NCT02051049

Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001)

Long-term Safety Follow-up Study of Patients Having Received Infusions of HepaStem

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Cellaion SA · Industry
• Sex: All
• Age: 23 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urea Cycle Disorders
• Crigler Najjar Syndrome

Timeline

• Start date: 2013-03-01
• Primary completion: 2018-04-01
• Completion: 2019-02-01
• First posted: 2014-01-31
• Last updated: 2019-05-28

Locations

1 site across 1 country: Belgium