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Stem Cells. 2019 Apr 25. doi: 10.1002/stem.3003. [Epub ahead of print]

A report from a workshop of the International Stem Cell Banking Initiative, held in collaboration GAiT and the Harvard Stem Cell Institute, Boston 2017.

Author information

1
Division of Intractable Diseases, Korea National Stem Cell Bank, Center for Biomedical Sciences, Korea National Institute of Health, Cheongju, Republic of Korea.
2
Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridge, UK.
3
The Azrieli Center for Stem Cells and Genetic Research, Institute of Life Sciences, Hebrew University of Jerusalem, Givat-Ram, Jerusalem, Israel.
4
Takara Bio Europe AB, Arvid Wallgrens Backe 20, SE413 46 Göteborg, Sweden.
5
Cell Line Development Memphis Meats, Berkeley, CA.
6
University of Minnesota, Minneapolis, Minnesota, USA.
7
European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Cambridge, UK.
8
Foundation for Biological Research and Innovation (FBRI), Kobe, Japan.
9
Institute for Frontier Life and Medical Sciences, Kyoto University, Kyoto, Japan.
10
Charité - Universitätsmedizin Berlin, Berlin-Brandenburg Center for Regenerative Therapies, Berlin, Germany.
11
Department of Chemical Physiology and Center for Regenerative Medicine, The Scripps Research Institute, La Jolla, California.
12
WiCell Research Institute (WiCell Stem Cell Bank), Madison, WI, USA.
13
UK Stem Cell Bank, National Institute for Biological Standards and Control, South Mimms, UK.
14
Adaptimmune Ltd., 60 Jubilee Avenue, Milton Park, Abingdon, Oxfordshire, UK.
15
Advanced Therapeutics, Scottish National Blood Transfusion Service, Edinburgh, UK.
16
Cell & Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, London, UK.
17
Global Alliance for iPSC Therapies (GAiT), The Jack Copland Centre, Edinburgh, UK.
18
Stem Cell Group, Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, SINGAPORE.
19
National Laboratory for Embryonic Stem Cells (LaNCE), Department of Genetics and Evolutionary Biology, Biosciences Institute, University of São Paulo, SP, Brazil.
20
Hematology and Stem Cell Laboratory, Faculty of Pharmacy, Universidade Federal do Rio Grande do Sul. Stem Cell Research Institute, Porto Alegre, RS, Brazil.
21
Department of Genetics, Rutgers, The State University of New Jersey, Life Sciences Building, Piscataway, NJ, USA.
22
Censo Biotechnologies Ltd, Roslin Innovation Centre, Midlothian, UK.
23
New York Stem Cell Foundation, New York, NY, USA.
24
State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.
25
International Stem Cell Banking Initiative, 2 High St, Barley, Hertfordshire, SG88HZ, UK.

Abstract

This report summarizes the recent activity of the International Stem Cell Banking Initiative (ISCBI) held at Harvard Stem Cell Institute, Boston, USA, on 18th Jun 2017. In this meeting, we aimed to find consensus on ongoing issues of quality control (QC), safety and efficacy of human pluripotent stem cell (hPSC) banks and their derivative cell therapy products for the global harmonization. In particular, assays for the QC testing such as pluripotency assays test and general QC testing criteria was intensively discussed. Moreover, the recent activities of global stem cell banking centres and the regulatory bodies were briefly summarized to provide an overview on global developments and issues. SIGNIFICANCE STATEMENT: ISCBI was established in 2007 with funding from the International Stem Cell Forum (www.stem-cell-forum.net/), with the remit to support hPSC banking centers, stem cell biologists, regulatory bodies and others involved and/or interested in biobanking. In this report, we provide a summary of the key points of discussion from the 2017 ISCBI meeting, with emphasis on data standardization, quality control and genetic for quality assurance and resource sharing. We believe that this report provides a useful global perspective on developments in pluripotent stem cell applications and guidance on evaluation of emerging technologies for culture, characterization, safety testing and ethical guidelines in the establishment of safe and effective stocks of stem cells for future regenerative medicine.

KEYWORDS:

Banking; Global harmonization; ISCBI; Pluripotent stem cells; Quality controls

PMID:
31021472
DOI:
10.1002/stem.3003

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