Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 16
- 主要终点
- Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization
研究概览
简要总结
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
详细描述
To assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 20-80 years of age
- •Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area
- •CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
- •On maximal medical therapy for anginal symptoms and or heart failure symptoms
- •Hemodynamic stability (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate < 110; Pulse-Oxygen > 95)
- •Ejection fraction ≤ 45
- •Left ventricular wall thickness ≥ 8 mm at the target site for cell injection, confirmed by 2D contrast echo within 4 weeks prior to enrollment, free of thrombus
排除标准
- •Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
- •Unstable angina
- •LV thrombus, as documented by echocardiography
- •Planned staged treatment of CAD or other intervention on the heart
- •Platelet count < 100,000/mm3
- •WBC < 2,000/mm3
- •TIA or stroke within 90 days prior to randomization
- •ICD shock within 30 days of randomization
- •Any condition requiring immunosuppressive medication
- •A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 60 days prior to randomization
- •Revascularization within 60 days prior to randomization
- •Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
- •Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and /or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN) prior to randomization
结局指标
主要结局
Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization
时间窗: 6 and 12 Months
Safety endpoints include: 1. Treatment emergent SAEs 2. Arrhythmia assessment via Holter monitoring 3. MACE defined as cardiac death and hospitalization for heart failure Feasibility endpoints include: 1. Change in mVO2 at 6 months 2. Change in LVESV/LVEDV at 6 months 3. Change in ejection fraction at 6 months 4. Change in perfusion defect at 6 months 5. Resource utilization 6. Change in heart failure symptoms, angina, and quality of life through 12 months
次要结局
未报告次要终点