Using thymic-derived Treg cells to prevent heart transplant rejection in children
Randomized, Exploratory and Prospective Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of the Transfusion of Autologous Treg Cells Obtained From Thymic Tissue in the Prevention of Rejection in Heart Transplant Children
This study is testing if using special immune cells from the thymus can help prevent heart transplant rejection in young children.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Hospital General Universitario Gregorio Marañon Academic / other |
| Drugs / interventions | Basiliximab |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT04924491 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of regulatory T cells (Treg) obtained from thymic tissue to prevent rejection in pediatric heart transplant patients. The approach involves isolating Treg cells from discarded thymic tissue during cardiac surgeries, which allows for a higher yield and purity of Tregs compared to traditional methods. The trial aims to assess the safety and efficacy of these autologous thyTreg infusions in children under two years of age who are undergoing heart transplantation. By enhancing the immune system's regulatory capabilities, the study seeks to improve transplant outcomes and patient longevity.
Who should consider this trial
Good fit: Ideal candidates for this study are children under two years of age who are eligible for heart transplantation and can tolerate immunosuppressive medications.
Not a fit: Patients with DiGeorge Syndrome or those with active infections or severe autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of graft rejection and improve long-term survival rates in pediatric heart transplant patients.
How similar studies have performed: While the use of Treg therapy has shown safety in previous studies, this specific approach utilizing thymic tissue is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madrid, Madrid
- Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Rafael Correa-Rocha, PhD — Hospital General Universitario Gregorio Marañon
- Study coordinator: Rafael Correa-Rocha, PhD
- Email: rafael.correa@iisgm.com
- Phone: 34 915866455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.