NCT00883727已完成1 期
A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- AE and ECG parameters
研究概览
简要总结
This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.
- •Patient has global left ventricular systolic dysfunction with an ejection fraction of <50% and >30%.
- •ECG with sign of acute anterior MI with ST-elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST-elevation ≥1 mm on all of the following leads- II, III, V5-V6 or STelevation ≥ 2 mm in at least 2 of the leads.
- •The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.
- •Patient with acute myocardial infarction within 10 days prior to IP administration.
- •Normal liver and renal function.
- •Able to understand study information provided to him.
- •Able to give voluntary written consent.
排除标准
- •History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
- •Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
- •Advanced renal dysfunction and creatinine ≥ 2mg%.
- •Advanced hepatic dysfunction.
- •Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Plasmalyte A (Drug)
stem cells
Experimental
干预措施: Stem cell (Drug)
结局指标
主要结局
AE and ECG parameters
时间窗: 6 months
次要结局
- Regional myocardial perfusion and infarct size(6 months)
研究者
研究点 (4)
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