Type 1 Diabetes Clinical Trial
Official title:
Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression
This single center phase 2 clinical trial, is designed for confirming the efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with previous kidney transplantation.
The beneficial effects of glycemic control on both survival and function of transplanted
kidneys in patients with type 1 diabetes mellitus have been recognized.
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell
transplantation, in patients with type 1 diabetes mellitus who have a stable kidney
allograft.
The study primary efficacy endpoint is graft survival defined as insulin independence and
HbA1c < 8% at 1 year post first transplant. Secondary outcomes are graft function and
metabolic control
The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus
regimen 6 months before islet transplantation to exclude negative effects on kidney graft
function.
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