HepaStem Long-Term Safety Registry (PROLONGSTEM)

May 27, 2024 updated by: Cellaion SA

HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
        • Hopital Erasme
      • Antwerp, Belgium, 2650
        • Antwerp University Hospital
      • Brussel, Belgium, 1200
        • UCL
      • Brussels, Belgium, 1020
        • Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHC MontLegia
      • Woluwe-Saint-Lambert, Belgium
        • Cliniques Universitaires Saint-luc
  • Bulgaria
      • Pleven, Bulgaria, 5803
        • University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
      • Ruse, Bulgaria, 7013
        • UMHAT Medica Ruse
      • Sofia, Bulgaria, 1606
        • Military Medical Academy
  • France
      • Amiens, France, 80080
        • Centre Hospitalier Universitaire Amiens Picardie
      • Angers, France, 49933
        • Centre Hospitalier Universitaire d'Angers
      • Bordeaux, France, 33608
        • University Hospital of Bordeaux
      • Lille, France, 59037
        • Chu Lille
      • Lyon, France, 69317
        • Hospices Civils de Lyon
      • Marseille, France, 13005
        • Assistance Publique Hopitaux de Marseille
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire de Montpellier
      • Paris, France, 75013
        • Assistance Publique Hopitaux de Paris
      • Strasbourg, France, 67000
        • Les Hôpitaux Universitaires de Strasbourg
      • Toulouse, France, 31059
        • CHU Toulouse
      • Villejuif, France, 94804
        • Hopital Paul Brousse
  • Poland
      • Mysłowice, Poland, 41-400
        • ID Clinic
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 8035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28049
        • Hospital Universitario Ramon y Cajal
      • Sabadell, Spain, 08208
        • Parc Tauli Hospital Universitari
      • Zaragoza, Spain, 50009
        • Hospital Unviersitario Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who received HepaStem in the interventional studies conducted by Promethera will be proposed to participate in this PROLONGSTEM study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of Adverse Events of Specific Interest (AESI)
Time Frame: 60 months

Adverse Events of Specific Interest (AESI):

  • Event with fatal outcome (Death)
  • Orthotopic Liver Transplantation (OLT) 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.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cellaion SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROLONGSTEM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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