Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells for Treating Decompensated Liver Cirrhosis Associated With HBV
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- cholinesterase in U/L
研究概览
简要总结
The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV.
详细描述
Investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with HBV, dividing them into 3 group：1) low-dose group: 100mL with 2.5×10^7 cells；2) medium-dose group: 100mL with 5.0×10^7 cells；3) high-dose group: 100mL with 1.0×10^8 cells. Each group contains 8 patients. Investigators treat the participants with human umbilical cord mesenchymal stem cells via venous transfusion. First investigators arrange a whole test for participants, such as vital sign examination, laboratory test, ECG, CT, MRI, ultrasound etc. Investigators screen these patients with a complete eligibility criteria. Then investigators proceed the therapy in the 1st, 8th and 15th day. There are 8 times of follow-up visit for these patients, 4 times of those are proceeded during the hospitalization, while other 4 times happens after the discharge. The follow-up visit includes vital sign examination, laboratory test, ECG, CT, MRI, ultrasound, Child-Pugh grade, MELD grade, SF-36 test. These follow-up visit last 24 weeks since the first treatment. After that, investigators also arrange a survival visit through phone or clinic each 6 months, lasting another 1.5 years. The main object of this research is investigating the survival rate, promotion of the liver function, improvement of health, safety of hUC-MSCs, tolerability of patients, for exploring a new way for the therapy of decompensated liver cirrhosis with HBV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 between 18 and 65 (including 18 and 65), regardless of gender;
- •Decompensated stage of viral hepatitis B cirrhosis;
- •The effect of conventional medical treatment is not good, and the condition is repeated;
- •ALB < 35g/L, TBIL < 170μmol/L, INR > 30%, Child-pugh score ≥7; MELD score ≤15;
- •Hgb > 70g/L, PLT > 3×109/L;
- •Unconditional acceptance for liver transplantation; 7）Participate in the clinical study voluntarily, cooperate with doctors to carry out the study, and sign informed consent.
排除标准
- •With spontaneous peritonitis or other serious infection;
- •Patients with hepatorenal syndrome;
- •Severe hepatic encephalopathy, massive hemorrhage of digestive tract or varicose
- •vein in recent 1 month;
- •Portal vein thrombosis; Complicated with serious diseases of heart, lung, kidney,
- •blood and endocrine system;
- •HIV positive;
- •Positive autoantibodies related to autoimmune liver disease;
- •Presence of liver or any type of malignant tumor;
- •Pregnant women, breast-feeding women or those with recent birth plans;
- •Those who have a history of alcohol and drug abuse and failed to get rid of it effectively;
- •Participated in other clinical trials within 3 months prior to enrollment;
- •Participated in clinical research on stem cells;
- •Unwillingness to sign informed consent;
- •Other conditions that the investigator considers inappropriate for patients to participate in this study.
结局指标
主要结局
cholinesterase in U/L
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Antithrombin in mg/L
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Serum albumin in g/L
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
aspartate aminotransferase in U/L
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Serum cholesterol in mmol/L
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Prothrombin activity in percentage
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
alanine aminotransferase in U/L
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Total bilirubin in μmol/L
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Direct bilirubin in μmol/L
时间窗: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
次要结局
- Child-Pugh grade(24 weeks)
- Interleukin-1β cells in pg/mL(24 weeks)
- The Medical outcomes study 36-item Short Form Health Survay scale (SF-36 scale)(24 weeks)
- Natural killer T cells in percentage(24 weeks)
- survival rate(2 years)
- Ascites(24 weeks)
- Th1 cells in percentage(24 weeks)
- Th2 cells in percentage(24 weeks)
- Interleukin-6 cells in pg/mL(24 weeks)
- Interleukin-4 cells in pg/mL(24 weeks)
- Interleukin-17A cells in pg/mL(24 weeks)
- Medical images(24 weeks)
- Interleukin-12 cells in pg/mL(24 weeks)
- Interleukin-15 cells in pg/mL(24 weeks)
- Rate of weight change(24 weeks)
- clinical symptoms(24 weeks)
- Interleukin-8 cells in pg/mL(24 weeks)
- MELD score(24 weeks)