Mathur, A;
Arnold, R;
Assmus, B;
Bartunek, J;
Belmans, A;
Boenig, H;
Crea, F;
... Zeiher, A; + view all
(2017)
The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: rationale and design of the BAMI trial.
European Journal of Hearth Failure
, 19
(11)
pp. 1545-1550.
10.1002/ejhf.829.
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Abstract
Over the past 13 years bone marrow‐derived mononuclear cells (BM‐MNCs) have been widely investigated for clinical efficacy in patients following acute myocardial infarction (AMI). These early phase II trials have used various surrogate markers to judge efficacy and, although promising, the results have been inconsistent. The phase III BAMI trial has therefore been designed to demonstrate that intracoronary infusion of BM‐MNCs is safe and will significantly reduce the time to first occurrence of all‐cause death in patients with reduced left ventricular ejection fraction after successful reperfusion for ST‐elevation AMI (powered with the aim of detecting a 25% reduction in all‐cause mortality). This is a multinational, multicentre, randomized, open‐label, controlled, parallel‐group phase III study aiming to enrol approximately 3000 patients in 11 European countries with at least 17 sites. Eligible patients who have impaired left ventricular ejection (≤45%) following successful reperfusion for AMI will be randomized to treatment or control group in a 1:1 ratio. The treatment group will receive intracoronary infusion of BM‐MNCs 2–8 days after successful reperfusion for AMI added on top of optimal standard of care. The control group will receive optimal standard of care. The primary endpoint is time from randomization to all‐cause death. The BAMI trial is pivotal and the largest trial to date of BM‐MNCs in patients with impaired left ventricular function following AMI. The aim of the trial is to provide a definitive answer as to whether BM‐MNCs reduce all‐cause mortality in this group of patients.
| Type: | Article |
|---|---|
| Title: | The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: rationale and design of the BAMI trial |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1002/ejhf.829 |
| Publisher version: | http://dx.doi.org/10.1002/ejhf.829 |
| Language: | English |
| Additional information: | Copyright © 2017 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
| Keywords: | Cell therapy, Cardiovascular disease, Bone marrow‐derived mononuclear cells, Myocardial infarction, Heart failure, Cardiac regeneration, BAMI |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Experimental and Translational Medicine |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10049759 |
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