A clinical research consortium sponsored by NIAID and JDRF
Shapiro J, Ricordi C, Hering B, DiMercurio B, Lindblad R, Cagliero E, Brendel 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, FL University of Minnesota, Minneapolis, MN National Institutes of Health, Bethesda, MD EMMES Corporation, Rockville, MD Massachusetts General Hospital, Boston, MA Justus-Liebig University, Giessen, Germany Pacific Northwest Research Institute, Seattle, WA University of Geneva, Geneva, Switzerland University of Milan, Milan, Italy Washington University, St Louis, MO Immune Tolerance Network, San Francisco, CA
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 hypoglycemia 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.
The trial is ongoing and we anticipate all transplants to be completed in the next several months. All 36 participants have been enrolled and have received at least one islet transplant. Clinical follow-up will continue for three years post final transplant with the primary endpoint assessed at the one-year time-point. Updated information regarding the number of transplants, insulin independence, glucose control, complications related to transplantation and overall safety will be available for presentation.
Conclusion: 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.
