PROLONGSTEM is a long term follow-up study of all the patients who havereceived at least one infusion of HepaStem

Phase 1

Conditions: This study will include all patients having received at least one infusionof the Investigational Medicinal Product (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by PrometheraBiosciences including patients suffering from urea cycle disorders (UCD),Crigler-Najjar (CN) and Fibro-inflammatory liver diseases
MedDRA version: 20.1Level: LLTClassification code 10021601Term: Inborn error of metabolism NOSSystem Organ Class: 100000004850
MedDRA version: 20.0Level: LLTClassification code 10008954Term: Chronic liver disease and cirrhosisSystem Organ Class: 100000004871
MedDRA version: 20.1Level: LLTClassification code 10049844Term: Acute liver failureSystem Organ Class: 100000004871
MedDRA version: 20.1Level: LLTClassification code 10013373Term: Disorders of urea cycle metabolismSystem Organ Class: 200000003094
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2017-003989-27-FR

Lead Sponsor: Promethera Biosciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 22

Inclusion Criteria

1- All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera Biosciences.
2- Written Informed Consent.
For a patient who is a minor (according to the national regulations), and for adult patients legally incapable: the parents or legal representative have provided a signed informed consent before enrolment. If the patient is capable of signing, he/she is required to sign an assent in parallel.
For adult patient (legally capable): patient has provided a written
informed consent before enrolment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

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