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

Research output: Contribution to journalArticle

  • 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
  • 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
  • Robert J Thomas
  • Marc Turner
  • Ludovic Vallier
  • Loriana Vitillo
  • Andrew Webster
  • David Williams

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Original languageEnglish
Pages (from-to)935-944
JournalRegenerative medicine
Volume13
Issue number8
Early online date29 Nov 2018
DOIs
Publication statusPublished - 1 Dec 2018

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, bio manufacturing 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. Whilst the focus of this meeting was on hPSC-derived cell therapies, many if the issues are generic to all cell-based medicines. The intent of this report is to summarise the key issues discussed and record the consensus reached on each of these by the expert delegates.

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