[关键词]
[摘要]
随着细胞治疗相关研究的不断推进,部分细胞治疗产品已经应用于临床研究。然而,我国相应的细胞治疗监管政策仍需进一步完善,这有利于我国的细胞治疗产业发展,同时保障患者利益。从不同类型的细胞治疗出发,结合现有技术能力,就目前细胞治疗可行的质量控制和管理方法做出论述,以期起到抛砖引玉的作用,引导社会各方制定更为科学规范的管理措施。
[Key word]
[Abstract]
With the efficacy proofs of immune cell therapy research, part of cell products have been applied in clinical practice. However, the companion management regulations in China still need to be further improved, which is beneficial to the development of cell therapy in China and guarantee of treatment for patients. Based on different types of cell therapy, this report discusses the quality control and management of cell therapy in regard to the techniques available. To cast a brick and attract jade, we provide suggestions for the scientific standardization of cell therapy.
[中图分类号]
R926
[基金项目]
国家科技重大专项课题——重大新药创制(2016ZX09101094);北京市科委企业技术创新平台建设(Z181100000518028)