EUCTR2017-003989-27-PL进行中（未招募）1 期
PROLONGSTEM: HepaStem Long-Term Safety RegistryRegistry for patients who have been administered HepaStem
Promethera Therapeutics0 个研究点目标入组 48 人开始时间: 2021年7月23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
- 48
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. Patients who have received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera Therapeutics.
- •Note: Patients currently participating in ongoing double-blinded controlled interventional studies during which HepaStem is administered will be invited to enter PROLONGSTEM study. Once this double-blinded controlled interventional study is complete and/or treatment is unblinded, the patients will be informed about the treatment they received. HepaStem-recipients will remain in the PROLONGSTEM study, and the participation of control-recipients in the PROLONGSTEM study will be terminated.
- •2. Patients who are able to understand and give written informed consent.
- •For children (as defined according to national regulations), and informed consent shall be sought from the parents or legal representatives on behalf of the child. If the child is capable of understanding the purpose of the study, he/she should provide an informed assent and sign the assent form. Minor patients at the time of inclusion who become adult (accoridng to national regulations) during the course of the study during the course of the PROLONGSTEM study should provide an informed consent (and sign the adul ICF) as soon as they reach adulthood.
- •For adult patients who are legally incapable of providing informed consent at the time of inclusion (due to an incapacitating condition such as brain disease or hepatic encephalopathy), a legal representative should provide a signed informed consent before enrollment. After improvement of the incapacitating condition, and as soon as the investigator considers that the patients have become capable to consent by themselves, the patients must sign the ICF.
- •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 38
- •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 orthotopic liver transplantation and who completed the 6-month FU follow-up documentation Organ Transplantation Questionnaire prior to the start of the PROLONGSTEM study.
- •Note: Patients who received an orthotopic liver transplantation and who did not complete the 6-month follow-up Organ Transplantation Questionnaire prior to the start of the PROLONGSTEM study may be included in the PROLONGSTEM study. These patients will remain in the PROLONGSTEM study until the completion of the 6-month follow-up Organ Transplantation Questionnaire. Data from the last visit of the previous clinical study conducted by the Sponsor (i.e., the start of the PROLONGSTEM study) up to the date of completion of the 6-month follow-up Organ Transplantation Questionnaire will be collected.
- •2. Patients who have received mature liver cells or stem cells other than HepaStem prior to the start of the PROLONGSTEM study.
- •Note: Patients who received mature liver cells or stem cells other than HepaStem after the last visit of the previous clinical study conducted by the Sponsor (i.e., the start of the PROLONGSTEM study) may be included in the PROLONGSTEM study. Only retrospective data (between the last visit of the previous study and before the administration of such cells) will be collected from those patients.
研究者
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