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Trial record 1 of 1 for:    NCT00605592
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UVA Islet Cell Transplantation in Patients With Type I Diabetes

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.
 
ClinicalTrials.gov Identifier: NCT00605592
Recruitment Status : Unknown
Verified February 2009 by University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : January 31, 2008
Last Update Posted : February 18, 2009
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE January 18, 2008
First Posted Date  ICMJE January 31, 2008
Last Update Posted Date February 18, 2009
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
A decrease in the average daily insulin requirement post-islet cell transplantation. [ Time Frame: Post-transplant ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UVA Islet Cell Transplantation in Patients With Type I Diabetes
Official Title  ICMJE UVA Islet Cell Transplantation in Patients With Type I Diabetes
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Islet cell transplant
Intervention: Procedure: Pancreatic Islets of Langerhans Cell Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 30, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2012
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00605592
Other Study ID Numbers  ICMJE 12839
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Brayman/MD, PhD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Kenneth Brayman, MD, PhD University of Virginia
PRS Account University of Virginia
Verification Date February 2009

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