On July 13, President Clinton announced the 10 centers chosen to replicate the Edmonton Protocol.
The $5 million Edmonton Protocol replication will begin this fall and will be overseen by the Immune Tolerance Network (ITN), a research program jointly funded by the National Institutes of Health (NIH) and the Juvenile Diabetes Foundation (JDF). As part of the replication, approximately 40 patients will receive islet transplants in the next 18 months through the ITN clinical trials.
“This is an important moment for people with diabetes,” said Mary Tyler Moore, international chairman of the JDF. “We greatly applaud the Administration’s commitment to diabetes research and are proud to partner with the NIH on replicating the Edmonton Protocol for human islet transplantation through the Immune Tolerance Network.”
Bringing the Cure Closer to Home
James Shapiro, MBBS, BMed, a transplant surgeon for the Edmonton Protocol team, told DIABETES HEALTH he is pleased with the announcement.
“I am thrilled that the proposed study, together with the preliminary extraordinary results from the Edmonton Protocol, was considered important enough to gain the attention of the U.S. President,” said Shapiro. “I’d be even more thrilled if the overall results of the multi-center study match up to the success we have seen in Edmonton. This will bring islet transplantation as a cure so much closer to all patients with diabetes.”
10 People Off Insulin After One Year
The Edmonton Protocol research team recently published its findings in The New England Journal of Medicine. Shapiro and colleagues at the University of Alberta in Edmonton transplanted islets in 10 people with type 1 diabetes. In previous studies, only eight percent of islet-transplant recipients have remained off insulin for one year.
The Edmonton Protocol is the first study in which 100 percent of islet-transplant recipients were completely insulin-independent after one year. The keys to the success of the Edmonton Protocol are a new anti-rejection drug combination, the avoidance of steroids and the delivery of sufficient islets.
According to the JDF, only “brittle” type 1 diabetes patients, ranging from 18 to 65 years of age, who are unable to properly control their sugars with even the most rigid insulin schedule, are eligible to participate. Patients must also suffer from one of the following:
- hypoglycemia unawareness
- at least one hypoglycemic reaction in the last 1.6 years that cannot be otherwise explained and required medical attention
- progressive secondary complications, such as vision, kidney, nerve or vascular problems, despite an optimal insulin regime
- failure of intensive insulin management, as judged by an independent endocrinologist
People with type 2 diabetes and children are not eligible for enrollment in the trial. In addition, type 1s with severe cardiac disease, active or recent history of substance abuse (including smoking), insulin requirements greater than 0.7 U/kg per day or active infection (including hepatitis B or C, HIV or TB) are not eligible to participate.
U.S. residents who meet the requirements who are interested in participating are asked to visit the ITN Web site at www.immunetolerance.org or call the ITN Patient Referral Hotline at (773) 834-5341.