Trials / Completed
CompletedNCT03632148
Effect of Liver MSCs in Blood of Patients With Liver Disease.
In Vitro Evaluation of the Effect of HepaStem in the Coagulation Activity in Blood of Patients With Liver Disease.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 9 (actual)
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
- Sex
- All
- Age
- 12 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2017-12-20
- Primary completion
- 2018-12-01
- Completion
- 2019-12-30
- First posted
- 2018-08-15
- Last updated
- 2020-03-27
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03632148. Inclusion in this directory is not an endorsement.