Latest results from international islet transplant study confirm potential patien...( San Francisco (June 6 2004) The Immun...),Health

San Francisco (June 6, 2004) The Immune Tolerance Network today released updated results from its multicenter clinical trial of the Edmonton Protocol for islet transplantation. The results provide further confirmation that transplantation of pancreatic islet cells can safely and effectively eliminate the need for daily insulin injections in patients with type 1 diabetes. The expanded results, encompassing the entire cohort of 36 patients enrolled in the trial also confirms that the technique can be successfully applied at multiple clinical centers.

Dr. James Shapiro, principal investigator of the study and Director of the Clinical Islet Transplant Program at the University of Alberta in Edmonton, Canada, reports that 19 of the 36 participants continue to be free from daily insulin injections for up to one year following their last transplant. Seven patients completed the procedure with only partial islet graft function and therefore continue to require insulin injections, although on average, at lower doses than prior to the procedure. Four patients withdrew from the study prior to completion of the protocol and six others had non-functioning grafts.

"This is an important result for the future of islet transplantation," said Shapiro. "With the completion of the treatment phase of the study, we can now say with confidence that that islet transplantation works for patients with serious and unstable type 1 diabetes and that it is possible to successfully apply a single standardized protocol at many different clinical sites," said Shapiro.

In addition, the investigators report that so far, few treatment-related complications have been noted and those were generally minor. The most common side effects of the technique were mouth ulcers, neutropenia and diarrhea, none of which were life-threatening.

With nine clinical centers participating in the trial, the ITN study is the largest clinical investigation of islet transplantation to dat
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Contact: Jeffrey B. Matthews
jmatthews@immunetolerance.org
604-518-0729
Immune Tolerance Network
6-Jun-2004

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