THIRD-PARTY BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVER TRANSPLANT RECIPIENTS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Liver Transplant Rejection
- Sponsor
- Monia Lorini
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Circulating naive and memory T cell conts (CD45RA/CD45RO)(flow cytometry analysis)
- Status
- Recruiting
- Last Updated
- 8 years ago
Overview
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.
Investigators
Monia Lorini
EC Secretary
A.O. Ospedale Papa Giovanni XXIII
Eligibility 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.
Outcomes
Primary Outcomes
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.
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.
Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes
Time Frame: At 12 and 60 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.