Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Left ventricular systolic function
研究概览
简要总结
This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction".
详细描述
Patients diagnosed with acute myocardial infarction will receive percutaneous coronary intervention to the culprit coronary artery according to standard procedures. For peripheral blood stem cell mobilization, Granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) will be injected for a total of 4 days, followed by collection of mobilized peripheral blood stem cell (mobPBSC) via apheresis. In ex-vivo setting, mobPBSC will be primed with angiopoietin 1 (Ang1) for 1 hour. A total of 2 X109 Ang1 primed mobPBSC will be injected to the culprit artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged ≥19 years and ≤ 80 years
- •A clinical diagnosis of acute myocardial infarction within 4 weeks from randomization
- •Successful percutaneous coronary intervention to the target lesion (TIMI flow grade 3 and residual stenosis <30% at the target lesion) with a drug-eluting stent and/or drug-eluting balloon
- •Agreement to give written informed consent.
排除标准
- •Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction <20%)
- •Patients with uncontrolled chest pain due to ischemia
- •Patients with uncontrolled arrythmia
- •Active malignancy, or incompletely treated malignancy
- •Active infectious disease
- •Uncontrolled hematologic disease, including coagulopathy or bleeding diathesis
- •Presence of non-cardiac comorbidity with life expectancy ≤1 year from randomization
- •Females with childbearing potential or breast-feeding
- •Refusal to give written informed consent
- •Other conditions that may result in protocol non-compliance by the committees
研究组 & 干预措施
Cell treatment arm
Patients who receive Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
干预措施: Autologous Peripheral Blood Stem Cell injection (Biological)
结局指标
主要结局
Left ventricular systolic function
时间窗: 12 months after treatment
Left ventricular ejection fraction measured by echocardiography (measured in percent)
次要结局
- Regional wall motion score index(12 months after treatment)
- B-natriuretic peptide level(12 months after treatment)
- 6-minute walk test(12 months after treatment)
- All-cause death(12 months after treatment)
- Target lesion Revascularization(12 months after treatment)
- Readmssion(12 months after treatment)
- Cardiovascular death(12 months after treatment)
- non-Target lesion Revascularization(12 months after treatment)
研究者
Hyun-Jai Cho
Professor
Seoul National University Hospital