HepaStem Long-Term Safety Registry – Registry for Patients who have been administered HepaStem
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Cellaïon SA
- 入组人数
- 67
- 试验地点
- 29
- 主要终点
- To document the occurrence of adverse events of special interest (AESIs) as defined below: • Event with fatal outcome (death) • Organ transplantation and outcome • Development of malignancy or unwanted tissue formation in different organs (tumor development malignant or not) • Disease linked to transmission of adventitious agents or reactivation of latent pathogens • Any adverse event (AE) judged to have a plausible causal relationship to HepaStem.
研究概览
简要总结
To assess the long-term safety of HepaStem therapy post administration in patients who have been infused with at least one dose of HepaStem in a previous interventional clinical study conducted by Promethera Therapeutics.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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 the PROLONGSTEM study. Once this doubleblinded 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.
- •Patients who are able to understand and give written informed consent. For children (as defined according to national regulations), an informed consent shall be sought from the parents or legal representative 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 an assent form. Minor patients at the time of inclusion who become adult (according to national regulations) during the course of the PROLONGSTEM study should provide an informed consent (and sign the adult 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.
排除标准
- •Patients who received an orthotopic liver transplantation and who completed the 6-month follow-up 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.
- •Patients who 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.
结局指标
主要结局
To document the occurrence of adverse events of special interest (AESIs) as defined below: • Event with fatal outcome (death) • Organ transplantation and outcome • Development of malignancy or unwanted tissue formation in different organs (tumor development malignant or not) • Disease linked to transmission of adventitious agents or reactivation of latent pathogens • Any adverse event (AE) judged to have a plausible causal relationship to HepaStem.
To document the occurrence of adverse events of special interest (AESIs) as defined below: • Event with fatal outcome (death) • Organ transplantation and outcome • Development of malignancy or unwanted tissue formation in different organs (tumor development malignant or not) • Disease linked to transmission of adventitious agents or reactivation of latent pathogens • Any adverse event (AE) judged to have a plausible causal relationship to HepaStem.
次要结局
未报告次要终点
研究者
Regulatory Affairs
Scientific
Cellaïon SA