MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Exercise test
研究概览
简要总结
Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital admissions for acute chest pain. In spite of improved treatments still many patients with CAD have daily attacks of severe chest pain and severely reduced life quality.
The investigators have established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with adipose derived stem cells to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
详细描述
In an open single centre pilot study we have evaluated the safety and efficacy of MSC treatment to improve heart muscle perfusion in patients with chronic CAD. Patients treated with MSCs had significant increased exercise capacity, reduction in angina, angina attacks and medication and in life quality at 6 months follow-up. For all the parameters there was a tendency towards improved outcome with increasing number of cells. The treatment with MSCs was safe.
The investigators have now established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with MSCs to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CCS III - IV
- •Coronary artery stenosis/occlusion not treatable with invasive procedures
- •LVEF > 40%
- •ETT between 2 - 10 min
排除标准
- •Valvular heart disease
- •FEV1 < 1
- •Severe systemic disease
- •Acute coronary syndrome > 2 months
结局指标
主要结局
Exercise test
时间窗: 6 months
次要结局
- Clinical evaluation(6 months)
研究者
JKastrup
Professor
Rigshospitalet, Denmark