Liver Transplant Rejection
Conditions
Keywords
Mesenchymal stromal cells; liver transplantation; tolerance.
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.
Interventions
BIOLOGICALMesenchymal Stromal Cells
Sponsors
Mario Negri Institute for Pharmacological Research
Monia Lorini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 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 | At 12 and 60 month. | — |
| Circulating naive and memory T cell conts (CD45RA/CD45RO)(flow cytometry analysis) | 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. | — |
| T-cell function in mixed lymphocyte reaction | 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. | — |
Countries
Italy
Contacts
Primary ContactGiuseppe Remuzzi, MD
Outcome results
None listed