Background
While accumulating clinical trials have focused on the impact of cell-therapy in patients with acute MI and ischemic cardiomyopathy, there are fewer efforts to examine cell-based therapy in patients with non-ischemic cardiomyopathy (NICM). We hypothesized that cell-therapy could have a similar impact in NICM.
Methods/Results
The POSIDEON-DCM trial is a phase I/II trial designed to address autologous vs. allogeneic bone marrow derived MSCs in patients with NICM. In this study, cells will be administered transendocardially with the NOGA injection-catheter system to patients (n=36) randomly allocated to two treatments groups: Group 1 (n=18 auto-hMSCs) and Group 2 (n=18 allo-hMSCs). The primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCS vs. auto-hMSCs in patients with NICM.
Conclusions
This study will establish safety of transendocardial injection of stem cells (TESI), compare phenotypic outcomes, and offer promising advances in the field of cell-based therapy in patients with NICM.