NCT02666391Unknown1 期
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)
South China Research Center for Stem Cell and Regenerative Medicine0 个研究点目标入组 64 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 64
- 主要终点
- Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).
研究概览
简要总结
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.
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
- •Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery;
- •LVEF (left ventricular ejection fraction): 25-45%;
- •Age between 18 and 70, borh gender;
- •Women of childbearing age agreed to take contraceptive measures during the whole study period;
- •No psychiatric illnesses and speaking dysfunction;
- •Informed consent.
排除标准
- •Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF<24%;
- •Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value;
- •Patients suffered from severe arrhythmia;
- •Patients suffered from stent thrombosis;
- •Patients receiving immunosuppressive therapy;
- •Patients have tumor or other lethal diseases (expectation of life<6 months);
- •Women who plan to be pregnant or are pregnant or nursing;
- •Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen);
- •Other clinical trial participants within 3 months;
- •Investigators judge other conditions not suitable for inclusion.
结局指标
主要结局
Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).
时间窗: 1 week, 18 month
Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.
时间窗: 1 week, 6 month, 12 month,18 month
次要结局
- Pump failure Killip classification(baseline, 1 week, 1 month, 6 month, 12 month,18 month)
- New York Heart Association(NYHA) classification(1 week, 1 month, 6 month, 12 month,18 month)
- Occurrence of major adverse event(3 day, 1 week, 1 month, 6 month, 12 month,18 month)
研究者
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