Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
研究概览
简要总结
This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
详细描述
Ischemic heart disease is a major public health problem in the industrialized and developing world. Current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic coronary artery disease
- •NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with.
- •Ejection fraction between 35% and 55%.
- •Stable medical therapy for at least one month
- •Patients clinically treated with coronary angioplasty with or without intraluminal stent.
- •Patients with surgical revascularization and without the possibility of new invasive intervention.
排除标准
- •Human immunodeficiency virus (HIV1-2), HTLV-1 and
- •An active uncontrolled infection.
- •Pregnancy.
- •Mental disability.
- •Terminal illnesses.
- •Valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic.
- •Life perspective by other diseases under 1 year.
- •History of severe arrhythmias
- •Renal dysfunction or against medication
- •Inability to perform cardiac catheterization.
研究组 & 干预措施
MSCs injection
Injection of autologous bone marrow-derived mesenchymal cells
干预措施: MSCs injection (Procedure)
结局指标
主要结局
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
时间窗: 3 months
次要结局
- Change in quality of life(3 months, 6 months, 12 months)
- Changes in exercise capacity(1 year)
- Changes in plasma inflammatory markers(6 months)
研究者
Alexandra Cristina Senegaglia
PhD
Pontifícia Universidade Católica do Paraná