Evidence map›Paper›PMID 28025189›Full record

Trial reportEuropean heart journal2017

Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial.

Jozef Bartunek, Andre Terzic, Beth A Davison, Gerasimos S Filippatos, Slavica Radovanovic, Branko Beleslin, Bela Merkely, Piotr Musialek, Wojciech Wojakowski, Peter Andreka and 45 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 118 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 10 pooled it
16.7field-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

118 citing papers in PubMed, 10 syntheses or guidelines pooled it, 182 citations in OpenAlex.

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  7. Stem cell therapy for dilated cardiomyopathy.The Cochrane database of systematic reviews · 2021
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58 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

55 authors at 20 institutions in 12 countries.

Jozef BartunekCardiovascular Center, Onze-Lieve-Vrouwziekenhuis OLV Hospital, Moorselbaan 164, Aalst, B-9300, Aalst, Belgium.
Andre TerzicMayo Clinic, Center for Regenerative Medicine, Department of Cardiovascular Diseases, 200 First Street SW, Rochester, Minnesota 550905, USA.
Beth A DavisonMomentum Research, Inc, Durham, NC, USA.
Gerasimos S FilippatosNational and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Athens, Greece.
Slavica RadovanovicUniversity Hospital Center Bezanijska Kosa, Belgrade, Serbia.
Branko BeleslinCardiology Clinic, Clinical Centre of Serbia, Medical School, University of Belgrade, Belgrade, Serbia.
Bela MerkelySemmelweis University Heart and Vascular Center, Budapest, Hungary.
Piotr MusialekJagiellonian University Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow, Poland.
Wojciech WojakowskiThird Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Peter AndrekaGottsegen Gyorgy Hungarian Institute of Cardiology, Budapest, Hungary.
Ivan G HorvathHeart Institute, University of Pécs, Pécs, Hungary.
Amos KatzDepartment of Cardiology, Barzilai Medical Center, Israel Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Dariouch DolatabadiDivision of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
Badih El NakadiDivision of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
Aleksandra ArandjelovicCardiology Department, Clinical Hospital Zvezdara, Belgrade, Serbia.
Istvan EdesDepartment of Cardiology, University of Debrecen, Debrecen, Hungary.
Petar M SeferovicUniversity of Belgrade School of Medicine, Belgrade University Medical Center, Belgrade, Serbia.
Slobodan ObradovicClinic of Emergency Medicine, Military Medical Academy, School of Medicine, University of Defense, Belgrade, Serbia.
Marc VanderheydenCardiovascular Center, Onze-Lieve-Vrouwziekenhuis OLV Hospital, Moorselbaan 164, Aalst, B-9300, Aalst, Belgium.
Nikola JagicClinical Center Kragujevac, Kragujevac, Serbia.
Ivo PetrovDepartment of Cardiology, Angiology, and Electrophysiology, City Clinic Heart and Vascular Institute, Sofia University, Sofia, Bulgaria.
Shaul AtarDepartment of Cardiology, Galilee Medical Center, Nahariya, Israel.
Majdi HalabiFaculty of Medicine in the Galilee, Bar-Ilan University, Safed, Israel.
Valeri L GelevDepartment of Cardiology, Angiology, and Electrophysiology, City Clinic Heart and Vascular Institute, Sofia University, Sofia, Bulgaria.
Michael K ShochatHeart Institute, Hillel Yaffe Medical Center, Hadera, Rappaport School of Medicine, Haifa, Israel, Technion.
Jaroslaw D KasprzakDepartment of Cardiology Medical University of Lodz, Lodz, Poland.
Ricardo Sanz-RuizHospital General Universitario Gregorio Marañón, Madrid, Spain.
Guy R HeyndrickxCardiovascular Center, Onze-Lieve-Vrouwziekenhuis OLV Hospital, Moorselbaan 164, Aalst, B-9300, Aalst, Belgium.
Noémi NyolczasMedical Centre, Hungarian Defense Forces, Budapest, Hungary.
Victor LegrandDepartment of Cardiology, Centre Hospitalier Universitaire de Liège, Liège, Belgium.
Antoine GuédèsDepartment of Cardiology, Universite Catholique de Louvain, CHU UcL Namur, Yvoir, Belgium.
Alex HeyseDepartment of Cardiology, AZ Glorieux, Ronse, Belgium.
Tiziano MoccettiCardiocentro Ticino, Lugano, Switzerland.
Francisco Fernandez-AvilesHospital General Universitario Gregorio Marañón, Madrid, Spain.
Pilar Jimenez-QuevedoDepartment of Cardiology, Hospital Clínico San Carlos, Madrid, Spain.
Antoni Bayes-GenisHospital Universitari Germans Trias I Pujol, Universitat Autònoma, Barcelona, Spain.
Jose Maria Hernandez-GarciaHospital Clinico Universitario Virgen de la Victoria, Malaga, Spain.
Flavio RibichiniDepartment of Cardiology, University of Verona, Italy.
Marcin GruchalaDepartment of Cardiology, Medical University of Gdansk, Gdansk, Poland.
Scott A WaldmanSidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.
John R TeerlinkSchool of Medicine, University of California San Francisco and Section of Cardiology, San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.
Bernard J GershMayo Clinic, Center for Regenerative Medicine, Department of Cardiovascular Diseases, 200 First Street SW, Rochester, Minnesota 550905, USA.
Thomas J PovsicDuke Clinical Research Institute and Duke Medicine, Durham, NC, USA.
Timothy D HenryCedars Sinai Heart Institute, Los Angeles, CA, USA.
Marco MetraCardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University and Spedali Civili, Brescia, Italy.
Roger J HajjarMount Sinai School of Medicine, New York, NY, USA.
Michal TenderaThird Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Atta BehfarMayo Clinic, Center for Regenerative Medicine, Department of Cardiovascular Diseases, 200 First Street SW, Rochester, Minnesota 550905, USA.
Bertrand AlexandreCelyad, Mont Saint Guibert, Belgium.
Aymeric SeronCelyad, Mont Saint Guibert, Belgium.
Wendy Gattis StoughDepartments of Clinical Research and Pharmacy Practice, Campbell University College of Pharmacy and Health Sciences, Cary, NC, USA.
Warren ShermanCelyad, Mont Saint Guibert, Belgium.
Gad CotterMomentum Research, Inc, Durham, NC, USA.
William WijnsCardiovascular Center, Onze-Lieve-Vrouwziekenhuis OLV Hospital, Moorselbaan 164, Aalst, B-9300, Aalst, Belgium.
CHART Program
Celyad (Belgium) · BEMayo Clinic · USOnze Lieve Vrouwziekenhuis Hospital · BEBar-Ilan University · ILGrand Charleroi Hospital · BEHospital General Universitario Gregorio Marañón · ESMedical University of Silesia · PLMomentum Research · USSofia University "St. Kliment Ohridski" · BGUniversity of Belgrade · RSBen-Gurion University of the Negev · ILCampbell University · USCentre Hospitalier Universitaire de Liège · BEClinical Centre of Kragujevac · RSClinical Research Institute · USEpatocentro Ticino · CHGdańsk Medical University · PLGottsegen National Cardiovascular Center · HUHillel Yaffe Medical Center · ILHospital Clínico San Carlos · ES

Funding

X-Ray Crystallography and Macromolecular CharacterizationP30CA056036 · NCI · THOMAS JEFFERSON UNIVERSITY · PI Andrew Chapman · 1995 to 2026
$94.8M
(PQ1) GUCY2C hormone loss translates APC-Beta-catenin mutations into epithelial transformationR01CA206026 · NCI · THOMAS JEFFERSON UNIVERSITY · PI WALDMAN, SCOTT A · 2016 to 2020
$1.8M
GUCY2C hormone signaling at the intersection of obesity and colorectal cancer(PQ1R01CA170533 · NCI · THOMAS JEFFERSON UNIVERSITY · PI WALDMAN, SCOTT A · 2012 to 2015
$1.3M
NCI NIH HHS R01 CA170533NCI NIH HHS R01 CA206026
6 · The paper itself

Abstract

aimsCardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. METHODS AND

resultsThis multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death.

conclusionThe primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.

Indexed as

AdultAgedDouble-Blind MethodFemaleHeart FailureHumansMaleMesenchymal Stem Cell TransplantationMiddle AgedMyocardial IschemiaProspective StudiesTreatment OutcomeYoung AdultCardiopoiesisCardiovascular diseaseDisease severityMarkerPrecision medicineRegenerative medicineStem cellTarget population

Identifiers

PMID28025189
PMCPMC5381596
OpenAlexW2564731431

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LicenceCC BY-NC
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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.