近日，伊朗设拉子医科大学Negar Azarpira团队研究了经冠状动脉输注间充质干细胞预防急性心肌梗死后心力衰竭的疗效。2025年10月29日，《英国医学杂志》发表了这一成果。

为了探讨冠状动脉内灌注间充质干细胞对心肌梗死后心力衰竭的影响，研究组在伊朗设拉子的三家三级医院进行了一项3期随机临床试验。招募420例第一ST段抬高急性心肌梗死患者，左室射血分数为40%，按1:2的比例随机分组，接受干预或标准治疗。

干预措施为在急性心肌梗死后3-7天内冠状动脉内输注同种异体华氏果冻源间充质干细胞。主要终点是心力衰竭的发生率。次要终点包括因心力衰竭再入院、全因死亡率、心血管死亡率和因心肌梗死再入院。比较两组心肌梗死后6个月内左室射血分数的变化。

最终分析共纳入396例患者（干预组136例，对照组260例），中位随访33.2个月。冠状动脉内灌注间充质干细胞对心力衰竭的发生率（2.77 v 6.48 / 100人年；风险比0.43,95%可信区间0.21 ~ 0.89；P=0.024）、心力衰竭再入院（0.92 v 4.20 / 100人年；0.22,0.06 ~ 0.74；P=0.015）以及心血管死亡率和心肌梗死或心力衰竭再入院的复合终点（2.80 v 7.16 / 100人年；0.39,0.19 ~ 0.82；P=0.012）具有预防作用。干预对心肌梗死再入院（1.23 v 3.06 / 100人年；风险比0.40,0.14 ~ 1.19；P=0.10）、全因死亡率（1.81 v 1.66 / 100人年；1.10,0.40 ~ 3.02；P=0.86）或心血管死亡率（0.91 v 1.33 / 100人年；0.68,0.18 ~ 2.57；P=0.57）无统计学意义。干预组左心室射血分数在6个月时较基线有显著改善（β=5.88, 95%可信区间4.00 ~ 7.76；P<0.001）。

研究结果表明，冠状动脉内输注沃顿胶来源的间充质干细胞显著降低心力衰竭发生率、心力衰竭再入院风险，以及急性心肌梗死患者心血管死亡率和心力衰竭或心肌梗死再入院的复合终点。提示该技术可作为心肌梗死后的一种有价值的辅助手术，以预防心力衰竭的发展并降低未来不良事件的风险。

附：英文原文

Title: Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8)

Author: Armin Attar, Seyed Alireza Mirhosseini, Anthony Mathur, Sheik Dowlut, Ahmad Monabati, Mohammad Kasaei, Firoozeh Abtahi, Yahya Kiwan, Massoud Vosough, Negar Azarpira

Issue&Volume: 2025/10/29

Abstract:

Objective To assess the effect of intracoronary infusion of mesenchymal stem cells on the development of post-myocardial infarction heart failure.

Design Phase 3 randomised clinical trial.

Setting Three tertiary hospitals in Shiraz, Iran.

Participants 420 patients with a first ST segment elevation acute myocardial infarction and left ventricular ejection fraction <40% were enrolled and randomised in a 1:2 ratio to receive intervention or standard care.

Intervention Intracoronary infusion of allogenic Wharton’s jelly derived mesenchymal stem cells within 3-7 days of acute myocardial infarction in addition to standard care.

Main outcome measures The primary endpoint was incidence of heart failure. Secondary endpoints included readmission to hospital for heart failure, all cause mortality, cardiovascular mortality, and readmission to hospital for myocardial infarction. Changes in left ventricular ejection fraction within six months post-myocardial infarction were compared between groups.

Results A total of 396 patients (136 in the intervention group and 260 in the control group) were included in the final analysis, with a median follow-up of 33.2 months. Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidence of heart failure (2.77 v 6.48 per 100 person years; hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024), readmission to hospital for heart failure (0.92 v 4.20 per 100 person years; 0.22, 0.06 to 0.74; P=0.015), and a composite endpoint of cardiovascular mortality and readmission for myocardial infarction or heart failure (2.80 v 7.16 per 100 person years; 0.39, 0.19 to 0.82; P=0.012). The intervention did not have a statistically significant effect on readmission to hospital for myocardial infarction (1.23 v 3.06 per 100 person years; hazard ratio 0.40, 0.14 to 1.19; P=0.10), all cause mortality (1.81 v 1.66 per 100 person years; 1.10, 0.40 to 3.02; P=0.86), or cardiovascular mortality (0.91 v 1.33 per 100 person years; 0.68, 0.18 to 2.57; P=0.57). Left ventricular ejection fraction in the intervention group showed a significantly greater improvement from baseline at six months compared with the control group (β=5.88, 95% confidence interval 4.00 to 7.76; P<0.001).

Conclusions Intracoronary infusion of Wharton’s jelly derived mesenchymal stem cells significantly reduced the risk of incidence of heart failure, readmission to hospital for heart failure, and the composite endpoint of cardiovascular mortality and readmission to hospital for heart failure or myocardial infarction in patients after an acute myocardial infarction, suggesting that this technique may serve as a valuable adjunctive procedure after myocardial infarction to prevent the development of heart failure and reduce the risk of future adverse events.

DOI: 10.1136/bmj-2024-083382

Source: https://www.bmj.com/content/391/bmj-2024-083382