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Cell Stem Cell. 2011 Jun 3;8(6):618-28. doi: 10.1016/j.stem.2011.05.012.

Assessing the safety of stem cell therapeutics.

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MRC Centre for Drug Safety Science, Division of Molecular & Clinical Pharmacology, The Institute of Translational Medicine, The University of Liverpool, Liverpool L69 3GE, UK.

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  • Cell Stem Cell. 2011 Aug 5;9(2):176.


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.

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