UVA Islet Cell Transplantation in Patients With Type I Diabetes
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|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
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 or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Procedure: Pancreatic Islets of Langerhans Cell Transplant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||UVA Islet Cell Transplantation in Patients With Type I Diabetes|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2012|
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.
- A decrease in the average daily insulin requirement post-islet cell transplantation. [ Time Frame: Post-transplant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605592
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Kenneth Brayman, MD, PhD||University of Virginia|