This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.
The main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. The other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
human pancreatic islet transplantation
University Hospital
Besançon, France
University Hospital, Department of Endocrinology
Grenoble, France
University Hospital, Department of Endocrinology
Lyon, France
University Hospital, Department of Endocrinology
Montpellier, France
Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves
Time frame: 12 months
Tolerance (Measurement of portal pressure during islet injection) Quality of life (Questionnaires SF-36 and DQOL at inclusion time, then every 6 months during their waiting period and then 6 months and 12 months after transplantation) Costs
Time frame: 12 months
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University Hospital, Department of Endocrinology
Nancy, France
University Hospital, Department of Endocrinology
Strasbourg, France
University Hospital, Department of Surgery
Geneva, Switzerland