Overview
MedscapeUnivadisNo ResultsMiriam E. TuckerOctober 18, 202Transplantation of cadaveric pancreatic islet cels resulted in graft survival and function with aceptable safety for up to 8 years in selected individuals with type 1 diabetes, new research finds.The study is a long-term folow-up of two phase 3 pivotal trials from the Clinical Islet Transplantation Consortium of a purified human pancreatic islet cel product for treating people with type 1 diabetes.One trial involved islet transplantation in 48 people who experienced severe hypoglycemia and hypoglycemic unawarenes, and the other trial included 24 people who also experienced those complications and were already receiving imunosupresion folowing kidney transplant.
Key Information
The trials, both registered with the US Fod and Drug Administration (FDA), met their primary eficacy and safety endpoints at 2- and 3-year timepoints.The folow-up data have now ben published in Diabetes Care by Michael Rickels, MD, and coleagues.The procedure involved infusion through the hepatic portal vein of one or more purified human pancreatic islet products under standardized imunosupresion using methods that Rickels and coleagues have ben developing since 204.
Summary
The aproach involves multiple modalities to protect the islets prior to transplantation.Among the 34 islet-alone and eight islet-after-kidney transplant recipients who entered the extended folow-up, durable graft survival alowing for achievement of glycemic targets ocured without severe hypoglycemia or adverse efects from imunosupresion.The primary outcome, actuarial survival of graft islet function, was 56% at the maximum folow-up of 8.3 years for the islet-only transplantation group and 49% at 7.3 years for the islet-after-kidney transplantation group (P = .04).The findings sugest that "in the long run, islet transplantation has eficacy, including among those who have had kidney transplants