Type 1 diabetes remains a therapeutic challenge, according to background information in the article. The success rate of islet (cells that produce insulin to control blood sugar levels) transplants has recently been increased markedly by transplanting a higher number of islets prepared from 2 to 4 donor pancreases. However, for islet transplants to become a widespread clinical reality, additional advances are still needed. In particular, restoration of insulin independence must be achieved with a single donor, as is also the case with pancreas transplants, to reduce the risks and costs and increase the availability of islet transplantation.
Bernhard J. Hering, M.D., of the University of Minnesota, Minneapolis, and colleagues conducted a study to assess the effectiveness and safety of islet transplantation from a single pancreas. The trial was conducted from July 2001 to August 2003 and enrolled eight women with type 1 diabetes.
During the trial there were no serious, unexpected, or procedure- or immunosuppression-related adverse events. All eight recipients achieved insulin independence and freedom from hypoglycemia. Five remained insulin-independent for longer than 1 year.
"Our results mark a distinct advance in islet transplant efficacy. We not only achieved insulin independence using islets from only 1 donor pancreas [as compared with 2 to 4 in another trial], we also achieved superior glycemic control (as evidenced by normal results of oral glucose tolerance testing in 4 of 5 recipients with sustained insulin independence) using significantly fewer islets," the authors write. "These findings may have implications for the ongoing transition of islet transplantation from clinical investigation to routine clinical care."
"While these findings may suggest a distinct advance in islet transplantation, further study in a larger population with longer follow-up will be critical to assess the risk-benefit ratio of this emerging therapeutic option," the researchers conclude.
(JAMA. 2005;293:830-835. Available post-embargo at JAMA.com )
Editor's Note: This study was supported by grants from Roche Laboratories Inc., the National Center for Research Resources, National Institutes of Health, and the Juvenile Diabetes Research Foundation. SangStat provided rabbit anti-thymocyte globulin. Wyeth-Ayerst supplied sirolimus.
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