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Sponsors and Collaborators: |
University of Virginia National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Wyeth |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00605592 |
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 |
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Diabetes Mellitus, Type 1 |
Procedure: Pancreatic Islets of Langerhans Cell Transplant |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | UVA Islet Cell Transplantation in Patients With Type I Diabetes |
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 |
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1: Experimental
Islet cell transplant
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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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Courtney Garbee, BS | 1-800-543-8814 | cfg2p@virginia.edu |
Contact: Claire McKinley, BS | 1-800-543-8814 | cw9ne@virginia.edu |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Principal Investigator: Kenneth Brayman, MD, PhD | |
Sub-Investigator: Anthony McCall, MD | |
Sub-Investigator: Robert Ketchum, PhD |
Principal Investigator: | Kenneth Brayman, MD, PhD | University of Virginia |
Responsible Party: | University of Virginia ( Kenneth Brayman/MD, PhD ) |
Study ID Numbers: | 12839 |
Study First Received: | January 18, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00605592 |
Health Authority: | United States: Food and Drug Administration |
Type 1 Diabetes Kidney Transplant Hypoglycemic Unawareness Islet Transplant |
Pancreatic Islet Cell Transplantation University of Virginia Islet Transplantation Kidney Transplantation |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |