Evidence map›Paper›PMID 33811444›Full record

Trial reportEuropean journal of heart failure2021

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.

Roberto Bolli, Raul D Mitrani, Joshua M Hare, Carl J Pepine, Emerson C Perin, James T Willerson, Jay H Traverse, Timothy D Henry, Phillip C Yang, Michael P Murphy and 29 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 100 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 7 pooled it
16.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 7 syntheses or guidelines pooled it, 159 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Article
  11. Review
  12. Review
  13. Stem cells in organogenesis and regeneration.Stem cell research & therapy · 2026
    Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Heart-derived endogenous stem cells.Molecular biology reports · 2025
    Review

40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors at 16 institutions in 2 countries.

Roberto BolliUniversity of Louisville, School of Medicine, Louisville, KY, USA.
Raul D MitraniUniversity of Miami, Miller School of Medicine, Miami, FL, USA.
Joshua M HareUniversity of Miami, Miller School of Medicine, Miami, FL, USA.
Carl J PepineUniversity of Florida College of Medicine, Gainesville, FL, USA.
Emerson C PerinTexas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston, TX, USA.
James T WillersonTexas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston, TX, USA.
Jay H TraverseMinneapolis Heart Institute Foundation at Abbott Northwestern Hospital, and University of Minnesota School of Medicine, Minneapolis, MN, USA.
Timothy D HenryThe Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, OH, USA.
Phillip C YangStanford University School of Medicine, Stanford, CA, USA.
Michael P MurphyIndiana University School of Medicine, Indianapolis, IN.
Keith L MarchUniversity of Florida College of Medicine, Gainesville, FL, USA.
Ivonne H SchulmanUniversity of Miami, Miller School of Medicine, Miami, FL, USA.
Sohail IkramUniversity of Louisville, School of Medicine, Louisville, KY, USA.
David P LeeStanford University School of Medicine, Stanford, CA, USA.
Connor O'BrienStanford University School of Medicine, Stanford, CA, USA.
Joao A LimaJohns Hopkins University, Cardiovascular Imaging, Baltimore, MD, USA.
Mohammad R OstovanehJohns Hopkins University, Cardiovascular Imaging, Baltimore, MD, USA.
Bharath Ambale-VenkateshJohns Hopkins University, Cardiovascular Imaging, Baltimore, MD, USA.
Gregory LewisMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Aisha KhanUniversity of Miami, Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL, USA.
Ketty BacallaoUniversity of Miami, Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL, USA.
Krystalenia ValasakiUniversity of Miami, Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL, USA.
Bangon LongsomboonUniversity of Miami, Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL, USA.
Adrian P GeeCenter for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX, USA.
Sara RichmanCenter for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX, USA.
Doris A TaylorTexas Heart Institute, CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston, TX, USA.
Dejian LaiUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
Shelly L SayreUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
Judy BettencourtUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
Rachel W VojvodicUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
Michelle L CohenUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
Lara SimpsonUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
David AguilarUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
Catalin LoghinUTHealth University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX, USA.
Lem MoyéUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
Ray F EbertNIH, National Heart, Lung and Blood Institute, Bethesda, MD, USA.
Barry R DavisUTHealth University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA.
Robert D SimariUniversity of Kansas, School of Medicine, Kansas City, KS, USA.
Cardiovascular Cell Therapy Research Network (CCTRN)
The University of Texas Health Science Center at Houston · USUniversity of Miami · USBaylor College of Medicine · USStanford University · USJohns Hopkins University · USUniversity of Louisville · USAbbott Northwestern Hospital · USChrist Hospital · USFlorida College · USHarvard University · USIndiana University School of MedicineJohns Hopkins Medicine · USNational Heart Lung and Blood Institute · USStem Cell Institute · PAUniversity of Florida · USUniversity of Kansas · US

Funding

Data Coordinating Center For The Cardiovascular Cell Therapy Research NetworkUM1HL087318 · NHLBI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI DAVIS, BARRY R · 2012 to 2018
$29.8M
Cardiovascular Cell Therapy Research Network - Data Coordinating CenterU01HL087318 · NHLBI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MOYE, LEMUEL A. · 2007 to 2011
$17.6M
MN Regional Cardiovascular Cell Therapy Clinical Res. Network: From AMI to PADUM1HL087394 · NHLBI · UNIVERSITY OF MINNESOTA · PI HENRY, TIMOTHY D · 2012 to 2018
$5.1M
Cardiovascular Cell Therapy Research NetworkUM1HL087365 · NHLBI · TEXAS HEART INSTITUTE · PI PERIN, EMERSON CARVALHO, WILLERSON, JAMES T. · 2012 to 2018
$4.8M
UFRCC for Cardiovascular Cell Therapy Research NetworkUM1HL087366 · NHLBI · UNIVERSITY OF FLORIDA · PI PEPINE, CARL J · 2012 to 2018
$4.7M
Cell Based Therapy for Non-Ischemic Dilated CardiomyopathyUM1HL113460 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI HARE, JOSHUA M · 2012 to 2018
$4.3M
Utility of Autologous and Allogeneic Cell Therapy for Peripheral Arterial DiseaseUM1HL113457 · NHLBI · INDIANA UNIVERSITY INDIANAPOLIS · PI MURPHY, MICHAEL PATRICK · 2012 to 2018
$3.0M
University of Louisville Regional Clinical Center for the CCTRNUM1HL113530 · NHLBI · UNIVERSITY OF LOUISVILLE · PI BOLLI, ROBERTO · 2012 to 2018
$2.9M
UFCC for Cardiovascular Cell Therapy Research NetworkU01HL087366 · NHLBI · UNIVERSITY OF FLORIDA · PI PEPINE, CARL J · 2007 to 2011
$2.6M
MN Cardiovascular Cell Therapy Clinical Research Network: From AMI to CHFU01HL087394 · NHLBI · UNIVERSITY OF MINNESOTA · PI HENRY, TIMOTHY D · 2007 to 2011
$1.9M
Cardiovascular Cell Therapy Research NetworkU01HL087365 · NHLBI · TEXAS HEART INSTITUTE · PI WILLERSON, JAMES T. · 2007 to 2011
$1.8M
Using Exosomes to Preserve Viability and Function in Anthracycline Induced Cardiomyopathy Patient Specific Cardiomyocytes After Exposure to DoxorubicinF32HL139046 · NHLBI · STANFORD UNIVERSITY · PI O'BRIEN, CONNOR · 2017 to 2018
$126k
NHLBI NIH HHS F32 HL139046NHLBI NIH HHS U01 HL087318NHLBI NIH HHS U01 HL087365NHLBI NIH HHS U01 HL087366NHLBI NIH HHS U01 HL087394NHLBI NIH HHS UM1 HL087318NHLBI NIH HHS UM1 HL087365NHLBI NIH HHS UM1 HL087366NHLBI NIH HHS UM1 HL087394NHLBI NIH HHS UM1 HL113457NHLBI NIH HHS UM1 HL113460NHLBI NIH HHS UM1 HL113530
6 · The paper itself

Abstract

aimsCONCERT-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 cells (CPCs), given alone or in combination, is feasible, safe, and beneficial in patients with heart failure (HF) caused by ischaemic cardiomyopathy. METHODS AND

resultsPatients 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.

conclusionsThis 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.

Indexed as

Heart FailureMesenchymal Stem CellsMesenchymal Stem Cell TransplantationHumansMinnesotaQuality of LifeStroke VolumeTreatment OutcomeVentricular Function, LeftCell-based therapyClinical trialHeart failure

Identifiers

PMID33811444
PMCPMC8357352
OpenAlexW3140018992

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.