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Abstract Details

Activity Number: 572
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306301
Title: Islet Cell Transplantation in Type 1 Diabetes: An Analysis of Clinical Outcomes in Data from Collaborative Islet Transplant Registry (CITR)
Author(s): Jawahar Tiwari*+ and Bruce Schneider and Franca Barton and Steven A Anderson
Companies: FDA/CBER and FDA/CBER and EMMES Corporation and FDA/CBER
Address: 1401 Rockville Pike, Rockville, MD, 20852, United States
Keywords: Islet cell transplant ; Type 1 diabetes ; CITR ; study design ; endpoint ; sample size

Allogeneic pancreatic islet cell transplantation is regulated as an experimental therapy by the Food and Drug Administration. We have analyzed four clinical and laboratory outcomes measured on 340 subjects who have received one, two, or three transplants. At one year, 59% (95% CI: 52, 64) of the subjects maintained HbA1c value at < 6.5 and were free of severe hypoglycemic episodes. The Kaplan-Meier survival analysis showed that 69%, 54%, and 44% of these one-year responders maintained this composite endpoint at two, three and four years, respectively. These and other outcome results can be very useful in developing study designs, sample size estimates, and analytical plans for future pivotal trials of islet cell transplantation.

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