Safety and efficacy of intracoronary hypoxia-preconditioned bone marrow mononuclear cell administration for acute myocardial infarction patients: The CHINA-AMI randomized controlled trial
Safety and efficacy of intracoronary hypoxia-preconditioned bone marrow mononuclear cell administration for acute myocardial infarction patients: The CHINA-AMI randomized controlled trial
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急性心肌梗死患者冠脉内缺氧预处理骨髓单核细胞给药的安全性和有效性：CHINA-AMI 随机对照试验
DOI：
10.1016/j.ijcard.2015.02.084
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发表时间：
2015-04-01
影响因子：
3.5
通讯作者：
Wang, Jian'an
中科院分区：
文献类型：
--
作者：
Hu, Xinyang;Huang, Xin;Wang, Jian'an
背景：临床前研究表明，低氧预适应可增强干细胞治疗心肌修复的潜力。方法：22例急性ST段抬高心肌梗死（STEMI）患者，随机分为2组，每组11例，分别经冠状动脉内注射低氧预处理的骨髓单个核细胞（HP-BMCs）和低氧预处理的骨髓单个核细胞（N-BMCs），观察两组再灌注成功后的安全性和可行性。结果：3组患者30 d和1年主要心血管不良事件发生率无显著性差异（P > 0. 05）。6个月和12个月时，HP-BMC组左室舒张末期容积（LVEDV）和左室收缩末期容积（LVESV）均较N-BMC组和对照组明显改善（P < 0.05）。左室射血分数（LVEF）、室壁运动评分指数（WMSI）在三组间无显著性差异。HP-BMCs组和NBMC组WMSI较对照组明显改善（P < 0.05）。6个月时，HP-BMC组和N-BMC组心肌灌注缺损率均显著低于对照组（P < 0.05，组内），但各组间无显著性差异（P> 0.05）。这些结果为将来在更大的患者队列中进行前瞻性随机临床试验提供了基础。(c)2015年，作者。出版社：Elsevier爱尔兰Ltd.
Background: Pre-clinical studies have shown that hypoxia preconditioning can enhance stem cell therapeutic potential for myocardial repair. We sought to investigate the safety and feasibility of intracoronary administration of hypoxia-preconditioned bone marrow mononuclear cells (HP-BMCs) for acute ST segment elevation myocardial infarction (STEMI).Methods: We randomized 22 patients with acute STEMI to receive intracoronary administration of normoxia bone marrow mononuclear cells (N-BMCs) (n= 11) or HP-BMCs (n= 11) following successful reperfusion. Another 14 patients receiving standard therapy were recruited as control (n= 14).Results: There were no differences in the occurrence of major adverse cardiovascular events at 30 days and 1 year among three groups. There were significant improvement in the change of left ventricular end-diastolic volume (LVEDV) and end-systolic volume (LVESV) inHP-BMC group both at 6 and 12 months compared with N-BMCs or control group (P < 0.05). No differences were observed in the change of left ventricular ejection fraction (LVEF), or wall motion score index (WMSI) among three groups. Nevertheless, WMSI was improved in HP-BMCs and NBMC group (P < 0.05, within group), but not in control. The ratio of myocardial perfusion defect determined by SPECT was significantly decreased in HP-BMCs and N-BMC groups at 6 months compared with baseline (P < 0.05, within group), but no significant differences were observed among three groups.Conclusions: Our results provide the first-in-man evidence that intracoronary administration of HP-BMCs following acute MI appears to be safe and feasible. These results provide the basis for future prospective randomized clinical trials in a larger patient cohort. (c) 2015 The Authors. Published by Elsevier Ireland Ltd.