Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop
Authors list
Glyn Stacey Peter Andrews Curtis Asante Ivana Barbaric Jaqueline Barry Louise Bisset Julian Braybrook Robin Buckle Amit Chandra Peter Coffey Sharon Crouch Philip Driver Amanda Evans John Gardner Patrick Ginty Christopher Goldring David C Hay Lyn Healy Anna Hows Claire Hutchinson Helen Jesson Tammy Kalber Sue Kimber Roland Leathers Sarah Moyle Trish Murray Michael Neale David Pan B Kevin Park Raul Elgueta Rebolledo Ian Rees Marcelo N Rivolta Allan Ritchie Eric J Roos Kourosh Saeb-Parsy Bernd Schröder Sujith Sebastien Angela Thomas Robert J Thomas Marc Turner Ludovic Vallier Loriana Vitillo Andrew Webster David Williams Toggle all authors (44)
Abstract
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.
Journal details
Journal Regenerative Medicine
Volume 13
Issue number 8
Pages 935-944
Publication date
Full text links
Publisher website (DOI) 10.2217/rme-2018-0120
Europe PubMed Central 30488776
Pubmed 30488776
Keywords
Type of publication