NCT02504437Unknown1 期
Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease
Academy Military Medical Science, China0 个研究点目标入组 200 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 主要终点
- LVEF (left ventricular ejection fraction)
研究概览
简要总结
The purpose of the present study is to evaluate the efficacy of the preconditioned autologous bone marrow mesenchymal stem cells for patients with ischemic heart diseases.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 75;
- •Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy
- •NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%;
- •No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS;
- •No psychiatric illnesses and speaking dysfunction;
- •Informed consent.
排除标准
- •More than 75 years old;
- •LVEF<24%;
- •Unstable hemodynamics, shock;
- •Severe infection;
- •Patients have tumor or other lethal diseases (expectation of life<6 months);
- •Radiation patients;
- •hematopoietic malignancy including Haemophiliacs;
- •Anemia (Hb<100g/L);
- •The other clinical trial participants within one month;
- •Abnormal increasing of the blood biochemical indicators that is not explained by the conditions;
- •Informed refusal.
结局指标
主要结局
LVEF (left ventricular ejection fraction)
时间窗: one year
次要结局
未报告次要终点
研究者
Xuetao Pei
Director, Head of South China Research Center for Stem Cell & Regenerative Medicine, AMMS, Guangzhou, China.
Academy Military Medical Science, China
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