Quality risk management and considerations on evaluation of stem cell-derived pancreatic islet cell medicinal products
LIU Dan
LU Jia-qi
YIN Hui-fang
WEI Wei
Abstract：In recent years,multiple stem cell-derived pancreatic islet cell medicinal products globally have advanced rapidly into clinical trials,demonstrating great application potential in the treatment and functional cure of diabetes mellitus.Currently,the similar medicinal products that have been approved for registration clinical trials in China are still in the early clinical research stages.Given the limited scientific cognition and application experience in human beings,the correlation between critical quality attributes of such products and their clinical safety and efficacy has not been established.Both the pharmaceutical research and development as well as regulation face major challenges.In view of differences between such medicinal products and other cell therapy medicinal products in terms of active ingredients,structures,functions and mechanisms of action,particular attention should be given to the evaluation of safety,efficacy,and quality controllability.Based on the characteristics,the progress in research and development as well as application of such products,including relevant guidelines for cell therapy medicinal products and the quality control practices for pancreatic islet transplantation technology for reference,this article aims at focusing on the quality risk management strategies and pharmaceutical evaluation considerations during the development and application of stem cell-derived pancreatic islet cell medicinal products,providing references for the research and development,as well as evaluation of such products.
Keywords：diabetes mellitusstem cell-derived pancreatic islet cell medicinal productsquality risk managementpharmaceutical evaluation
Publication Date：2025-12-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2598-2604 )