Decompensated CirrhosisCIRRHOTIQUE01NCT03632148
Effect of Liver MSCs in Blood of Patients With Liver Disease.
An observational study of Decompensated Cirrhosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Decompensated Cirrhosis
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Dec 2017to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: hospitalised cirrhotic patients in hepatology or intensive care unit
Who may be able to join
- acute de-compensated cirrhotic patients
Who cannot join
- anticoagulant treatment except for prophylactic heparin treatment
- coagulopathy
- thrombosis
- cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Decompensated Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start20 Dec 2017
- Primary completion1 Dec 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephenne Xavier, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632148
- Sponsor's protocol ID
- 2017/23JUI/331
- Acronym
- CIRRHOTIQUE01
- Status last verified
- Mar 2020
- First submitted
- 13 Aug 2018
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Evaluation of the Effect of HepaStem in the Coagulation Activity in Blood of Patients With Liver Disease.
- ClinicalTrials.gov ID
- NCT03632148
- Acronym / sponsor ID
- CIRRHOTIQUE01 / 2017/23JUI/331
- Conditions
- Decompensated Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hospitalised cirrhotic patients in hepatology or intensive care unit
Key inclusion criteria (1 listed)
- acute de-compensated cirrhotic patients
Key exclusion criteria (4 listed)
- anticoagulant treatment except for prophylactic heparin treatment
- coagulopathy
- thrombosis
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompensated Cirrhosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood parameters in tubing loop model (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020; AzTrials last refreshed its copy on 26 Oct 2026.