Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Heart failure hospitalization
研究概览
简要总结
The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction
- •Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of < 45% by echocardiography.
- •Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf,
- •Willingness to attend all scheduled safety follow-up visits
- •Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF <45).
排除标准
- •Hemodynamic instability as demonstrated by any of the following,
- •Requirement of intra-aortic balloon pump of left ventricular assist device,
- •Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmHg,
- •Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb < 10 g/dL, WBC < 4 or > 11x109/L, or platelets < 100x109/L), kidney failure (creatinine level > 2.5 mg/dL, or creatinine clearance < 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse,
- •Prosthetic valves,
- •Hypertrophic or restrictive cardiomyopathy,
- •Women of child-bearing potential,
- •Inability to comply with the protocol,
- •Currently using implantable electronic defibrillator or pacemaker
研究组 & 干预措施
Intracoronary Group
Dosage of intracoronary route is ±50 million MSCs for each subject.
干预措施: Mesenchymal Stem Cells (Biological)
Intravenous Group
Dosage of intravenous route is 2 million MSCs/kg for each subject.
干预措施: Mesenchymal Stem Cells (Biological)
结局指标
主要结局
Heart failure hospitalization
时间窗: 12 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Major adverse cardiac events (MACE) endpoints of mortality
时间窗: 12 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
时间窗: 12 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
时间窗: 12 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
次要结局
- Electrocardiography (ECG)(12 months after stem cell)
- Echocardiography(12 months after stem cell)
- Cardiac MRI(12 months after stem cell)
- Wellness Parameter(6 months after stem cell)
- Laboratory Assessment(12 months after stem cell)