Evidence map›Paper›PMID 29703749›Full record

ArticleCirculation research2018

Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit

Roberto Bolli, Joshua M Hare, Keith L March, Carl J Pepine, James T Willerson, Emerson C Perin, Phillip C Yang, Timothy D Henry, Jay H Traverse, Raul D Mitrani and 15 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Circulation research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02501811 (A Phase II, Randomized, Placebo-Controlled Study of the Safety, Feasibility, & Efficacy of Autologous Mesenchymal Stem Cells & C-kit+ Cardiac Stem Cells, Alone or in Combination, Administered Transendocardially in Subjects With Ischemic HF), which is not on this map. Cited by 55 papers.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed
–field-weighted citation impact
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.

NCT02501811 phase2completednot on this map

A Phase II, Randomized, Placebo-Controlled Study of the Safety, Feasibility, & Efficacy of Autologous Mesenchymal Stem Cells & C-kit+ Cardiac Stem Cells, Alone or in Combination, Administered Transendocardially in Subjects With Ischemic HF

TypeinterventionalSponsorThe University of Texas Health Science Center, HoustonRan2015 to 2020Enrolled125ConditionsIschemic CardiomyopathyArmsMesenchymal Stem Cells (MSC), c-kit+ cells, Placebo (Plasmalyte A)
3 · Its place in the literature

Who cites it

55 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. C-kitHeliyon · 2023
    Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Roberto BolliFrom the Division of Cardiovascular Medicine, University of Louisville, KY (R.B., J.L.).
Joshua M HareInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, FL (J.M.H., A.K., R.D.M., I.H.-S.).
Keith L MarchDivision of Cardiovascular Medicine, UFHealth at University of Florida, Gainesville (K.L.M., C.J.P.).
Carl J PepineDivision of Cardiovascular Medicine, UFHealth at University of Florida, Gainesville (K.L.M., C.J.P.).
James T WillersonTexas Heart Institute, CHI St. Luke's Health, Houston (J.T.W., E.C.P., D.A.T.).
Emerson C PerinTexas Heart Institute, CHI St. Luke's Health, Houston (J.T.W., E.C.P., D.A.T.).
Phillip C YangCardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.).
Timothy D HenryDivision of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, CA (T.D.H.).
Jay H TraverseMinneapolis Heart Institute Foundation at Abbott Northwestern Hospital, MN (J.H.T.).
Raul D MitraniInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, FL (J.M.H., A.K., R.D.M., I.H.-S.).
Aisha KhanFrom the Division of Cardiovascular Medicine, University of Louisville, KY (R.B., J.L.).
Ivonne Hernandez-SchulmanInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, FL (J.M.H., A.K., R.D.M., I.H.-S.).
Doris A TaylorTexas Heart Institute, CHI St. Luke's Health, Houston (J.T.W., E.C.P., D.A.T.).
Darcy L DiFedeBiological Consulting, LLC, Miami, FL (D.L.D.).
João A C LimaDivision of Cardiology, Johns Hopkins University, Baltimore, MD (J.A.C.L.).
Atul ChughFranciscan Saint Francis Health, Indianapolis, IN (A.C.).
John LoughranFrom the Division of Cardiovascular Medicine, University of Louisville, KY (R.B., J.L.).
Rachel W VojvodicCoordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).
Shelly L SayreCoordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).
Judy BettencourtCoordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).
Michelle CohenCoordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).
Lem MoyéCoordinating 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.
Ray F EbertNIH, National Heart, Lung, and Blood Institute, Division of Cardiovascular Sciences, Bethesda, MD (R.F.E.).
Robert D Simari
Cardiovascular Cell Therapy Research Network (CCTRN)

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
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
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
Mesenchymal stem cell therapy for endothelial dysfunction in diabetesR01HL134558 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI HARE, JOSHUA M · 2016 to 2020
$3.2M
NHLBI NIH HHS R01 HL134558NHLBI NIH HHS UM1 HL087318NHLBI NIH HHS UM1 HL087366NHLBI NIH HHS UM1 HL087394NHLBI NIH HHS UM1 HL113460
6 · The paper itself

Abstract

rationaleAutologous bone marrow mesenchymal stem cells (MSCs) and c-kit

objectiveCONCERT-HF (Combination of Mesenchymal and c-kit METHODS AND

resultsUsing 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.

conclusionsCONCERT-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 registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02501811.

Indexed as

Clinical Trials, Phase II as TopicCombined Modality TherapyDouble-Blind MethodFeasibility StudiesHeart FailureHumansMesenchymal Stem Cell TransplantationMulticenter Studies as TopicMyocardial IschemiaMyocytes, CardiacProto-Oncogene Proteins c-kitRandomized Controlled Trials as TopicResearch DesignStem Cell TransplantationTransplantation, AutologousTreatment OutcomeProto-Oncogene Proteins c-kitcell-based therapyclinical trialcoronary artery diseaseheart failure

Identifiers

PMID29703749
PMCPMC5993622

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Registered trials

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.