Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
NCT00285233 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2012-08-02
Summary
The objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression.
Conditions
Interventions
- BIOLOGICAL
-
Allogeneic islets of Langerhans transplant
Allogeneic islets of Langerhans transplant
Sponsors & Collaborators
-
Roche Pharma AG
collaborator INDUSTRY -
Juvenile Diabetes Research Foundation
collaborator OTHER - lead OTHER
Principal Investigators
-
Bernhard J. Hering, M.D. · University of Minnesota
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2000-09-30
- Primary Completion
- 2004-09-30
- Completion
- 2005-03-31
Countries
- United States
Study Locations
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