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.
Single group
Autologous Tolerogenic Dendritic Cells
Biological/Vaccine• Autologous Tolerogenic Dendritic Cells (D+1 to D+3 post-transplantation), ATDC, 1 million ATDC/Kg over a period of 30 minutes (up to 1 hour) will administer between Day 1 and Day 3 after transplantation.
Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor.
Proportion of patients with toxicity/side effects during and after administration.
Rate of infectious disease that required hospitalization at 6 and 12 months.
Proportion of patients with severe or serious infections at 6 months and 12 months.
To evaluate incidence of biopsy proven acute rejection episodes in patients treated with ATDC as adjunctive therapy to SOC
Incidence of BPAR at 3 and 12months after transplantation.
To evaluate renal function up to 1 year after transplantation
Renal function at 3, 6 and 12 months after transplantation as assessed by estimated glomerular filtration rate (eGFR)
To evaluate renal function up to 1 year after transplantation
Renal function at 3, 6 and 12 months after transplantation as assessed by serum/plasma creatinine levels
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