UVA Islet Cell Transplantation in Patients With Type I Diabetes
NCT00605592
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Adult Trials: 18+ Years
- 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
- 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
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| 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:
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| 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 | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| Investigators ICMJE |
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| 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 | ||||