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

Phase II Study Assessing the Combined Use of Autologous Bone Marrow Derived Mononuclear Cells and G-csf With Percutaneous Circulatory Assistance in the Treatment of Dilated Cardiomyopathy

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

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