IRCT201612201031N20已完成2 期
The effect of intramyocardial transplantation of autologous bone marrow derived MNC (MonoNuclear Cell) and CD133+ cells comparison to placebo, on LVEF in MI patients, A Phase II/III, Multicenter, Placebo-Controlled, Randomized, Double-Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •18-75 years; First ST elevation myocardial infarction (STEMI) 10 days - 3 months; Post-acute myocardial infarction (AMI) left ventricular ejection fraction (LVEF) as assessed by echocardiography: 20%-45%; Target lesion must be located in the left anterior descending (LAD) section; Coronary artery bypass graft (CABG) candidate; At least 4 akinetic segments (assessed by stress echocardiography).
- •Exclusion criteria:
- •History of prior AMI; Active infection; History of recurrent infection; Positive test for syphilis (RPR); Hepatitis B and C (HBsAg, anti-HBc, anti-HCV); HIV or HTLV-1; Documented terminal illness or malignancy; Documented autoimmune disease; Pulmonary edema; Urgent or emergency CABG; Systolic blood pressure <80 mmHg; 4000 > leukocytes (µL) >15000; AST >100 IU/L or ALT >100 IU/L; Hemoglobin <10 g/dL; Platelets <100,000/µL; INR >1.8
排除标准
- 未提供
研究者
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