Chronic Renal Failure Clinical Trial
Official title:
Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)
The general aim of the present study is to test a cell therapy with third-party ex-vivo
expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce
tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared
accordingly to established protocols, starting from the remnants in the bag and filter at the
end of the bone marrow infusions. 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.
The proposed study will be developed in two phases: i) a pilot explorative
safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).
n/a
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