A Phase <scp>II</scp> study of autologous mesenchymal stromal cells and c?kit positive cardiac cells, alone or in combination, in patients with ischaemic heart failure: the <scp>CCTRN CONCERT?HF</scp> trial

Aims CONCERT-HF is an NHLBI-sponsored, double-blind, placebo-controlled, Phase II trial designed to determine whether treatment with autologous bone marrow-derived mesenchymal stromal cells (MSCs) and c-kit positive cardiac (CPCs), given alone or in combination, feasible, safe, beneficial patients heart failure (HF) caused by ischaemic cardiomyopathy. Methods results Patients were randomized (1:1:1:1) transendocardial injection of MSCs combined CPCs, alone, CPCs placebo, followed for 12 months. Seven centres enrolled 125 participants left ventricular ejection fraction 28.6 ± 6.1% scar size 19.4 5.8%, New York Heart Association class III. The proportion major adverse events (MACE) was significantly decreased (?22% vs. P = 0.043). Quality life (Minnesota Living Failure Questionnaire score) improved (P 0.050) + 0.023) placebo. Left fraction, volumes, size, 6-min walking distance, peak oxygen consumption did not differ among groups. Conclusions This the first multicentre assessing a combination two cell types from different tissues HF patients. show that safe feasible. Even maximal guideline-directed therapy, both associated clinical outcomes (MACE quality life, respectively) without affecting function structure, suggesting possible systemic paracrine cellular mechanisms. Combining improvement these outcomes. These suggest potential important effects support further investigation