Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- child-pugh classification
研究概览
简要总结
This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients.
详细描述
Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, umbilical cord blood mononuclear cells transfusion has been shown to lead to the regression of liver fibrosis in animal model. The investigators thus investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, the incidence of hepatocellular carcinoma and mortality and so on. And the efficacy was evaluated with the measurement of alanine aminotransferase (ALT), glutamic oxaloacetic transaminase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), albumin (ALB), cholinesterase (CHE), prothrombin time (PT) and child-pugh score.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment
排除标准
- •Patients with C class by child-pugh score
- •Patients in the acute phase of severe hepatitis
- •Patients have been diagnosed with cancer of the liver
- •Patients with severe cardiopulmonary cerebral disease, and in the failure state
- •Patients in Highly allergic constitution
- •Patients with moderately severe mental disease
结局指标
主要结局
child-pugh classification
时间窗: whinin 7 days before transplantation, 1,3 and 6 months after transplantation
1. child-pugh A (child-pugh score 5-6) 2. child-pugh B (child-pugh score 7-9) 3. child-pugh C (child-pugh score≥10)
次要结局
- vital signs(1, 2 and 3 days after transplantation)
- coagulation(whinin 7 days before transplantation, 1,3,6 months after transplantation)
- mortality(1, 3 and 6 months after transplantation)
- liver function(whinin 7 days before transplantation, 1,3 and 6 months after transplantation)
- incidence of hepatocellular carcinoma(1, 3 and 6 months after transplantation)
研究者
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University