An interventional study of Autologous Thymus Transplant in Congenital Heart Disease (CHD), sponsored by Children's Hospital Medical Center, Cincinnati. Not yet recruiting. Open to participants aged 2 Months to 2 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
Of 205 non-industry interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 36 months is close to that.
Counting every sponsor, half of 223 studies reached it within 34 months; a quarter within 17 and three quarters within 57.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati →