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

In Vitro Evaluation of the Effect of HepaStem in the Coagulation Activity 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.

Study Overview

• Status: Completed
• Conditions: Decompensated Cirrhosis

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospitalised cirrhotic patients in hepatology or intensive care unit

Description

Inclusion Criteria:

• acute de-compensated cirrhotic patients

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood parameters in tubing loop model	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.	1 day
Fibrin formation in thrombodynamics	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.	1 day

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 2017/23JUI/331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No