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Donislecel is an allogeneic pancreatic islet cellular therapy consisting of purified islets of Langerhans derived from deceased donor pancreata. It is indicated for the treatment of adults with Type 1 diabetes who are unable to reach target glycated hemoglobin (HbA1c) levels due to repeated episodes of severe hypoglycemia despite intensive diabetes management and education. The therapy is administered via a single or repeated infusion into the hepatic portal vein. Once engrafted, the transplanted islets secrete insulin in response to blood glucose levels, thereby regulating glycemic control and potentially achieving insulin independence in some patients. Developed by CellTrans in collaboration with the University of Illinois Chicago, donislecel received FDA approval in June 2023 as the first cellular therapy for Type 1 diabetes.
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