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Multicenter Trial of the Edmonton Protocol to Begin in Fall 2000

Beginning in the fall of 2000, ten centers around the world will attempt to replicate the success of the Edmonton Protocol for islet cell transplants, President Clinton announced on July 13, 2000. Approximately 40 patients will receive islet cell transplants over the next 18 months. Children are not included in these trials.

Participating Centers

North America Centers

• University of Alberta Islet Transplantation Program, Edmonton, Alberta, Canada
• Diabetes Research Institute, University of Miami, Miami, Florida
• Diabetes Institute for Immunology and Transplantation, University of Minnesota, Minneapolis, Minnesota
• Juvenile Diabetes Foundation Center for Islet Transplantation, Harvard Medical School, Boston, Massachusetts
• Diabetes Research Training Center, Washington University, St. Louis, Missouri
• Pacific Northwest Research Institute, Seattle, Washington
• Organ/Tissue Transplant Research Center, National Institutes of Health, Washington, D.C.

European Centers

• Islet Transplant Centre, Justis-Liebig University, Giessen, Germany
• San Raffaele Scientific Institute, University of Milan, Milan, Italy
• University Hospital, Geneva, Switzerland

Patient Selection Criteria

Men and women between the ages of 18 to 65 who have had type 1 diabetes at least five years and who:

1. cannot control their blood sugar even with intensive insulin therapy
2. do not adequately sense the onset of hypoglycemia (low blood sugar)
3. have had a least one hypoglycemic reaction in the last 1.6 years that cannot be otherwise explained and required medical attention
4. have secondary complications of diabetes, such as progressive vision, kidney, nerve or vascular problems despite efforts to optimize control of blood sugar

Patients with severe cardiac disease, active or recent history of substance abuse (including smoking), excessive insulin resistance, or an active infection (including hepatitis B or C, HIV, or TB) are not eligible.

Patient Information Hotlines

More information for patients wishing to participate is available on the Immune Tolerance Network web site or from the ITN Patient Referral Hotline at (773) 834-5341 in the United States. Canadian residents may phone (780) 407-1501. Referral forms are to be completed, signed by the patient's physician and returned by January 1, 2001. Patients who appear to meet all the criteria will be contacted for further consultation prior to a final evaluation.

For More Information

• President Clinton Announces Major New Investment in Diabetes Research, Treatment, and Prevention.
• NIH Press Release on the New Clinical Trials
• Immune Tolerance Network Summary of the New Trials
• Immune Tolerance Network Press Release
• University of Alberta News about the New Trials
• Harvard University Press Release
• JDF News Release
• Alberta Foundation Reports on Successful Islet Transplants (original story)
• Islet Transplantation in Seven Patients with Type 1 Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen (original publication in the New England Journal of Medicine)

Posted July 16, 2000

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Last Updated: Thursday August 29, 2002 20:59:48
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