Donislecel

Donislecel is the first allogeneic pancreatic islet cellular from deceased donor pancreatic cells used for the treatment of adult type 1 diabetes with unsuccessful control of glycated hemoglobin, despite intensive diabetes management and treatments. The primary mechanism of action of donislecel is attributed to the secretion of insulin and other pancreatic hormones from infused allogeneic islet cells to mimic endogenous glucose control and homeostasis. The approval of donislecel was based on the safety and effectiveness evaluated in 2 clinical trials with 30 type 1 diabetic patients. Overall, 21 patients achieved insulin independence for a year or more, with 11 patients not needing insulin for 1 to 5 years and 10 patients for more than 5 years. Donislecel is particularly beneficial for type 1 diabetic patients with hypoglycemia unawareness, the inability to detect blood glucose dropping and thus unable to prevent further hypoglycemia, by not relying on exogenous and intentional insulin administration to control blood glucose. Donislecel was approved by the FDA on June 28, 2023, and is available under the brand name LANTIDRA from CellTrans Inc.