Intracoronary Allogenic Umbilical Cord Mesenchymal Stem Cell Reduce Infarct Size, Reverse Remodelling, and Improve Cardiac Function
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Myocardial infarct size change
研究概览
简要总结
The goal of this clinical trial is to learn about the effectiveness of Umbilical Cord Mesenchymal Stem Cell (UC MSC) therapy in patients with STEMI against infarct myocardial size reduction and prevent the incidence of heart failure in the future
详细描述
Participants who have already done Primary Percutaneous Coronary Intervention (PCI) will be informed about the procedure and risk of this clinical trial. After written consent, 60 participants will be check for their eligibility criteria and randomized into intervention (get UC MSC transplantation) and control group. All participants will be check for their biochemical blood analysis: Interleukin-10 (IL-10), Vascular Endothelial Growth Factor (VEGF), Galectin-3, GATA Binding Protein-4 (GATA-4), and Beclin 1 (1 day before transplantation, 7 dan 14 days after transplantation); infarct size and left ventricular ejection fraction (LVEF) through Cardiac MRI (7-10 days after Primary PCI and 6 months after transplantation) and echocardiography (every month); and major adverse cardiac events/MACE (every month). The result will be access after 6 months follow up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 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 treated with primary PCI maximum 12 hours after onset of chest pain
排除标准
- •Patients with history of coronary artery bypass grafting surgery
- •Patients with history of heart failure before admission
- •Patients with cardiogenic shock
- •Patients with cancer disease
- •Patients with malignant arrythmia
- •Patients with chronic kidney disease
- •Patients with haemostasis disorder
- •Patients with infection
- •Patients with stroke
结局指标
主要结局
Myocardial infarct size change
时间窗: 6 months
Myocardial infarct size change in percentage measure with Cardiac MRI 7-10 days after primary PCI to 6 months after UC-MSC transplantation. The method used by measuring the area of infarction in a series of slices and multiplying the area times the slice thickness to determine a volume.
次要结局
- Left Ventricular Ejection Fraction (LVEF) with Echocardiography(6 months)
- Major Cardiac Adverse Event (MACE)(6 months)
- Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI(6 months)
研究者
dr. Dede Moeswir, Sp.PD, KKV
Principal Investigator
Indonesia University