Regulatory approval of islet transplantation for treatment of type 1 diabetes: Implications and what is on the horizon.

For the first time, the US Food and Drug Administration (FDA) approved the use of a cell therapy for the treatment of type 1 diabetes. These cells, allogeneic pancreatic islets sourced from cadaveric organ donors, are implanted into the liver microvasculature via portal vein infusion. To suppress graft rejection of the foreign cells, transplant recipients are required to receive daily, systemic immune suppression. Indications for use are for the treatment of type 1 diabetes in people with high glycemic liability indicators (i.e., repeated episodes of severe hypoglycemia and off-target hemoglobin A1C [HbA1c]) despite aggressive disease management. This approval, coordinated by the Center for Biologics Evaluation and Research arm of the FDA, is specific to the biological product donislecel, designated as the tradename “Lantidra” by the company CellTrans.