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Donislecel is a cell-based biologic therapy consisting of allogeneic pancreatic islet cells (primarily insulin-producing beta cells) isolated from the pancreata of deceased donors. It is indicated for the treatment of adults with brittle Type 1 diabetes mellitus who are unable to achieve target glycated hemoglobin levels due to repeated episodes of severe hypoglycemia despite intensive diabetes management. The therapy is administered via a percutaneous transhepatic infusion into the hepatic portal vein. Once engrafted, the transplanted islet cells function endogenously to secrete insulin in response to blood glucose levels, thereby improving glycemic control and potentially leading to insulin independence. The procedure is typically performed using the Edmonton Protocol, a glucocorticoid-free immunosuppressive regimen (including agents like daclizumab, sirolimus, and tacrolimus) designed to prevent allograft rejection while avoiding the beta-cell toxicity associated with steroids.
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