Carpenter Melissa K
Carpenter Group Consulting, Seattle, WA, United States.
Prog Brain Res. 2017;230:151-163. doi: 10.1016/bs.pbr.2016.12.008. Epub 2017 Mar 7.
The development of pluripotent stem cell (PSC) therapies is rapidly advancing, and a number of PSC-derived cell products are currently being tested in clinical trials. The biological complexity of these therapies results in specific challenges in complying with regulatory guidelines. This includes the choice of starting material, reproducible and consistent manufacturing, and preclinical safety and efficacy assessment of the PSC-derived product. This review discusses current US cell therapy regulations and strategies for compliance with these regulations when developing PSC-derived products.
多能干细胞（PSC）疗法的发展正在迅速推进，目前有多种PSC衍生的细胞产品正在临床试验中进行测试。这些疗法的生物学复杂性给遵守监管指南带来了特定挑战。这包括起始材料的选择、可重复且一致的生产，以及PSC衍生产品的临床前安全性和有效性评估。本综述讨论了美国当前的细胞疗法法规以及在开发PSC衍生产品时遵守这些法规的策略。
