[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rafael Correa-Rocha\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100433466","phase-1-cell-therapy-with-treg-cells-obtained-from-thymic-tissue-thytreg-to-prevent-rejection-in-heart-transplant-children-100433466",false,"NCT04924491","Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children","Randomized, Exploratory and Prospective Phase I\u002FII 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","THYTECH","Inclusion Criteria:\n\n1. Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.\n2. Patients without contraindication to immunosuppressive drugs.\n3. Parents and\u002For guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document\n\nExclusion Criteria:\n\n1. Patients with DiGeorge Syndrome, since their thymic function is affected.\n2. Human immunodeficiency virus positive serology\n3. Epstein-Barr virus active infection\n4. Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies\n5. Patients with a history of previous malignancy\n6. Patients who have participated in other intervention studies in the last month.\n7. Patients who have received induction therapy with Basiliximab or Thymoglobulin.\n8. Patients who have previously been thymectomized or transplanted.\n9. Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)\n10. Patients who will receive an asystole heart","ALL","2 Years",{"count":20,"type":21},11,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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\u002FII clinical trial to test the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children.\n\nCondition or disease: Heart Transplantation Intervention\u002Ftreatment: Regulatory T Cell (Treg) Infusion",[28],"Heart Transplantation",[30,31,32,33,34,35],"Cardiac Disease","Regulatory T cell","Immunomodulation","Tolerogenic protocol","Immunosuppressive Agents","Immunologic Factors","RECRUITING","2025-01-30",{"date":39,"type":40},"2025-02-03","ACTUAL",{"date":42,"type":40},"2020-09-10",{"date":44,"type":21},"2026-12-31",{"name":46,"class":47},"Rafael Correa-Rocha","OTHER",""]