drugset / Trial / NCT01049633
B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure
Expanded access
No longer available
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
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 immunosuppressive medications and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic Pancreatic Islet Cells | Cell therapy | — | — |
| Background | Aspirin | Small molecule | 81 mg | Oral |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |
| Background | Clotrimazole | Unknown | — | Oral |
| Background | Enoxaparin sodium | Other / unclassified | 30 mg | Subcutaneous |
| Background | Heparin | Other / unclassified | — | — |
| Background | Pentoxifylline | Small molecule | 400 mg | Oral |
| Background | Sirolimus | Small molecule | — | — |
| Background | Tacrolimus | Small molecule | 0.015 mg/kg | Oral |
| Background | Trimethoprim/sulfamethoxazole | Unknown | 80 mg | Oral |
| Background | Trimethoprim/sulfamethoxazole | Unknown | 400 mg | Oral |
| Background | Valganciclovir | Small molecule | 900 mg | Oral |