Evidence map›Paper›PMID 35043578›Full record

Trial reportESC heart failure2022

Five-year follow-up of intracoronary autologous cell therapy in acute myocardial infarction: the REGENERATE-AMI trial.

Anthony Mathur, Doo Sun Sim, Fizzah Choudry, Jessry Veerapen, Martina Colicchia, Tymoteusz Turlejski, Mohsin Hussain, Stephen Hamshere, Didier Locca, Roby Rakhit and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in ESC heart failure, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 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

17 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  9. Article
  10. Stem Cell Therapy in Ischemic Heart Failure.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025
    Review
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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.

Anthony MathurCentre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.
Doo Sun SimCentre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.
Fizzah ChoudryCentre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.
Jessry VeerapenCentre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.
Martina ColicchiaDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Tymoteusz TurlejskiDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Mohsin HussainCentre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.
Stephen HamshereDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Didier LoccaCentre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.
Roby RakhitDepartment of Cardiology, The Royal Free Hospital, Royal Free London Foundation Trust, London, UK.
Tom CrakeDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Jens KastrupRigshospitalet and University of Copenhagen, Copenhagen, Denmark.
Samir AgrawalHaemato-Oncology, Barts Health NHS Trust & Immunobiology, Blizard Institute, Queen Mary University of London, London, UK.
Daniel A JonesCentre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.
John MartinUniversity College London, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe long-term outcomes of the intracoronary delivery of autologous bone marrow-derived cells (BMCs) after acute myocardial infarction are not well established. Following the promising 1 year results of the REGENERATE-AMI trial (despite it not achieving its primary endpoint), this paper presents the analysis of the 5 year clinical outcomes of these acute myocardial infarction patients who were treated with an early intracoronary autologous BMC infusion or placebo. METHODS AND

resultsA 5 year follow-up of major adverse cardiac events (defined as the composite of all-cause death, recurrent myocardial infarction, and all coronary revascularization) and of rehospitalization for heart failure was completed in 85 patients (BMC n = 46 and placebo n = 39). The incidence of major adverse cardiac events was similar between the BMC-treated patients and the placebo group (26.1% vs. 18.0%, P = 0.41). There were no cases of cardiac death in either group, but an increase in non-cardiac death was seen in the BMC group (6.5% vs. 0%, P = 0.11). The rates of recurrent myocardial infarction and repeat revascularization were similar between the two groups. There were no cases of rehospitalization for heart failure in either group.

conclusionThis 5 year follow-up analysis of the REGENERATE-AMI trial did not show an improvement in clinical outcomes for patients treated with cell therapy. This contrasts with the 1 year results which showed improvements in the surrogate outcome measures of ejection fraction and myocardial salvage index.

Indexed as

Bone Marrow TransplantationMyocardial InfarctionFollow-Up StudiesHumansTransplantation, AutologousTreatment OutcomeMyocardial infarctionPercutaneous coronary interventionStem cells

Identifiers

PMID35043578
PMCPMC8934988

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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.