UVA Islet Cell Transplantation in Patients With Type I Diabetes
This trial is active, not recruiting.
|Condition||diabetes mellitus, type 1|
|Treatment||pancreatic islets of langerhans cell transplant|
|Sponsor||University of Virginia|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||January 2007|
|End date||January 2012|
|Trial size||20 participants|
|Trial identifier||NCT00605592, 12839|
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.
|Intervention model||single group assignment|
A decrease in the average daily insulin requirement post-islet cell transplantation.
time frame: Post-transplant
Male or female participants from 18 years up to 65 years old.
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
|Official title||UVA Islet Cell Transplantation in Patients With Type I Diabetes|
|Principal investigator||Kenneth Brayman, MD, PhD|
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