Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number and nature of adverse events
研究概览
简要总结
Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.
详细描述
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study.
Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention.
Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 y
- •No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).
- •Maximal tolerable angina and heart failure medication
- •NYHA functional classification (I-III)
- •Signed informed consent
排除标准
- •Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
- •Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
- •History with malignant disease within 5 y of inclusion or suspected malignity
- •Severe heart failure (NYHA functional classification IV)
- •Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis
- •Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia
- •Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment
- •Patients with reduced immune response or treated with immunosuppressive medication
- •Combined with severe infectious diseases
- •Pregnant or fertile women
- •Socially and mentally disabilities
结局指标
主要结局
Number and nature of adverse events
时间窗: Within the first year after intracoronary infusion
Evidence for new clinical/biological abnormalities.
Incidence of major adverse coronary events (MACE)
时间窗: Within the first year after intracoronary infusion
Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure.
次要结局
- Assessment of heart function by left ventricular ejection fraction(Post cell transplantation: 1, 3, 6，12 months)
- Exercise Time and Level(Post cell transplantation: 1, 3, 6, 12 months)
- Quantify myocardium perfusion measured by SPECT(Post cell transplantation: 6, 12 months)
- Clinical Improvement in NYHA Classification(1 year)