Regulatory overview of mesenchymal stem cell products in Japan and analysis of Stemirac review report
Stem cells refer to a class of cells with self-renewal and multi-directional differentiation potential,which have broad application prospects in the field of regenerative medicine.In 2018,Stemirac was conditionally approved as an autologous bone marrow mesenchymal stem cell therapy product in Japan.This article introduces the regulatory system and approval standards for mesenchymal stem cell products in Japan,analyzes and studies the review report of Stemirac,aiming to provide ideas and reference for the research and development,clinical trials and evaluation of mesenchymal stem cell products in China.
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