Evidence map›Paper›PMID 24036024›Full record

Trial reportJournal of the American College of Cardiology2014

Intracoronary cardiosphere-derived cells after myocardial infarction: evidence of therapeutic regeneration in the final 1-year results of the CADUCEUS trial (CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction).

Konstantinos Malliaras, Raj R Makkar, Rachel R Smith, Ke Cheng, Edwin Wu, Robert O Bonow, Linda Marbán, Adam Mendizabal, Eugenio Cingolani, Peter V Johnston and 4 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00893360 (A Phase I Randomized, Dose Escalation Study of the Safety and Efficacy of Intracoronary Delivery of Cardiosphere-Derived Stem Cells in Patients With Ischemic Left Ventricular Dysfunction and a Recent Myocardial Infarction), which is not on this map. Cited by 255 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
255citing papers in PubMed, 6 pooled it
49.7field-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.

NCT00893360 phase1completednot on this map

A Phase I Randomized, Dose Escalation Study of the Safety and Efficacy of Intracoronary Delivery of Cardiosphere-Derived Stem Cells in Patients With Ischemic Left Ventricular Dysfunction and a Recent Myocardial Infarction

TypeinterventionalSponsorCedars-Sinai Medical CenterRan2009 to 2012Enrolled31ConditionsRecent Myocardial Infarction, Ventricular DysfunctionArmsAutologous stem cell infusion
3 · Its place in the literature

Who cites it

255 citing papers in PubMed, 6 syntheses or guidelines pooled it, 490 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Review
  14. Article
  15. Utilization of Stem Cells in Medicine: A Narrative Review.International journal of molecular sciences · 2025
    Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article

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

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

14 authors at 4 institutions in 1 country.

Konstantinos MalliarasCedars-Sinai Heart Institute, Los Angeles, California.
Raj R MakkarCedars-Sinai Heart Institute, Los Angeles, California.
Rachel R SmithCedars-Sinai Heart Institute, Los Angeles, California.
Ke ChengCedars-Sinai Heart Institute, Los Angeles, California.
Edwin WuDivision of Cardiology, Department of Medicine, Bluhm Cardiovascular Institute, Northwestern University Feinberg School of Medicine, Northwestern Memorial Hospital, Chicago, Illinois.
Robert O BonowDivision of Cardiology, Department of Medicine, Bluhm Cardiovascular Institute, Northwestern University Feinberg School of Medicine, Northwestern Memorial Hospital, Chicago, Illinois.
Linda MarbánCedars-Sinai Heart Institute, Los Angeles, California.
Adam MendizabalEMMES Corporation, Rockville, Maryland.
Eugenio CingolaniCedars-Sinai Heart Institute, Los Angeles, California.
Peter V JohnstonDivision of Cardiology, Department of Medicine, The Johns Hopkins University, Baltimore, Maryland.
Gary GerstenblithDivision of Cardiology, Department of Medicine, The Johns Hopkins University, Baltimore, Maryland.
Karl H SchuleriDivision of Cardiology, Department of Medicine, The Johns Hopkins University, Baltimore, Maryland.
Albert C LardoDivision of Cardiology, Department of Medicine, The Johns Hopkins University, Baltimore, Maryland; Department of Biomedical Engineering, The Johns Hopkins University, Baltimore, Maryland.
Eduardo MarbánCedars-Sinai Heart Institute, Los Angeles, California. Electronic address: eduardo.marban@csmc.edu.
Johns Hopkins University · USNorthwestern University · USCedars-Sinai Medical Center · USEmmes (United States) · US

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Mesenchymal Stem Cell CardiomyoplastyU54HL081028 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI HARE, JOSHUA M · 2005 to 2009
$12.1M
NCATS NIH HHS UL1 TR001079NHLBI NIH HHS U54 HL081028NHLBI NIH HHS U54-HL081028
6 · The paper itself

Abstract

objectivesThis study sought to report full 1-year results, detailed magnetic resonance imaging analysis, and determinants of efficacy in the prospective, randomized, controlled CADUCEUS (CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction) trial.

backgroundCardiosphere-derived cells (CDCs) exerted regenerative effects at 6 months in the CADUCEUS trial. Complete results at the final 1-year endpoint are unknown.

methodsAutologous CDCs (12.5 to 25 × 10(6)) grown from endomyocardial biopsy specimens were infused via the intracoronary route in 17 patients with left ventricular dysfunction 1.5 to 3 months after myocardial infarction (MI) (plus 1 infused off-protocol 14 months post-MI). Eight patients were followed as routine-care control patients.

resultsIn 13.4 months of follow-up, safety endpoints were equivalent between groups. At 1 year, magnetic resonance imaging revealed that CDC-treated patients had smaller scar size compared with control patients. Scar mass decreased and viable mass increased in CDC-treated patients but not in control patients. The single patient infused 14 months post-MI responded similarly. CDC therapy led to improved regional function of infarcted segments compared with control patients. Scar shrinkage correlated with an increase in viability and with improvement in regional function. Scar reduction correlated with baseline scar size but not with a history of temporally remote MI or time from MI to infusion. The changes in left ventricular ejection fraction in CDC-treated subjects were consistent with the natural relationship between scar size and ejection fraction post-MI.

conclusionsIntracoronary administration of autologous CDCs did not raise significant safety concerns. Preliminary indications of bioactivity include decreased scar size, increased viable myocardium, and improved regional function of infarcted myocardium at 1 year post-treatment. These results, which are consistent with therapeutic regeneration, merit further investigation in future trials. (CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction [CADUCEUS]; NCT00893360).

Indexed as

Recovery of FunctionAgedBiopsyCoronary VesselsElectrocardiography, AmbulatoryFemaleFollow-Up StudiesHeart VentriclesHumansInjections, Intra-ArterialMagnetic Resonance Imaging, CineMaleMiddle AgedMyocardial InfarctionMyocytes, CardiacStem Cell Transplantationcardiosphere-derived cellcardiosphere-derived cellsCDCCK-MBcomputed tomographycreatine kinase-myocardial bandCTData and Safety Monitoring BoardDSMBEccEDVEFejection fractionend-diastolic volumeend-systolic volumeESVfull width at half maximumFWHMICDimplantable cardioverter-defibrillatorleft ventricularleft ventricular ejection fractionLVLVEFmagnetic resonance imagingMIMRImyocardial infarctionmyocardial regenerationNew York Heart AssociationNYHAoxygen consumptionSAEserious adverse event(s)systolic circumferential strainTnItroponin IVo(2)

Identifiers

PMID24036024
PMCPMC3947063
OpenAlexW2169224177

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.