Stem Cell Mobilization (Plerixafor) and Immunologic Reset in New Onset Type 1 Diabetes Mellitus
An Outline of This Clinical Trial
Most type 1 diabetes (T1D) patients require insulin injections for the rest of their lives. In this study, we hope to eliminate their need for taking insulin injections by using this autologous hematopoietic stem cell mobilization approach combined with alemtuzumab, etanercept, anakinra and liraglutide treatment regimen.
Stem cells are very young cells, which reside in the bone marrow, and they have the potential to differentiate into a number of cell types with different functions. By using a stem cell mobilizer (Plerixafor - Mozobil®), stem cells are stimulated out of the bone marrow space, and mobilize into the bloodstream. Theoretically, these mobilized stem cells will travel to the pancreas, grow and potentially differentiate into insulin producing cells.
Study participants will be randomly placed into one of the two treatment groups. One group will receive alemtuzumab infusion and injections of plerixafor, etanercept, anakinra and liraglutide. The treatment therapy will last for a period of 24 months. The other group will receive placebo (medical non-active substance) by infusion and injections for 12 months, and then receive the study treatment regimen for the next 12 months.
Participants will be followed for 24 months with tests and assessments to be performed at each key study visit (Month 3, 6, 9, 12, 18 and 24). All medications to be used in this study (plerixafor, alemtuzumab, anakinra, etanercept and liraglutide) are approved by Health Canada.
To be eligible for this study, participants must be an adult (between the ages of 18 and 45 years old), and have been diagnosed with T1D within 100 days.