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

NCT ID: NCT03632148

Last Updated: 2020-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-20

Study Completion Date

2019-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Decompensated Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* acute de-compensated cirrhotic patients

Exclusion Criteria

* anticoagulant treatment except for prophylactic heparin treatment
* coagulopathy
* thrombosis
* cancer
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Stephenne Xavier

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2017/23JUI/331

Identifier Type: -

Identifier Source: org_study_id

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