A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trial

• Published in: European heart journal Vol. 37; no. 3; pp. 256 - 263
• Main Authors: Choudry, Fizzah, Hamshere, Stephen, Saunders, Natalie, Veerapen, Jessry, Bavnbek, Katrine, Knight, Charles, Pellerin, Denis, Locca, Didier, Westwood, Mark, Rakhit, Roby, Crake, Tom, Kastrup, Jens, Parmar, Mahesh, Agrawal, Samir, Jones, Daniel, Martin, John, Mathur, Anthony
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 14-01-2016
• Subjects: Anterior Wall Myocardial Infarction - pathology; Anterior Wall Myocardial Infarction - physiopathology; Anterior Wall Myocardial Infarction - therapy; Bone Marrow Transplantation - methods; Clinical Research; Computed Tomography Angiography; Double-Blind Method; Female; Humans; Magnetic Resonance Angiography; Male; Middle Aged; Natriuretic Peptide, Brain - metabolism; Peptide Fragments - metabolism; Percutaneous Coronary Intervention - methods; Quality of Life; Salvage Therapy - methods; Stroke Volume - physiology; Transplantation, Autologous; Ventricular Dysfunction, Left - diagnosis; Primary percutaneous coronary intervention; Stem cell therapy; Acute myocardial infarction; Cardiac magnetic resonance imaging
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehv493

Clinical trials suggest that intracoronary delivery of autologous bone marrow-derived cells (BMCs) 1-7 days post-acute myocardial infarction (AMI) may improve left ventricular (LV) function. Earlier time points have not been evaluated. We sought to determine the effect of intracoronary autologous BMC on LV function when delivered within 24 h of successful reperfusion therapy.
A multi-centre phase II randomized, double-blind, and placebo-controlled trial. One hundred patients with anterior AMI and significant regional wall motion abnormality were randomized to receive either intracoronary infusion of BMC or placebo (1:1) within 24 h of successful primary percutaneous intervention (PPCI). The primary endpoint was the change in left ventricular ejection fraction (LVEF) between baseline and 1 year as determined by advanced cardiac imaging. At 1 year, although LVEF increased compared with baseline in both groups, the between-group difference favouring BMC was small (2.2%; 95% confidence interval, CI: -0.5 to 5.0; P = 0.10). However, there was a significantly greater myocardial salvage index in the BMC-treated group compared with placebo (0.1%; 95% CI: 0.0-0.20; P = 0.048). Major adverse events were rare in both treatment groups.
The early infusion of intracoronary BMC following PPCI for patients with AMI and regional wall motion abnormality leads to a small non-significant improvement in LVEF when compared with placebo; however, it may play an important role in infarct remodelling and myocardial salvage.