Long-term Safety Follow-up Study of Patients Having Received Infusions of HepaStem
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Urea Cycle Disorders
- Sponsor
- Cellaion SA
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Characterisation of the long term safety profile of HepaStem therapy.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to assess the long-term safety follow-up of patients having been treated with HepaStem.
Detailed Description
The primary objective of the SAF001 study is the long-term safety surveillance of the patients post infusion with HepaStem. Furthermore, the evolution of both the metabolic condition and the quality of life are followed. As much as possible, the surveillance will mimic the standard follow-up of the respective diseases (standard of care). The surveillance will end when the patient is undergoing an organ transplant or takes part in another research study. This surveillance will last up to a maximum of 48 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject having received HepaStem during a former interventional clinical study and who have terminated their participation in that study.
Exclusion Criteria
- •Subject has received mature liver cells, stem cells transplantation other than HepaStem, or organ liver transplant.
Outcomes
Primary Outcomes
Characterisation of the long term safety profile of HepaStem therapy.
Time Frame: 4 years
Assessment of safety will be achieved by evaluating the following parameters * Physical examination * Vital signs * Laboratory tests * Liver tumor markers * Autoimmune markers related to liver pathology * Anti-HLA antibodies specific for donor cell haplotypes * Morphology of liver, bile ducts, and portal system by ultrasound * Morphology of the kidneys by ultrasound * Non-serious or serious Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) related to HepaStem therapy.
Secondary Outcomes
- To characterize the disease evolution after having received HepaStem therapy and to report on general safety.(4 years)