Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- survival rate
研究概览
简要总结
HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.
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
- •Aged 18-65 years
- •Liver failure
- •Negative pregnancy test (female patients in fertile age)
- •Written consent
- •HBsAg positive
- •TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
- •INR≥1.5 or 20%<PTA≤40%
- •17≤MELD score≤30
排除标准
- •Hepatocellular carcinoma or other malignancies
- •Severe problems in other vital organs(e.g.the heart,renal or lungs)
- •Pregnant or lactating women
- •Severe bacteria infection
- •Anticipated with difficulty of follow-up observation
- •Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
- •Other candidates who are judged to be not applicable to this study by doctors
研究组 & 干预措施
Conventional treatment
Participants will receive conventional treatment and then be followed until the week 72 study visit.
干预措施: Conventional treatment (Drug)
Conventional plus BM-MSC treatment
Participants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
干预措施: Conventional plus BM-MSC treatment (Genetic)
Conventional plus UC-MSC treatment
Participants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
干预措施: Conventional plus UC-MSC treatment (Genetic)
结局指标
主要结局
survival rate
时间窗: 72 weeks
The survival rate and time
次要结局
- Liver function(72 weeks after treatment)
- Marker of liver cancer(72 weeks after treatment)
- The degree of hepatic necrosis(2 years after treatment)
- The improvement of symptoms(72 weeks after treatment)
- The score for Model for End-Stage Liver Disease(72 weeks after treatment)
- The improvement of immune function(72 weeks after treatment)
- complications(Between 0 to 8 hours after MSC transfusion)
- The incidence of hepatocellular carcinoma(72 weeks after treatment)
研究者
Qi Zhang, MD
Deputy Director, Office of International Cooperation & Exchange Office of Hongkong, Macao & Taiwan Affairs
Third Affiliated Hospital, Sun Yat-Sen University