NCT03629015撤回1 期
The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)
研究概览
简要总结
To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALF or ACLF patients.
- •Subjects are between 20 and 70 years of age.
- •MELD scores meet 17 ≤ MELD ≤
- •Subjects who had completed signing informed consent.
排除标准
- •Subjects who had been enrolled in any other cell therapy within six months.
- •Females with a positive pregnancy test result.
- •Subjects have contraindication for liver transplantation.
- •Subjects with psychiatric illnesses.
- •Subjects who are diagnosed as active tuberculosis (TB).
- •Subjects with immunological disorders (e.g. autoimmune hepatitis) or using immunosuppressive drugs (e.g. steroid for immunosuppression) within six months prior to screening visit.
- •Subjects with unstable illnesses or contraindication for this clinical trial according to investigator's judgment.
结局指标
主要结局
The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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