Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2014-10-31
2025-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MSC and Kidney Transplant Tolerance (Phase A)
NCT02565459
Clinical Trial With MSC for Graft Versus Host Disease Treatment
NCT02687646
Safety and Efficacy of Human Mesenchymal Stem Cells for Treatment of Liver Failure
NCT01218464
Umbilical Cord Derived Mesenchymal Stromal Cells For The Treatment of Severe Steroid-resistant Graft Versus Host Disease
NCT02032446
Mesenchymal Stromal Cell Therapy in Renal Recipients
NCT02057965
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mesenchymal Stromal Cells (MSC)
A single intravenous infusion (1-2 millions of MSCs per kilogram body weight) of ex-vivo expanded third-party MSC (from healthy donors) will be performed in patients assigned to the MSC procedure in addition to the liver transplantation.
Mesenchymal Stromal Cells
No treatment.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mesenchymal Stromal Cells
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Capable of understanding the purpose and risk of the study
* Written informed consent
Exclusion Criteria
* Any clinical relevant condition that might affect study participation and/or study results
* Pregnant women and nursing mothers
* Unwillingness or inability to follow the study protocol in the investigator's opinion.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mario Negri Institute for Pharmacological Research
OTHER
Monia Lorini
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Monia Lorini
EC Secretary
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giuseppe Remuzzi, MD
Role: STUDY_CHAIR
A.O. Ospedale Papa Giovanni XXIII
Norberto Perico, MD
Role: STUDY_DIRECTOR
IRCCS-Istituto di Ricerche Farmacologiche M. Negri
Michele Colledan, MD
Role: PRINCIPAL_INVESTIGATOR
A.O. Ospedale Papa Giovanni XXIII
Stefano Fagiuoli, MD
Role: PRINCIPAL_INVESTIGATOR
A.O. Ospedale Papa Giovanni XXIII
Martino Introna, MD
Role: PRINCIPAL_INVESTIGATOR
Laboratorio G.Lanzani, Bergamo, Italy
Alessandro Rambaldi, MD
Role: PRINCIPAL_INVESTIGATOR
A.O. Ospedale Papa Giovanni XXIII
Antonio Pinna, MD
Role: PRINCIPAL_INVESTIGATOR
Policlinico S. Orsola Bologna, Italy
Claudio Velati, MD
Role: PRINCIPAL_INVESTIGATOR
Policlinico S. Orsola Bologna, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
U.S.C Nefrologia e Dialisi
Bergamo, , Italy
USC Chirurgia Generale III
Bergamo, , Italy
USC Ematologia
Bergamo, , Italy
USC Gastroenterologia
Bergamo, , Italy
Servizio di Immunoematologia e Medicina Trasfusionale
Bologna, , Italy
Unità Chirurgia Generale e Trapianti
Bologna, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Claudio Velati, MD
Role: primary
Marina Buzzi, MD
Role: backup
Antonio Pinna, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Casiraghi F, Perico N, Podesta MA, Todeschini M, Zambelli M, Colledan M, Camagni S, Fagiuoli S, Pinna AD, Cescon M, Bertuzzo V, Maroni L, Introna M, Capelli C, Golay JT, Buzzi M, Mister M, Ordonez PYR, Breno M, Mele C, Villa A, Remuzzi G; MSC-LIVER Study Group. Third-party bone marrow-derived mesenchymal stromal cell infusion before liver transplantation: A randomized controlled trial. Am J Transplant. 2021 Aug;21(8):2795-2809. doi: 10.1111/ajt.16468. Epub 2021 Feb 22.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-001531-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MSC liver transplant tolerance
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.