RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Rafael Correa-Rocha • ClinicalTrials.gov ID: NCT04924491

Registry updated: 2026-09-18

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Description

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

Interventions

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

Eligibility criteria

Inclusion Criteria: 1. Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant. 2. Patients without contraindication to immunosuppressive drugs. 3. 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 Exclusion Criteria: 1. Patients with DiGeorge Syndrome, since their thymic function is affected. 2. Human immunodeficiency virus positive serology 3. Epstein-Barr virus active infection 4. Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies 5. Patients with a history of previous malignancy 6. Patients who have participated in other intervention studies in the last month. 7. Patients who have received induction therapy with Basiliximab or Thymoglobulin. 8. Patients who have previously been thymectomized or transplanted. 9. Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes) 10. Patients who will receive an asystole heart

Conditions

Heart Transplantation

Locations

Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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