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RECRUITING
NCT04924491
PHASE1/PHASE2

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

Sponsor: Rafael Correa-Rocha

View on ClinicalTrials.gov

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

Official title: Randomized, Exploratory and Prospective Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of the Transfusion of Autologous Treg Cells Obtained From Thymic Tissue in the Prevention of Rejection in Heart Transplant Children

Key Details

Gender

All

Age Range

Any - 2 Years

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2020-09-10

Completion Date

2026-12-31

Last Updated

2025-02-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous thyTreg

Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)

Locations (1)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain