NCT03572660Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 Mar 2018
- Start date
- 24 Dec 2018
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- Barts & The London NHS Trust
- Diseases
- Heart failure
- NCT number
- NCT03572660
- EudraCT number
- 2018-001063-23
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 24 Dec 2018 to the primary completion date, 31 Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cardiac surgery.
- Concomitant disease with a life expectancy of less than one year
- Patients on renal replacement therapy.
Other illness
- Congenital heart disease.
- Clinically significant valvular heart disease.
- 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.
- 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.
- Neoplastic disease without documented remission within the past 5 years.
Lab values
- Weight of patient that exceeds the maximum limit of the cardiac catheterisation laboratory table / CT scanner.
- 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).
Other
- 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)
- Follow-up impossible (no fixed abode, etc.)
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.