Pre-Transplant Drug Regimen Promotes Long-Term Insulin Independence
DRI Director of Clinical Islet Transplantation Dr. Rodolfo Alejandro (right) and the clinical cell transplant team together with collaborators Dr. Bernhard Hering and his team at the University of Minnesota have shown that long-term insulin independence can be achieved in islet transplant patients who receive potent anti-rejection drugs during the pre-transplant or “induction” phase. Patients who received the profound T-cell depleting agents (most notably, Campath) were twice as likely to remain insulin free for more than five years as compared to patients receiving the previously-tested drugs. Insulin independence rates in the recipients approach those seen in pancreas transplants.
The results of the study, which were published in the May issue of the American Journal of Transplantation, suggest that this drug regimen may benefit long-term outcomes through improved engraftment of a greater number of islets – fewer islets die off during initial implantation – and minimized recurrent autoimmunity.
Researchers will now test the regimen in a multi-center clinical trial conducted by the NIH Clinical Islet Transplantation (CIT) Consortium with the hope of gaining FDA approval for this promising biologic therapy. The CIT is a network of clinical centers established in 2004 to conduct studies of islet transplantation in patients with type 1 diabetes.
During the ADA’s 72nd Scientific Sessions in June, DRI Scientific Director, Dr. Camillo Ricordi, chair of the Consortium and one of its principal investigators, reported that enrollment in first Phase III clinical trial is now complete.
>> A webcast of Dr. Ricordi's presentation is available to ADA members on the American Diabetes Association website.
# # #