Genes & CellsGenes & CellsГены и КлеткиGenes and Cells2313-18292500-2562Human Stem Cells Institute68347110.17816/gc683471ReviewsНаучные обзорыUnknownSafety, Legal Aspects, and Current State of Research on Biomedical Cell Products and Drugs Derived Using Induced Pluripotent Stem Cell TechnologyБЕЗОПАСНОСТЬ, ПРАВОВЫЕ АСПЕКТЫ И СОСТОЯНИЕ ИССЛЕДОВАНИЙ ПРИМЕНЕНИЯ БИОМЕДИЦИНСКИХ КЛЕТОЧНЫХ ПРОДУКТОВ, ПОЛУЧЕННЫХ С ИСПОЛЬЗОВАНИЕМ ТЕХНОЛОГИИ ИНДУЦИРОВАННЫХ ПЛЮРИПОТЕНТНЫХ СТВОЛОВЫХ КЛЕТОКhttps://orcid.org/0000-0003-2305-493657193354943K-1158-20182751-1747GalitsynaElena ValerievnaГалицынаЕлена Валерьевна
Russian Federation

Ведущий специалист, Отдел экспертизы,Координационный центр исследований и разработок в области медицинскойнауки

galitsynaev@mednet.ruhttps://orcid.org/0000-0003-0187-18984361-1951UlyakinaNatalya AlexandrovnaУлякинаНаталья Александровнаulyakinana@mednet.ruhttps://orcid.org/0000-0001-9063-0601J-9829-20144004-6894GusevAlexander BorisovichГусевАлександр Борисовичgusevab@mednet.ruhttps://orcid.org/0000-0001-8136-99318474-7767VladimirovGeorgiy KВладимировГеоргий Константиновичvladimirovgk@mednet.ruRussian research Institute of HealthФедеральное государственное бюджетное учреждение «Центральный научно-исследовательский институт организации и информатизации здравоохранения» Минздрава России,050620262120906202517022026Copyright ©; , Eco-VectorCopyright ©; , Эко-ВекторEco-VectorЭко-Векторhttps://eco-vector.com/for_authors.php#07https://genescells.ru/2313-1829/article/view/683471

cellular therapy products, advanced therapy medicinal products (ATMP), induced pluripotent stem cells (iPSCs), embryonic stem cells (ESCs), mesenchymal stem cells (MSCs), cell therapy, clinical trials, preclinical studies, good manufacturing practice (GMP).биомедицинские клеточные продукты (БМКП), индуцированные плюрипотентные стволовые клетки (ИПСК), эмбриональные стволовые клетки (ЭСК), мультипотентные мехзенхимальные стволовые клетки (ММСК), клеточная терапия, клинические исследования, доклинические исследования, надлежащая производственная практика (GMP).Russian Research Institute of Health, Moscow, RussiaФГБУ «Центральный научно-исследовательский институт организации и информатизации здравоохранения» Министерства здравоохранения Российской Федерации, Москва, РоссияСПИСОК ЛИТЕРАТУРЫ / REFERENCES1. Mansouri V, Beheshtizadeh N, Gharibshahian M, et al. Recent advances in regenerative medicine strategies for cancer treatment. Biomedicine and Pharmacotherapy. 2021;141:111875. doi: 10.1016/j.biopha.2021.111875.2. Christodoulou I, Goulielmaki M, Devetzi M, et al. Mesenchymal stem cells in preclinical cancer cytotherapy: a systematic review. Stem Cell Research and Therapy. 2018;9(1):336. doi: 10.1186/s13287-018-1078-8.3. Jukes JM, van Blitterswijk CA, de Boer J. Skeletal tissue engineering using embryonic stem cells. Journal of Tissue Engineering and Regenerative Medicine. 2010;4(3):165–180. doi: 10.1002/term.234.4. DeFrancesco L. Fits and starts for Geron. Nature Biotechnology. 2009;27:877. doi: 10.1038/nbt1009-877b.5. Ye L, Swingen C, Zhang J. Induced pluripotent stem cells and their potential for basic and clinical sciences. Current Cardiology Reviews. 2013;9(1):63-72. doi: 10.2174/157340313805076278.6. Goldman B. Embryonic Stem Cells 2.0. Nature Reports Stem Cells. 2008. doi: 10.1038/stemcells.2008.67.7. Takahashi K, Tanabe K, Ohnuki M, et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007;131(5):861-72. doi: 10.1016/j.cell.2007.11.019.8. Yu J, Vodyanik MA, Smuga-Otto K, et al. Induced pluripotent stem cell lines derived from human somatic cells. Science. 2007;318(5858):1917-1920. doi: 10.1126/science.1151526.9. Golubinskaya PA, Ruchko ES, Pikina AS, et al. Tissue-engineered and cell-based therapies for cartilage defects. Genes and Cells. 2025;20(1):5-17. doi: 10.17816/gc640858.10. Pristyazhnyuk IE, Menzorov AG. Generation of American mink induced pluripotent stem cells: a protocol. Vavilov Journal of Genetics and Breeding. 2017; 21(6):701-709. (In Russ.). doi: 10.18699/VJ17.288.11. Buta C, David R, Dressel R, et al. Reconsidering pluripotency tests: do we still need teratoma assays? Stem Cell Research. 2013;11(1):552-62. doi: 10.1016/j.scr.2013.03.001.12. Knoepfler PS. Deconstructing stem cell tumorigenicity: a roadmap to safe regenerative medicine. Stem Cells. 2009;27(5):1050-6. doi: 10.1002/stem.37.13. Masuda S, Yokoo T, Sugimoto N, et al. A Simplified In Vitro Teratoma assay for pluripotent stem cells injected into rodent fetal organs. Cell Medicine. 2012;3(1-3):103-112. doi: 10.3727/215517912X639351.14. Miyawaki S, Okada Y, Okano H, et al. Teratoma Formation Assay for Assessing Pluripotency and tumorigenicity of pluripotent stem cells. Bio-Protocol. 2017;7(16):e2518. doi: 10.21769/BioProtoc.2518.15. Nori S, Okada Y, Yasuda A, et al. Grafted human-induced pluripotent stem-cell-derived neurospheres promote motor functional recovery after spinal cord injury in mice. Proceedings of the National Academy of Sciences of the USA. 2011;108(40):16825-30. doi: 10.1073/pnas.1108077108.16. Nori S, Okada Y, Nishimura S, et al. Long-term safety issues of iPSC-based cell therapy in a spinal cord injury model: oncogenic transformation with epithelial-mesenchymal transition. Stem Cell Reports. 2015;4(3):360-373. doi: 10.1016/j.stemcr.2015.01.006.17. Han L, He H, Yang Y, et al. Distinctive clinical and pathologic features of immature teratomas arising from induced pluripotent stem cell-derived beta cell injection in a diabetes patient. Stem Cells and Development. 2022;31(5-6):97-101. doi: 10.1089/scd.2021.0255.18. Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell. 2006;126(4):663–676. doi: 10.1016/j.cell.2006.07.024.19. Medvedev SP, Shevchenko AI, Zakian SM. Induced pluripotent stem cells: problems and advantages when applying them in regenerative medicine. Acta Naturae. 2010;2(2):18-28.20. Kanemura H, Go MJ, Shikamura M, et al. Tumorigenicity studies of induced pluripotent stem cell (iPSC)-derived retinal pigment epithelium (RPE) for the treatment of age-related macular degeneration. PLoS One. 2014;9(1):e85336. doi: 10.1371/journal.pone.0085336.21. Cerneckis J, Cai H, Shi Y. Induced pluripotent stem cells (iPSCs): molecular mechanisms of induction and applications. Signal Transduction and Targeted Therapy. 2024;9(1):112. doi: 10.1038/s41392-024-01809-0.22. Gutierrez-Aranda I, Ramos-Mejia V, Bueno C, et al. Human induced pluripotent stem cells develop teratoma more efficiently and faster than human embryonic stem cells regardless the site of injection. Stem Cells. 2010;28(9):1568-1570. doi: 10.1002/stem.471.23. Nakagawa M, Takizawa N, Narita M, et al. Promotion of direct reprogramming by transformation-deficient Myc. Proceedings of the National Academy of Sciences of the USA. 2010;107(32):14152-14157. doi: 10.1073/pnas.1009374107.24. Zhao T, Zhang ZN, Rong Z, et al. Immunogenicity of induced pluripotent stem cells. Nature. 2011;474(7350):212–215. doi: 10.1038/nature10135.25. Qiao Y, Agboola OS, Hu X, et al. Tumorigenic and immunogenic properties of induced pluripotent stem cells: a promising cancer vaccine. Stem Cell Reviews and Reports. 2020;16(6):1049-1061. doi: 10.1007/s12015-020-10042-5.26. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for human somatic cell therapy and gene therapy. Human Gene Therapy. 2001;12(3):303-314. doi: 10.1089/10430340150218431.27. Daley GQ, Hyun I, Apperley JF, et al. Setting global standards for stem cell research and clinical translation: the 2016 ISSCR guidelines. Stem Cell Reports. 2016;6:787–797.28. Moradi S, Mahdizadeh H, Šarić T, et al. Research and therapy with induced pluripotent stem cells (iPSCs): social, legal, and ethical considerations. Stem Cell Research and Therapy. 2019;10(1):341. doi: 10.1186/s13287-019-1455-y.29. Bauer SR. Stem cell-based products in medicine: FDA regulatory considerations. Handbook of stem cells. 2004:805–814. doi: 10.1016/B978-012436643-5/50163-2.30. Goodman L. States step in for stem cell research. Journal of Clinical Investigation. 2004;113(10):1376-1377. doi: 10.1172/JCI21950.31. Lovell-Badge R, Anthony E, Barker RA, et al. ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update. Stem Cell Reports. 2021;16(6):1398-1408. doi: 10.1016/j.stemcr.2021.05.012.32. Khamitova GM. Some legal aspects of the use of stem cells in medical practice. Law and legislation. 2024;(2):193-198. (In Russ.). doi: 10.24412/2073-3313-2024-2-193-198 EDN: https://elibrary.ru/KHBXKB.33. Kawamura T, Ito Y, Ito E, et al. Safety confirmation of induced pluripotent stem cell-derived cardiomyocyte patch transplantation for ischemic cardiomyopathy: first three case reports. Frontiers in Cardiovascular Medicine. 2023;10:1182209. doi: 10.3389/fcvm.2023.1182209.34. Kishino Y, Fukuda K. Unlocking the pragmatic potential of regenerative therapies in heart failure with next-generation treatments. Biomedicines. 2023;11(3):915. doi: 10.3390/biomedicines11030915.35. Bloor AJC, Patel A, Griffin JE, et al. Production, safety and efficacy of iPSC-derived mesenchymal stromal cells in acute steroid-resistant graft versus host disease: a phase I, multicenter, open-label, dose-escalation study. Nature Medicine. 2020;26(11):1720-1725. doi: 10.1038/s41591-020-1050-x.36. Zhao Y, Bai X, Guo S. et al. Efficacy and safety of CAR-T therapy targeting CLL1 in patients with extramedullary diseases of acute myeloid leukemia. Journal of Translational Medicine. 2024;22(1):888. doi: 10.1186/s12967-024-05705-7.37. Sawamoto N, Doi D, Nakanishi E, et al. Phase I/II trial of iPS-cell-derived dopaminergic cells for Parkinson's disease. Nature. 2025;641(8064):971-977. doi: 10.1038/s41586-025-08700-0.