Diabetes Mellitus, Type 1
Conditions
Keywords
Type 1 Diabetes, Kidney Transplant, Hypoglycemic Unawareness, Islet Transplant, Pancreatic Islet Cell Transplantation, University of Virginia, Islet Transplantation, Kidney Transplantation
Brief summary
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.
Interventions
PROCEDUREPancreatic Islets of Langerhans Cell Transplant
Transplantation of islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Wyeth is now a wholly owned subsidiary of Pfizer
University of Virginia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A decrease in the average daily insulin requirement post-islet cell transplantation. | Post-transplant |
Countries
United States
Outcome results
None listed