The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.
Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
Adequate venous access and absence of contraindications for leukoapheresis.
Women of childbearing age must take contraceptive measures.
Subjects with active TB.
Patients on the waiting list multiple organ transplants.
A significantly abnormal general serum screening lab result defined as WBC<3.0x103/ml, Hgb<8.0 g/dL, platelet count <100x103/ml, SGOT>3x upper limit.
HIV-positive subjects.