Emory to Join Stem Cell-based Trial

The objective of the ELPIS Trial is to advance the clinical application of MSCs in the treatment of HLHS patients and to potentially uncover
the mechanism by which MSCs can improve ventricular function in this unique patient subset. In Phase I/II adult clinical trials, we have previously shown the safety and preliminary efficacy of allogeneic MSC treatment in adult ischemic patients by the proposed remodeling mechanisms of direct cell-cell interactions with
myocardial cells and indirect paracrine effects in order to reduce myocardial fibrosis, stimulate angiogenesis, and stimulate endogenous c-kit+ cardiac progenitor cells (CPCs) in the left ventricle (LV).11,12 We have recently shown MSC injections preserve RV dysfunction by activating endogenous pathways of
ventricular remodeling in a swine model of RV pressure overload, replicating features of HLHS.13,14 We hypothesize that MSCs will facilitate remodeling of the RV in HLHS patients by both direct and indirect mechanisms and improve ventricular function. We will overlay our novel therapeutic MSC strategy on the stage II bidirectional cavopulmonary anastomosis operation in HLHS patients and rigorously validate potential mechanisms for RV improvement.

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