Evidence map›Paper›PMID 26516172›Full record

Trial reportEuropean heart journal2016

Improved outcome with repeated intracoronary injection of bone marrow-derived cells within a registry: rationale for the randomized outcome trial REPEAT.

Birgit Assmus, Samer Alakmeh, Salvatore De Rosa, Halvard Bönig, Eva Hermann, Wayne C Levy, Stefanie Dimmeler, Andreas M Zeiher

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 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.

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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Stem cell therapy for dilated cardiomyopathy.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Cell Therapy in the Treatment of Coronary Heart Disease.International journal of molecular sciences · 2023
    Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Function Follows Form - A Review of Cardiac Cell Therapy.Circulation journal : official journal of the Japanese Circulation Society · 2019
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Birgit AssmusDivision of Cardiology, Department of Medicine III, Goethe University Frankfurt, Theodor-Stern-Kai 7, Frankfurt 60590, Germany German Center for Cardiovascular Research DZHK, Partner Site Frankfurt Rhine-Main, Berlin, Germany b.assmus@em.uni-frankfurt.de.
Samer AlakmehDivision of Cardiology, Department of Medicine III, Goethe University Frankfurt, Theodor-Stern-Kai 7, Frankfurt 60590, Germany.
Salvatore De RosaDivision of Cardiology, Department of Medicine III, Goethe University Frankfurt, Theodor-Stern-Kai 7, Frankfurt 60590, Germany.
Halvard BönigGerman Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology Goethe University, Frankfurt, Germany.
Eva HermannGerman Center for Cardiovascular Research DZHK, Partner Site Frankfurt Rhine-Main, Berlin, Germany Institute of Biostatistics and Mathematical Modeling, Goethe University Frankfurt, Frankfurt, Germany.
Wayne C LevyDivision of Cardiology, University of Washington, Seattle, WA 98195, USA.
Stefanie DimmelerGerman Center for Cardiovascular Research DZHK, Partner Site Frankfurt Rhine-Main, Berlin, Germany Institute for Cardiovascular Regeneration, Molecular Medicine, Goethe University Frankfurt, Frankfurt, Germany.
Andreas M ZeiherDivision of Cardiology, Department of Medicine III, Goethe University Frankfurt, Theodor-Stern-Kai 7, Frankfurt 60590, Germany German Center for Cardiovascular Research DZHK, Partner Site Frankfurt Rhine-Main, Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsRegenerative therapies have evolved as a promising new option in the treatment of post-infarction heart failure. A major limitation of intracoronary application of autologous bone marrow-derived mononuclear cells (BM-MNCs) is that homing of the applied cells is profoundly reduced in patients with post-infarction heart failure compared with patients with acute myocardial infarction. However, early pilot and also randomized controlled trials have demonstrated significant improvements in overall cardiac function. The aim of the present analysis was to quantify a potential mortality risk reduction and reduced hospitalization in order to provide data for a prospective outcome trial. METHODS AND

resultsThe results of an ongoing single-centre registry including 297 post-infarction heart failure patients suggest that repeated intracoronary application of autologous bone marrow-derived cells is associated with a significant better 2-year survival compared with a single BM-MNC application (2-year survival 93.6 vs. 84.0%, P = 0.03). Likewise, mortality is significantly lower at 2-year follow-up compared with the mortality estimated by the use of the Seattle Heart Failure Model (SHFM) in patients receiving repeated BM-MNC application (observed mortality 6.4%, predicted mortality 16.2%, P = 0.02). Although the trend persisted at 3-year follow-up, the mortality reduction was no longer statistically significant between single and repeated treatment (mortality 21.9 vs. 13.7%, P = 0.06).

conclusionRepeated intracoronary administration of BM-MNC appears to be associated with improved clinical outcome compared with single treatment at 2 years. This registry provides the rationale for the design of the multicentre randomized, controlled, open-label REPEAT trial, which prospectively compares the effects of single vs. repeated intracoronary application of autologous BM-MNC on total and SHFM-predicted mortality in patients with chronic post-infarction heart failure.

Indexed as

Bone Marrow CellsAgedBone Marrow TransplantationFemaleHeart FailureHumansMaleMiddle AgedMyocardial InfarctionProspective StudiesRegistriesRisk FactorsTreatment OutcomeCell therapyChronic heart failureIschaemic cardiomyopathyOutcome trial

Identifiers

PMID26516172
PMCPMC5841212

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.