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Trial record 10 of 881 for:    Liver Transplant

MSC Therapy in Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02260375
Recruitment Status : Recruiting
First Posted : October 9, 2014
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by (Responsible Party):
Monia Lorini, A.O. Ospedale Papa Giovanni XXIII

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Liver Transplant Rejection Biological: Mesenchymal Stromal Cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: THIRD-PARTY BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVER TRANSPLANT RECIPIENTS
Study Start Date : October 2014
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes [ Time Frame: At 12 and 60 month. ]
  3. 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. ]
  4. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260375


Contacts
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Contact: Giuseppe Remuzzi, MD 0039 0352674037 gremuzzi@hpg23.it

Locations
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Italy
U.S.C Nefrologia e Dialisi Recruiting
Bergamo, Italy, 24127
Contact: Giuseppe Remuzzi, MD    0039 0352674037    gremuzzi@hpg23.it   
Principal Investigator: Giuseppe Remuzzi, MD         
USC Chirurgia Generale III Recruiting
Bergamo, Italy, 24127
Contact: Michele Colledan, Md    00390352674347    mcolledan@hpg23.it   
Principal Investigator: Marco Zambelli, MD         
USC Ematologia Recruiting
Bergamo, Italy, 24127
Contact: Alessandro Rambaldi, MD    00390352673684    arambaldi@hpg23.it   
Sub-Investigator: Alessandro Rambaldi, MD         
USC Gastroenterologia Recruiting
Bergamo, Italy, 24127
Contact: Stefano Fagiuoli, MD    00390352674259    sfagiuoli@hpg23.it   
Sub-Investigator: Giulia Magini, MD         
Servizio di Immunoematologia e Medicina Trasfusionale Recruiting
Bologna, Italy, 40138
Contact: Claudio Velati, MD         
Contact: Marina Buzzi, MD         
Sub-Investigator: Claudio Velati, MD         
Unità Chirurgia Generale e Trapianti Recruiting
Bologna, Italy, 40138
Contact: Antonio Pinna, MD         
Principal Investigator: Antonio Pinna, MD         
Sponsors and Collaborators
Monia Lorini
Mario Negri Institute for Pharmacological Research
Investigators
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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: Alessandro Rambaldi, MD A.O. Ospedale Papa Giovanni XXIII
Principal Investigator: Antonio Pinna, MD Policlinico S. Orsola Bologna, Italy
Principal Investigator: Claudio Velati, MD Policlinico S. Orsola Bologna, Italy

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Responsible Party: Monia Lorini, EC Secretary, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT02260375     History of Changes
Other Study ID Numbers: MSC liver transplant tolerance
2014-001531-37 ( EudraCT Number )
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Monia Lorini, A.O. Ospedale Papa Giovanni XXIII:
Mesenchymal stromal cells; liver transplantation; tolerance.