A Randomized, Open-label, Multicenter Trial for the Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Absolute changes in global LVEF by SPECT
研究概览
简要总结
Early reperfusion strategies in tandem with remarkable advances in drugs and devices for treating myocardial infarction (MI) have contributed to a reduction in early mortality, but cardiovascular disease remains the leading cause of death worldwide. Current management strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart failure. In this respect, stem-cell therapy has shown potential benefits for repairing the damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive therapeutic candidates because of their high capacity for replication: paracrine effect: ability to preserve potency: and because they do not cause adverse reactions to allogeneic versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but only one clinical trial using MSCs via the intracoronary route in the setting of acute myocardial infarction (AMI) has been carried out. The investigators therefore assessed the safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in patients with AMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years
- •ischemic chest pain for >30 min
- •admitted to hospital <24 h after the onset of chest pain
- •electrocardiography showed ST segment elevation >1 mm in two consecutive leads in the limb leads or >2 mm in the precordial leads
- •they could be enrolled in the study <72 h after successful revascularization
排除标准
- •cardiogenic shock (defined as systolic blood pressure <90 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation)
- •life-threatening arrhythmia
- •impossible conditions for cardiac catheterization
- •advanced renal or hepatic dysfunction
- •history of previous coronary artery bypass graft
- •history of hematologic disease
- •history of malignancy
- •major bleeding requiring blood transfusion
- •stroke or transient ischemic attack in the previous 6 months
- •structural abnormalities of the central nervous system (brain tumor, aneurysm, history of surgery)
- •traumatic injury after myocardial infarction
- •use of corticosteroids or antibiotics during the previous month
- •major surgical procedure in the previous 3 months
- •cardiopulmonary resuscitation for >10 min within the previous 2 weeks
- •positive skin test for penicillin
- •positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test)
- •pregnancy, possible candidate for pregnancy or breastfeeding females
- •drug abusers
- •inappropriate patients to participate in the study according to the chief investigator
研究组 & 干预措施
Mesenchymal stem cell treatment group
干预措施: Mesenchymal stem cell (Drug)
Control group
All patients were required to have successful revascularization of an infarct-related artery on coronary angiography at the time of randomization. All patients received aspirin (300 mg loading dose, then 100 mg daily) and clopidogrel (600 mg loading dose, then 75 mg daily) with optimal medical therapy according to the American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines for treatment of ST-segment elevation myocardial infarction (STEMI)
干预措施: Control group (Drug)
结局指标
主要结局
Absolute changes in global LVEF by SPECT
时间窗: baseline and 6 months
Absolute changes in global left ventricular ejection fraction (LVEF) as measured by SPECT 6 months after cell infusion
次要结局
- Changes in left ventricular end-diastolic volume (LVEDV)(baseline and 6 months)
- Changes in left ventricular end-systolic volume (LVESV)(baseline and 6 months)
- Changes in regional wall motion score index (WMSI) by Echocardiography(baseline and 6 months)
- Major adverse cardiac event (MACE)(6 months)