RecruitingPhase 1Phase 2NCT04924491

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

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


Sponsor

Rafael Correa-Rocha

Enrollment

11 participants

Start Date

Sep 10, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Max Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Autologous thyTreg for people with heart transplantation. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous 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

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NCT04924491


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