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

 Familial Dilated Cardiomyopathy / Posted 2 weeks ago

Brief Summary
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.
Detailed Description
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).
  • Inclusion Criteria :
    • Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
    • Sexes Eligible for Study: All
    • Accepts Healthy Volunteers: No
    • 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 :
    • NYHA I-II.
    • 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
  • Study start date : December 24, 2018
  • Study end date : July 30, 2024
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Anthony Mathur (Barts & The London NHS Trust)
Contact details

St Bartholomew's Hospital, LondonLondon,England,EC1A 7BE  Show Phone Number anthony.mathur@bartshealth.nhs.uk www.bartshealth.nhs.uk

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