China is likely to start a mass – scale clinical trial of stem cell therapy for type 2 diabetes in the third quarter of 2025, which is based on a series of previous approvals and research achievements in the field of stem cell therapy for diabetes. The specific situation is as follows:
Approval of related drug clinical trials: On March 24, 2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration approved the implied license of a domestic new – drug clinical trial of umbilical cord mesenchymal stem cells for the treatment of type 2 diabetes patients. The approved human umbilical cord mesenchymal stem cell injection (E10I) will bring more treatment options for diabetes patients.
Breakthrough in allogeneic islet products: On April 18, 2025, the “allogeneic human regenerated islet injection (E – islet 01)” jointly developed by Yin Hao’s team obtained the implied license of clinical trials from the National Medical Products Administration. This is the second allogeneic universal regenerated islet product in the world and the first in China to enter the clinical trial stage. E – islet 01 uses cutting – edge technologies such as cell reprogramming and directed differentiation to transform healthy donor – derived blood cells into endodermal stem cells, and then uses endodermal stem cells as raw materials to prepare regenerated islets in a directed manner. It has the same structure and function as healthy islets, and can maintain blood sugar homeostasis.
In addition, Shanghai Jiao Tong University Affiliated Ruijin Hospital’s research team has achieved the world’s first “stem cell + 3D – printed islet” transplantation surgery, and plans to launch a large – scale clinical trial in 2025. The research shows that stem cell – derived islet transplantation has a good curative effect on type 2 diabetes patients, which also provides a foundation for the subsequent large – scale trial.
