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UVA Islet Cell Transplantation in Patients With Type I Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University of Virginia.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605592
First Posted: January 31, 2008
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Virginia
January 18, 2008
January 31, 2008
February 18, 2009
January 2007
January 2012   (Final data collection date for primary outcome measure)
A decrease in the average daily insulin requirement post-islet cell transplantation. [ Time Frame: Post-transplant ]
Same as current
Complete list of historical versions of study NCT00605592 on ClinicalTrials.gov Archive Site
Not Provided
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UVA Islet Cell Transplantation in Patients With Type I Diabetes
UVA Islet Cell Transplantation in Patients With Type I Diabetes

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
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.
Other Names:
  • Islet Cell Transplant
  • Pancreatic Islet Cell Transplantation
Experimental: 1
Islet cell transplant
Intervention: Procedure: Pancreatic Islets of Langerhans Cell Transplant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
January 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00605592
12839
Yes
Not Provided
Not Provided
Kenneth Brayman/MD, PhD, University of Virginia
University of Virginia
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Kenneth Brayman, MD, PhD University of Virginia
University of Virginia
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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