关键词: 细胞治疗, 临床研究, 受试者保护, 伦理审查, 全链条保护策略

Abstract:

 In recent years， cell therapy has been at the forefront of exploration and research in disease treatment.Core technology paths such as stem cell therapy， immune cell therapy， and gene and cell engineering therapy provide new treatment ideas for some serious and refractory diseases.Due to the unique biological activity and differentiation ability of active ingredients， the preparation of complex cell therapy products， and the species differences in the interaction between cell therapy products and the human body， cell therapy is far different from other treatment methods， and various medical institutions are competing to carry it out.In clinical research practice， cell therapy clinical research still faces many practical challenges， such as insufficient industry special legislation， limited legal effect， imperfect regulatory coordination mechanism， and lack of some regulatory rules.Therefore， higher requirements and challenges are also put forward for the management of cell therapy clinical research norms and the protection of the safety and rights of subjects.Focusing on the current status and key issues of participant safety and rights protection in clinical cell therapy research. It delves into the underlying causes from the perspectives of research teams， ethics committees， and the supervision of ethical review systems. To explore the strategies and risk prevention mechanisms for the protection of the rights and interests of participants in the whole chain of six dimensions： research team， project management department， ethics committee， medical institution， government management and social supervision，to provide a reference for medical institutions to conduct clinical cell therapy research more standardly and compliantly.It is suggested that public hospitals should establish a full-chain protection strategy for the rights and interests of subjects in cell therapy clinical research to protect the rights and interests of subjects in cell therapy clinical research to the greatest extent， so as to ensure scientific， standardized and safe research and promote the healthy development of cell therapy technology.

Key words: Cell therapy； , Clinical research； , Protection of participants； , Ethical review； , Full chain protection strategy