HepaStem Long-Term Safety Registry (PROLONGSTEM)

Cellaion

Status: Terminated

Conditions: Crigler-Najjar Syndrome; Acute on Chronic Liver Failure; Urea Cycle Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT03343756

PROLONGSTEM

Details and patient eligibility

About

All patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by Promethera Biosciences

Enrollment: 44 patients

Sex: All

Ages: 5 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera.

Exclusion criteria

• Patients who received an OLT and completed 6-month FU documentation prior to the start of the PROLONGSTEM study.
• Patients who have received mature liver cells or stem cells other than HepaStem prior to the start of the PROLONGSTEM study.