Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children

Phase 1/2 Recruiting 11 enrolled Rafael Correa-Rocha Instituto de Salud Carlos III · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

The investigators developed a protocol to isolate Treg cells from thymic tissue (thyTreg) discarded in pediatric cardiac surgeries. After completing the pre-clinical studies, the investigators have initiated a phase I/II clinical trial to test the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children. Condition or disease: Heart Transplantation Intervention/treatment: Regulatory T Cell (Treg) Infusion

Timeline

Start: 2020-09-10
Primary completion: 2026-12-31
Completion: 2026-12-31

Publications

Bernaldo-de-Quiros E, Cozar B, Lopez-Esteban R, Clemente M, Gil-Jaurena JM, Pardo C, Pita A, Perez-Caballero R, Camino M, Gil N, Fernandez-Santos ME, Suarez S, Pion M, Martinez-Bonet M, Correa-Rocha R. A Novel GMP Protocol to Produce High-Quality Treg Cells From the Pediatric Thymic Tissue to Be Employed as Cellular Therapy. Front Immunol. 2022 May 16;13:893576. doi: 10.3389/fimmu.2022.893576. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Autologous thyTreg	Cell therapy	1e+07 cells/kg	—
Subject	Autologous thyTreg	Cell therapy	2e+07 cells/kg	—

Indications

No indication recorded.