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Clinical Trial
. 2018 Jun 8;122(12):1703-1715.
doi: 10.1161/CIRCRESAHA.118.312978. Epub 2018 Apr 27.

Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit+ Cardiac Stem Cells As Regenerative Therapy for Heart Failure)

Roberto Bolli  1 , Joshua M Hare  2 , Keith L March  3 , Carl J Pepine  3 , James T Willerson  4 , Emerson C Perin  4 , Phillip C Yang  5 , Timothy D Henry  6 , Jay H Traverse  7 , Raul D Mitrani  2 , Aisha Khan  1 , Ivonne Hernandez-Schulman  2 , Doris A Taylor  4 , Darcy L DiFede  8 , João A C Lima  9 , Atul Chugh  10 , John Loughran  1 , Rachel W Vojvodic  11 , Shelly L Sayre  11 , Judy Bettencourt  11 , Michelle Cohen  11 , Lem Moyé  12 , Ray F Ebert  13 , Robert D Simari; Cardiovascular Cell Therapy Research Network (CCTRN)
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Free PMC article
Clinical Trial

Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit+ Cardiac Stem Cells As Regenerative Therapy for Heart Failure)

Roberto Bolli et al. Circ Res. .
Free PMC article

Abstract

Rationale: Autologous bone marrow mesenchymal stem cells (MSCs) and c-kit+ cardiac progenitor cells (CPCs) are 2 promising cell types being evaluated for patients with heart failure (HF) secondary to ischemic cardiomyopathy. No information is available in humans about the relative efficacy of MSCs and CPCs and whether their combination is more efficacious than either cell type alone.

Objective: CONCERT-HF (Combination of Mesenchymal and c-kit+ Cardiac Stem Cells As Regenerative Therapy for Heart Failure) is a phase II trial aimed at elucidating these issues by assessing the feasibility, safety, and efficacy of transendocardial administration of autologous MSCs and CPCs, alone and in combination, in patients with HF caused by chronic ischemic cardiomyopathy (coronary artery disease and old myocardial infarction).

Methods and results: Using a randomized, double-blinded, placebo-controlled, multicenter, multitreatment, and adaptive design, CONCERT-HF examines whether administration of MSCs alone, CPCs alone, or MSCs+CPCs in this population alleviates left ventricular remodeling and dysfunction, reduces scar size, improves quality of life, or augments functional capacity. The 4-arm design enables comparisons of MSCs alone with CPCs alone and with their combination. CONCERT-HF consists of 162 patients, 18 in a safety lead-in phase (stage 1) and 144 in the main trial (stage 2). Stage 1 is complete, and stage 2 is currently randomizing patients from 7 centers across the United States.

Conclusions: CONCERT-HF will provide important insights into the potential therapeutic utility of MSCs and CPCs, given alone and in combination, for patients with HF secondary to ischemic cardiomyopathy.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02501811.

Keywords: cell-based therapy; clinical trial; coronary artery disease; heart failure.

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Figure 1
Protocol Overview for Stage 2.
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