Quality control guidelines for clinical-grade human induced pluripotent stem cell lines

Author:

Sullivan Stephen1,Stacey Glyn N2,Akazawa Chihiro3,Aoyama Naoki4,Baptista Ricardo5,Bedford Patrick6,Bennaceur Griscelli Annelise7,Chandra Amit8,Elwood Ngaire910,Girard Mathilde11,Kawamata Shin12,Hanatani Tadaaki13,Latsis Theodoros7,Lin Stephen14,Ludwig Tenneille E15,Malygina Tamara16,Mack Amanda17,Mountford Joanne C18,Noggle Scott19,Pereira Lygia V20,Price Jack21,Sheldon Michael22,Srivastava Alok2324,Stachelscheid Harald25,Velayudhan Shaji R2324,Ward Natalie J5,Turner Marc L1518,Barry Jacqueline15,Song Jihwan126

Affiliation:

1. Global Alliance for iPSC Therapies (GAiT), The Jack Copland Centre, Edinburgh, UK

2. International Stem Cell Banking Initiative, 2 High St, Barley, Hertfordshire, UK

3. Department of Biochemistry and Biophysics, Graduate School of Health Care Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan

4. Japan Agency for Medical Research and Development (AMED), Chiyoda-ku, Tokyo, Japan

5. Cell & Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, London, UK

6. Centre for Commercialization of Regenerative Medicine (CCRM), Toronto, ON, Canada

7. APHP-Hopital Paul Brousse Université Paris Sud/ESteam Paris Inserm UMR 935, Villejuif, France

8. Centre for Biological Engineering, Loughborough University, Holywell Park, Loughborough, UK

9. Cord Blood Research, Murdoch Children's Research Institute, Melbourne, VIC 3052, Australia

10. Department of Paediatrics, University of Melbourne, Parkville, Victoria 3052, Australia

11. Yposkesi, 2 Rue Henri Auguste Desbruères, 91100 Corbeil-Essonnes, France

12. Foundation Biomedical Research and Innovation (FBRI), Research and Development Center for Cell Therapy, Chuo-ku, Kobe, Japan

13. Center for iPS Cell Research and Application (CiRA), Kyoto University, Kyoto, Japan

14. California Institute for Regenerative Medicine (CIRM), Lake Merritt Plaza, 1999 Harrison Street STE 1650, Oakland, CA, USA

15. WiCell Research Institute (WiCell Stem Cell Bank), Madison, WI 53719, USA

16. Optec LLC, Inzhenernaya Str., 28 Novosibirsk, 630090, Russia

17. Fujifilm Cellular Dynamics International, 525 Science Dr., Madison, WI 53711, USA

18. Advanced Therapeutics, Scottish National Blood Transfusion Service, Edinburgh, UK

19. New York Stem Cell Foundation Laboratories, New York, NY 10032, USA

20. Department of Genetics and Evolutionary Biology, Institute of Biosciences, University of São Paulo, São Paulo, Brazil

21. UK Stem Cell Bank, National Institute for Biological Standards and Control, Hertfordshire, UK

22. Department of Genetics, Rutgers, The State University of New Jersey, Piscataway, NJ 08854-8009, USA

23. Department of Haematology, Christian Medical College, Vellore- 632004, Tamil Nadu, India

24. Centre for Stem Cell Research, Christian Medical College, Vellore- 632004, Tamil Nadu, India

25. Charité – Universita¨tsmedizin Berlin, Berlin Institute of Health and Berlin-Brandenburg Center for Regenerative Therapies, Berlin 13353, Germany

26. Department of Biomedical Science, CHA Stem Cell Institute, CHA University, Seongnam-si, Gyeonggi-do, Republic of Korea

Abstract

Use of clinical-grade human induced pluripotent stem cell (iPSC) lines as a starting material for the generation of cellular therapeutics requires demonstration of comparability of lines derived from different individuals and in different facilities. This requires agreement on the critical quality attributes of such lines and the assays that should be used. Working from established recommendations and guidance from the International Stem Cell Banking Initiative for human embryonic stem cell banking, and concentrating on those issues more relevant to iPSCs, a series of consensus workshops has made initial recommendations on the minimum dataset required to consider an iPSC line of clinical grade, which are outlined in this report. Continued evolution of this field will likely lead to revision of these guidelines on a regular basis.

Publisher

Future Medicine Ltd

Subject

Embryology,Biomedical Engineering

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