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.
Researchers 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.
Infants diagnosed with CHD requiring their first cardiac surgery through a sternotomy.
Age: 2 months to 2 years old at time of cardiac surgery.
Parents or legal guardians have provided informed consent.
Patients with previous cardiac surgery through a sternotomy.
Patients with a planned partial thymectomy.
Patients with congenital athymia or thymic atrophy.
Known severe immunodeficiency unrelated to thymus function.
Single group
Autologous Thymus Transplant
Procedure/SurgeryAutologous 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.
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).
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.
Number of Enrolled Participants
Percentage of eligible patients who enroll in the study compared with those approached and eligible.
Incidence of Postoperative Infections
Number and type of postoperative infections documented in the medical record.
Length of Hospital Stay
Total number of days from surgery to hospital discharge.
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.
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Score
Parent/guardian-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.
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