中国药理学与毒理学杂志2025，Vol.39Issue(4)：296-302,7.DOI:10.3867/j.issn.1000-3002.2025.04.007
间充质干细胞治疗产品申报进展及成药性挑战
Progress in registration of mesenchymal stem cell therapy products and challenges to drugability
摘要
Abstract
Mesenchymal stem cells(MSCs)have become a key focus in the development of cell-based therapeutic products due to their wide availability,lack of ethical constraints,and potential for immune privileges.However,the transition from basic MSC transplantation techniques to fully devel-oped therapeutic drugs presents numerous challenges given the current regulatory framework in China and from the perspective of drug development and review.This article summarizes the problems faced in this transition,particularly the challenges posed by theheterogeneity of MSC sources,the complexity of unique manufacturing processes,and the complexities of quality characterization.The article also offers suggestions and countermeasures in the hopes of advancing the research,development,and registration of MSC-based therapeutic products.关键词
间充质干细胞/成药性/异质性/质量表征Key words
mesenchymal stem cell/drugability/heterogeneity/quality characterization分类
医药卫生引用本文复制引用
韩冬梅,周菂,张毅,魏开坤..间充质干细胞治疗产品申报进展及成药性挑战[J].中国药理学与毒理学杂志,2025,39(4):296-302,7.基金项目
药品监管科学全国重点实验室课题(2023SKLD-RS0139) State Key Laboratory of Drug Regulatory Science Project(2023SKLDRS0139) （2023SKLD-RS0139）
