Recently, a Chinese research team published their latest online findings, marking the world’s first minimally invasive transplantation of regenerated islets (E-islets) derived from both autologous and allogeneic stem cells. This breakthrough successfully restored pancreatic islet function and enabled autonomous blood glucose regulation in patients with Type 1 Diabetes (T1D). It represents the first exploratory clinical study globally reporting the treatment of T1D using autologous/allogeneic stem cell-derived regenerated islet transplantation. The research paper was published in the international academic journal The Lancet Diabetes & Endocrinology.
After over two decades of in-depth research, the team pioneered an innovative technological system based on definitive endoderm stem cells.
This novel platform offers distinct advantages:
Precise Differentiation: Guided lineage commitment restricts development exclusively to endoderm-derived tissues (pancreas, liver), eliminating aberrant differentiation risks.
Streamlined Manufacturing: Differentiation protocols simplified from 10 steps to 2, reducing production cycles from 5–6 weeks to merely 2 weeks for drastically enhanced efficiency.
Safety Superiority: These endoderm stem cells exhibit no in vivo proliferation capacity, minimizing tumorigenic risks inherent to conventional stem cell therapies.Leveraging this globally leading directed differentiation technology, the team engineered therapeutic regenerated islets (E-islets) tailored for diabetes with severe islet damage or failure. Administered via portal vein infusion, E-islets functionally integrate as native pancreatic tissue to sustain stable glycemic control.
Clinical Breakthrough: Three Patients Validated Islet Functional Restoration
The research team conducted clinical trials on three T1D patients using either autologous or allogeneic endoderm stem cell-derived E-islets, evaluating efficacy and safety under tailored immunosuppressive regimens with encouraging outcomes.
For the first time internationally, the study confirmed that both autologous and allogeneic regenerated islet transplantation achieve definitive therapeutic endpoints in T1D patients: restored endogenous islet function, insulin-independent glycemic homeostasis, and complete exogenous insulin withdrawal. This durable intervention sustains long-term euglycemia and effectively prevents microvascular complications. The study indicates that long-term adjuvant immunosuppression remains necessary to mitigate autoimmune recurrence in T1D.