NCT01353690终止1 期
A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure
Cook MyoSite4 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2011年2月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Incidence of major adverse events associated with the use of AMDC
研究概览
简要总结
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by ischemia.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 but less than 80 years
- •Prior myocardial infarction
- •Depressed left ventricular ejection fraction (LVEF) ≤ 35%
- •NYHA functional classification of II to IV
排除标准
- •Not under stable optimal medical management
- •Cardiac surgery or percutaneous coronary intervention within 3 months
- •Occurrence of myocardial infarction (MI) within 6 months, in the case of first MI, or 3 months, in the case of any subsequent MI
- •Prior cell, gene, or transmyocardial laser revascularization therapy
- •Ventricular wall thickness in target region ≤ 5 mm
- •Moderate to severe aortic valve stenosis or mechanical valve replacement
- •Left ventricular aneurysm or thrombus
- •Left ventricular dysfunction associated with a reversible cause
- •Vascular disease preventing percutaneous vascular access
- •History of myopathic disease
- •History of neoplasia within 5 years, except for basal cell carcinoma
- •Receiving or planning to receive anti-cancer medications
- •Serum creatinine > 3.0 mg/dl
- •Pregnant, planning to become pregnant, or breastfeeding a child in the next 18 months
- •Life expectancy of less than 1 year
- •Morbid obesity (defined as BMI > 35)
- •History of bleeding diathesis or coagulopathy
- •Positive for HIV, Hepatitis B, or Hepatitis C
- •Known hypersensitivity or contraindication to study product or treatment procedure
- •Enrolled in another research project at the time of enrollment
- •Unable to provide informed consent
- •Unable or unwilling to commit to the follow-up clinical procedures
结局指标
主要结局
Incidence of major adverse events associated with the use of AMDC
时间窗: 12 Months
次要结局
未报告次要终点
研究者
研究点 (4)
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