42
            [TIMESTAMP_X] => 2015-09-07 20:29:18
            [IBLOCK_ID] => 2
            [NAME] => Полный текст
            [ACTIVE] => Y
            [SORT] => 500
            [CODE] => FULL_TEXT_RU
            [DEFAULT_VALUE] => Array
                (
                    [TEXT] => 
                    [TYPE] => HTML
                )

            [PROPERTY_TYPE] => S
            [ROW_COUNT] => 1
            [COL_COUNT] => 30
            [LIST_TYPE] => L
            [MULTIPLE] => N
            [XML_ID] => 42
            [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] => 
            [VALUE] => 
            [DESCRIPTION] => 
            [VALUE_ENUM] => 
            [VALUE_XML_ID] => 
            [VALUE_SORT] => 
            [~VALUE] => 
            [~DESCRIPTION] => 
            [~NAME] => Полный текст
            [~DEFAULT_VALUE] => Array
                (
                    [TEXT] => 
                    [TYPE] => HTML
                )

        )

    [PDF_RU] => Array
        (
            [ID] => 43
            [TIMESTAMP_X] => 2015-09-09 16:05:20
            [IBLOCK_ID] => 2
            [NAME] => PDF RUS
            [ACTIVE] => Y
            [SORT] => 500
            [CODE] => PDF_RU
            [DEFAULT_VALUE] => 
            [PROPERTY_TYPE] => F
            [ROW_COUNT] => 1
            [COL_COUNT] => 30
            [LIST_TYPE] => L
            [MULTIPLE] => N
            [XML_ID] => 43
            [FILE_TYPE] => doc, txt, rtf, pdf
            [MULTIPLE_CNT] => 5
            [TMP_ID] => 
            [LINK_IBLOCK_ID] => 0
            [WITH_DESCRIPTION] => N
            [SEARCHABLE] => N
            [FILTRABLE] => N
            [IS_REQUIRED] => N
            [VERSION] => 1
            [USER_TYPE] => 
            [USER_TYPE_SETTINGS] => 
            [HINT] => 
            [PROPERTY_VALUE_ID] => 25910
            [VALUE] => 1925
            [DESCRIPTION] => 
            [VALUE_ENUM] => 
            [VALUE_XML_ID] => 
            [VALUE_SORT] => 
            [~VALUE] => 1925
            [~DESCRIPTION] => 
            [~NAME] => PDF RUS
            [~DEFAULT_VALUE] => 
        )

    [PDF_EN] => Array
        (
            [ID] => 44
            [TIMESTAMP_X] => 2015-09-09 16:05:20
            [IBLOCK_ID] => 2
            [NAME] => PDF ENG
            [ACTIVE] => Y
            [SORT] => 500
            [CODE] => PDF_EN
            [DEFAULT_VALUE] => 
            [PROPERTY_TYPE] => F
            [ROW_COUNT] => 1
            [COL_COUNT] => 30
            [LIST_TYPE] => L
            [MULTIPLE] => N
            [XML_ID] => 44
            [FILE_TYPE] => doc, txt, rtf, pdf
            [MULTIPLE_CNT] => 5
            [TMP_ID] => 
            [LINK_IBLOCK_ID] => 0
            [WITH_DESCRIPTION] => N
            [SEARCHABLE] => N
            [FILTRABLE] => N
            [IS_REQUIRED] => N
            [VERSION] => 1
            [USER_TYPE] => 
            [USER_TYPE_SETTINGS] => 
            [HINT] => 
            [PROPERTY_VALUE_ID] => 25911
            [VALUE] => 1926
            [DESCRIPTION] => 
            [VALUE_ENUM] => 
            [VALUE_XML_ID] => 
            [VALUE_SORT] => 
            [~VALUE] => 1926
            [~DESCRIPTION] => 
            [~NAME] => PDF ENG
            [~DEFAULT_VALUE] => 
        )

    [NAME_LONG] => Array
        (
            [ID] => 45
            [TIMESTAMP_X] => 2023-04-13 00:55:00
            [IBLOCK_ID] => 2
            [NAME] => Название (для очень длинных заголовков)
            [ACTIVE] => Y
            [SORT] => 500
            [CODE] => NAME_LONG
            [DEFAULT_VALUE] => Array
                (
                    [TYPE] => HTML
                    [TEXT] => 
                )

            [PROPERTY_TYPE] => S
            [ROW_COUNT] => 1
            [COL_COUNT] => 30
            [LIST_TYPE] => L
            [MULTIPLE] => N
            [XML_ID] => 45
            [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] => 80
                )

            [HINT] => 
            [PROPERTY_VALUE_ID] => 
            [VALUE] => 
            [DESCRIPTION] => 
            [VALUE_ENUM] => 
            [VALUE_XML_ID] => 
            [VALUE_SORT] => 
            [~VALUE] => 
            [~DESCRIPTION] => 
            [~NAME] => Название (для очень длинных заголовков)
            [~DEFAULT_VALUE] => Array
                (
                    [TYPE] => HTML
                    [TEXT] => 
                )

        )

)