Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
Recruiting now · Phase 1/Phase 2
Conditions studied: Heart Transplantation
In brief
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
Key facts
- Study ID
- NCT04924491
- Run by
- Rafael Correa-Rocha
- People needed
- 11
- Starts
- 2020-09-10
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-02-03
Who can join
Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Patients with a history of previous malignancy
- Patients who have participated in other intervention studies in the last month.
- Patients who have received induction therapy with Basiliximab or Thymoglobulin.
- Patients who have previously been thymectomized or transplanted.
- Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
- Patients who will receive an asystole heart
Where it is running
- Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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