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
Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.
Patients without contraindication to immunosuppressive drugs.
Parents and/or guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document
Patients with DiGeorge Syndrome, since their thymic function is affected.
Human immunodeficiency virus positive serology
Epstein-Barr virus active infection
Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies
Rafael Correa-Rocha
Lead sponsor
Hospital General Universitario Gregorio Marañon
Sponsor institution
Instituto de Salud Carlos III
Collaborator