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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00073281 |
Purpose
This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.
| Condition | Intervention | Phase |
|
Diabetes Mellitus, Type 1 |
Procedure: Islet transplantation |
Phase I |
| MedlinePlus related topics: | Diabetes Diabetes Type 1 Islet Cell Transplantation |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Islet Transplantation for Patients With Type 1 Diabetes and Stable Renal Allografts Using Steroid Sparing Immunosuppression |
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | December 2004 |
We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient's portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and an immunosuppressive protocol that avoids glucocorticoids.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations More Information
| Study ID Numbers: | 9903 |
| First Received: | November 18, 2003 |
| Last Updated: | May 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00073281 |
| Health Authority: | United States: Federal Government |
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