Edmonton Protocol clinical trial shows islet transplantation shows promising results

The Edmonton Protocol clinical trial, led by University of Alberta researcher Dr. James Shapiro, shows islet transplantation is a promising procedure for certain patients with severe Type 1 Diabetes. This research is published in the September 28, 2006 edition of The New England Journal of Medicine.

"This is the very first time a multicentre, international trial has been done in islet research," said Shapiro, a professor in the U of A Faculty of Medicine and Dentistry. "This really shows that islet transplantation can be tremendously successful in protecting against hypoglycemic unawareness."

Thirty-six adult volunteers at nine clinical trial sites in North America and Europe received up to three infusions of insulin-producing islets, which are non-functioning in people with Type 1 diabetes. The trial was designed to gauge how well the transplanted islets would function in regulating blood sugars. The results show that 44 per cent of the transplant recipients no longer needed insulin injections a year after their final treatment. An additional 28 per cent of them had partial islet function. Insulin independence did not persist indefinitely in most cases. However, individuals with functioning islets had improved control of their diabetes, even though they still needed to take insulin shots.

The first international, multicentre trial of the Edmonton Protocol is a standardized approach to islet transplantation. This approach demonstrates that this may be an appropriate therapy that can dramatically benefit certain patients with severe complications of Type 1 Diabetes Mellitus.

This Edmonton Protocol multicentre clinical trial was conducted by the Immune Tolerance Network (ITN) and supported by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney diseases (NIDDK) and the Juvenile Diabetes Research Foundation (JDRF).