NCT03343756终止不适用
HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem
Cellaion SA29 个研究点 分布在 5 个国家目标入组 44 人开始时间: 2018年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 29
- 主要终点
- Occurrence of Adverse Events of Specific Interest (AESI)
研究概览
简要总结
All patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by Promethera Biosciences
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera.
排除标准
- •Patients who received an OLT and completed 6-month FU documentation prior to the start of the PROLONGSTEM study.
- •Patients who have received mature liver cells or stem cells other than HepaStem prior to the start of the PROLONGSTEM study.
结局指标
主要结局
Occurrence of Adverse Events of Specific Interest (AESI)
时间窗: 60 months
Adverse Events of Specific Interest (AESI): * Event with fatal outcome (Death) * Orthotopic Liver Transplantation (OLT) and Outcome. * Development of Malignancy or unwanted tissue formation in different organs (tumor malignant or not). * Disease linked to transmission of adventitious agents or reactivation of latent pathogens. * Any AE which in the opinion of the Investigator has a plausible causal relationship to HepaStem.
次要结局
未报告次要终点
研究者
研究点 (29)
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