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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
U.S.C Nefrologia e Dialisi
Bergamo, Italy
RECRUITINGUSC Chirurgia Generale III
Bergamo, Italy
RECRUITINGUSC Ematologia
Bergamo, Italy
Number of adverse events
At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Time frame: Changes from baseline up to 120 month.
Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes
Time frame: At 12 and 60 month.
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.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
USC Gastroenterologia
Bergamo, Italy
RECRUITINGServizio di Immunoematologia e Medicina Trasfusionale
Bologna, Italy
RECRUITINGUnità Chirurgia Generale e Trapianti
Bologna, Italy
RECRUITING