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

Urea Cycle Disorders Clinical Trial

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

Clinical Trial Summary

The purpose of this study is to assess the long-term safety follow-up of patients having been treated with HepaStem.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02051049
Study type Observational
Source Promethera Biosciences
Contact
Status Completed
Phase
Start date March 2013
Completion date February 2019
View Details
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