Overview
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
Description
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
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