Trials / Active Not Recruiting
Active Not RecruitingNCT03572660
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Barts & The London NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Bone marrow derived mononuclear cells and G-CSF | Intra-coronary infusion |
Timeline
- Start date
- 2018-12-24
- Primary completion
- 2030-03-31
- Completion
- 2030-03-31
- First posted
- 2018-06-28
- Last updated
- 2026-04-06
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03572660. Inclusion in this directory is not an endorsement.