Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial
Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial
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DOI：
10.1016/s0140-6736(05)67861-0
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发表时间：
2006-01-14
期刊：
影响因子：
168.9
通讯作者：
Van de Werf, F
中科院分区：
文献类型：
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作者：
Janssens, S;Dubois, C;Van de Werf, F
背景
再灌注疗法对ST段抬高型急性心肌梗死（STEMI）的益处受到梗死后左心室（LV）功能障碍的限制。我们的目的是研究在梗死相关动脉内移植自体骨髓来源干细胞（BMSC）对左心室功能和结构的影响。
方法
我们对67例患者进行了一项随机、双盲、安慰剂对照研究，这些患者在成功接受STEMI经皮冠状动脉介入治疗1天后采集骨髓。我们给予患者最佳药物治疗，并输注安慰剂（n = 34）或BMSC（n = 33）。我们的主要终点是左心室射血分数的增加，次要终点是随访4个月时梗死面积的变化和局部左心室功能的改变，所有这些均通过磁共振成像（MRI）评估。我们通过连续的1 - [（11）C]乙酸正电子发射断层扫描（PET）评估心肌灌注和氧化代谢的变化。分析是按照方案进行的。本研究在clinicaltrials.gov注册，编号为NCT00264316。
结果
经皮冠状动脉介入治疗4天后，对照组平均整体左心室射血分数为46.9%（标准差8.2），BMSC组为48.5%（7.2），4个月后分别增加到49.1%（10.7）和51.8%（8.8；治疗效果的比值比为1.036，95%置信区间0.961 - 1.118，p = 0.36）。与安慰剂输注相比，BMSC移植与心肌梗死面积显著减小（BMSC治疗效果为28%，p = 0.036）以及局部收缩功能更好的恢复相关。两组的心肌灌注和代谢增加情况相似。我们注意到BMSC移植没有相关并发症，BMSC组除1例患者外均完成了4个月的随访。
解释
在最佳再灌注治疗24小时内进行冠状动脉内自体骨髓细胞移植不会增强心肌梗死后整体左心室功能的恢复，但可能对梗死重塑产生有利影响。
Background The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by post-infarction left-ventricular (LV) dysfunction. Our aim was to investigate the effect of autologous bone marrow-derived stem cell (BMSC) transfer in the infarct-related artery on LV function and structure.Methods We did a randomised, double-blind, placebo-controlled study in 67 patients from whom we harvested bone marrow 1 day after successful percutaneous coronary intervention for STEML We assigned patients optimum medical treatment and infusion of placebo (n=34) or BMSC (n=33). Our primary endpoint was the increase in LV ejection fraction and our secondary endpoints were change in infarct size and regional LV function at 4 months' follow-up, all assessed by MRI. We assessed changes in myocardial perfusion and oxidative metabolism with serial 1-[(11)C]acetate PET. Analyses were per protocol. This study is registered with clinicaltrials.gov, number NCT00264316.Findings Mean global LV ejection fraction 4 days after percutaneous coronary intervention was 46.9% (SD 8.2) in controls and 48.5% (7.2) in BMSC patients, and increased after 4 months to 49.1% (10.7) and 51.8% (8.8; OR for treatment effect 1.036, 95% Cl 0.961-1.118, p=0.36). Compared with placebo infusion, BMSC transfer was associated with a significant reduction in myocardial infarct size (BM S C treatment effect 28%, p=0.036) and a better recovery of regional systolic function. Myocardial perfusion and metabolism increased similarly in both groups. We noted no complications associated with BMSC transfer and all but one patient in the BMSC group completed the 4 months' follow-up.Interpretation intracoronary transfer of autologous bone marrow cells within 24 h of optimum reperfusion therapy does not augment recovery of global LV function after myocardial infarction, but could favourably affect infarct remodelling.