Clinical trial NCT00605592: UVA Islet Cell Transplantation in Patients With Type I Diabetes
Official title: UVA Islet Cell Transplantation in Patients With Type I Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes
Kidney Transplant
Hypoglycemic Unawareness
Islet Transplant
Pancreatic Islet Cell Transplantation
University of Virginia
Islet Transplantation
Kidney Transplantation
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2008-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: A decrease in the average daily insulin requirement post-islet cell transplantation.
timeFrame: Post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Kenneth Brayman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: