UVA Islet Cell Transplantation in Patients With Type I Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00605592
First received: January 18, 2008
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Procedure: Pancreatic Islets of Langerhans Cell Transplant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: UVA Islet Cell Transplantation in Patients With Type I Diabetes

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • A decrease in the average daily insulin requirement post-islet cell transplantation. [ Time Frame: Post-transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Islet cell transplant
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605592

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Kenneth Brayman, MD, PhD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth Brayman/MD, PhD, University of Virginia
ClinicalTrials.gov Identifier: NCT00605592     History of Changes
Other Study ID Numbers: 12839
Study First Received: January 18, 2008
Last Updated: February 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
Type 1 Diabetes
Kidney Transplant
Hypoglycemic Unawareness
Islet Transplant
Pancreatic Islet Cell Transplantation
University of Virginia
Islet Transplantation
Kidney Transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014