Myocardial Cell Vein Transplantation for Chronic Heart Failure
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Quality of life assessment
研究概览
简要总结
Based on the safety evaluation of primates, the best cell transplantation scheme was integrated. One patient with CHF caused by coronary heart disease, one patient with CHF caused by dilatation and one patient with CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation. The safety evaluation of human body was completed and combined with subjective and objective indexes respectively. Structural and functional indicators were used to evaluate the therapeutic effect of cell transplantation. The results of animal experiments confirmed the safety and effectiveness of intravenous myocardial cell transplantation, and clarified its possible mechanism.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It accords with the diagnostic standard of chronic heart failure.
- •The etiological diagnosis accords with the corresponding diagnostic standard.
- •The age is 30~80 years old.
- •Cardiac function classification is III- grade IV.
- •Signed informed consent.
排除标准
- •Those who did not meet the diagnostic criteria and were included in the standard.
- •Patients with severe dyspnea (such as COPD with pulmonary encephalopathy, upper gastrointestinal bleeding, etc.) accompanied by obvious hypoxemia and hemodynamic instability.
- •Patients with severe primary diseases, such as liver and kidney diseases, hematological diseases, autoimmune diseases, malignant tumors, progressive diseases or diseases with poor prognosis, such as severe infection, severe water and electrolyte disorders, acid-base imbalance.
- •Various infectious diseases.
- •Participants in other clinical trials in the past two months.
结局指标
主要结局
Quality of life assessment
时间窗: 6 months
Minnesota Heart Failure Scale for Quality of Life. Scale ranges (0-100), do higher values represent a worse outcome. The higher the score, the lower the quality of life.
Curative effect evaluation
时间窗: 6 months
Cardiac Function Measurement by Cardiac Color Doppler Ultrasound. Under normal conditions, left ventricular ejection fraction is more than 50%. The lower ejection fraction, the worse heart function.
次要结局
未报告次要终点
研究者
Anlong Xu
professor
Beijing University of Chinese Medicine