605592
Last Update Posted: 2009-02-18
Recruiting status is unknown
All Genders accepted | 18 Years-65 Years |
20 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
UVA Islet Cell Transplantation in Patients With Type I Diabetes
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.
Eligibility
Relevant conditions:
Diabetes Mellitus, Type 1
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Data sourced from ClinicalTrials.gov