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

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.

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. 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.
• 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