Diabetes Dateline
Winter 2008
Research News
NIH Recruits Participants for Islet Transplantation Trials
The National Institutes of Health (NIH) is recruiting participants for several islet transplantation studies to improve the safety and long-term success of transplanting islets in people with type 1 diabetes whose islets have been destroyed.
Islets contain the insulin-producing cells of the pancreas. In islet transplantation, thousands of islets are isolated from a donor pancreas and injected into the portal vein feeding a recipient’s liver. In a successful transplant, the islets become embedded in the liver and begin producing insulin.
One of the studies, a pivotal phase 3 trial, plans to enroll 130 participants who have received a kidney transplant to compare the success of islet transplantation versus intensive insulin treatment, according to Thomas L. Eggerman, M.D., Ph.D., director of the Islet Transplantation Clinical Trials Program at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The NIDDK is conducting the studies with the National Institute of Allergy and Infectious Diseases.
Another pivotal phase 3 trial plans to study the success of islet transplantation in 48 subjects with very hard-to-control type 1 diabetes. Experimental islet transplantation procedures are currently limited to participants who have had a kidney transplant or who have very hard-to-control type 1 diabetes.
Other islet transplantation studies are aimed at improving transplant approaches, said Eggerman. Through the Clinical Islet Transplantation Consortium (CITC), these studies will focus on
- improving the number of islets that survive transplantation
- reducing the side effects of immunosuppression
- achieving good blood glucose control without hypoglycemia
- following the fate of islets after transplantation and determining why donor islets sometimes fail
- evaluating new ways to safely prevent immune rejection of donor tissues
For more information about the islet transplantation studies, call 1–877–isletstudy (475–3878) or visit www.citisletstudy.org. For a copy of an NIDDK fact sheet about islet transplantation, go to www.diabetes.niddk.nih.gov/dm/pubs/pancreaticislet.
The Clinical Islet Transplantation Consortium (CITC) includes the following sites and principal investigators:
University of Minnesota Bernhard J. Hering, M.D.
Northwestern University Dixon B. Kaufman, M.D., Ph.D.
Uppsala University Olle Korsgren, M.D., Ph.D.
Emory University Christian Larsen, M.D., Ph.D.
University of Pennsylvania Ali Naji, M.D., Ph.D.
University of Miami Camillo Ricordi, M.D.
University of Alberta James Shapiro, M.D., Ph.D., F.R.C.S.C.
The data management center is located at the University of Iowa. The project director is William R. Clarke, Ph.D.
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NIH Publication No. 08–4562
March 2008
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