The objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression.
To assess the safety and efficacy of a new single-donor islet allotransplant protocol focusing on minimization of ischemic damage by the two-layer pancreas preservation technique, attenuation of posttransplant nonspecific inflammatory responses by etanercept and anti-thymocyte globulin, deletion/inactivation of autoreactive T cells by anti-thymocyte globulin and daclizumab induction immunotherapy, and potent yet non-diabetogenic maintenance immunosuppression with sirolimus and delayed mycophenolate mofetil instead of tacrolimus for the reestablishment of stable glycemic control in recipients with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Allogeneic islets of Langerhans transplant
University of Minnesota
Minneapolis, Minnesota, United States
Assess the incidence and severity of hypoglycemia in type 1 diabetic subjects receiving an islet allotransplant and immunotherapy during the first year posttransplant.
Time frame: 1 year
Assess liver laboratory tests during the first year following intraportal islet allotransplantation.
Time frame: 1 yr
Assess the incidence, type, and severity of islet transplant-related infectious complications during the first year posttransplant.
Time frame: 1 year
Assess the proportion of recipients who develop alloantibodies directed at donor alloantigens during the first year posttransplant.
Time frame: 1 year
Monitor the incidence, timing, and severity of adverse events as well as their relationship to the islet transplant procedure and additional protocol-regulated treatment products during the first year after islet transplantation.
Time frame: 1 year
Assess the proportion of type 1 diabetic subjects receiving delayed mycophenolate mofetil instead of tacrolimus who achieve insulin independence in the first year after transplantation of allogeneic islets.
Time frame: 1 year
Assess the proportion of type 1 diabetic islet allograft recipients with full and partial alloislet function at one year post transplant.
Time frame: 1 year
Assess the glycemic control, insulin secretory responses, and the glucose disposal rate during the first year posttransplant.
Time frame: 1 year
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Effect of donor age, pretransplant islet insulin secretory response, # of transplanted islet equivalents, # of transplanted beta cells, pretransplant insulin action, recipient BMI and immunosuppressive therapy on safety and efficacy.
Time frame: 1 year
Assess, in a selected group of islet allotransplant recipients, the autoimmune and alloimmune responses to transplanted islets at intervals during the first year posttransplant.
Time frame: 1 year