Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)
Summary
Type 1 diabetes is an autoimmune disease characterized by destruction of pancreatic beta-cells, resulting in absolute deficiency of insulin. Presently there is no known cure. Our proposed interventional trial is based on 'immunological reset' approach: T-depletion therapy and anti-inflammatory treatment will restore self-tolerance in T1DM; Autologous, peripheral-blood mobilized hematopoietic CD34+-enriched stem cells and a long-acting GLP-1 analogue will promote pancreatic islet regeneration and repair. The short-term goals of this protocol is to demonstrate that subjects with new-onset T1DM undergoing autologous hematopoietic stem cell mobilization and immunologic reset will have greater preservation of endogenous insulin secretion compared to controls, and foremost that this nonmyeloablative treatment is safe, without the need for chronic immune suppression.
Timeline
- Start
- 2017-08-15
- Primary completion
- 2024-07-15
- Completion
- 2024-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 30 mg | Intravenous |
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Subject | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | Liraglutide | Peptide | 1.2 mg | Subcutaneous |
| Subject | Plerixafor | Small molecule | 0.24 mg/kg | Subcutaneous |