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

Stem Cell Res Ther. 2023 Sep 23;14(1):264. doi: 10.1186/s13287-023-03495-1.

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.

Keywords: Intracoronary injection; Mesenchymal stromal cell; Myocardial infarction; Stroke volume; Ventricular function.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Hematopoietic Stem Cell Transplantation*
  • Humans
  • Iran
  • Mesenchymal Stem Cells*
  • Myocardial Infarction* / diagnostic imaging
  • Myocardial Infarction* / therapy
  • Percutaneous Coronary Intervention*
  • Single-Blind Method
  • Stroke Volume
  • Ventricular Function, Left

Associated data

  • IRCT/IRCT20201116049408N1