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HepaStem Long-Term Safety Registry (PROLONGSTEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343756
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2017
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Promethera Biosciences

Brief Summary:
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

Condition or disease
Urea Cycle Disorder Crigler-Najjar Syndrome

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Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Other
Time Perspective: Other
Official Title: HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who received HepaStem in the interventional studies conducted by Promethera Biosciences will be proposed to participate in this PROLONGSTEM study.
Criteria

Inclusion Criteria:

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343756


Locations
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Belgium
UCL
Brussel, Belgium, 1200
UZ Leuven
Leuven, Belgium, 3000
France
CHU Lille
Lille, France, 59037
CHU Toulouse
Toulouse, France, 31059
Spain
Hospital de Badajoz
Badajoz, Spain, 06010
Sponsors and Collaborators
Promethera Biosciences

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Responsible Party: Promethera Biosciences
ClinicalTrials.gov Identifier: NCT03343756     History of Changes
Other Study ID Numbers: PROLONGSTEM
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urea Cycle Disorders, Inborn
Crigler-Najjar Syndrome
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Hyperbilirubinemia, Hereditary