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Clinical Trial
. 2014 Dec;7(9):769-80.
doi: 10.1007/s12265-014-9594-0. Epub 2014 Oct 30.

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

Muzammil Mushtaq  1 , Darcy L DiFede, Samuel Golpanian, Aisha Khan, Samirah A Gomes, Adam Mendizabal, Alan W Heldman, Joshua M Hare
Affiliations
Clinical Trial

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

Muzammil Mushtaq et al. J Cardiovasc Transl Res. 2014 Dec.

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.

Trial registration: ClinicalTrials.gov NCT01392625.

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Figures

Fig. 1
Fig. 1. NOGA-MYOSTAR injection catheter
Injection catheter parts shown in (A), and heart tracing in (B) shows catheter within left ventricle under fluoroscopy; white arrow points to tip of catheter. (C) displays an exteriorized needle tip, engaged with endocardium, injecting cells (purple).
Fig. 2
Fig. 2
Endomyocardial biopsy technique using the bioptome
Fig. 3
Fig. 3. Cell harvesting and culture
(A) and (B) show endomyocardial biopsy specimen in culture dish. Several days after culture, in (B), mixed cell population proliferate peripherally around specimen. Black arrows in (C) point to immunostained c-Kit+ cells post-magnetic selection. (D) shows isolated c-Kit+ cells at P3 stage, with an example of a single c-Kit+ cell in green rectangle.
Fig. 4
Fig. 4. NOGA XP Cardiac Navigation System
NOGA mapping projections of the left ventricle in RAO views pre-injection (A) and post-injection (B). Corresponding fluoroscopic images with endocardial tracings are shown in (C) and (D). Numbers indicate injection sites. NOGA mapping projections of the left ventricle in LAO views pre-injection (E) and post-injection (F), and corresponding fluoroscopic images with endocardial tracings are displayed in (G) and (H). Regional, or “bull’s eye”, NOGA mapping views can be seen in (I) and (J) pre- and post-injection, respectively.
See this image and copyright information in PMC

References

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