title: Rationale and design of the Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Dilated Cardiomyopathy (the POSEIDON-DCM study): a phase I/II, randomized pilot study of the comparative safety and efficacy of transendocardial injection of autologous mesenchymal stem cell vs. allogeneic mesenchymal stem cells in patients with non-ischemic dilated cardiomyopathy.
abstract: While accumulating clinical trials have focused on the impact of cell therapy in patients with acute myocardial infarction (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. The POSEIDON-DCM trial is a phase I/II trial designed to address autologous vs. allogeneic bone marrow-derived mesenchymal stem cells (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 treatment groups: group 1 (n = 18 auto-human mesenchymal stem cells (hMSC)) 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. 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.
authors.affiliation: Interdisciplinary Stem Cell Institute, Biomedical Research Building, University of Miami Miller School of Medicine, 1501 NW 10th Avenue (Suite 909), Miami, FL, 33136, USA.
authors.forename: Muzammil
authors.initials: M
authors.lastname: Mushtaq
authors.forename: Darcy L
authors.initials: DL
authors.lastname: DiFede
authors.forename: Samuel
authors.initials: S
authors.lastname: Golpanian
authors.forename: Aisha
authors.initials: A
authors.lastname: Khan
authors.forename: Samirah A
authors.initials: SA
authors.lastname: Gomes
authors.forename: Adam
authors.initials: A
authors.lastname: Mendizabal
authors.forename: Alan W
authors.initials: AW
authors.lastname: Heldman
authors.forename: Joshua M
authors.initials: JM
authors.lastname: Hare
mesh_terms: D001706:Biopsy; D002311:Cardiomyopathy, Dilated / Q000628:therapy*; D004699:Endocardium / Q000166:cytology; D006801:Humans; D007267:Injections / Q000379:methods; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D010865:Pilot Projects; D020858:Tissue and Organ Harvesting / Q000379:methods; D014182:Transplantation, Autologous; D014184:Transplantation, Homologous; D016896:Treatment Outcome