Format

Send to

Choose Destination
Circ Res. 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).

Author information

1
From the Division of Cardiovascular Medicine, University of Louisville, KY (R.B., J.L.).
2
Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, FL (J.M.H., A.K., R.D.M., I.H.-S.).
3
Division of Cardiovascular Medicine, UFHealth at University of Florida, Gainesville (K.L.M., C.J.P.).
4
Texas Heart Institute, CHI St. Luke's Health, Houston (J.T.W., E.C.P., D.A.T.).
5
Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.).
6
Division of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, CA (T.D.H.).
7
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, MN (J.H.T.).
8
Biological Consulting, LLC, Miami, FL (D.L.D.).
9
Division of Cardiology, Johns Hopkins University, Baltimore, MD (J.A.C.L.).
10
Franciscan Saint Francis Health, Indianapolis, IN (A.C.).
11
Coordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).
12
Coordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.) lemmoye@msn.com.
13
NIH, National Heart, Lung, and Blood Institute, Division of Cardiovascular Sciences, Bethesda, MD (R.F.E.).

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

PMID:
29703749
PMCID:
PMC5993622
DOI:
10.1161/CIRCRESAHA.118.312978
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center