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
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by (Responsible Party):
Stephenne Xavier, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Liver MSCs or Adult Derived Human LiverStem/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.
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
12 Years to 80 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
hospitalised cirrhotic patients in hepatology or intensive care unit
acute de-compensated cirrhotic patients
anticoagulant treatment except for prophylactic heparin treatment