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

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 co...

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Bibliographic Details
Published in:Journal of cardiovascular translational research 2014-12, Vol.7 (9), p.769-780
Main Authors: Mushtaq, Muzammil, DiFede, Darcy L., Golpanian, Samuel, Khan, Aisha, Gomes, Samirah A., Mendizabal, Adam, Heldman, Alan W., Hare, Joshua M.
Format: Article
Language:English
Subjects:
Biomedical Engineering and Bioengineering
Biomedicine
Biopsy
Cardiology
Cardiomyopathy, Dilated - therapy
Endocardium - cytology
Human Genetics
Humans
Injections - methods
Medicine
Medicine & Public Health
Mesenchymal Stem Cell Transplantation - methods
Pilot Projects
Tissue and Organ Harvesting - methods
Transplantation, Autologous
Transplantation, Homologous
Treatment Outcome
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Summary: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.
ISSN:1937-5387
1937-5395
DOI:10.1007/s12265-014-9594-0