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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional
HepaStem Long-Term Safety Registry – Registry for Patients who have been administered HepaStem
At a glance
Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Cellaïon SA
Enrolment target
67
Start
03 Feb 2023
This study will include all patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HALPC during a previous interventional clinical study conducted by Promethera Biosciences or Promethera Therapeutics including patients suffering from urea cycle disorders (UCD)Crigler-Najjar (CN) and Fibroinflammatory liver diseases.
What is this study about?
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.
Who may be eligible?
Age 18 Years to any · Sex: All
Locations (5)
- —Spain
- —Belgium
- —France
- —Bulgaria
- —Poland
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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