The general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. MSCs will be prepared accordingly to established protocols, starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4 months before kidney transplant. From these samples, MSCs will be expanded in Good Manufacturing Practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
U.O. Nefrologia e Dialisi
Bergamo, Italy
Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis).
Time frame: Changes from baseline at 6 and 12 months after transplant.
T-cell function by ELISPOT assay in mixed lymphocyte reaction.
Time frame: Changes from baseline at 6 and 12 months after transplant.
Number of adverse events.
At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Time frame: Changes from baseline up to 48 months.
Circulating regulatory T cell count.
Time frame: Changes from baseline at 6 and 12 months after transplant.
Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR.
Time frame: Changes from baseline at 6 and 12 months after transplant.
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