Can stem cell therapy cure or treat type 1 diabetes?

In a study published in the New England Journal of Medicine in June 2025, all 12 patients with at least one year of follow-up who received a full-dose infusion of stem cell-derived islet cells reached the ADA-recommended targets of an HbA1c below 7 percent and more than 70 percent time in range. Ten of the 12 were insulin-independent at one year, and none had a severe hypoglycemic event after day 90.

The same report described two deaths among participants, one linked to immunosuppression and one to progression of a preexisting condition. The therapy requires immunosuppression, which carries real risks, and it is designed for people with impaired hypoglycemic awareness and severe hypoglycemic events rather than for everyone with type 1 diabetes.

Zimislecel holds FDA Fast Track and Regenerative Medicine Advanced Therapy designations, and the pivotal phase of its study is underway. As of October 2026, no marketing application has been approved, so the therapy is investigational and available only through clinical trials, not at clinics.

The results are a genuine milestone for the field, and they are not an invitation to seek unapproved stem cell treatments marketed for diabetes. Anyone who has type 1 diabetes should manage the condition with their endocrinologist and follow credible sources for trial news. If you hear a stem cell diabetes claim, ask whether it describes this manufactured islet product in a registered trial, and be very cautious about any clinic offering unapproved injections for diabetes.