Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Incidence of Adverse Event of Special Interest (AESI)
研究概览
简要总结
The goal of this observational study is to learn about the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 study.
The main question it aims to answer is:
- Do adverse event of special interest (AESI) or liver transplantation occur during the 5 years after Cellgram-LC administration?
Participants who previously received Cellgram-LC in the PMC-P-07 study and voluntarily consent to participate in this long-term follow-up study will be followed for 5 years after Cellgram-LC administration through telephone visits to collect information on AESI and liver transplantation.
详细描述
To evaluate the safety for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who received Cellgram-LC in the PMC-P-07 clinical trial.
- •Participants who voluntarily provide written informed consent to participate in this study.
排除标准
- 未提供
研究组 & 干预措施
Cellgram-LC-treated Participants
Participants who previously received Cellgram-LC in the PMC-P-07 study and voluntarily provide written informed consent to participate in this long-term follow-up study.
结局指标
主要结局
Incidence of Adverse Event of Special Interest (AESI)
时间窗: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.
Adverse event of special interest (AESI) include death, neoplasm or malignancy in any tissue or organ, immune reactions including worsening of pre-existing autoimmune disease or new-onset autoimmune disease, and other delayed adverse events considered related to Cellgram-LC.
Occurrence of Liver Transplantation
时间窗: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.
The number and percentage of participants who undergo liver transplantation will be summarized during the 5-year follow-up period after Cellgram-LC administration.
次要结局
未报告次要终点