Umbilical Cord Blood Derived Mesenchymal Stem Cells Infusion for HBV-Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 261
- 主要终点
- The survival time of patients after UC-MSC infusions.
研究概览
简要总结
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity < 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease;
- •Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
- •End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.
排除标准
- •Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
- •Concomitant autoimmune disease;
- •Superinfection with other hepatitis viruses;
- •Important organ dysfunctions not due to liver disease or malignancies;
- •Pregnancy and lactation;
- •Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
- •Bioartificial liver support therapy;
- •Previous liver transplantation.
研究组 & 干预措施
Group MSC-1
Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 8 weeks.
干预措施: umbilical cord blood mesenchymal stem cells (Drug)
Group MSC-2
Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 4 weeks.
干预措施: umbilical cord blood mesenchymal stem cells (Drug)
结局指标
主要结局
The survival time of patients after UC-MSC infusions.
时间窗: 52 weeks
The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.
时间窗: 52 weeks
次要结局
- The influence on levels of ALB(g/L) after UC-MSC infusions(1,2,3,4,8,12,24,36,52weeks)
- The influence on levels of TBil (umol/L) after UC-MSC infusions(1,2,3,4,8,12,24,36,52weeks)
- The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions(1,2,3,4,8,12,24,36,52weeks)
- Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- Comparison of levels of perforin among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- The influence on levels of INR after UC-MSC infusions(1,2,3,4,8,12,24,36,52weeks)
- Comparison of levels of NKG2A among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- Comparison of levels of FasL among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions(1,2,3,4,8,12,24,36,52weeks)
- Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- Comparison of levels of NKG2D among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- Comparison of levels of NKP46 among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- Comparison of levels of gramzymeB among the groups after UC-MSC infusions(2,4,8,12,24,36,52 weeks)
- The incidence of fatal complications after UC-MSC infusions.(52 weeks)
研究者
Lin Bingliang
Professor
Sun Yat-sen University