This article summarizes the recent activity of the International Stem Cell Banking Initiative (ISCBI) held at the California Institute for Regenerative Medicine (CIRM) in California (June 26, 2016) and the Korean National Institutes for Health in Korea (October 19–20, 2016). Through the workshops, ISCBI is endeavoring to support a new paradigm for human medicine using pluripotent stem cells (hPSC) for cell therapies. Priority considerations for ISCBI include ensuring the safety and efficacy of a final cell therapy product and quality assured source materials, such as stem cells and primary donor cells. To these ends, ISCBI aims to promote global harmonization on quality and safety control of stem cells for research and the development of starting materials for cell therapies, with regular workshops involving hPSC banking centers, biologists, and regulatory bodies. Here, we provide a brief overview of two such recent activities, with summaries of key issues raised. Stem Cells Translational Medicine 2017;6:1956–1962.
Bibliographical noteFunding Information:
The ISCBI organizers extend their appreciation to all participants in the workshops for their contributions leading to the conclusions. We especially thank CiRM and KNIH (2016-NG61002-00) for their financial support for the workshops.
QC Test Package Required for iPSC Banks for Clinical Use Established at the Foundation for Biomedical Research and Innovation
International Stem Cell Banking Initiative (ISCBI) was established in 2007 with funding from the International Stem Cell Forum (http://www.stem-cell-forum.net/), with the remit to support human pluripotent stem cells (hPSC) banking centers, stem cell biologists, regulatory bodies, and others involved and/or interested in biobanking [1–3]. The ISCBI members have held regular workshops and have published a series of publications including best practice for the preparation and dissemination of hPSCs for research and clinical application [4, 5]. The ISCBI meetings regularly
Prof. Andreas Kurtz (Charité Universit€atsmedizin, Berlin, Germany) reported on the hPSCreg database funded by the European Commission (EC), which now contained information on about 1,600 hPSC lines from 26 countries. The EC requires registration and certification of all human embryonic stem cell (hESC) and hiPSC lines by the registry before they can be used for EC-funded research, which involves validation of ethical provenance, identity and evidence of pluripotency. A more convenient facility for registering cell lines in batches is available for cooperation partners. hPSCreg adopts provisions to protect donor privacy. For instance, certain cell line’s genetic and clinical data sets, which might be misused to reidentify anonymized donors, for example, human leukocyte antigen (HLA) and short tandem repeat (STR) profiles, genetic sequences, are held on the database, but are not released publicly if open access was not granted by the consenting donor . The registry makes only two alleles of a STR profile available for public access, which would enable researchers to initiate independent confirmation of cell authenticity without releasing full STR profiles. Delegates supported the need for a standardized nomenclature for cell naming as published by International Stem Cell Initiative (ISCI) contributors , which also included a recommendation on minimal information to be included in publications of new hPSC lines. hPSCreg has implemented an automated tool and register for naming of hPSC lines according to a modification of the nomenclature standard  (https://hpscreg.eu/). It was acknowledged that day-to-day use of simplified local names was likely to continue for convenience; but it was felt timely to try to persuade scientists to use a standard nomenclature for formal identification, reporting, and referencing of cell lines.
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- Data standardization
- Human embryonic stem cell (hESC)
- Human pluripotent stem cells
- Induced pluripotent stem cell (iPSC)
- Informed consents
- Quality assurance
- Quality control
- Stem cell banking