Trial | NCT02260375  Report issue

Title

MSC Therapy in Liver Transplantation
THIRD-PARTY BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVER TRANSPLANT RECIPIENTS

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    20
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 Started
Oct 31
2014
Primary Completion
Oct 31
2024
Anticipated
Study Completion
Oct 31
2025
Anticipated
Last Update
Apr 06
2018

Biological Mesenchymal Stromal Cells

Mesenchymal Stromal Cells (MSC) Experimental

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.

No treatment. No Intervention

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.
No Results Posted