[摘要] 细胞治疗涉及包括肿瘤在内的多种疾病的干细胞治疗和免疫细胞治疗。随着生命科学和医学的进步以及人们对健康需求的不断提高，细胞治疗成为重要的前沿探索领域，其创新性理论、技术和临床研究结果不断涌现，为细胞治疗产业化发展奠定了良好基础。国外已有部分细胞治疗产品获得监管部门的批准。我国细胞治疗行业目前处在一个良好的发展机遇期，如何建立完善的监管、指导体制与规则，更好地激发科研与转化活力，为患者创造更多福祉，有序推进本行业发展，是值得深入思考的问题。本文从干细胞治疗、以抗原嵌合受体修饰T细胞（chimeric antigen receptor T-cell，CAR-T）疗法为代表的免疫细胞治疗的研究现状以及我国细胞治疗行业监管等角度进行阐述，并对我国细胞治疗行业提出若干建议，供业内同行参考。

[Abstract] Cell therapy includes stem cell therapy and immunotherapy for multiple diseases including cancer. With the progress in life science and medicine as well as people’s increasing demands for health, cell therapy has become an important frontier research field.Constantly emerged innovative theories, technologies and clinical outcomes of cell therapy have laid a solid foundation for the development of cell therapy industrialization. Now some cell therapy products have already been approved by the regulatory authorities abroad;and in China, cell therapy is in a period of great opportunities. Therefore, how to optimize the supervision and guiding system and provisions,to better stimulate the vitality of research and transformation, to create more benefits for patients and to promote the development of the industry in an orderly manner have become an issues that worth deep consideration. In this paper, we discussed the current progress on stem cell therapy and immunotherapy represented by chimeric antigen receptor T-Cell (CAR-T) in both domestic and overseas,and the industry supervision of cell therapy in China; in addition, we also put forward some suggestions for the development of cell therapy in China for the reference of peers in this field.

北京市科学技术委员会年度创新基地培育与发展专项（No. Z171100002217069）