Effect of Once Versus Twice Intracoronary Injection of Allogeneic-Derived Mesenchymal Stromal Cells after Acute Myocardial Infarction: BOOSTER-TAHA7 Randomized Clinical Trial.
Research Square (Research Square)(2023)
Abstract
Background Mesenchymal stromal cell (MSC) transplantation can improve the left ventricular ejection fraction (LVEF) after an acute myocardial infarction (AMI). Transplanted MSCs exert a paracrine effect, which might be augmented if repeated doses are administered. This study aimed to compare the effects of single versus double transplantation of Wharton’s jelly MSCs (WJ-MSCs) on LVEF post-AMI. Methods We conducted a single-blind, randomized, multicenter trial. After 3–7 days of an AMI treated successfully by primary PCI, 70 patients younger than 65 with LVEF < 40% on baseline echocardiography were randomized to receive conventional care, a single intracoronary infusion of WJ-MSCs, or a repeated infusion 10 days later. The primary endpoint was the 6-month LVEF improvement as per cardiac magnetic resonance (CMR) imaging. Results The mean baseline EF measured by CMR was similar (~ 40%) in all three groups. By the end of the trial, while all patients experienced a rise in EF, the most significant change was seen in the repeated intervention group. Compared to the control group ( n = 25), single MSC transplantation ( n = 20) improved the EF by 4.54 ± 2%, and repeated intervention ( n = 20) did so by 7.45 ± 2% when measured by CMR imaging ( P < 0.001); when evaluated by echocardiography, these values were 6.71 ± 2.4 and 10.71 ± 2.5%, respectively ( P < 0.001). Conclusions Intracoronary transplantation of WJ-MSCs 3–7 days after AMI in selected patients significantly improves LVEF, with the infusion of a booster dose 10 days later augmenting this effect. Trial registration : Trial registration: Iranian Registry of Clinical Trials, IRCT20201116049408N1. Retrospectively Registered 20 Nov. 2020, https://en.irct.ir/trial/52357
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Key words
Myocardial infarction,Mesenchymal stromal cell,Intracoronary injection,Ventricular function,Stroke volume
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