Intra Cardiac Autologous Stem Cells Infusion May Improve Clinical Outcomes in Failing Heart Subjects Refractory to Maximal Drug Therapy and Internal Cardioverter With a Defibrillator (ICD) Recipients
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- reduction in angor symptoms
研究概览
简要总结
stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous history of myocardial infarction and coronary artery revascularization. These patients, without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in consecutive 30 selected patients the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, and associated to reduction of angina after a treatment with stem cells intra thoracic infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization.
排除标准
- •inflammatory chronic diseases, neoplastic diseases.
研究组 & 干预措施
stem cells infusion
干预措施: stem cells infusion (Drug)
结局指标
主要结局
reduction in angor symptoms
时间窗: 12 months
NYHA class improvement
时间窗: 12 months
reduction in hospitalization rate
时间窗: 12 months
次要结局
未报告次要终点
研究者
Celestino Sardu
principal investigator
University of Campania "Luigi Vanvitelli"