Umbilical Cord Mesenchymal Stem Cell Transfusion in Patients With Severe Liver Cirrhosis
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The level of serum total bilirubin (TB)
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) transfusion in the treatment of liver cirrhosis. Liver function will be monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.
详细描述
Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly in 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA)and albumin (ALB) will be examined at re-transplantation, and 3 days to 2 years post-transplantation. The efficacy of umbilical cord MSCs transfusion will be investigated. The efficacy of different interventional therapies will also be compared.
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
- Single (Participant)
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
- •Age 18-70 years.
- •Imaging evidences of liver cirrhosis.
- •Child-Plough score of 8 or more.
- •Model for End-Stage Liver Disease score of 20 or more.
排除标准
- •Liver tumor on ultrasonography, CT or MRI examination.
- •Problems in organs other than liver (e.g. heart or lungs).
- •History of moderate to severe hepatic encephalopathy or variceal bleeding.
- •Imaging evidences of vascular thromboses.
研究组 & 干预措施
Conserved Therapy
Conserved Therapy
干预措施: Conserved Therapy (Drug)
Interventional Therapy
Patients with liver cirrhosis will be randomly divided into three groups.
- Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group.2. Umbilical cord MSCs will be infused to patients intravenously for another group. The control group will receive conserved therapy. The efficacy of different interventional therapies will be compared.
干预措施: Hepatic artery infusion or Intravenous infusion (Procedure)
结局指标
主要结局
The level of serum total bilirubin (TB)
时间窗: 1 year
Overall survival
时间窗: 1 year
The level of serum prealbumin(PA)
时间窗: 1 year
The level of serum alanine aminotransferase (ALT）
时间窗: 1 year
The level of serum prothrombin time (PT)
时间窗: 1 year
The level of serum albumin (ALB)
时间窗: 1 year
次要结局
- The level of serum prothrombin time (PT)(2 years)
- liver biopsy(2 years)
- Overall survival(2 years)
- The level of serum alanine aminotransferase (ALT）(2 years)
- The level of serum total bilirubin (TB)(2 years)
- The level of serum albumin (ALB)(2 years)
研究者
Yufang Shi
principal investigator
Chinese Academy of Sciences