MSC Therapy in Liver Transplantation

April 5, 2018 updated by: Monia Lorini

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • U.S.C Nefrologia e Dialisi
        • Principal Investigator:
          • Giuseppe Remuzzi, MD
        • Contact:
      • Bergamo, Italy, 24127
        • Recruiting
        • USC Chirurgia Generale III
        • Contact:
        • Principal Investigator:
          • Marco Zambelli, MD
      • Bergamo, Italy, 24127
        • Recruiting
        • USC Ematologia
        • Contact:
        • Sub-Investigator:
          • Alessandro Rambaldi, MD
      • Bergamo, Italy, 24127
        • Recruiting
        • USC Gastroenterologia
        • Contact:
        • Sub-Investigator:
          • Giulia Magini, MD
      • Bologna, Italy, 40138
        • Recruiting
        • Servizio di Immunoematologia e Medicina Trasfusionale
        • Contact:
          • Claudio Velati, MD
        • Contact:
          • Marina Buzzi, MD
        • Sub-Investigator:
          • Claudio Velati, MD
      • Bologna, Italy, 40138
        • Recruiting
        • Unità Chirurgia Generale e Trapianti
        • Contact:
          • Antonio Pinna, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Mesenchymal Stromal Cells
No Intervention: No treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: Changes from baseline up to 120 month.
At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Changes from baseline up to 120 month.
Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes
Time Frame: At 12 and 60 month.
At 12 and 60 month.
Circulating naive and memory T cell conts (CD45RA/CD45RO)(flow cytometry analysis)
Time Frame: 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.
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.
T-cell function in mixed lymphocyte reaction
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monia Lorini

Collaborators

Mario Negri Institute for Pharmacological Research

Investigators

  • Study Chair: Giuseppe Remuzzi, MD, A.O. Ospedale Papa Giovanni XXIII
  • Study Director: Norberto Perico, MD, IRCCS-Istituto di Ricerche Farmacologiche M. Negri
  • Principal Investigator: Michele Colledan, MD, A.O. Ospedale Papa Giovanni XXIII
  • Principal Investigator: Stefano Fagiuoli, MD, A.O. Ospedale Papa Giovanni XXIII
  • Principal Investigator: Martino Introna, MD, Laboratorio G.Lanzani, Bergamo, Italy
  • Principal Investigator: Antonio Pinna, MD, Policlinico S. Orsola Bologna, Italy
  • Principal Investigator: Claudio Velati, MD, Policlinico S. Orsola Bologna, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MSC liver transplant tolerance
  • 2014-001531-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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