cGMP Facilities, Center for Cell & Gene Therapy, Baylor College of Medicine, Houston, TX, USA.
Adv Exp Med Biol. 2018;1098:189-198. doi: 10.1007/978-3-319-97421-7_10.
Cellular therapies have moved to the forefront based upon promising results from clinical trials using both chimeric antigen receptor T lymphocytes to treat leukemia and other cell types to restore structure and function to tissues that have been damaged by disease or physical injury. The pace at which these treatments have evolved has posed a regulatory challenge to agencies, such as the Food and Drug Administration (FDA). This chapter describes how a specific regulatory strategy was developed and how it has evolved in response to the demand for these new therapies.
细胞疗法基于嵌合抗原受体 T 淋巴细胞治疗白血病和其他细胞类型以恢复因疾病或物理损伤而受损组织的结构和功能的临床试验的有希望结果，已经成为前沿。这些治疗方法的发展速度给食品和药物管理局 (FDA) 等机构带来了监管挑战。本章描述了如何制定特定的监管策略以及如何根据对这些新疗法的需求进行演变。
