NCT01219452Unknown1 期
Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy
Qingdao University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年10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
- 30
- 试验地点
- 1
- 主要终点
- echocardiography
研究概览
简要总结
The main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.
详细描述
Children with Idiopathic dilated cardiomyopathy class II to III NYHA with ejection fraction over 20% were selected for phase II clinical trial, umbilical cord mesenchymal stem cells were injected into limb muscle and followed for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both genders with established clinical and echocardiographic diagnosis of dilated cardiomyopathy whose parents accept to participate in the trail.
- •They should have symptoms and /or signs of heart failure, despite optimized medical treatment.
- •Ejection fraction of left ventricular should be less than 50%, but more than 20%.
排除标准
- •associate coronary artery disease.
- •any history or suspicion of a toxic , pharmacologic or deposit etiology.
- •associated malignant or pre -malignant systemic disease.
- •associated hematologic disorder.
- •a history of sustained ventricular tachycardia or fibrillation.
- •a history of syncope during the previous year, or with an active infectious disease or positive tests to viral disease.
结局指标
主要结局
echocardiography
时间窗: 3 months
次要结局
- 24h HOLTER(2 months)
- The level of serum BNP,TNI,HGF、LIF and G/M-CSF(3 months)
- The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells(2 months)
研究者
研究点 (1)
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