A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Healios K.K.
- 入组人数
- 34
- 试验地点
- 11
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either gender, 18-85 years of age, inclusive
- •Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
- •Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%
排除标准
- •Previous Coronary Artery Bypass Graft (CABG)
- •Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
- •Previous solid organ transplant
- •Anticipated need for additional planned coronary revascularization procedure(s)
- •Hemodynamic instability
- •Mechanical complications of the index acute myocardial infarction
研究组 & 干预措施
AMI MultiStem cells
AMI MultiStem cells is a cell therapy medicinal product originating from adherent stem cells taken from the bone marrow of a non-related donor and expanded ex vivo.
干预措施: AMI MultiStem cells (Biological)
Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
干预措施: Sham (Other)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: 30 days
To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
To assess the effects of AMI MultiStem therapy on cardiac function
时间窗: Day 120
To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
次要结局
- To assess the incidence of Major Adverse Cardiovascular Events (MACE)(Day 365)
- Incidence and severity of adverse events(Day 365)
- To assess the effects of AMI MultiStem therapy on cardiac function(Day 365)