Vertex

Previous studies have shown that transplantation of stem cell–derived islets can have beneficial effects in people with type 1 diabetes. In this study, islets generated from stem cells that have been engineered to be compatible with all blood groups are transplanted into people with difficult-to-manage type 1 diabetes. The transplantation restores endogenous insulin production, resulting in a substantial improvement in glucose regulation and, in some cases, the complete elimination of the need for insulin therapy. However, treatment with immunosuppressive medication is still required to prevent rejection of the transplanted cells.

Vertex

Study objective

Transplantation of stem cell–derived islets to restore endogenous insulin production.

We are looking for people with

Type 1 diabetes for at least 5 years
At least one severe hypoglycaemic episode

Important reasons why you cannot participate:

You are pregnant or planning to become pregnant
You are using immunosuppressive medication
You have cancer or have had cancer recently
You use recreational drugs and are unable to stop (this also includes tobacco use and consumption of more than two alcoholic drinks per day)
You use more than 60 units of insulin per day

The study is scheduled to begin in early 2027.

Background information

Over the past several years, researchers have succeeded in generating islets of Langerhans—the insulin-producing cells in humans—from stem cells. An initial study demonstrated that these stem cell–derived islets are both effective and safe in restoring endogenous insulin production in people with difficult-to-manage type 1 diabetes. This resulted in the elimination of insulin requirements in approximately 8 out of 10 recipients and significantly improved glucose management in the remaining participants.

On the other hand, immunosuppressive medication is still required to prevent rejection of the transplanted cells. This also serves as a safety measure: if any problems were to arise with the cells, simply discontinuing the immunosuppressive therapy would allow the body’s immune system to eliminate them.

However, these insulin-producing stem cell–derived islets were only suitable for people with blood group A. The cells have now been modified in the laboratory so that they are compatible with individuals of any blood group. This study aims to evaluate whether these modified cells remain effective in restoring endogenous insulin production.

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