Ireland
--:--IST
Recruiting Phase 1/2

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

NCT04924491 · tracked via the Priya Life Science Spain tracker
Sponsor
Rafael Correa-Rocha
Phase
Phase 1/2
Started
2020-09-10
Last updated
2026-09-18

Condition(s) studied

Heart Transplantation

Investigational drug(s) / intervention(s)

Autologous thyTreg

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

Study 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

Sex
ALL
Min age
—
Max age
2 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Repopulation of Treg cells in the patient, determined as the increase of Treg values in peripheral blood with respect to pre-transplant values or in comparison with a control cohort of non-treated patients. — 24 months

Trial sites (1)

FacilityCityRegionStatus
Hospital General Universitario Gregorio Marañon Madrid Madrid Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04924491 on ClinicalTrials.gov ↗ ← All trials in Spain