Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Severity of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.
详细描述
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis.
To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.
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
- •The patient who have signed the informed consent document;
- •Clinical, radiological, or biochemical evidence of liver cirrhosis.
排除标准
- •Pregnant women or lactating mothers;
- •Patients who have received any anti-inflammatory drugs including herb-drug within 14 days;
- •Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment;
- •Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
- •Abnormal blood coagulation, combine other tumor or special condition;
- •Patients who had participated in other clinical trials within three months prior to this study.
结局指标
主要结局
Severity of adverse events
时间窗: 12 months
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
次要结局
- Hepatic function(1, 3 ,6 and 12 months)
- Liver fibrosis index(1, 3 ,6 and 12 months)