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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.
University Hospital of Lille
Lille, Nord, France
Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 8% at one year after the transplantation
Percent of insulin-independent patients with a Glycosylated Hemoglobin (HbA1c) under 8% at one year after injection of approximately 10,000 islets equivalents / kg (IE/kg).
Time frame: One year
The number of adverse events
The number of adverse events related to the procedure and to the immunosuppression
Time frame: 1 year
Number of severe episodes of hypoglycemia
Number of severe episodes of hypoglycemia (requiring the use of third)
Time frame: 1 year
Evaluation of Diabetes complications
Evaluation of Diabetes complications: retinopathy, neuropathy, nephropathy
Time frame: 1 year
Lipid metabolism
Lipid metabolism assessed by measurement of total cholesterol and HDL cholesterol, triglycerides, ApoA1, apoB, apoE, free fatty acids and lipid.
Time frame: 1 year
Evaluation of kidney function
Evaluation of kidney function (creatinine, creatinine clearance,proteinurie)
Time frame: 1 year
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