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Clinical Trials/NCT00605592
NCT00605592UnknownPhase 1

UVA Islet Cell Transplantation in Patients With Type I Diabetes

University of Virginia2 sites in 1 country20 target enrollmentStarted: January 2007Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
20
Locations
2
Primary Endpoint
A decrease in the average daily insulin requirement post-islet cell transplantation.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

A decrease in the average daily insulin requirement post-islet cell transplantation.

Time Frame: Post-transplant

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (2)

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