Combination stem cell therapy for the treatment of medically refractory XXXX : a Phase I study.

@entity1 @entity951 @entity741 @entity63
PURPOSE: Infusion of a source of endothelial progenitor cells (EPC) into the @entity63 myocardium is emerging as a promising therapy for @entity63 , probably mediated by the formation of new blood vessels. Studies have shown that while the procedure is safe and feasible, efficacy results are contentious. The investigators hypothesized that the infusion of a combination cell product consisting of a source of EPC and mesenchymal stem cells (MSC) is safe and promotes the formation of more stable and mature blood vessels resulting in improved clinical outcomes. METHODS: Ten @entity1 with stable @entity951 (class III to IV) on maximal medical therapy were included. All @entity1 had >=  70% stenosis in at least one coronary artery, and none was considered a candidate for percutaneous coronary intervention or coronary artery bypass graft. End points were feasibility and safety of intracoronary infusion of the combination cell product and assessment of @entity741 , left ventricular ejection fraction (LVEF), and quality of life at 6 months postinfusion. RESULTS: Six months after cell infusion there were no adverse clinical events. Functional cardiac evaluation during the same period showed significant improvements in LVEF (average increase: 11%, P = .02) and @entity741 (average decrease: 1.8 fold, P = .02). Additionally, all @entity1 described significant improvements in quality of life. CONCLUSIONS: Despite the inherent limitations associated with a Phase I clinical trial, this study demonstrates that the intracoronary infusion of the combination cell product is feasible and safe and also insinuates that this form of therapy may be beneficial.
