Evidence map›Paper›PMID 26333366›Full record

Trial reportEuropean heart journal2015

Randomized trial of combination cytokine and adult autologous bone marrow progenitor cell administration in patients with non-ischaemic dilated cardiomyopathy: the REGENERATE-DCM clinical trial.

Stephen Hamshere, Samer Arnous, Tawfiq Choudhury, Fizzah Choudry, Abdul Mozid, Chia Yeo, Catherine Barrett, Natalie Saunders, Ankur Gulati, Charles Knight and 10 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 10 pooled it
6.2field-weighted citation impact, top 3% 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

49 citing papers in PubMed, 10 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Pooled it
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  8. Stem cell therapy for dilated cardiomyopathy.The Cochrane database of systematic reviews · 2021
    Pooled it
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  11. CD34Stem cells translational medicine · 2018
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  16. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 1 country.

Stephen HamshereDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Samer ArnousDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Tawfiq ChoudhuryDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Fizzah ChoudryDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Abdul MozidDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Chia YeoDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Catherine BarrettDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Natalie SaundersStem Cell Laboratory, Barts Health NHS Trust and Blizard Institute, Queen Mary University of London, London, UK.
Ankur GulatiCardiovascular Magnetic Resonance Unit, Royal Brompton Hospital, Imperial College London, Sydney Street, London UK SW3 6NP, UK.
Charles KnightDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Didier LoccaDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
Ceri DaviesDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK Barts Health NIHR Cardiovascular Biomedical Research Unit, London Chest Hospital, Barts Health NHS Trust, London E2 9JX, UK.
Martin R CowieImperial College London (Royal Brompton Hospital), London UK SW3 6NP, UK.
Sanjay PrasadCardiovascular Magnetic Resonance Unit, Royal Brompton Hospital, Imperial College London, Sydney Street, London UK SW3 6NP, UK.
Mahesh ParmarCancer Division, Medical Research Council, Clinical Trials Unit, London, UK.
Samir AgrawalStem Cell Laboratory, Barts Health NHS Trust and Blizard Institute, Queen Mary University of London, London, UK.
Daniel JonesDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
John MartinBritish Heart Foundation Laboratories, Department of Medicine, University College London, London WC1E 6JJ, UK.
William McKennaInstitute of Cardiovascular Science, University College London, The Heart Hospital, UCLH, 16-18 Westmoreland Street, London W1G 8PH, UK.
Anthony MathurDepartment of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK Barts Health NIHR Cardiovascular Biomedical Research Unit, London Chest Hospital, Barts Health NHS Trust, London E2 9JX, UK a.mathur@qmul.ac.uk.
St Bartholomew's Hospital · GBBarts Health NHS Trust · GBImperial College London · GBLondon Chest Hospital · GBUniversity College London · GBMedical Research Council · GBQueen Mary University of London · GBRoyal Brompton Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe REGENERATE-DCM trial is the first phase II randomized, placebo-controlled trial aiming to assess if granulocyte colony-stimulating factor (G-CSF) administration with or without adjunctive intracoronary (IC) delivery of autologous bone marrow-derived cells (BMCs) improves global left ventricular (LV) function in patients with dilated cardiomyopathy (DCM) and significant cardiac dysfunction. METHODS AND

resultsSixty patients with DCM and left ventricular ejection fraction (LVEF) at referral of ≤45%, New York Heart Association (NYHA) classification ≥2 and no secondary cause for the cardiomyopathy were randomized equally into four groups: peripheral placebo (saline), peripheral G-CSF, peripheral G-CSF and IC serum, and peripheral G-CSF and IC BMC. All patients, except the peripheral placebo group, received 5 days of G-CSF. In the IC groups, this was followed by bone marrow harvest and IC infusion of cells or serum on Day 6. The primary endpoint was LVEF change from baseline to 3 months, determined by advanced cardiac imaging. At 3 months, peripheral G-CSF combined with IC BMC therapy was associated with a 5.37% point increase in LVEF (38.30% ± 12.97 from 32.93% ± 16.46 P = 0.0138), which was maintained to 1 year. This was associated with a decrease in NYHA classification, reduced NT-pro BNP, and improved exercise capacity and quality of life. No significant change in LVEF was seen in the remaining treatment groups.

conclusionThis is the first randomized, placebo-controlled trial with a novel combination of G-CSF and IC cell therapy that demonstrates an improvement in cardiac function, symptoms, and biochemical parameters in patients with DCM.

Indexed as

Adult Stem CellsBone Marrow TransplantationCardiomyopathy, DilatedCombined Modality TherapyExercise ToleranceFemaleGranulocyte Colony-Stimulating FactorHumansMaleMiddle AgedNatriuretic Peptide, BrainPeptide FragmentsQuality of LifeStem Cell TransplantationStroke VolumeTreatment OutcomeGranulocyte Colony-Stimulating FactorNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)Dilated cardiomyopathyGranulocyte colony-stimulating factorHeart failureStem cells

Identifiers

PMID26333366
PMCPMC4654774
OpenAlexW2268225201

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.