Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT03572660
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM
Sponsor:
Barts & The London NHS Trust
Organization:
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCM-Support
Brief 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
* 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-001063-23 | EUDRACT_NUMBER | None | View |