Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatment pancreatic islets of langerhans cell transplant
Phase phase 1
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Islet cell transplant
pancreatic islets of langerhans cell transplant Islet 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.

Primary Outcomes

Measure
A decrease in the average daily insulin requirement post-islet cell transplantation.
time frame: Post-transplant

Eligibility Criteria

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

Additional Information

Official title UVA Islet Cell Transplantation in Patients With Type I Diabetes
Principal investigator Kenneth Brayman, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University of Virginia.