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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
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).
Time frame: Within 30 days after surgery
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.
Time frame: Baseline, 6 months, and 12 months after surgery
Number of Enrolled Participants
Percentage of eligible patients who enroll in the study compared with those approached and eligible.
Time frame: From enrollment to the end of treatment (approximately 24 months).
Incidence of Postoperative Infections
Number and type of postoperative infections documented in the medical record.
Time frame: Within 12 months after surgery
Length of Hospital Stay
Total number of days from surgery to hospital discharge.
Time frame: Total number of days spent in the hospital from surgery to discharge assessed up to 30 days post-surgery.
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.
Time frame: Within 12 months after surgery.
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.
Time frame: 12 months after surgery.
Rate of Overall Survival
Survival status of study participants
Time frame: 24 months after surgery
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/or absolute count of each immune cell subset among peripheral blood mononuclear cells.
Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery
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.
Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery.
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.
Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery.
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