Phase I Study to Evaluate the Efficacy and Safety of Intramyocardial Implantation of Peripheral Mononuclear Cells With CD34+ Stem Cells in Patient With Ischemic Cardiomyopathy After Preparatory Course of Shock - Wave Therapy
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in global left ventricular ejection fraction and regional wall motion score index
研究概览
简要总结
This is a randomized study of efficiency and safety of intramyocardial implantation of peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with myocardial ischemia after preparatory course of shock - wave therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ischemic cardiomyopaty and HF II-IV NYHA class
- •MI more than 6 months before the study
- •LVEF less than 35%
- •Absence effect of coronary revascularization during 6 months
- •Optimal pharmacological therapy no less than 8 weeks
- •Heart transplantation is contraindicated
- •Patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
- •Patients giving informed consent
排除标准
- •Acute coronary syndrome
- •Coronary revascularization less than 6 months
- •Patients requiring surgical correction of post-MI aneurism
- •LV wall thickness less than 5 mm in site of possible injection
- •Patients with CRT implanted within 3 month before cells injection
- •Clinically significant associated diseases
- •Active oncology desiase
- •Pregnancy
研究组 & 干预措施
Standard therapy
Treatment with standard therapy. Cardiospec shock-wave therapy
Stem cells
Group of of intramyocardial implantation of peripheral mononuclear cells with CD34+ stem cells in patient with ischemic cardiomyopathy after preparatory course of shock - wave therapy.
干预措施: Intramyocardial implantation of stem cells (Biological)
结局指标
主要结局
Change in global left ventricular ejection fraction and regional wall motion score index
时间窗: 6 and12 months
Change in global left ventricular ejection fraction and regional wall motion score index.
次要结局
- Incidence of the major adverse cardiac events(6 and 12 months)
研究者
Iurii Kozlov
Dr., PhD Iurii I Karpenko
Odessa National Medical University