MSC Therapy in Liver Transplantation
THIRD-PARTY BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVER TRANSPLANT RECIPIENTS
Lead SponsorA.O. Ospedale Papa Giovanni XXIII
Indication/ConditionLiver Transplant Rejection
Intervention/Treatmentautologous mesenchymal stem cells ...
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.
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.
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.