Assessing the safety of stem cell therapeutics

Chris E.P. Goldring, Paul A. Duffy, Nissim Benvenisty, Peter W. Andrews, Uri Ben-David, Rowena Eakins, Neil French, Neil A. Hanley, Lorna Kelly, Neil R. Kitteringham, Jens Kurth, Deborah Ladenheim, Hugh Laverty, James McBlane, Gopalan Narayanan, Sara Patel, Jens Reinhardt, Annamaria Rossi, Michaela Sharpe, B. Kevin Park

Research output: Contribution to journalReview articlepeer-review


Unprecedented developments in stem cell research herald a new era of hope and expectation for novel therapies. However, they also present a major challenge for regulators since safety assessment criteria, designed for conventional agents, are largely inappropriate for cell-based therapies. This article aims to set out the safety issues pertaining to novel stem cell-derived treatments, to identify knowledge gaps that require further research, and to suggest a roadmap for developing safety assessment criteria. It is essential that regulators, pharmaceutical providers, and safety scientists work together to frame new safety guidelines, based on "acceptable risk," so that patients are adequately protected but the safety "bar" is not set so high that exciting new treatments are lost.

Original languageEnglish
Pages (from-to)618-628
Number of pages11
JournalCell Stem Cell
Issue number6
StatePublished - 3 Jun 2011
Externally publishedYes


FundersFunder number
Wellcome Trust
Medical Research CouncilG0700785, G0700654
National Institute for Health Research


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