Safety and Efficacy of Stem Cells From Human Exfoliated Deciduous Teeth for Treatment of Decompensated Liver Cirrhosis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Model for End-Stage Liver Disease (MELD)-Na score
研究概览
简要总结
This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.
详细描述
At present, there is still no effective treatment for liver cirrhosis, and the use of stem cells for the treatment of cirrhosis has caused great concern.Stem cells from human exfoliated deciduous teeth (SHED) has been shown to be safe and effective for liver diseases. Randomization controlled studies are needed to confirm the long term effect of SHED treatment for liver cirrhosis. The present study aimed to investigate the safety and efficacy of SHED in hepatitis B related liver cirrhosis patients.
This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). SHED infusion (1x10E6 cells/kg body weight) via peripheral vein will be given at week 0,4,8,12.The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blind to the randomization results of the participants.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years
- •HBV-related liver cirrhosis with presentations of decompensation
- •Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit;
- •Child-Pugh score B and MELD-Na score≤25
- •Written consent
排除标准
- •Hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis
- •Child-Pugh score A or C
- •Hepatocellular carcinoma or other malignancies
- •Cirrhosis or liver failure caused by non-Hepatitis B
- •Pregnancy or breastfeeding
- •Severe bacteria infection,coinfection with HIV or other viral hepatitis.
- •History of severe allergy to biological products or history of immunization within half a year
- •Patients or family members refused to participate in the study
- •Drug abuse or alcohol abuse
- •Other candidates who are judged to be not applicable to this study by doctors.
结局指标
主要结局
Model for End-Stage Liver Disease (MELD)-Na score
时间窗: baseline and 4,8,12,16,24 week
The MELD-Na score is a reliable measure of mortality risk in patients with end-stage liver disease. MELD-Na score=3.8ln\[bilirubin (mg/dl)\]+11.21ln(INR) +9.6ln\[creatinine (mg/dl) +6.4\* (cause: cholestasis and alcoholic cirrhosis are 0, others are 1) +1.59\* (135-Na)
次要结局
- Changes of life quality(baseline and 4,8,12,16,24 week)
- Changes of liver function(baseline and 4,8,12,16,24 week)
- Survival Rate at half of one year(half of one year)
- Child-Pugh score(baseline and 4,8,12,16,24 week)