Stopped: Failure to enroll the number of patients required by the protocol due to the low number of living donor transplants performed at the Clinical Center
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.
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Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis).
Timeframe: Changes from baseline at 6 and 12 months after transplant.
T-cell function by ELISPOT assay in mixed lymphocyte reaction.
Timeframe: Changes from baseline at 6 and 12 months after transplant.
Number of adverse events.
Timeframe: Changes from baseline up to 48 months.
Circulating regulatory T cell count.
Timeframe: Changes from baseline at 6 and 12 months after transplant.
Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR.
Timeframe: Changes from baseline at 6 and 12 months after transplant.