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Effect of Liver MSCs in Blood of Patients With Liver Disease. (CIRRHOTIQUE01)

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ClinicalTrials.gov Identifier: NCT03632148
Recruitment Status : Enrolling by invitation
First Posted : August 15, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Stephenne Xavier, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
Liver MSCs or Adult Derived Human Liver Stem/progenitor Cells (ADHLSCs) infusions are currently being developed as a therapeutic medicinal product for the treatment of different liver defects. Nevertheless, a main concern for clinicians and health authorities is the risk of therapy-induced thrombosis, which has been reported in several patients after intravenous infusion. Previous studies showed in fact that most MSCs express a procoagulant activity. ADHLSCs could be used to treat acute de-compensated cirrhotic patients due to their immunomodulatory and anti-fibrotic effects. However in these patients, disturbances of coagulation and haemostasis are common and result in profound haemostatic alterations that can lead to thrombosis as well as to bleeding complications. The aim of this study is to evaluate the effect of ADHLSCs in cirrhotic blood compared to control blood.

Condition or disease
Decompensated Cirrhosis

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: In Vitro Evaluation of the Effect of HepaStem in the Coagulation Activity in Blood of Patients With Liver Disease.
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases




Primary Outcome Measures :
  1. Blood parameters in tubing loop model [ Time Frame: 1 day ]
    We plan to use the tubing loop model to study the interaction between acute-on-chronic liver failure patient's blood and ADHLSCss. The tubing loop model is a whole blood coagulation in vitro model that mimics the blood flow circulation. It consists of loops made of polyvinyl chloride tubing coated with heparin without any release of heparin in blood. This technique can be used to mimic cell infusion in an in vitro model as close as possible to a patient infusion. Blood parameters are studied after 5 and 60min incubation.

  2. Fibrin formation in thrombodynamics [ Time Frame: 1 day ]
    The thrombodynamics analyser system records and analyses spatiotemporal dynamics of formation of a fibrin clot in a platelet poor plasma (PPP) sample. We plan to use this model to study the interaction between acute-on-chronic liver failure patient's plasma and ADHLSCss.


Biospecimen Retention:   Samples Without DNA
blood plasma


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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
hospitalised cirrhotic patients in hepatology or intensive care unit
Criteria

Inclusion Criteria:

  • acute de-compensated cirrhotic patients

Exclusion Criteria:

  • anticoagulant treatment except for prophylactic heparin treatment
  • coagulopathy
  • thrombosis
  • cancer

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): NCT03632148


Locations
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Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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Responsible Party: Stephenne Xavier, Clinical Professor, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03632148     History of Changes
Other Study ID Numbers: 2017/23JUI/331
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 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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Liver Diseases
Liver Cirrhosis
Digestive System Diseases