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Recruiting Phase 2 NCT03572660

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

Trial Parameters

Condition Dilated Cardiomyopathy
Sponsor Barts & The London NHS Trust
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2018-12-24
Completion 2030-03-31
Interventions
Bone marrow derived mononuclear cells and G-CSF

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

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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