Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- liver volume calculated by MRI
研究概览
简要总结
Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. Umbilical cord mesenchyma stem cell with self-and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures in patients liver cirrhosis will be evaluated.
详细描述
This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of liver cirrhosis;
- •Without hepatic encephalopathy;
- •No ascites or have easily dissipated ascites;
- •Value of bilirubin is less than 100;
- •Value of albumin is greater than 16 g / L;
- •Prothrombin time is less than 21 seconds;
排除标准
- •Severe cardiovascular disease, and immunocompromised patients;
- •Patients with localized lesions affecting graft infection;
- •Coagulation disorders;
- •Liver nodules more than 2cm or Liver cancer
结局指标
主要结局
liver volume calculated by MRI
时间窗: 3 days before transplantation, 6 and 12 months after transplantation
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
次要结局
- liver biopsy(whinin 7 days before transplantation, 6 and 12 months after transplantation)
- liver enzyme fiber spectrum(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- portal vein and splenic vein measure(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- blood biochemistry(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- coagulation(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- blood test(whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation)
- gastroscopy(whinin 7 days before transplantation, 6 and 12 months after transplantation)