drugset / Trial / NCT00315614
Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus
Phase 2
Terminated
3 enrolled
University of Miami
Diabetes Research Institute Foundation · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
NaSingle-groupOpen-labelTreatment
Summary
SPECIFIC AIMS: * To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation. * To induce a state of donor specific tolerance and eliminate the need for continuous immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells with islets and utilization of the monoclonal antibody Campath-1H for induction of Immunosuppression. * To assess long-term function of successful islet cell transplants in patients with Type 1 diabetes mellitus. * To determine whether the natural history of the microvascular, macrovascular and neuropathic complications are altered following successful transplantation of islet
Timeline
- Start
- 2000-12
- Primary completion
- 2010-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD34 Bone Marrow | Cell therapy | — | Other |
| Subject | Islet | Cell therapy | — | — |