drugset / Trial / NCT00468442
B-Lymphocyte Immunotherapy in Islet Transplantation
Phase 2
Terminated
2 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
NaSingle-groupOpen-labelTreatment
Summary
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with the immunosuppressive medications and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Timeline
- Start
- 2006-11
- Primary completion
- 2011-09
- Completion
- 2011-09
Outcome
Outcome not reported
Stopped: “Lack of efficacy”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic Pancreatic Islet Cells | Cell therapy | — | Other |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | — |
| Background | Daclizumab | Monoclonal antibody | — | — |
| Background | Rituximab | Monoclonal antibody | — | — |
| Background | Sirolimus | Small molecule | — | — |