Diabetes Mellitus, Type I Clinical Trial
Official title:
Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients
The purpose of the study is to learn if islet transplantation is an effective treatment for
Type 1 diabetes in people who have had a kidney transplant.
The primary objectives of the study are:
- To set up islet transplantation in patients who have had a kidney transplant and who are
using an immunosuppressive regimen that works
The Secondary objective of the study is:
- To find out if successful islet transplantation leads to improved metabolic control and
reduced renal complication from diabetes
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving
insulin independence. For the first islet transplant, patients will receive induction therapy
with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance
immunosuppression regimen already in place for their renal allograft. Induction therapy for
subsequent transplants will be 2doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
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