drugset / Trial / NCT00286624
Anti-Thymocyte Globulin, Cyclosporine, and RAD in Islet Transplantation
Phase 1/2
Completed
6 enrolled
University of Minnesota
Juvenile Diabetes Research Foundation · collabNational Institutes of Health (NIH) · collabNovartis · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study was designed to test the safety and efficacy of up to 3 pancreatic alloislet transplants in type 1 diabetic patients with hypoglycemia unawareness. 6 subjects were transplanted under this protocol using anti-thymocyte globulin induction immunosuppression and everolimus with cyclosporine maintenance immunosuppression.
Timeline
- Start
- 2003-03
- Primary completion
- 2006-08
- Completion
- 2006-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic Islets of Langerhans | Cell therapy | 3000 unknown | Other |
| Subject | Allogeneic Islets of Langerhans | Cell therapy | 5000 unknown | Other |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
| Background | Cyclosporine | Peptide | 3 mg/kg | — |
| Background | Everolimus | Small molecule | 1.5 mg | Oral |