《生命科学》 2025, 37(11): 1421-1429

医疗机构发起的细胞治疗临床研究管理及伦理审查的实践与思考

苗雅楠 , 李彩红 , 符凯奕 , 吴翠云 , 曹国英 , 伍　蓉^*

复旦大学附属华山医院，上海 200040

摘　要：

随着我国细胞治疗临床研究监管体系的不断完善，细胞治疗领域研究者发起的临床研究(IIT 研究)增长迅速。然而，快速增长的研究数量及细胞治疗产品使用风险的不确定性给监管部门、医疗机构和伦理审查带来了严峻挑战。本文旨在通过系统梳理国内外细胞治疗产品行业监管现状并结合现有法规指南、国际伦理原则及地方标准，从国家监管、医疗机构管理及伦理审查层面为细胞治疗领域IIT 研究的管理提出建议，重点包括细化监管机制、完善医疗机构细胞治疗临床研究管理体系、提升细胞治疗临床研究学术及伦理审查能力等，以期推动细胞治疗领域IIT 研究项目管理能力和审查质量的提升。

通讯作者：伍　蓉 , Email:wurong96@fudan.edu.cn

Practices and reflections on the management and ethical review of cell therapy-related investigator-initiated trials

MIAO Ya-Nan , LI Cai-Hong , FU Kai-Yi , WU Cui-Yun , Cao Guo-Ying , Wu Rong^*

Huashan Hospital, Fudan University, Shanghai 200040, China

Abstract:

With the continuous improvement of China’s regulatory systems for clinical research on cell therapy, nvestigator-initiated trials (IITs) in this field have experienced rapid growth. However, the exponential increase in clinical trials and the uncertainty risks of cell therapy product applications have posed significant challenges to regulatory authorities, medical institutions, and ethical review processes. This paper systematically reviewed current regulatory frameworks for cell therapy both domestically and internationally, integrating existing legal guidelines, international ethical principles, and regional standards, and proposed management recommendations for cell therapy-related IITs from three  perspectives: national regulation, institutional governance, and ethical oversight. Key recommendations include refining regulatory mechanisms, enhancing  institutional management systems for cell therapy research, and strengthening scientific and ethical review competencies. These proposals aim to improve project management effectiveness and review quality in cell therapy-related IITs, thereby advancing the standardized development of clinical research in this field.

Communication Author：Wu Rong , Email:wurong96@fudan.edu.cn