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Dilated CardiomyopathyPhase 2DCM-SupportNCT03572660

Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM

A Phase 2 study testing Bone marrow derived mononuclear cells and G-CSF in people with Dilated Cardiomyopathy, run by Barts & The London NHS Trust at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

DCM Support is recruiting patients with dilated cardiomyopathy and heart failure symptoms. The goal of this clinical trial is to examine whether treatment with a patient's own stem cells can improve their heart function and alleviate heart failure symptoms. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Dilated Cardiomyopathy
What is being tested?
Bone marrow derived mononuclear cells and G-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
24 Dec 2018to 31 Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervision of a physician or a heart failure nurse specialist.
  • NYHA class ≥ 2 symptoms despite having received optimal medical therapy and appropriate device therapy, as per clinical guidelines for an interval of at least 3 months.
  • No other treatment options available as part of the current best standard of care.
  • LVEF ≤35% on any imaging modality performed as part of the screening phase.

Who cannot join

  • Congenital heart disease.
  • Clinically significant valvular heart disease.
  • Patients who are not suitable for a Percutaneous Mechanical Support Device (E.g. unsuitable femoral artery anatomy, unable able to lie flat for prolonged time to accommodate the stem cell infusion \& presence of LV thrombus)
  • Weight of patient that exceeds the maximum limit of the cardiac catheterisation laboratory table / CT scanner.
  • Cardiomyopathy 2o to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia.
  • Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.
Show all 20Show fewer
  • Previous cardiac surgery.
  • Contra-indication for bone marrow aspiration (thrombocytopaenia - platelet count <80 x 10(9)/L or extensive surgical scarring/anatomical deformity at site of bone marrow puncture).
  • Known active infection on admission as defined by a temperature >37.5°C or on a short course of antibiotics.
  • An active infection of hepatitis B, hepatitis C, syphilis or HTLV
  • Known HIV infection
  • Chronic inflammatory disease requiring on-going medication.
  • Concomitant disease with a life expectancy of less than one year
  • Follow-up impossible (no fixed abode, etc.)
  • Neoplastic disease without documented remission within the past 5 years.
  • Patients on renal replacement therapy.
  • Subjects of childbearing potential unless βHCG negative and are on adequate contraception during the trial.
  • Patients falling into the vulnerable category or lacking capacity
  • Patients who are unable to understand or read written English will be excluded from the trial.
  • Killip Class III or above

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • St Bartholomew's Hospital

    London, EC1A 7BE

Other trials in United Kingdom

About this study

Official title: Phase II Study Assessing the Combined Use of Autologous Bone Marrow Derived Mononuclear Cells and G-csf With Percutaneous Circulatory Assistance in the Treatment of Dilated Cardiomyopathy

DCM Support is recruiting patients with dilated cardiomyopathy and heart failure symptoms. The goal of this clinical trial is to examine whether treatment with a patient's own stem cells can improve their heart function and alleviate heart failure symptoms.

  • Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic.
  • The stem cells will be infused into the arteries that supply blood to the heart under local anaesthetic.
  • A mini heart pump will be used to take the strain off the heart during the procedure.
  • The follow-up involves a phone call at 1 month and clinic visits at 3 and 12 months
Read the detailed description

DCM SUPPORT is a single centre, single arm clinical trial taking place at St Bartholomew's Hospital in London, UK.

  • It is recruiting patients with dilated cardiomyopathy and ongoing heart failure symptoms
  • All patients undergo a bone marrow aspiration after 5 days of subcutaneous G-CSF injections
  • After cell processing, bone marrow-derived mononuclear cells are infused into the coronary arteries using the stop-flow technique. An intra-procedural Impella CP device is used to support the circulation.
  • The primary endpoint is change in left ventricular ejection fraction at 3 months as measured by cardiac CT.
Being tested
Bone marrow derived mononuclear cells and G-CSF
Keywords
Stem Cell, Circulatory Support, Heart Failure, G-CSF
Medical subject headings
Cardiomyopathy, Dilated, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone marrow derived mononuclear cells and G-CSFBiological

    Intra-coronary infusion

Study groups in NCT03572660
Study groupRoleWhat they receive
BMMNC intervention armOtherBone marrow derived mononuclear cells and G-CSF
Receives: Biological: Bone marrow derived mononuclear cells and G-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in left ventricular ejection fraction

    Change in left ventricular ejection fraction as measured by cardiac CT

    Measured: Baseline to 3 months

Secondary outcomes (12)

  1. Change in left ventricular ejection fraction

    Change in left ventricular ejection fraction as measured by cardiac CT

    Measured: Baseline to 12 months

  2. Change in exercise capacity

    Change in exercise capacity as assessed by a 6-minute walk test

    Measured: Baseline to 3 and 12 months

  3. Change in heart failure symptoms

    Change in heart failure symptoms as measured by NYHA classification

    Measured: Baseline to 3 and 12 months

  4. Change in quality of life as assessed by Minnesota Living with Heart Failure Questionnaire scores

    Change in quality of life as measured by MLHFQ (The 21-item MLHFQ uses a 6-point Likert scale, where 0 = no, 1= very little and 5= very much. The questions are intended to be representative of the ways heart failure can affect physical and emotional dimensions of quality of life)

    Measured: Baseline to 3 and 12 months

  5. Change in quality of life as measured by EuroQol-5 Dimension 5 Levels questionnaires

    Change in quality of life as measured by EQ-5D-5L questionnaires (the scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression)

    Measured: Baseline to 3 and 12 months

  6. Procedural safety as assessed by in-hospital procedural related morbidity/mortality

    Procedural safety as assessed by in-hospital procedural related morbidity/mortality

    Measured: In-hospital procedural time

  7. Change in biochemical markers of heart failure

    Change in biochemical markers of heart failure as measured by change in NT-proBNP

    Measured: Baseline to 3 and 12 months

  8. Assessment of rates of MACE (cumulative & individual components)

    Rates of MACE (all-cause death, myocardial infarction, hospitalisation for heart failure, major arrhythmias [defined as VT and VF])

    Measured: 3 and 12 months

  9. Assessment of rates of stroke

    Assessment of rates of stroke

    Measured: 3 and 12 months

  10. Assessment of peri-procedural myocardial infarction

    Assessment of peri-procedural myocardial infarction as per SCAI definition measured by change in troponin (MI defined by increase in troponin >70 times upper limit of normal from baseline).

    Measured: Day 0 and Day 6

  11. Change in renal function

    Change in renal function from baseline at 3 and 12 months as measured by creatinine levels.

    Measured: Baseline to 3 and 12 months

  12. Change in inflammatory markers

    Change in inflammatory markers as measured by change in C-reactive protein

    Measured: Baseline to 3 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2018
  2. Study start24 Dec 2018
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm intervention study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03572660
Sponsor's protocol ID
Reda 012357
Other IDs
2018-001063-23, 2018
Acronym
DCM-Support
Status last verified
Apr 2026
First submitted
29 Mar 2018
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fawaz S, Ramaseshan R, Khan S, Davies JR, Collet C, Karamasis GV, Cook CM, Jones DA, Mathur A, Keeble TR. Left Ventricular Unloading in Nonischemic Dilated Cardiomyopathy Improves Coronary Haemodynamic Reserve. Catheter Cardiovasc Interv. 2025 Jun;105(7):1719-1722. doi: 10.1002/ccd.31514. Epub 2025 Mar 27.

    PubMed 40145630

  • Reid A, Hussain M, Veerapen J, Ramaseshan R, Hall R, Bowles R, Jones DA, Mathur A. DCM Support: cell therapy and circulatory support for dilated cardiomyopathy patients with severe ventricular impairment. ESC Heart Fail. 2023 Aug;10(4):2664-2671. doi: 10.1002/ehf2.14393. Epub 2023 May 15.

    PubMed 37190883

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bone marrow derived mononuclear cells and G-CSF in people with Dilated Cardiomyopathy, run by Barts & The London NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in left ventricular ejection fraction (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03572660, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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