The USFDA has approved the first allogenic pancreatic islet cellular therapy for treating type 1 diabetes (T1D) in adults who are unable to achieve target glycated hemoglobin and experience recurrent severe hypoglycemia episodes. The allogenic pancreatic islet cells were generated from deceased donor pancreatic cells. These cells secrete insulin after being infused into the hepatic portal vein . The approval was granted based on the findings of two clinical trials.
Clinical trials The allogenic pancreatic islet cells were infused once or up to three times into 30 T1D patients with hypoglycemic unawareness. Following the treatment, 21 patients attained a stage at which they did not need exogenous insulin for a year or more . Similarly, 11 patients did not need exogenous insulin administration for one to five years and 10 patients did not need exogenous insulin for over five years. …
