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

  • End date
    Jul 30, 2024
  • participants needed
  • sponsor
    Barts & The London NHS Trust
Updated on 14 April 2022
ct scan
medical therapy
ejection fraction
heart failure
dilated cardiomyopathy


The DCM SUPPORT study is a single centre, single arm study evaluating the change in left ventricular ejection fraction with the combines use of bone marrow derived stem cells and G-CSF with a percutaneous circulatory assistance for the treatment of dilated cardiomyopathy.


The DCM SUPPORT study is a single centre, single arm, phase II pilot study. The primary endpoint will be a change in LVEF from baseline measured by a CT scan of the heart at 3 months. The secondary endpoints include change in LVEF from baseline measured by a CT scan of the heart at 12 months, in-hospital procedural related morbidity / mortality and assessment of major adverse cardiac events (MACE; death, heart attack, need for repeat heart revascularisation), change in exercise capacity and NYHA class at 3 months and 12 months respectively. The NYHA classification is a quantitative way of assessing a patient's heart failure symptoms. It places patients into one of four categories (I - IV).

Condition Dilated Cardiomyopathy
Treatment Bone marrow derived mononuclear cells and G-CSF
Clinical Study IdentifierNCT03572660
SponsorBarts & The London NHS Trust
Last Modified on14 April 2022


Yes No Not Sure

Inclusion Criteria

Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervision of a physician or a heart failure nurse specialist
NYHA class III or IV 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 current best standard care
LVEF ≤30% on the cardiac CT scan performed as part of the screening phase

Exclusion Criteria

Documented latest ejection fraction >30% (any imaging modality)
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 catheter 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
Known active infection at time of randomisation
Positive virology tests
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
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