Majority of Edmonton Protocol Participants Don’t Stay Off Insulin After One Year

Despite successfully restoring insulin production and blood-glucose stability after transplantation, insulin independence is usually not sustainable after the Edmonton Protocol.

The Edmonton Protocol team, lead by James Shapiro, MD, PhD, FRCS, conducted an international, multi-center trial to “explore the feasibility and reproducibility of islet transplantation with the use of a single common protocol.” Thirty-six type 1s were enrolled and underwent islet transplantation at nine international sites.

“Of the 36 subjects, 16 met the primary end point, 10 had partial function, and 10 had complete graft loss one year after the final transplantation,” write the researchers. “A total of 21 subjects attained insulin independence with good glycemic control at any point throughout the trial. Of these subjects, 16 required insulin again at two years; five of the 16 subjects who reached the primary end point remained insulin-independent at two years.”

New England Journal of Medicine, September 28, 2006

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