The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The result of liver function and liver histological improvement.
研究概览
简要总结
The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.
详细描述
To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18~70 years.
- •Liver cirrhosis
- •written consent
排除标准
- •The end-stage of liver cirrhosis.
- •Severe problems in other vital organs(e.g.the heart,renal or lungs).
- •Hepatocellular carcinoma or other malignancies
- •Pregnancy
- •Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
- •Cardiac, renal or respiratory failure
- •Active thrombosis of the portal or hepatic veins
研究组 & 干预措施
umbilical cord mesenchymal stem cells
Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.
干预措施: umbilical cord Mesenchymal Stem Cells (Biological)
Conserved therapy
Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
干预措施: Conserved therapy (Drug)
结局指标
主要结局
The result of liver function and liver histological improvement.
时间窗: every 4 weeks
次要结局
- The disappearance or reduction of abdominal dropsy(every 4 weeks)
- The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )(every 4 weeks)