IPITA Publication Alert: Results of Phase III US Islet Trial
The International Pancreas and Islet Transplant Association would like to make you aware of an important development in the field of pancreatic islet transplantation that was recently published in Diabetes Care (http://care.diabetesjournals.org/content/early/recent).
As you may know, unlike the case in many other countries, pancreatic islet transplantation is currently considered an experimental procedure in the United States. For the past decade, an NIH sponsored consortium (CIT) has worked to gain the needed phase III data to support an application to the FDA to establish isolated islet transplantation as an approved procedure. This approval is seen as essential to the future of islet transplantation in the US as it will allow reimbursement for the procedure.
The paper by Hering et al in Diabetes Care reports the results of a multicenter single arm trial of islet transplantation at 8 sites in North America including 48 patients with impaired hypoglycemic awareness and history of severe hypoglycemic events. The islets were prepared by a standardized manufacturing regimen, under GMP conditions. Complications from the procedure were rare with about 10% suffering procedure related bleeding, development of DSA in 4%, opportunistic infections in 2% and an immunosuppression associated reduction in GFR from 102 at baseline to 90 ml/min at 1 year. Efficacy of the procedure was clearly evident with 42 of 48 patients meeting the primary end point of freedom from severe hypoglycemia and excellent glycemic control (HBA1c <7%), with 34 of 48 continuing to meet these criteria of success at the 2 year time point. 52% gained full insulin independence at day 75, and 42% remained so at the 2 year follow-up mark. Although this rate of insulin independence appears low, it must be noted that insulin independence was not the intent of the trial, rather excellent glycemic control and freedom from hypoglycemia was the prioritized outcome.
The positive results of this study further establish the effectiveness of islet transplantation in care of select Type I diabetics with labile disease and set the stage for approval of the procedure in the US as standard of care.
The Council of IPITA