Efficacy of Autologous Mesenchymal Stem Cell Transplantation Via Liver Artery in Liver Cirrhosis Patients With Refractory Ascites
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in immune function,liver function in blood
研究概览
简要总结
Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in liver cirrhosis patients with refractory ascites are very wretched. The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect and influence of MSCs in the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Aged 18~65 years. Ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite.
排除标准
- •history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
- •Prothrombin time is less than 30s. Severe problems in other vital organs(e.g.the heart,renal or lungs). Liver tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. Imaging evidences of vascular thromboses.
- •Exclusion Criteria:
研究组 & 干预措施
autologous bone marrow mesenchymal stem cells transplantation
Every patient is given 1x106 MSCs per kg infused via liver artery
干预措施: autologous bone marrow mesenchymal stem cells transplantation (Biological)
autologous bone marrow mesenchymal stem cells transplantation
Every patient is given 1x106 MSCs per kg infused via liver artery
干预措施: autologous bone marrow msenchymal stem cells transplantation (Biological)
mesenchymal stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
干预措施: autologous bone marrow msenchymal stem cells transplantation (Biological)
stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
干预措施: autologous bone marrow mesenchymal stem cells transplantation (Biological)
stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
干预措施: autologous bone marrow msenchymal stem cells transplantation (Biological)
mesenchymal stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
干预措施: autologous bone marrow mesenchymal stem cells transplantation (Biological)
结局指标
主要结局
change in immune function,liver function in blood
时间窗: before and one to 12 weeks after therapy
次要结局
未报告次要终点
研究者
Shihui
Department of Gastroenterology and Hepatology
Nanjing PLA General Hospital