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

Cellaion

Status: Completed

Conditions: Urea Cycle Disorders; Crigler Najjar Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT02051049

SAF001

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: Under 23 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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.

Trial design

9 participants in 1 patient group

Inborn errors of liver metabolism