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MSC Therapy in Liver Transplantation

NCT02260375 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-04-06

No results posted yet for this study

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.

Conditions

  • Liver Transplant Rejection

Interventions

BIOLOGICAL

Mesenchymal Stromal Cells

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Monia Lorini

    lead OTHER

Principal Investigators

  • Giuseppe Remuzzi, MD · A.O. Ospedale Papa Giovanni XXIII

  • Norberto Perico, MD · IRCCS-Istituto di Ricerche Farmacologiche M. Negri

  • Michele Colledan, MD · A.O. Ospedale Papa Giovanni XXIII

  • Stefano Fagiuoli, MD · A.O. Ospedale Papa Giovanni XXIII

  • Martino Introna, MD · Laboratorio G.Lanzani, Bergamo, Italy

  • Alessandro Rambaldi, MD · A.O. Ospedale Papa Giovanni XXIII

  • Antonio Pinna, MD · Policlinico S. Orsola Bologna, Italy

  • Claudio Velati, MD · Policlinico S. Orsola Bologna, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2024-10-31
Completion
2025-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260375 on ClinicalTrials.gov