Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- major adverse cardiac and cerebrovascular event
研究概览
简要总结
The purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.
详细描述
The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic zones by SPECT but without any option for revascularization. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+cells. All patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. CD133+ cells were selected with CliniMacs system and were injected transendocardially guided by the NOGA XP system.
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, Care Provider, Investigator)
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
- •Functional class II- IV angina on maximal medical therapy
- •Myocardial Ischemia/viability demonstrated by a reversible perfusion defect by means imaging techniques
- •Patients should not be amenable to any type of revascularization procedure (percutaneous or surgical)
- •Signed informed consent
排除标准
- •Age <18 years or >75 years.
- •Atrial fibrillation.
- •LV thrombus
- •Acute myocardial infarction in the last 3 months
- •An LV wall thickness of <8 mm at the target site for cell injection
- •A history of malignancy in the last 5 years
结局指标
主要结局
major adverse cardiac and cerebrovascular event
时间窗: 6, 12 and 24 months
cardiovascular death, non-fatal myocardial infarction (MI), ischemic stroke, need for revascularization or , procedure-related complications (: pericardial effusion/cardiac tamponade, vascular complications and sustained ventricular arrhythmias).
次要结局
- Efficacy(6 months)
研究者
Pilar Jimenez Quevedo
MD, PhD
Hospital San Carlos, Madrid