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

190 Scopus citations


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 languageAmerican English
Pages (from-to)618-628
Number of pages11
JournalCell Stem Cell
Issue number6
StatePublished - 3 Jun 2011

Bibliographical note

Funding Information:
C.E.P.G., R.E., N.F., N.A.H., L.K., N.R.K., H.L., and B.K.P. would like to thank the Medical Research Council (MRC); Frank Bonner, Ernie Harpur, and Rebecca Lumsden at Stem Cells for Safer Medicines; and The Association of British Pharmaceutical Companies (ABPI). C.E.P.G and R.E. thank Gillian Wallace and acknowledge the support of Life Technologies. N.H. acknowledges the support of The Wellcome Trust and The National Institute for Health Research. Peter Andrews wishes to thank the MRC and Yorkshire Cancer Research (YCR). An Industry-Academic-Regulator workshop that was held in Liverpool, UK, on Nov. 24, 2010, formed the initiative for the development of this manuscript.


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