Moos Malcolm
Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA.
Trends Pharmacol Sci. 2008 Dec;29(12):591-3. doi: 10.1016/j.tips.2008.09.003. Epub 2008 Oct 18.
The therapeutic potential of products derived from stem cells of various types has prompted increasing research and development and public attention. Initiation of human clinical trials in the not-too-distant future is now a realistic possibility. It is, therefore, important to weigh the potential benefits against known, theoretical and totally unsuspected risks in light of current knowledge to ensure that subjects participating in these trials are afforded the most reasonable balance possible between potential risks and potential benefits. There are no apparent differences in fundamental, qualitative biological characteristics between stem-cell-derived products and other cellular therapies regulated by the United States Food and Drug Administration (FDA). Existing authorities can, therefore, be applied. Nevertheless, these products do have properties that require careful evaluation.
各类干细胞衍生产品的治疗潜力引发了越来越多的研发和公众关注。在不久的将来启动人体临床试验如今已成为现实的可能性。因此，根据现有知识权衡潜在益处与已知、理论上以及完全意想不到的风险非常重要，以确保参与这些试验的受试者在潜在风险和潜在益处之间获得最合理的平衡。干细胞衍生产品与美国食品药品监督管理局（FDA）监管的其他细胞疗法在基本的、定性的生物学特性方面没有明显差异。因此，可以应用现有规定。然而，这些产品确实具有需要仔细评估的特性。
