Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 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
Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells transplantation by intramyocardial multiple precision injection in ischemic heart failure patients.
详细描述
The increase of prevalence of heart failure in human population requires to develop new and effective methods of treatment. One of them is stem cells transplantation into a myocardial tissue, which cause the improvement of contractility, myocardial remodelling after myocardial infarction (MI), dilated cardiomyopathy, etc. Use of autologous stem cells does not require of immunosuppressive therapy and does not correlate with some ethical problems. Clinical application of mesenchymal stem cells always requires a step of culturing, which is associated with increased risk of contamination Therefore haemopoietic stem cells, endothelial progenitor cells or mononuclear bone marrow cells are often used to be transplant for treatment of heart failure (HF) patients.Using NOGA XP Cardiac Navigation System improves specificity of transplantations, that is decisive.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coronary artery disease (CAD) and HF II-III NYHA class
- •MI more than 6 months before the study
- •LVEF less than 35%
- •absence of indication to coronary revascularization
- •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
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
次要结局
- Incidence of the major adverse cardiac events(6 and 12 months)