Evidence map›Paper›PMID 26662998›Full record

Trial reportEuropean journal of heart failure2016

Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design.

Jozef Bartunek, Beth Davison, Warren Sherman, Thomas Povsic, Timothy D Henry, Bernard Gersh, Marco Metra, Gerasimos Filippatos, Roger Hajjar, Atta Behfar and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of heart failure, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01768702 (Efficacy and Safety of Bone Marrow-derived Mesenchymal Cardiopoietic Cells), which is not on this map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
–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.

NCT01768702 phase3completednot on this map

Efficacy and Safety of Bone Marrow-derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure.

TypeinterventionalSponsorCelyad Oncology SARan2012 to 2017Enrolled315ConditionsHeart FailureArmsInjection of C3BS-CQR-1, Sham, no injection
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Stem cell therapy for dilated cardiomyopathy.The Cochrane database of systematic reviews · 2021
    Pooled it
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  19. Brachyury engineers cardiac repair competent stem cells.Stem cells translational medicine · 2021
    Article
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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

15 authors.

Jozef BartunekCardiovascular Centre, OLV Hospital, Aalst, Belgium.
Beth DavisonMomentum Research Inc., Durham, NC, USA.
Warren ShermanCelyad S.A., Mont Saint Guibert, Belgium.
Thomas PovsicDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Timothy D HenryCedars Sinai Heart Institute, Los Angeles, CA, USA.
Bernard GershMayo Clinic College of Medicine, Division of Cardiovascular Diseases, Department of Medicine, Rochester, MN, USA.
Marco MetraCardiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Italy.
Gerasimos FilippatosAthens University Hospital, Attikon, Greece.
Roger HajjarMount Sinai School of Medicine, New York, NY, USA.
Atta BehfarMayo Clinic College of Medicine, Division of Cardiovascular Diseases, Department of Medicine, Rochester, MN, USA.
Christian HomsyCelyad S.A., Mont Saint Guibert, Belgium.
Gad CotterMomentum Research Inc., Durham, NC, USA.
William WijnsCardiovascular Centre, OLV Hospital, Aalst, Belgium.
Michal Tendera3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.
Andre TerzicMayo Clinic College of Medicine, Division of Cardiovascular Diseases, Department of Medicine, Rochester, MN, USA.

Funding

SUMO1 and SERCA2a FunctionR01HL117505 · NHLBI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI WEBER, THOMAS · 2013 to 2020
$3.4M
Targeting Abnormal Calcium Cycling Using Novel Gene Therapy VectorsR01HL119046 · NHLBI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI AKAR, FADI GABRIEL, HAJJAR, ROGER J. · 2014 to 2017
$2.9M
Role of miR25 in Heart FailureR01HL128072 · NHLBI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HAJJAR, ROGER J., MERCOLA, MARK · 2015 to 2018
$2.5M
Regression of cardiac hypertrophyR01HL093183 · NHLBI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HAJJAR, ROGER J. · 2009 to 2010
$1.1M
NHLBI NIH HHS R01 HL093183NHLBI NIH HHS R01 HL117505NHLBI NIH HHS R01 HL119046NHLBI NIH HHS R01 HL128072
6 · The paper itself

Abstract

aimsCardiopoiesis is a conditioning programme that aims to upgrade the cardioregenerative aptitude of patient-derived stem cells through lineage specification. Cardiopoietic stem cells tested initially for feasibility and safety exhibited signs of clinical benefit in patients with ischaemic heart failure (HF) warranting definitive evaluation. Accordingly, CHART-1 is designed as a large randomized, sham-controlled multicentre study aimed to validate cardiopoietic stem cell therapy.

methodsPatients (n = 240) with chronic HF secondary to ischaemic heart disease, reduced LVEF (<35%), and at high risk for recurrent HF-related events, despite optimal medical therapy, will be randomized 1:1 to receive 600 × 10(6) bone marrow-derived and lineage-directed autologous cardiopoietic stem cells administered via a retention-enhanced intramyocardial injection catheter or a sham procedure. The primary efficacy endpoint is a hierarchical composite of mortality, worsening HF, Minnesota Living with Heart Failure Questionnaire score, 6 min walk test, LV end-systolic volume, and LVEF at 9 months. The secondary efficacy endpoint is the time to cardiovascular death or worsening HF at 12 months. Safety endpoints include mortality, readmissions, aborted sudden deaths, and serious adverse events at 12 and 24 months.

conclusionThe CHART-1 clinical trial is powered to examine the therapeutic impact of lineage-directed stem cells as a strategy to achieve cardiac regeneration in HF populations. On completion, CHART-1 will offer a definitive evaluation of the efficacy and safety of cardiopoietic stem cells in the treatment of chronic ischaemic HF.

trial registrationNCT01768702.

Indexed as

RegenerationAdultChronic DiseaseEpidemiologic Research DesignHeartHeart FailureHumansMesenchymal Stem Cell TransplantationMyocardial IschemiaStem CellsCardiopoiesisHeart failureIschaemic cardiomyopathyRegenerative medicineStem cell

Identifiers

PMID26662998
PMCPMC5064644

What OpenQuestion holds

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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.