Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- liver volume calculated by MRI
研究概览
简要总结
The current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. In the other hand,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 and classical therapy in patients liver cirrhosis will be evaluated and compared.
详细描述
This study will includ two research centers, the number of patients in transplantation group will be 30, the number of patients in classical therapy group will be 30. All the inclusion and exclusion criteria will be same and the data analysis will be complete by the epidemiological commissioner.
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 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.
研究组 & 干预措施
stem cell transplantation therapy
umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.
干预措施: stem cell transplantation through interventional procedure (Procedure)
antiviral therapy
Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin.
干预措施: antiviral therapy (lamivudine, other antiviral drugs) (Drug)
结局指标
主要结局
liver volume calculated by MRI
时间窗: baseline
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
change from baseline in liver volume calculated by MRI at 6 months
时间窗: 6 months after treatment
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
change from baseline in liver volume calculated by MRI at 12 months
时间窗: 12 months after treatment
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
次要结局
- blood biochemistry(baseline, 1,3,6 and 12 months after treatment or transplantation)
- blood test(baseline,1,3,6 and 12 months after treatment or transplantation)
- liver enzyme fiber spectrum(baseline,1,3,6 and 12 months after treatment or transplantation)
- coagulation(baselin,1,3,6 and 12 months after treatment or transplantation)
- portal vein and splenic vein measure(baseline,1,3,6 and 12 months after treatment or transplantation)
- estrogen and progestin in blood(baseline,1,3,6 and 12 months after treatment or transplantation)