Reference : Cardiopoietic stem cell therapy in heart failure: the C-CURE (Cardiopoietic stem Cell...
Scientific journals : Article
Human health sciences : Cardiovascular & respiratory systems
http://hdl.handle.net/2268/168401
Cardiopoietic stem cell therapy in heart failure: the C-CURE (Cardiopoietic stem Cell therapy in heart failURE) multicenter randomized trial with lineage-specified biologics.
English
Bartunek, Jozef [> >]
Behfar, Atta [> >]
Dolatabadi, Dariouch [> >]
Vanderheyden, Marc [> >]
Ostojic, Miodrag [> >]
Dens, Jo [> >]
El Nakadi, Badih [> >]
Banovic, Marko [> >]
Beleslin, Branko [> >]
Vrolix, Mathias [> >]
Legrand, Victor mailto [Université de Liège - ULiège > Département des sciences cliniques > Cardiologie >]
Vrints, Christian [> >]
Vanoverschelde, Jean Louis [> >]
Crespo-Diaz, Ruben [> >]
Homsy, Christian [> >]
Tendera, Michal [> >]
Waldman, Scott [> >]
Wijns, William [> >]
Terzic, Andre [> >]
2013
Journal of the American College of Cardiology
61
23
2329-38
Yes (verified by ORBi)
0735-1097
1558-3597
United States
[en] Aged ; Female ; Follow-Up Studies ; Graft Rejection ; Graft Survival ; Heart Failure/diagnosis/mortality/therapy ; Heart Function Tests ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Mesenchymal Stem Cell Transplantation/methods ; Middle Aged ; Prospective Studies ; Reference Values ; Risk Assessment ; Stroke Volume/physiology ; Survival Rate ; Time Factors ; Treatment Outcome ; Ventricular Remodeling/physiology
[en] OBJECTIVES: This study sought to evaluate the feasibility and safety of autologous bone marrow-derived and cardiogenically oriented mesenchymal stem cell therapy and to probe for signs of efficacy in patients with chronic heart failure. BACKGROUND: In pre-clinical heart failure models, cardiopoietic stem cell therapy improves left ventricular function and blunts pathological remodeling. METHODS: The C-CURE (Cardiopoietic stem Cell therapy in heart failURE) trial, a prospective, multicenter, randomized trial, was conducted in patients with heart failure of ischemic origin who received standard of care or standard of care plus lineage-specified stem cells. In the cell therapy arm, bone marrow was harvested and isolated mesenchymal stem cells were exposed to a cardiogenic cocktail. Derived cardiopoietic stem cells, meeting release criteria under Good Manufacturing Practice, were delivered by endomyocardial injections guided by left ventricular electromechanical mapping. Data acquisition and analysis were performed in blinded fashion. The primary endpoint was feasibility/safety at 2-year follow-up. Secondary endpoints included cardiac structure/function and measures of global clinical performance 6 months post-therapy. RESULTS: Mesenchymal stem cell cocktail-based priming was achieved for each patient with the dose attained in 75% and delivery without complications in 100% of cases. There was no evidence of increased cardiac or systemic toxicity induced by cardiopoietic cell therapy. Left ventricular ejection fraction was improved by cell therapy (from 27.5 +/- 1.0% to 34.5 +/- 1.1%) versus standard of care alone (from 27.8 +/- 2.0% to 28.0 +/- 1.8%, p < 0.0001) and was associated with a reduction in left ventricular end-systolic volume (-24.8 +/- 3.0 ml vs. -8.8 +/- 3.9 ml, p < 0.001). Cell therapy also improved the 6-min walk distance (+62 +/- 18 m vs. -15 +/- 20 m, p < 0.01) and provided a superior composite clinical score encompassing cardiac parameters in tandem with New York Heart Association functional class, quality of life, physical performance, hospitalization, and event-free survival. CONCLUSIONS: The C-CURE trial implements the paradigm of lineage guidance in cell therapy. Cardiopoietic stem cell therapy was found feasible and safe with signs of benefit in chronic heart failure, meriting definitive clinical evaluation. (C-Cure Clinical Trial; NCT00810238).
http://hdl.handle.net/2268/168401
10.1016/j.jacc.2013.02.071
Copyright (c) 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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