Editorial: First Regulatory Approval for Allogeneic Pancreatic Islet Beta Cell Infusion for Adult Patients with Type 1 Diabetes Mellitus
Dinah V. Parums
Abstract
Type 1 diabetes mellitus affects adults and children, with an increasing number of newly-diagnosed cases each year. Type 1 diabetes involves a primary functional defect in pancreatic islet beta cells, resulting in secondary autoimmunity that results in T-cell-mediated beta cell death. However, pancreatic transplantation is a complex procedure, with complications that include transplant organ failure due to rejection or ischemia-reperfusion injury, safety issues of the duodenal-duodenal anastomosis technique, and the availability of segmental or whole organs. On June 28, 2023, the FDA Center for Biologics Evaluation and Research (CBER) approved Lantidra (donislecel), the first allogeneic (deceased donor) pancreatic islet cell therapy for the treatment of adults with type 1 diabetes who do not achieve target glycated hemoglobin levels because of repeated episodes of severe hypoglycemia, despite current management. This Editorial aims to highlight the increasing global health burden of type 1 diabetes, previous approaches to pancreatic transplant methods and introduces the first regulatory approval for allogeneic pancreatic islet beta cell infusion, a novel approach to transplantation.