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PROLONGSTEM is a long term follow-up study of all the patients who have received at least one infusion of HepaStem
EU CTIS ID: 2022-500251-22-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.