Progress in registration of mesenchymal stem cell therapy products and challenges to drugability
10.3867/j.issn.1000-3002.2025.04.007
- VernacularTitle:间充质干细胞治疗产品申报进展及成药性挑战
- Author:
Dongmei HAN
1
;
Di ZHOU
;
Yi ZHANG
;
Kaikun WEI
Author Information
1. 国家药品监督管理局药品审评中心,北京 100076;药品监管科学全国重点实验室,北京 102629
- Publication Type:Journal Article
- Keywords:
mesenchymal stem cell;
drugability;
heterogeneity;
quality characterization
- From:
Chinese Journal of Pharmacology and Toxicology
2025;39(4):296-302
- CountryChina
- Language:Chinese
-
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.
