Abstract Title:
Standardization of human islet isolation procedures for a multicenter transplant trial
Author List:
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.
Affiliations:
Clinical Islet Program, Edmonton, Canada
Diabetes Research Institute, Miami, FL
University of Minnesota, Minneapolis, MN
National Institute of Health, Bethesda, MD
EMMES Corporation, Bethesda, MD
Massachusetts General Hospital, Boston, MA
Washington University, St Louis, MO
Pacific Northwest Research Institute, Seattle, WA
Justus-Leibig University, Giessen, Germany
University of Milan, Italy
University of Geneva Hospital, Geneva, Switzerland
Immune Tolerance Network, San Francisco, CA
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.
Meeting Name:
64th Scientific Sessions of the American Diabetes Association
Meeting Place:
Orlando, FL
Publication/Meeting Year:
