Effect of once versus twice intracoronary injection of allogeneic-derived mesenchymal stromal cells after acute myocardial infarction: BOOSTER-TAHA7 randomized clinical trial

Stem Cell Research & Therapy

Research

Marjan Faghih¹  Javad Kojuri²  Armin Attar³  Massoud Vosough⁴  Mani Ramzi⁵  Ahmad Monabati⁶  Kamran Hessami⁷  Seyed Ali Hosseini⁷  Mohsen Farjoud Kouhanjani⁷ 

[1] Department of Biostatistics, School of Medicine, Arak University of Medical Sciences, Arak, Iran;Department of Cardiovascular Medicine, Shiraz University of Medical Sciences, Shiraz, Iran;Department of Cardiovascular Medicine, TAHA Clinical Trial Group, School of Medicine, Shiraz University of Medical Sciences, Zand Street, 71344-1864, Shiraz, Iran;Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran;Hematopathology and Molecular Pathology Service, Department of Pathology, Hematology Research Center, Shiraz University of Medical Sciences, 71344-1864, Shiraz, Iran;Hematopathology and Molecular Pathology Service, Department of Pathology, Hematology Research Center, Shiraz University of Medical Sciences, 71344-1864, Shiraz, Iran;Department of Pathology, Shiraz University of Medical Sciences, Shiraz, Iran;School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran;

关键词: Myocardial infarction;    Mesenchymal stromal cell;    Intracoronary injection;    Ventricular function;    Stroke volume;   

DOI  :  10.1186/s13287-023-03495-1

 received in 2023-04-09, accepted in 2023-09-12,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMesenchymal 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.MethodsWe 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.ResultsThe 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).ConclusionsIntracoronary 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

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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