A Phase II study of autologous mesenchymal stromal cells and c-kit positive cardiac cells, alone or in combination, in patients with ischaemic heart failure: the CCTRN CONCERT-HF trial.
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Bolli Roberto, Mitrani Raul D, Hare Joshua M, Pepine Carl J, Perin Emerson C, Willerson James T, Traverse Jay H, Henry Timothy D, Yang Phillip C, Murphy Michael P, March Keith L, Schulman Ivonne H, Ikram Sohail, Lee David P, O'Brien Connor, Lima Joao A, Ostovaneh Mohammad R, Ambale-Venkatesh Bharath, Lewis Gregory, Khan Aisha, Bacallao Ketty, Valasaki Krystalenia, Longsomboon Bangon, Gee Adrian P, Richman Sara, Taylor Doris A, Lai Dejian, Sayre Shelly L, Bettencourt Judy, Vojvodic Rachel W, Cohen Michelle L, Simpson Lara, Aguilar David, Loghin Catalin, Moyé Lem, Ebert Ray F, Davis Barry R, Simari Robert D, Cardiovascular Cell Therapy Research Network (CCTRN)
Аннотация
METHODS AND RESULTS: Patients were randomized (1:1:1:1) to transendocardial injection of MSCs combined with CPCs, MSCs alone, CPCs alone, or placebo, and followed for 12 months. Seven centres enrolled 125 participants with left ventricular ejection fraction of 28.6 ± 6.1% and scar size 19.4 ± 5.8%, in New York Heart Association class II or III. The proportion of major adverse cardiac events (MACE) was significantly decreased by CPCs alone (-22% vs. placebo, P = 0.043). Quality of life (Minnesota Living with Heart Failure Questionnaire score) was significantly improved by MSCs alone (P = 0.050) and MSCs + CPCs (P = 0.023) vs. placebo. Left ventricular ejection fraction, left ventricular volumes, scar size, 6-min walking distance, and peak oxygen consumption did not differ significantly among groups.
CONCLUSIONS: This is the first multicentre trial assessing CPCs and a combination of two cell types from different tissues in HF patients. The results show that treatment is safe and feasible. Even with maximal guideline-directed therapy, both CPCs and MSCs were associated with improved clinical outcomes (MACE and quality of life, respectively) in ischaemic HF without affecting left ventricular function or structure, suggesting possible systemic or paracrine cellular mechanisms. Combining MSCs with CPCs was associated with improvement in both these outcomes. These results suggest potential important beneficial effects of CPCs and MSCs and support further investigation in HF patients.