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

PROLONGSTEM: HepaStem Long-Term Safety Registry Registry for patients who have been administered HepaStem

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003989-27-BE

Enrollment

Registered

2017-11-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study will include all patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HALPC during a previous interventional clinical study conducted by Promethera Biosciences or Promethera Therapeutics including patients suffering from urea cycle disorders (UCD), Crigler-Najjar (CN) and Fibro-inflammatory liver diseases MedDRA version: 20.1 Level: LLT Classification code 10021601 Term: Inborn error of metabolism NOS System Organ Class: 100000004850

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1- All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera Biosciences or Promethera Therapeutics. 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 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Longitudinal evaluation of the long-term safety post-HepaStem administration.;Secondary Objective: Not applicable;Primary end point(s): Primary: Occurrence of Adverse Events of Specific Interest (AESI): - Event with fatal outcome (Death) - Organ Transplantation and Outcome. - Development of Malignancy or unwanted tissue formation in different organs (tumor malignant or not). - Disease linked to transmission of adventitious agents or reactivation of latent pathogens. - Any AE which in the opinion of the investigator has a plausible causal relationship to HepaStem. These AESI should be considered as medically important and reported as SAE.;Timepoint(s) of evaluation of this end point: Patients who previously received the IMP HepaStem in the context of an interventional study with HepaStem administration will be followed-up for long-term safety surveillance up to 5 years in this PROLONGSTEM study.	—

Measure

Time frame

Main Objective: Longitudinal evaluation of the long-term safety post-HepaStem administration.;Secondary Objective: Not applicable;Primary end point(s): Primary: Occurrence of Adverse Events of Specific Interest (AESI): - Event with fatal outcome (Death) - Organ Transplantation and Outcome. - Development of Malignancy or unwanted tissue formation in different organs (tumor malignant or not). - Disease linked to transmission of adventitious agents or reactivation of latent pathogens. - Any AE which in the opinion of the investigator has a plausible causal relationship to HepaStem. These AESI should be considered as medically important and reported as SAE.;Timepoint(s) of evaluation of this end point: Patients who previously received the IMP HepaStem in the context of an interventional study with HepaStem administration will be followed-up for long-term safety surveillance up to 5 years in this PROLONGSTEM study.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium, Bulgaria, France, Poland, Spain, United Kingdom

Contacts

Public ContactWelcome desk

Promethera Therapeutics

regulatory@promethera.com+32 10 394300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026