Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Alberta
Collaborator:
Alberta Innovates Health Solutions
Treatments:
Alemtuzumab Etanercept Interleukin 1 Receptor Antagonist Protein JM 3100 Liraglutide Plerixafor