Evidence map›Paper›PMID 27790824›Full record

Trial reportEuropean journal of heart failure2017

An exploratory randomized control study of combination cytokine and adult autologous bone marrow progenitor cell administration in patients with ischaemic cardiomyopathy: the REGENERATE-IHD clinical trial.

Tawfiq Choudhury, Abdul Mozid, Steve Hamshere, Chia Yeo, Cyril Pellaton, Samer Arnous, Natalie Saunders, Pat Brookman, Ajay Jain, Didier Locca and 12 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of heart failure, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 5 pooled it
3.1field-weighted citation impact, top 8% 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

15 citing papers in PubMed, 5 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Highlights in heart failure.ESC heart failure · 2019
    Pooled it
  5. Pooled it
  6. Review
  7. Article
  8. Review
  9. Locoregional delivery of stem cell-based therapies.Science translational medicine · 2020
    Review
  10. Function Follows Form - A Review of Cardiac Cell Therapy.Circulation journal : official journal of the Japanese Circulation Society · 2019
    Review
  11. Article
  12. De motu cordis: the future of regenerative medicine.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2019
    Article
  13. Article
  14. Article
  15. Overcoming the Roadblocks to Cardiac Cell Therapy Using Tissue Engineering.Journal of the American College of Cardiology · 2017
    Review
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

22 authors at 4 institutions in 1 country.

Tawfiq ChoudhuryDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Abdul MozidDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Steve HamshereDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Chia YeoDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Cyril PellatonDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Samer ArnousDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Natalie SaundersStem Cell Laboratory, Barts Health NHS Trust and Blizard Institute, Queen Mary University of London, London, UK.
Pat BrookmanDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Ajay JainDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Didier LoccaDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Andrew ArchboldDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Charles KnightDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Andrew WraggDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Ceri DaviesDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Peter MillsDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Mahesh ParmarMRC Clinical Trials Unit, London, UK.
Martin RothmanDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Fizzah ChoudryDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Daniel A JonesDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Samir AgrawalStem Cell Laboratory, Barts Health NHS Trust and Blizard Institute, Queen Mary University of London, London, UK.
John MartinBritish Heart Foundation Laboratories, Department of Medicine, University College London, London, UK.
Anthony MathurDepartment of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
Barts Health NHS Trust · GBQueen Mary University of London · GBBritish Heart Foundation · GBMRC Clinical Trials Unit at UCL · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe effect of combined cytokine and cell therapy in ischaemic cardiomyopathy is unknown. Meta-analyses suggest improved cardiac function with cell therapy. The optimal cell delivery route remains unclear. We investigated whether granulocyte colony-stimulating factor (G-CSF) alone or in combination with intracoronary (i.c.) or intramyocardial (i.m.) injection of autologous bone marrow-derived cells (BMCs) improves cardiac function. METHODS AND

resultsNinety patients with symptomatic ischaemic cardiomyopathy and no further treatment options were enrolled in the randomized, placebo-controlled, single-centre REGENERATE-IHD study. Randomization was to one of three arms: peripheral, i.c., or i.m. In each arm, patients were randomized to active treatment or placebo. All patients, apart from the peripheral placebo group (saline only) received G-CSF for 5 days. The i.c. and i.m. arms received either BMCs or serum (placebo). The primary endpoint was change in LVEF at 1 year assessed by cardiac magnetic resonance imaging/computed tomography. The i.m. BMC group showed a significant improvement in LVEF of 4.99% (95% confidence interval 0.33-9.6%; P = 0.038) at 1 year. This group also showed a reduction in NYHA class at 1 year and NT-proBNP at 6 months. No other group showed a significant change in LVEF. This finding is supported by post-hoc between-group comparisons.

conclusionWe have shown that G-CSF combined with autologous i.m. BMCs has a beneficial effect on cardiac function and symptoms. However, this result should be considered preliminary in support of a clinical benefit of i.m. stem cell infusion in 'no option' patients and needs further exploration in a larger study.

Indexed as

AgedBone Marrow TransplantationCardiomyopathiesCoronary VesselsFemaleGranulocyte Colony-Stimulating FactorHumansInjections, Intra-ArterialInjections, IntramuscularMagnetic Resonance ImagingMaleMiddle AgedMyocardial IschemiaMyocardiumNatriuretic Peptide, BrainPeptide FragmentsGranulocyte Colony-Stimulating FactorNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)Bone marrow-derived cellsGranulocyte colony-stimulating factorIschaemic cardiomyopathy

Identifiers

PMID27790824
PMCPMC5248636
OpenAlexW2544941039

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.