Stacey Glyn, Andrews Peter, Asante Curtis, Barbaric Ivana, Barry Jaqueline, Bisset Louise, Braybrook Julian, Buckle Robin, Chandra Amit, Coffey Peter, Crouch Sharon, Driver Philip, Evans Amanda, Gardner John, Ginty Patrick, Goldring Christopher, Hay David C, Healy Lyn, Hows Anna, Hutchinson Claire, Jesson Helen, Kalber Tammy, Kimber Sue, Leathers Roland, Moyle Sarah, Murray Trish, Neale Michael, Pan David, Park B Kevin, Rebolledo Raul Elgueta, Rees Ian, Rivolta Marcelo N, Ritchie Allan, Roos Eric J, Saeb-Parsy Kourosh, Schröder Bernd, Sebastian Sujith, Thomas Angela, Thomas Robert J, Turner Marc, Vallier Ludovic, Vitillo Loriana, Webster Andrew, Williams David
International Stem Cell Banking Initiative, 2 High Street, Barley, Hertfordshire, SG8 8HZ, UK.
Department of Biomedical Sciences, Centre for Stem Cell Biology, University of Sheffield, Sheffield, South Yourkshire, S10 2TN, UK.
Regen Med. 2018 Dec;13(8):935-944. doi: 10.2217/rme-2018-0120. Epub 2018 Nov 29.
Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.
人类多能干细胞（hPSCs）具有变革医学的潜力。然而，要确保此类细胞产品的安全性仍存在障碍。需要基于科学理解源材料的要求以及合适的材料。hPSC生物学、临床转化、生物制造和监管问题领域的领导者齐聚一堂，以确定生产hPSC衍生疗法的源材料要求，并确定细胞治疗产品安全性的其他关键问题。虽然本次会议的重点是hPSC衍生的细胞疗法，但许多问题是所有基于细胞的药物所共有的。本报告旨在总结所讨论的关键问题，并记录专家代表在每个问题上达成的共识。
