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Landmark study of islet transplantation reveals potential benefits in uncontrolled type 1 diabetes

San Francisco, CA, September 27, 2006 -- The results of the world's first multicenter clinical trial of islet transplantation have confirmed the technique's potential benefits in patients with difficult-to-control type 1 (or "juvenile") diabetes. Published in the September 28, 2006 issue of the New England Journal of Medicine, the international team of investigators report that the Edmonton Protocol for islet transplantation can safely and successfully promote long-term stabilization of blood sugar levels in "brittle" diabetes patients and in some cases, relieve them of the need for insulin injections altogether for at least two years.

The multicenter study, begun in 2001, studied 36 volunteers diagnosed with "brittle" type 1 diabetes: patients who, despite their best efforts, had wide, unpredictable fluctuations in their blood sugar levels. Using the Edmonton Protocol for type 1 diabetes, each participant received up to three infusions of donated insulin-producing islet cells at one of 9 participating clinical centers in the US, Canada and Europe. The study was sponsored by the Immune Tolerance Network (ITN), with funding and support from the Juvenile Diabetes Research Foundation (JDRF), the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK). NIAID and NIDDK are both components of the National Institutes of Health (NIH).

Investigators found that one year after receiving the final transplant, 72% (26/36) of patients had benefited from the technique, with 16 patients achieving freedom from insulin injections and 10 requiring insulin, but maintaining improved control of blood glucose levels. After two years, five of these 26 patients remained insulin independent, while the remainder continued to require less insulin by injection and showed improved measures of blood glucose control and reversal of hypoglycemic unawareness--a condition in which people wit
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Contact: Jeffrey B. Matthews, PhD
jmatthews@immunetolerance.org
604-921-6597
Immune Tolerance Network
27-Sep-2006


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