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

Official 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

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 20 participants

Interventions

• BIOLOGICAL: Bone marrow derived mononuclear cells and G-CSF — Intra-coronary infusion

Primary Outcomes

• Change in left ventricular ejection fraction (Baseline to 3 months)

Secondary Outcomes

• Change in left ventricular ejection fraction (Baseline to 12 months)
• Change in exercise capacity (Baseline to 3 and 12 months)
• Change in heart failure symptoms (Baseline to 3 and 12 months)
• Change in quality of life as assessed by Minnesota Living with Heart Failure Questionnaire scores (Baseline to 3 and 12 months)
• Change in quality of life as measured by EuroQol-5 Dimension 5 Levels questionnaires (Baseline to 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. 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

Trial Locations

• St Bartholomew's Hospital, London, United Kingdom

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