Science-based assessment of source materials for cell-based medicines: Report of a stakeholders workshop

Glyn N Stacey, Peter W Andrews, Curtis Asante, Ivana Barbaric, Jacqueline Barry, Louise Bisset, Julian Braybrook, Robin Buckle, Amit Chandra, Peter Coffey, Sharon Crouch, Philip Driver, Amanda Evans, John Grant Gardner, Patrick Ginty, Christopher Goldring, David Hay, Lyn E Healy, Anna Hows, Claire HutchinsonHelen Jesson, Tammy L. Kalber, Sue Kimber, Roland Leathers, Sarah Moyle, Trish Murray, Michael Neale, David Pan, Brian Park, Raul Elgueta Robolledo, Ian Rees, Marcelo Rivolta, Allan Ritchie, Eric Roos, Kourosh Saeb-Parsy, Bernd Schröder, Sujith Sebastien, Angela Thomas, Robert Thomas, Marc L. Turner, Ludovic Vallier, Andrew Webster, David Williams

Research output: Contribution to journalArticleOtherpeer-review

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)935-944
Number of pages10
JournalRegenerative Medicine
Volume13
Issue number8
DOIs
Publication statusPublished - 1 Dec 2018

Keywords

  • ancillary materials
  • cell-based medicines
  • cell therapy
  • characterization regulatory science
  • efficacy
  • raw materials
  • regenerative medicine
  • safety
  • starting materials

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