NCT02052427已完成2 期
Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization II
Cytori Therapeutics2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire
研究概览
简要总结
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
详细描述
To assess the safety and efficacy 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
- Quadruple (Participant, Care Provider, 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 and < 80 years of age
- •Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
- •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 (SBP ≥ 90 mm/Hg, HR <110)
- •Ejection fraction ≥ 20% and ≤ 45%
- •Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
- •Left ventricular wall thickness ≥ 8 mm at the target site for cell injection
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 prior to randomization
- •Any condition requiring immunosuppressive medication
- •A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 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)
- •Hemoglobin ≤ 10.0 g/dL
结局指标
主要结局
Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire
时间窗: 6 months post treatment
Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment.
次要结局
- Secondary Efficacy - Change in perfusion defect(6 months post treatment)
- Secondary Efficacy - Change in Ejection Fraction(6 months post treatment)
- Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life(through 12 months post treatment)
- Secondary Efficacy - Change in mVO2(6 months post treatment)
- Secondary Efficacy - Change in LVESV/LVEDV(6 months post treatment)
- Secondary Efficacy - Resource Utilization(through 12 months post treatment)
研究者
研究点 (2)
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