Effect of Liver MSCs in Blood of Patients With Liver Disease.

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.

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Key information

Conditions

Decompensated Cirrhosis

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

acute de-compensated cirrhotic patients

Exclusion criteria

anticoagulant treatment except for prophylactic heparin treatment
coagulopathy
thrombosis
cancer

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

In Vitro Evaluation of the Effect of HepaStem in the Coagulation Activity in Blood of Patients With Liver Disease.

Acronym: CIRRHOTIQUE01

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Aug 15, 2018
Registry last updated: Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed