NCT04050163已完成1 期
Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.
Honya Medical Inc4 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年1月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Incidence of Treatment Emergent Adverse Events
研究概览
简要总结
The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single/participant blinded
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20~80
- •Acute Myocardial Infarction 1 to 10 days
- •Cardiac enzyme CK-MB or Troponin > 2X of high-end normal value
- •ST-elevation on EKG (STEMI)
- •Presence of regional wall motion abnormality
- •Left ventricular ejection fraction (LVEF) of ≤40%
- •Hemodynamically stable past 24 hour
- •Participants with adequate pulmonary function
- •Peripheral artery oxygen saturation ≥97%
- •Karnofsky performance status scores of ≥60.
排除标准
- •Age <20 or >80
- •Pregnant or breast feeding
- •Positive adventitious infections (such as HIV, hepatitis )
- •Revascularization via coronary artery bypass surgery is required
- •Coronary revascularization procedures is anticipated during the 6-month study period
- •Severe aortic or mitral valve narrowing
- •Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
- •Short of breath unable to receive PCI examination or treatment
- •Malignant tumor
- •Hematopoietic dysplasia
- •Severe organ disease
- •With less than 1 year of life expectancy
- •Chronic kidney disease with CCr<20ml/min
- •Kidney disease on renal dialysis
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events
时间窗: 12 months
Number of Adverse Events
次要结局
- End diastolic volume(12 months)
- Left ventricular ejection fraction (LVEF)(12 months)
- Participants Functional Activity by NYHA Classification(12 months)
- Left ventricle stroke volume(12 months)
- Participants Functional Activity by CCS Classification(12 months)
研究者
研究点 (4)
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