EUCTR2017-003989-27-FR进行中（未招募）1 期
PROLONGSTEM: HepaStem Long-Term Safety RegistryRegistry for patients who have been administered HepaStem
Promethera Biosciences0 个研究点目标入组 22 人开始时间: 2018年4月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1- All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera Biosciences.
- •2- Written Informed Consent.
- •For a patient who is a minor (according to the national regulations), and for adult patients legally incapable: the parents or legal representative have provided a signed informed consent before enrolment. If the patient is capable of signing, he/she is required to sign an assent in parallel.
- •For adult patient (legally capable): patient has provided a written
- •informed consent before enrolment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1- Patients who received an OLT and completed 6-month FU documentation prior to the start of the PROLONGSTEM study.
- •2- Patients who have received mature liver cells or stem cells other than HepaStem prior to the start of the PROLONGSTEM study.
研究者
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