Trials / Completed
CompletedNCT01569178
BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction
The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 375 (actual)
- Sponsor
- Queen Mary University of London · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(\</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bone Marrow aspiration and intracoronary reinfusion | Bone marrow-derived progenitor cells are obtained from 50ml bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2019-11-27
- Completion
- 2019-11-27
- First posted
- 2012-04-03
- Last updated
- 2021-04-13
Locations
33 sites across 10 countries: Belgium, Czechia, Denmark, Finland, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01569178. Inclusion in this directory is not an endorsement.