Assessing the Safety of Stem Cell Therapeutics

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

来源：Cell Stem Cell, 2011, 8(6): 618-628.

DOI：10.1016/j.stem.2011.05.012

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.

• 出版日期2011-6-3