Scientists in Shanghai have developed a potentially groundbreaking treatment for diabetes that targets the root cause of the disease rather than just its symptoms, offering hope for a functional cure.

The therapy has enabled patients with type 1 diabetes to achieve reconstruction of islet function and autonomous blood glucose regulation, according to researchers at the Shanghai-based Center for Excellence in Molecular Cell Science of the Chinese Academy of Sciences.

The team has to date tested the safety and efficacy of the treatment on six patients. The approach uses autologous and allogeneic stem cell-derived regenerative islets, which are transplanted through a minimally invasive procedure.

Findings from the exploratory clinical study — the first of its kind globally — were recently published in The Lancet Diabetes and Endocrinology. The research was conducted jointly with Shanghai Changzheng Hospital.

Type 1 diabetes is an autoimmune disease in which the body's immune system attacks and destroys islet beta cells, leading to insufficient insulin production. Patients must rely on lifelong insulin injections and frequent blood glucose monitoring, facing risks of severe complications as well as long-term physical and psychological burdens.

While cadaveric islet transplantation has shown effectiveness, its widespread use is constrained by a severe shortage of donors. The global medical community has long sought scalable solutions for regenerating islet tissue in vitro.

Researchers likened the process of regenerating islets to "replacing parts" in the human body.

Conventional methods rely on pluripotent stem cells, which can develop into many types of human cells but require a complex, multistep differentiation process that is difficult to control, often resulting in low purity.

After more than two decades of research, the Shanghai team pioneered a new approach based on endodermal stem cells. Instead of starting from pluripotent cells — likened to the "root" of a tree — the scientists begin from a more advanced stage, comparable to the "trunk".

This method allows for more precise differentiation, directing development specifically toward endoderm-derived organs such as the pancreas and liver, while avoiding unwanted cell types.

The process has been streamlined from about 10 steps to just two, reducing the production cycle from at least five weeks to two. Importantly, endodermal stem cells do not proliferate in the body, significantly lowering the risk of tumor formation associated with traditional approaches, the researchers said.

Using this technology, the team created regenerative islet tissue, known as "E-islets".

Once transplanted into patients through the hepatic portal vein — a vein that carries blood from the abdomen to the liver for filtration and processing — these E-islets function like natural islet cells to regulate blood glucose levels.

"This technology addresses the root cause of the disease by repairing damaged components of the human body, offering hope for a cure," said Cheng Xin, a lead scientist on the project. "This is fundamentally different from insulin injections, which only manage symptoms."

An allogeneic E-islet injection product developed using the proprietary technology received approval for clinical trials in China in April 2025 and in the United States in January 2026. It is currently the only regenerative islet therapy to have obtained such approvals in both countries. Clinical trials are progressing steadily, and if successful, the product could be approved for market use by 2029, Cheng said.