Presented at:
64th Scientific Sessions of the American Diabetes Association, Orlando, FL, June 4-8, 2004
Standardization of human islet isolation procedures for a multicenter transplant trial
Lakey JRT, Ricordi C, Herring B, Dimercurio B, Lindblad R, Olack B, Reems JA, Ansite J, Brandhorst D, Bertuzzi F; Berney T; Viviano L, O'Neil J; Close N, Shapiro AMJ
Clinical islet transplantation has made significant advances in the past years. Consistency and reproducibility of human islet isolations have limited progress in the field of clinical islet transplantation for patients with longstanding Type 1 diabetes. The Immune Tolerance Network international multi center trial using the Edmonton Protocol sought to standardize and validate islet isolation procedures amongst the nine participating groups. This was the first attempt to standardize the isolation procedure in an international multi-center trial for islet transplantation.
The steps involved in standardizing and reproducing islet isolations involve developing a protocol, distribution of standard operating procedures, including those used to enumerate islet equivalents, on site inspection of facilities and isolation procedures and review of qualifying islet isolation data.
To date, 192 human islet isolations have been attempted as part of this trial and 36 patients have received islets from at least one donor pancreas. The trial is ongoing and we anticipate all isolations to be completed in the next several months. Updated information regarding islet isolations, donor characteristics, clinical outcomes, and challenges encountered will be available for presentation upon completion of the trial. Data analysis comparing donor and islet isolation related factors between successful and non-successful islet isolation will be presented.
To date, this multi-center trial has shown that the Edmonton Protocol is reproducible in several centres internationally and that this procedure is safe and effective in islet alone diabetic recipients.