International Practice of Storing Human Cell Lines Intended for Clinical Use
https://doi.org/10.30895/2221-996X-2018-18-4-216-224
Abstract
Currently, the Russian Federation does not have a well-established state-controlled market for cell banks (CB) containing cell material that is potentially applicable for clinical purposes. Cryopreservation of cells in cell bank (CB) is an important step in the production of a number of biomedical cell products and makes it possible to overcome difficulties faced by manufacturers during production and storage of large amounts of cell material. At present there are a large number of human cell lines in the world, which are stored in CB owned by commercial and public organisations in different countries. In addition, new cell lines are being banked every year. All this makes it difficult to find cell material suitable for production purposes or that could potentially be used as donor material in clinics. This study analysed the international practice of storing human cell lines for clinical use. The authors of the study systematised the existing CB worldwide and analysed regulatory documents governing the activities of these banks in different countries. The analysis revealed a trend towards formation of CB, often specialising in certain types of cells, as well as a trend towards creation of registries giving full information about cell lines including data on their scientific application. The increasing development and clinical use of cell therapy products in the Russian Federation and abroad will most likely lead to the increase in the number of CB and registry systems, as well as amounts of materials stored in them, including cell lines intended for clinical use.
Keywords
About the Authors
O. A. RachinskayaRussian Federation
8/2 Petrovsky Blvd, Moscow 127051
Candidate of Biological Sciences, 1st Professional Category Expert of the Laboratory of Biomedical Cell Products of the Testing Centre for Evaluation of Medicinal Products’ Quality
A. A. Chaplenko
Russian Federation
8/2 Petrovsky Blvd, Moscow 127051
2nd Professional Category Expert of the Laboratory of Biomedical Cell Products of the Testing Centre for Evaluation of Medicinal Products’ Quality
E. V. Melnikova
Russian Federation
8/2 Petrovsky Blvd, Moscow 127051
Candidate of Biological Sciences, Chief Expert of the Laboratory of Biomedical Cell Products of the Testing Centre for Evaluation of Medicinal Products’ Quality
I. S. Semenova
Russian Federation
8/2 Petrovsky Blvd, Moscow 127051
Candidate of Biological Sciences, 1st Professional Category Expert of the Laboratory of Biomedical Cell Products of the Testing Centre for Evaluation of Medicinal Products’ Quality
Yu. V. Olefir
Russian Federation
8/2 Petrovsky Blvd, Moscow 127051
Doctor of Medical Sciences, Director General of Medicinal Products` Evaluation
References
1. Abbasalizadeh S, Pakzad M, Cabral JMS, Baharvand H. Allogenic cell therapy manufacturing: process development technologies and facility design options. Expert Opin Biol Ther. 2017;17(10):1201–19. http://doi.org/10.1080/14712598.2017.1354982
2. Мельникова ЕВ, Меркулова ОВ, Чапленко АА, Меркулов ВА. Дизайн доклинических исследований биомедицинских клеточных продуктов: особенности, ключевые принципы и требования. БИОпрепараты. Профилактика, диагностика, лечение. 2017;17(3):133–44. [Melnikova EV, Merkulova OV, Chaplenko AA, Merkulov VA. Design of preclinical studies of biomedical cell products: characteristics, key principles and requirements. BIOpreparaty. Profilaktika, diagnostika, lechenie = BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(3):133–44 (In Russ.)]
3. Harris DT. Stem cell banking for regenerative and personalized medicine. Biomedicines. 2014;2(1):50–79. http://doi.org/10.3390/biomedicines2010050
4. Isasi RM, Knoppers BM. Governing stem cell banks and registries: emerging issues. Stem Cell Res. 2009;3(2–3):96–105. http://doi.org/10.1016/j.scr.2009.05.003
5. Armitage JO. Bone marrow transplantation. N. Engl J Med. 1994;330(12):827–38. http://doi.org/10.1056/NEJM199403243301206
6. Thomas ED, Lochte HL Jr, Lu WC, Ferrebee JW. Intravenous infusion of bone marrow in patients receiving radiation and chemotherapy. N Engl J Med. 1957;257(11):491–6. http://doi.org/10.1056/NEJM195709122571102
7. Сopelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. 2006;354(17):1813–26. http://doi.org/10.1056/NEJMra052638
8. Broxmeyer HE, Douglas GW, Hangoc G, Cooper S, Bard J, English D, et al. Human umbilical cord blood as a potential source of transplantable hematopoietic stem/progenitor cells. Proc Natl Acad Sci USA. 1989;86(10):3828–32.
9. Кобзева ИВ, Астрелина ТА, Яковлева МВ, Подколзина ЭА, Карпова ЕЭ, Лебедева ЛЛ и др. Системный подход к обеспечению качества гемопоэтических стволовых клеток пуповинной крови для клинического применения. Клеточная трансплантология и тканевая инженерия. 2011;6(1):55–8. [Kobzeva IV, Astrelina TA, Yakovleva MV, Podkolzina EA, Karpova EE, Lebedeva LL, et al. A systemic approach to quality assurance of umbilical cord blood hematopoietic stem cells designed for clinical use. Kletochnaya transplantologiya i tkanevaya inzheneriya = Cellular Transplantation and Tissue Engineering. 2011;6(1):55–8 (In Russ.)]
10. Berz D, McCormack EM, Winer ES, Colvin GA, Quesenberry PJ. Cryopreservation of hematopoietic stem cells. Am J Hematol. 2007;82(6):463–72. http://doi.org/10.1002/ajh.20707
11. Solves P, Mirabet V, Perales A, Carbonell-Uberos F, Roig R. Banking strategies for improving the hematopoietic stem cell content of umbilical cord blood units for transplantation. Cerr Stem Cell Res Ther. 2008;3(2):79–84. http://doi.org/10.2174/157488808784223096
12. Исаев АА, Квашнина НВ, Приходько АВ. Банки пуповинной крови — деятельность, ее регулирование, перспективы. Клеточная трансплантология и тканевая инженерия. 2006;3(1):88–98. [Isaev AA, Kvashnina NV, Prikhod’ko AV. Cord blood banks: activity, its regulation, prospects. Kletochnaya transplantologiya i tkanevaya inzheneriya = Cellular Transplantation and Tissue Engineering. 2006;3(1):88–98 (In Russ.)]
13. Rocha V, Broxmeyer HE. New approaches for improving engraftment after cord blood transplantation. Biol Blood Marrow Transplant. 2010;16(1):126–32. http://doi.org/10.1016/j.bbmt.2009.11.001
14. Broxmeyer HE. Umbilical cord transplantation: epilogue. Semin Hematol. 2010;47(1):97–103. http://doi.org/10.1053/j.seminhematol.2009.10.002
15. Thirumala S, Scott Goebel WS, Woods EJ. Clinical grade adult stem cell banking. Organogenesis. 2009;5(3):143–54. http://doi.org/10.4161/org.5.3.9811
16. Stacey GN, Connon CJ, Coopman K, Dickson AJ, Fuller B, Hunt CJ, et al. Preservation and stability of cell therapy products: recommendations from an expert workshop. Regen Med. 2017;12(5):553–64. http://doi.org/10.2217/rme-2017-0073
17. Акопян АС, Белоусов ДЮ, Рысулы МР, Куликов АВ. Некоторые актуальные проблемы клинических исследований стволовых клеток. Качественная клиническая практика. 2010;(1):22–8. [Akopyan AS, Belousov DYu, Rysuly MR, Kulikov AV. Nekotorye aktual’nye problemy klinicheskikh issledovaniy stvolovykh kletok. Kachestvennaya klinicheskaya praktika. 2010;(1):22–8 (In Russ.)]
18. Feigal EG, Tsokas K, Viswanathan S, Zhang J, Priest C, Pearce J, Mount N. Proceedings: international regulatory considerations on development pathways for cell therapies. Stem Cells Transl Med. 2014;3(8):879–87. http://doi.org/10.5966/sctm.2014-0122
19. Исаев АА, Мелихова ВС. Коммерческие аспекты выделения, хранения и применения стволовых клеток пуповинной крови: мировой опыт. Клеточная трансплантология и тканевая инженерия. 2008;3(4):66–70. [Isaev AA, Melikhova VS. Commercial aspects of isolation, storage and use of cord blood stem cells: the world experience. Kletochnaya transplantologiya i tkanevaya inzheneriya = Cellular Transplantation and Tissue Engineering. 2008;3(4):66–70 (In Russ.)]
20. Woods EJ, Pollok KE, Byers MA, Perry BC, Purtteman J, Heimfeld S, et al. Cord blood stem cell cryopreservation. Transfus Med Hemother. 2007;34:276–85. http://doi.org/10.1159/000104183
21. Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007;100(9):1249–60. http://doi.org/10.1161/01.RES.0000265074.83288.09
22. Unger C, Skottman H, Blomberg P, Dilber MS, Hovatta O. Good manufacturing practice and clinical-grade human embryonic stem cell lines. Hum Mol Genet. 2008;17(R1):48–53. http://doi.org/10.1093/hmg/ddn079
23. Reuther T, Kettmann C, Scheer M, Kochel M, Iida S, Kubler AC. Cryopreservation of osteoblast-like cells: viability and differentiation with replacement of fetal bovine serum in vitro. Cells Tissues Organs. 2006;183(1):32–40. http://doi.org/10.1159/000094904
24. Макаров АВ, Арутюнян ИВ, Аполихина ИА, Тетерина ТА, Саидова АС, Адамян ЛВ. Тканеинженерные конструкции для лечения стрессового недержания мочи. В кн.: Материалы II Национального конгресса по регенеративной медицине. М.; 2015. С. 109–10. [Makarov AV, Arutyunyan IV, Apolikhina IA, Teterina TA, Saidova AS, Adamyan LV. Tissue engineering designs for the treatment of stress urinary incontinence. In: Materials of the II National Congress on Regenerative Medicine. Moscow; 2015. P. 109–10 (In Russ.)]
25. Блинова МИ, Никольский НН, Михайлова НА. 25-летний опыт применения дермального эквивалента: итоги и перспективы. В кн.: Материалы II Национального конгресса по регенеративной медицине. М.; 2015. С. 33–4. [Blinova MI, Nikol’skiy NN, Mikhailova NA. 25 years experience in the use of dermal equivalent: results and prospects. In: Materials of the II National Congress on Regenerative Medicine. Moscow; 2015. P. 33–4 (In Russ.)]
Review
For citations:
Rachinskaya O.A., Chaplenko A.A., Melnikova E.V., Semenova I.S., Olefir Yu.V. International Practice of Storing Human Cell Lines Intended for Clinical Use. BIOpreparations. Prevention, Diagnosis, Treatment. 2018;18(4):216-224. (In Russ.) https://doi.org/10.30895/2221-996X-2018-18-4-216-224