Islet Transplantation in Type 1 Diabetic Patients
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | February 2002 |
| End Date: | October 2011 |
Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers
Our hypothesis is that a successful clinical islet transplant program can be established at
the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus -
based immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following
research questions: 1) will treatment of islet transplant recipients with thiazolidinediones
(i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets
necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are
optimal candidates for islet transplantation (i.e. islet transplant alone or islet after
kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and
not used for pancreas transplantation be used for islet transplantation?
the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus -
based immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following
research questions: 1) will treatment of islet transplant recipients with thiazolidinediones
(i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets
necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are
optimal candidates for islet transplantation (i.e. islet transplant alone or islet after
kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and
not used for pancreas transplantation be used for islet transplantation?
Inclusion Criteria:
- 16 Type I insulin-dependent diabetic subjects ages 18-60,(8 who have received a prior
kidney or liver transplant and have stable renal function, and 8 who have labile
glucose regulation and who have failed a trial of intensive exogenous insulin therapy
and who have preserved native renal function)
Exclusion Criteria:
- untreated proliferative diabetic retinopathy;
- HgbA1C >12%; creatinine clearance < 80 ml/minute or macroalbuminuria > 0.3 gm/24 hrs;
- presence of panel reactive antibodies >20%
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