UVA Islet Cell Transplantation in Patients With Type I Diabetes

NCT ID: NCT00605592

Last Updated: 2009-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Islet cell transplant

Group Type: EXPERIMENTAL

Pancreatic Islets of Langerhans Cell Transplant

Intervention Type: PROCEDURE

Transplantation of islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.

Interventions

Pancreatic 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.

Intervention Type: PROCEDURE

Other Intervention Names

Islet Cell Transplant; Pancreatic Islet Cell Transplantation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

University of Virginia

Principal Investigators

Kenneth Brayman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

12839

Identifier Type: -

Identifier Source: org_study_id