Not Yet RecruitingPhase 1

Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients

Spain30 participantsStarted 2025-05

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Must have given written informed consent

Exclusion criteria

✕. 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.
✕. Subjects who test positive for HBV infection \[positive HBVsAg or HBVeAg/DNA\] or HCV infection \[RNA+\].
✕. Subjects with active CMV or EBV infection as defined by positive PCR.
✕. Subjects with a known history of previous myocardial infarction within one year of screening.
✕. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.

What they're measuring

Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor.

Timeframe: at day 1 and day 3

Trial details

NCT IDNCT06852625

SponsorFundacion Clinic per a la Recerca Biomédica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Fritz Diekmann, Dr

+34932775444 fdiekman@clinic.cat

View on ClinicalTrials.gov More Kidney Transplant Rejection trials