use of bone marrow derived stem cell and g-csf with circulatory assistance in the treatment of dcm

Conditions: Dilated Cardiomyopathy

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

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.

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. 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

Keywords: stem cell circulatory support heart failure g-csf