Presented at:
International Congress of Transplantation, Vienna, Austria, 5-10 September 2004
Standardization of human islet isolation for an international multi-center transplant trial
Shapiro AMJ, Ricordi C, Hering B, DiMercurio B, Lindblad R, Alejandro R, Cagliero E, Brendal M, Robertson P, Berney T, Secchi A, Brennan D, Ramos, E, Viviano L, Ryan E, . Close N, Lakey J.
University of Alberta, Edmonton, Canada; University of Miami, Miami, United States; University of Minnesota, Minnesota, United States; National Institutes of Health, Bethesda, United States; The EMMES Corporation, Rockville, United States; Massachusetts General Hospital, Boston, United States; Justus-Liebig University, Giessen, Germany; Pacific Northwest Research Institute, Seattle, United States; University of Geneva, Geneva, Switzerland; University of Milan, Milan, Italy; Washington University, St Louis, United States; Immune Tolerance Network, San Francisco, United States
The Immune Tolerance network international multicenter trial using the Edmonton Protocol was designed to explore the safety and efficacy of islet-alone transplantation in patients with Type 1 diabetes. Stringent enrollment criteria included metabolic lability, recurrent hypoglycemic or progressive complications of diabetes. Only optimal patients were selected based on strict weight limitation (70kg) and adequate renal reserve (CC>80ml/min/1.73m). The trial involved nine sites in Canada, the US and Europe, with a target enrollment of 36 patients.
All 36 participants have been enrolled and have received at least one islet transplant. We anticipate all transplants to be completed in the next several months. Clinical follow-up will continue for three years post final transplant with the primary endpoint assessed at one-year post the patient's final transplant. Updated information regarding the number of transplants, insulin independence, glucose control, complications related to transplantation and overall safety will be available for presentation.
Conclusions: The preliminary findings from this trial support the safety and efficacy of islet-alone transplantation, and indicate that the Edmonton Protocol may be successfully replicated across centers internationally. Standardization of islet processing between centers remains a major challenge, but it should not delay the development of successful clinical protocols in the field of islet transplantation.