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Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients (ATDC-PICI)
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.
Details
| Lead sponsor | Fundacion Clinic per a la Recerca Biomédica |
|---|---|
| Phase | Phase 1 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 30 |
| Start date | 2025-05 |
| Completion | 2028-03 |
Conditions
- Kidney Transplant Rejection
Interventions
- Autologous Tolerogenic Dendritic Cells
Primary outcomes
- Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor. — at day 1 and day 3
Proportion of patients with toxicity/side effects during and after administration.
Countries
Spain