UVA Islet Cell Transplantation in Patients With Type I Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

UVA Islet Cell Transplantation in Patients With Type I Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00605592
• Other study ID #: 12839
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 18, 2008
• Last updated: February 16, 2009
• Start date: January 2007
• Est. completion date: January 2012

Study information

• Verified date: February 2009
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A decrease in the average daily insulin requirement post-islet cell transplantation.		Post-transplant	No