Allogeneic human pancreatic islet cells

Allogeneic human pancreatic islet cells (e.g., donislecel) are a cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target glycated hemoglobin because of current repeated episodes of severe hypoglycemia (FDA, 2023). The therapy involves the transplantation of purified islets of Langerhans from a deceased donor into the recipient's hepatic portal vein. Once engrafted in the liver, these cells function as a biological sensor and delivery system, secreting insulin and other hormones like glucagon and somatostatin to maintain physiological glucose homeostasis (NIH, 2023). This intervention addresses the absolute insulin deficiency caused by the autoimmune destruction of endogenous beta cells. While it can lead to insulin independence, the primary clinical benefit is the reduction or elimination of severe hypoglycemic events (PubMed, PMID: 32654571). Because the cells are allogeneic, patients must remain on lifelong immunosuppressive regimens to prevent graft rejection, which introduces significant safety concerns regarding infection and long-term organ toxicity (StatPearls, 2023).

Other names

Islet cell transplantationAllogeneic islet cellsHuman islets of LangerhansDonislecelLantidra

Restoration of endogenous insulin secretion and glycemic regulation through the infusion of functional beta cells into the portal vein, which then engraft in the liver and respond to blood glucose levels (FDA, 2023; NIH, 2023).