Heart Transplantation Clinical Trial
— THYTECHOfficial title:
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
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
Status | Recruiting |
Enrollment | 11 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Gregorio Marañon | Madrid |
Lead Sponsor | Collaborator |
---|---|
Rafael Correa-Rocha | Fundación Familia Alonso, Instituto de Salud Carlos III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Secondary | Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography) that require treatment in the 2 years post-transplant | 24 months | ||
Secondary | Number of Treg cells in peripheral blood | 24 months | ||
Secondary | Change in the number of naive and memory Treg cells, and the production/levels of interferon gamma and interleukins (IL-4, IL-17A and IL-10). | 24 months | ||
Secondary | Decrease of cell subsets related with rejection (CD8 T cells subsets, activated T cells, antibody-secreting B cells) during the post-transplant follow-up period. | 24 months | ||
Secondary | Overall patient survival rate at 24 months. | 24 months | ||
Secondary | Change on parameters of electrocardiogram (PR, QRS and corrected QT interval) of transplanted heart. | 24 months | ||
Secondary | Change on parameters of echocardiogram (mitral and tricuspid regurgitation; mitral and tissue mitral Doppler; and tricuspid and tissue tricuspid Doppler ) of transplanted heart. | 24 months | ||
Secondary | Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V4.03 criteria. | 24 months |
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