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Liver Transplant RejectionPhase 1NCT02260375

MSC Therapy in Liver Transplantation

A Phase 1 study testing Mesenchymal Stromal Cells in people with Liver Transplant Rejection, run by Monia Lorini at 6 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The general aim of the present study is to test a cell therapy with third-party allogeneic ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Transplant Rejection
What is being tested?
Mesenchymal Stromal Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
6 sitesItaly
Study dates
Oct 2014to Oct 2025
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For this study, the following inclusion criteria should be fulfilled before starting withdrawal of drugs after 1 year post-transplant:
  • First liver transplant
  • Capable of understanding the purpose and risk of the study
  • Written informed consent

Who cannot join

  • Specific contraindication to MSC infusion
  • 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.

Trial locations and contacts

6 sites in 1 country.

Giuseppe Remuzzi, MD contact

0039 0352674037

gremuzzi@hpg23.it

6 sites in 1 country

Italy6 sites, 6 recruiting

  • U.S.C Nefrologia e Dialisi

    Bergamo, 24127

    Giuseppe Remuzzi, MD, 0039 0352674037, gremuzzi@hpg23.it

    Giuseppe Remuzzi, MD

    Recruiting

  • USC Chirurgia Generale III

    Bergamo, 24127

    Michele Colledan, Md, 00390352674347, mcolledan@hpg23.it

    Marco Zambelli, MD

    Recruiting

  • USC Ematologia

    Bergamo, 24127

    Alessandro Rambaldi, MD, 00390352673684, arambaldi@hpg23.it

    Alessandro Rambaldi, MD

    Recruiting

  • USC Gastroenterologia

    Bergamo, 24127

    Stefano Fagiuoli, MD, 00390352674259, sfagiuoli@hpg23.it

    Giulia Magini, MD

    Recruiting

  • Servizio di Immunoematologia e Medicina Trasfusionale

    Bologna, 40138

    Claudio Velati, MD

    Marina Buzzi, MD

    Recruiting

  • Unità Chirurgia Generale e Trapianti

    Bologna, 40138

    Antonio Pinna, MD

    Antonio Pinna, MD

    Recruiting

Other trials in Italy

About this study

Official title: THIRD-PARTY BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVER TRANSPLANT RECIPIENTS

The general aim of the present study is to test a cell therapy with third-party allogeneic ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs will be prepared accordingly to established protocols , starting from diagnostic samples of bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities and used for the present study in patients undergoing liver transplantation.

Being tested
Mesenchymal Stromal Cells
Keywords
Mesenchymal stromal cells; liver transplantation; tolerance.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal Stromal CellsBiological

Study groups in NCT02260375
Study groupRoleWhat they receive
Mesenchymal Stromal Cells (MSC)ExperimentalA 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.
Receives: Biological: Mesenchymal Stromal Cells
No treatment.No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events

    At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.

    Measured: Changes from baseline up to 120 month.

  2. Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes

    Measured: At 12 and 60 month.

  3. Circulating naive and memory T cell conts (CD45RA/CD45RO)(flow cytometry analysis)

    Measured: Changes from baseline at 6 and 12 months after transplant, then every 6 months till the first 3 years after transplant and then yearly up to 120 month.

  4. T-cell function in mixed lymphocyte reaction

    Measured: Changes from baseline at 6 and 12 months after transplant, then every 6 months till the first 3 years after transplant and then yearly up to 120 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02260375
Sponsor's protocol ID
MSC liver transplant tolerance
Other IDs
2014-001531-37, 2014
Status last verified
Apr 2018
First submitted
6 Oct 2014
Last updated
6 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33370477

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mesenchymal Stromal Cells in people with Liver Transplant Rejection, run by Monia Lorini at 6 sites in Italy.

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 4 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: status not confirmed, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giuseppe Remuzzi, MD (0039 0352674037, gremuzzi@hpg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events (time frame: Changes from baseline up to 120 month.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02260375, which also lists 1 linked publication.

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 6 Apr 2018.

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