UVA Islet Cell Transplantation in Patients With Type I Diabetes

Study Overview
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Brief Summary
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This protocol will provide islet cell transplantation to two separate populations in need of a pancreas transplant: Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney Transplant The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and may benefit from transplantation over continuing insulin therapy, even though chronic immunosuppression is required. We believe that in these patients, the islet transplant procedure promises enough potential benefit to justify subjecting patients who have not previously had a transplant to the risk of immunosuppression. In patients who are already subject to the dangers of chronic immunosuppression for other reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure itself is the principal additional risk and this risk should be minimal. In these patients (our Group II), the potential benefit from improved glycemic control is that it promises to slow or even reverse diabetic complications, such as vascular problems leading to kidney damage. It is this rationale that has made pancreas transplantation a widely accepted option in patients with renal failure, despite the risks associated with whole pancreas transplantation. Islet cell transplantation aims to provide a potentially lower risk procedure that has similar relief from diabetic complications.

Official Title
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UVA Islet Cell Transplantation in Patients With Type I Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Procedure: Pancreatic Islets of Langerhans Cell Transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type I Diabetes Mellitus for at least 5 years Unstable control of diabetes despite intensive care by an endocrinologist, including episodes of dangerously low blood sugars Group I must have healthy kidneys Group II (islet after kidney) must have a stable kidney allograft for at least 6 months Exclusion Criteria: Unstable diabetic eye disease Poor kidney function Type II Diabetes as determined by blood tests Any history of cancer, except certain skin cancers Pregnant or unwilling to use adequate birth control Very high hemoglobin A1c levels Poor control of blood pressure, despite use of medications Very high insulin requirements History of exposure to HIV Active Hepatitis B or Hepatitis C infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Islet cell transplant | Procedure: Pancreatic Islets of Langerhans Cell Transplant<br>* Transplantation of islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.<br>* Other names: Pancreatic Islet Cell Transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A decrease in the average daily insulin requirement post-islet cell transplantation. |  | Post-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Kidney Transplant, Hypoglycemic Unawareness, Islet Transplant, Pancreatic Islet Cell Transplantation, University of Virginia, Islet Transplantation, Kidney Transplantation