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
|Condition or disease|
|Urea Cycle Disorder Crigler-Najjar Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||22 participants|
|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|
- 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.
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
|Brussel, Belgium, 1200|
|Leuven, Belgium, 3000|
|Lille, France, 59037|
|Toulouse, France, 31059|
|Hospital de Badajoz|
|Badajoz, Spain, 06010|