NCT04924491 Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
| NCT ID | NCT04924491 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rafael Correa-Rocha |
| Condition | Heart Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 11 participants |
| Start Date | 2020-09-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 11 participants in total. It began in 2020-09-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Rafael Correa-Rocha, PhD
PRINCIPAL INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Frequently Asked Questions
Who can join the NCT04924491 clinical trial?
This trial is open to participants of all sexes, up to 2 Years, studying Heart Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04924491 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04924491 currently recruiting?
Yes, NCT04924491 is actively recruiting participants. Contact the research team at rafael.correa@iisgm.com for enrollment information.
Where is the NCT04924491 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT04924491 clinical trial?
NCT04924491 is sponsored by Rafael Correa-Rocha. The principal investigator is Rafael Correa-Rocha, PhD at Hospital General Universitario Gregorio Marañon. The trial plans to enroll 11 participants.