https://www.cas.cn/cm/202603/t20260319_5104634.shtml

https://www.thelancet.com/journals/landia/article/PIIS2213-8587(25)00423-1/fulltext

A research group at the CAS IInstitute of Biochemistry and Cell Biology,, in collaboration with Shanghai Changzheng Hospital, has achieved the reconstruction of islet function and autonomous blood glucose regulation in patients with type 1 diabetes by using minimally invasive transplantation of regenerated islets (E-islets) derived from autologous and allogeneic stem cells, respectively.

Diabetes is a chronic disease. Type 1 diabetes (T1D) is more common in children and adolescents and has long been considered an irreversible chronic disease, requiring patients to rely on insulin injections and frequent blood glucose monitoring for life. Traditional islet transplantation, while effective, is hampered by a severe shortage of donors, limiting its accessibility to a wide range of patients. Achieving large-scale regeneration of islet tissue has become a pressing challenge for the global medical community.

The research team has establishing an endoderm stem cell-based technological system. Utilizing in vitro directed differentiation technology, they constructed regenerated E-islets for the treatment of type 1 diabetes with severely impaired/exhausted pancreatic function. After these regenerated islets were transplanted into the body via portal vein infusion, they functioned like normal pancreatic tissue, regulating blood sugar levels.

Three patients with type 1 diabetes (T1D) participated in this study, each receiving regenerated islets (E-islets) derived from autologous or allogeneic endoderm stem cells. These three cases encompass the world’s first autologous and China’s first allogeneic regenerated islet transplantation for type 1 diabetes, as well as the world’s first regenerated islet transplantation for type 1 diabetes in an adolescent. The longest clinical cure in this case has been achieved for over 26 months.

Based on this proprietary technology, the allogeneic human regenerated islet injection (E-islet 01) received new drug clinical trial approvals in China in April 2025 and in the United States in January 2026. Clinical trials are currently underway.