Department of Cardiovascular Medicine, TAHA Clinical Trial Group, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, 71344-1864, Iran.
School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Stem Cell Res Ther. 2023 Sep 23;14(1):264. doi: 10.1186/s13287-023-03495-1.
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.
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.
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).
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: Iranian Registry of Clinical Trials, IRCT20201116049408N1. Retrospectively Registered 20 Nov. 2020, https://en.irct.ir/trial/52357.
间充质基质细胞（MSC）移植可改善急性心肌梗死（AMI）后的左心室射血分数（LVEF）。移植的 MSC 发挥旁分泌作用，如果给予重复剂量，这种作用可能会增强。本研究旨在比较单次与双次注射牙髓基质细胞（WJ-MSC）对 AMI 后 LVEF 的影响。
我们进行了一项单盲、随机、多中心试验。在通过直接经皮冠状动脉介入治疗成功治疗 AMI 后 3-7 天后，70 名年龄小于 65 岁且基线超声心动图 LVEF<40%的患者被随机分为接受常规治疗、单次冠状动脉内输注 WJ-MSC 或 10 天后重复输注。主要终点是心脏磁共振（CMR）成像评估的 6 个月 LVEF 改善。
三组患者的 CMR 测量的平均基线 EF 相似（约 40%）。试验结束时，虽然所有患者的 EF 均有所升高，但重复干预组的变化最显著。与对照组（n=25）相比，单次 MSC 移植（n=20）使 EF 增加 4.54±2%，重复干预（n=20）使 EF 增加 7.45±2%，CMR 成像测量（P<0.001）；超声心动图评估时，这些值分别为 6.71±2.4%和 10.71±2.5%（P<0.001）。
在选定的患者中，AMI 后 3-7 天经冠状动脉内输注 WJ-MSC 可显著提高 LVEF，10 天后给予增强剂可增强这种效果。
伊朗临床试验注册中心，IRCT20201116049408N1。2020 年 11 月 20 日回顾性注册，https://en.irct.ir/trial/52357.
