[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654442":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":53,"studyPopulation":53,"armGroups":60,"interventions":66,"overallOfficials":72,"centralContacts":76,"locations":53,"responsibleParty":82,"collaborators":53,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":53,"studyType":98,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":107,"whyStopped":53,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":53},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":53},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Rate of Complications from Autologous Thymus Reimplantation","Proportion of participants experiencing one or more thymus reimplantation-related postoperative complications (e.g., surgical site infection, bleeding requiring transfusion, thromboembolic events, or unplanned return to the operating room).","Within 30 days after surgery",{"measure":14,"description":15,"timeFrame":16},"Rate of Success of Thymus Reimplantation","Evidence of immune reconstitution based on T-cell counts, recent thymic emigrants (TREC assays), T-cell repertoire diversity, and T-cell functional assessments.","Baseline, 6 months, and 12 months after surgery",{"measure":18,"description":19,"timeFrame":20},"Number of Enrolled Participants","Percentage of eligible patients who enroll in the study compared with those approached and eligible.","From enrollment to the end of treatment (approximately 24 months).",[22,26,30,34,38,42,46,50],{"measure":23,"description":24,"timeFrame":25},"Incidence of Postoperative Infections","Number and type of postoperative infections documented in the medical record.","Within 12 months after surgery",{"measure":27,"description":28,"timeFrame":29},"Length of Hospital Stay","Total number of days from surgery to hospital discharge.","Total number of days spent in the hospital from surgery to discharge assessed up to 30 days post-surgery.",{"measure":31,"description":32,"timeFrame":33},"Number of Participants with Postoperative Complications","Incidence and severity of postoperative complications, including wound infections, respiratory infections, systemic infections, bleeding, and graft-related adverse events.","Within 12 months after surgery.",{"measure":35,"description":36,"timeFrame":37},"Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Score","Parent\u002Fguardian-reported quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL), a validated pediatric quality of life questionnaire. The outcome measure will be the change in PedsQL Total Score from baseline to 12 months following surgery. PedsQL scores range from 0 to 100, with higher scores indicating better quality of life.","12 months after surgery.",{"measure":39,"description":40,"timeFrame":41},"Rate of Overall Survival","Survival status of study participants","24 months after surgery",{"measure":43,"description":44,"timeFrame":45},"Change From Baseline in T-cell, B-cell, and NK-cell Subset Frequencies","Changes in T-cell, B-cell, and natural killer (NK) cell subsets measured by flow cytometry. Results will be reported as the percentage and\u002For absolute count of each immune cell subset among peripheral blood mononuclear cells.","Baseline and 1, 3, 6, 12, and 24 months after surgery",{"measure":47,"description":48,"timeFrame":49},"Change From Baseline in Immune Cell Functional Assay Results","Changes in immune cell function assessed by validated functional assays, including measures of immune cell activity and responsiveness.","Baseline and 1, 3, 6, 12, and 24 months after surgery.",{"measure":51,"description":52,"timeFrame":49},"Change From Baseline in Immune-Related Gene Expression Levels","Changes in expression levels of immune-related genes measured using gene expression analyses of peripheral blood samples.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"NA","SINGLE_GROUP","TREATMENT",{"masking":59,"maskingDescription":53,"whoMasked":53},"NONE",[61],{"label":62,"type":63,"description":53,"interventionNames":64},"Surgical Intervention","EXPERIMENTAL",[65],"Procedure: Autologous Thymus Transplant",[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":53},"PROCEDURE","Autologous Thymus Transplant","Autologous thymus transplantation (ATT) is an emerging therapeutic approach by the Cardiothoracic Surgery team at CCHMC that involves using the patient's own thymic tissue to restore immune function. For children with congenital heart disease (CHD), especially those undergoing cardiac surgery, the thymus is often removed or damaged, leading to potential immunodeficiencies. ATT aims to mitigate these issues.",[62],[73],{"name":74,"affiliation":5,"role":75},"Carolina Moore, PhD, MBA","PRINCIPAL_INVESTIGATOR",[77],{"name":78,"role":79,"phone":80,"phoneExt":53,"email":81},"Hannah Cope","CONTACT","513-636-9537","Hannah.Cope@cchmc.org",{"type":83,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100654442","autologous-thymus-transplant-in-children-with-congenital-heart-disease-a-pilot-study-100654442",false,"NCT07799259","Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study","Autologous Thymus Transplant in CHD Patients With no Congenital Athymia - A Pilot Study","ATTT","Inclusion Criteria:\n\n* Infants diagnosed with CHD requiring their first cardiac surgery through a sternotomy.\n* Age: 2 months to 2 years old at time of cardiac surgery.\n* Parents or legal guardians have provided informed consent.\n\nExclusion Criteria:\n\n* Patients with previous cardiac surgery through a sternotomy.\n* Patients with a planned partial thymectomy.\n* Patients with congenital athymia or thymic atrophy.\n* Known severe immunodeficiency unrelated to thymus function.\n* Presence of severe non-cardiac congenital anomalies.\n* Parent or guardians who refuse to consent.","ALL","2 Months","2 Years",{"count":96,"type":97},10,"ESTIMATED","INTERVENTIONAL",[55],"This pilot study will look at whether putting back a child's own thymus tissue during heart surgery is safe and may help support the immune system in children with congenital heart disease (CHD). During some heart surgeries, the thymus gland is removed to allow surgeons access to the heart. The thymus is important for helping the body develop infection-fighting immune cells.\n\nResearchers will compare children who have their thymus tissue reimplanted with children who have the thymus removed but not reimplanted. The study will evaluate the safety of the procedure, whether the transplanted tissue survives and functions, and whether it helps maintain or improve immune system health. Researchers will also monitor infections, recovery after surgery, hospital stays, quality of life, and overall health outcomes. Blood samples will be collected over time to better understand how the immune system changes after surgery and whether thymus reimplantation provides long-term benefits. Participants will be followed for up to 24 months after surgery.",[102],"Congenital Heart Disease (CHD)",[104,105,106],"pediatric congenital heart disease","congenital heart disease","Autologous thymus transplantation","NOT_YET_RECRUITING","2026-08-31",{"date":110,"type":111},"2026-09-02","ACTUAL",{"date":113,"type":97},"2026-09",{"date":115,"type":97},"2029-12",{"name":5,"class":6}]