A phase II study of autologous mesenchymal stromal cells and c‐kit positive cardiac cells, alone or in combination, in patients with ischemic heart failure: The CCTRN CONCERT‐HF trial

Researchers assessed feasibility, safety, as well as benefits of treatment with autologous bone marrow‐derived mesenchymal stromal cells (MSCs) and c‐kit positive cardiac cells (CPCs), administered alone or together, among patients with heart failure (HF) secondary to ischemic cardiomyopathy, in an NHLBI‐sponsored, double‐blind, placebo‐controlled, Phase II trial (CONCERT‐HF). They randomly assigned patients (1:1:1:1) to transendocardial injection of MSCs combined with CPCs, MSCs alone, CPCs alone, or placebo, and observed them for 12 months. Findings of this first multicenter trial for evaluating CPCs and a combination of two cell types from different tissues in HF patients revealed the safety as well as the feasibility of the treatment. In ischemic HF, improved clinical results (major adverse cardiac events and quality of life, respectively) in relation to both CPCs and MSCs were seen with no impact on LV function or structure, even with maximal guideline‐directed therapy. This is indicative of likely systemic or paracrine cellular mechanisms. Improvement in both these outcomes was achieved by integrating MSCs with CPCs. Based on the findings of this study, CPCs and MSCs were concluded to confer potential important beneficial impacts in HF patients.