Long-term Safety Follow-up Study of Patients Having Received Infusions of HepaStem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Characterisation of the long term safety profile of HepaStem therapy.
研究概览
简要总结
The purpose of this study is to assess the long-term safety follow-up of patients having been treated with HepaStem.
详细描述
The primary objective of the SAF001 study is the long-term safety surveillance of the patients post infusion with HepaStem. Furthermore, the evolution of both the metabolic condition and the quality of life are followed. As much as possible, the surveillance will mimic the standard follow-up of the respective diseases (standard of care). The surveillance will end when the patient is undergoing an organ transplant or takes part in another research study. This surveillance will last up to a maximum of 48 months.
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
- — 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject having received HepaStem during a former interventional clinical study and who have terminated their participation in that study.
排除标准
- •Subject has received mature liver cells, stem cells transplantation other than HepaStem, or organ liver transplant.
结局指标
主要结局
Characterisation of the long term safety profile of HepaStem therapy.
时间窗: 4 years
Assessment of safety will be achieved by evaluating the following parameters * Physical examination * Vital signs * Laboratory tests * Liver tumor markers * Autoimmune markers related to liver pathology * Anti-HLA antibodies specific for donor cell haplotypes * Morphology of liver, bile ducts, and portal system by ultrasound * Morphology of the kidneys by ultrasound * Non-serious or serious Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) related to HepaStem therapy.
次要结局
- To characterize the disease evolution after having received HepaStem therapy and to report on general safety.(4 years)