NCT03572660

Brief 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.

  • 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
47mo left

Started Dec 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Dec 2018Mar 2030

First Submitted

Initial submission to the registry

March 29, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

December 24, 2018

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

11.3 years

First QC Date

March 29, 2018

Last Update Submit

July 18, 2025

Conditions

Dilated Cardiomyopathy

Keywords

Stem CellCirculatory SupportHeart FailureG-CSF

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricular ejection fraction

    Change in left ventricular ejection fraction as measured by cardiac CT

    Baseline to 3 months

Secondary Outcomes (12)

  • Change in left ventricular ejection fraction

    Baseline to 12 months

  • Change in exercise capacity

    Baseline to 3 and 12 months

  • Change in heart failure symptoms

    Baseline to 3 and 12 months

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

    Baseline to 3 and 12 months

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

    Baseline to 3 and 12 months

  • +7 more secondary outcomes

Study Arms (1)

BMMNC intervention arm

OTHER

Bone marrow derived mononuclear cells and G-CSF

Biological: Bone marrow derived mononuclear cells and G-CSF

Interventions

Bone marrow derived mononuclear cells and G-CSFBIOLOGICAL

Intra-coronary infusion

BMMNC intervention arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40145630DERIVED

  • 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.

    PMID: 37190883DERIVED

MeSH Terms

Conditions

Cardiomyopathy, DilatedHeart Failure

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Anthony Mathur

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Mathur

CONTACT

0203 765 8704a.mathur@qmul.ac.uk

Sonia Bastos

CONTACT

0203 765 8704s.bastos@nhs.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm intervention study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

June 28, 2018

Study Start

December 24, 2018

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)