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NCT07799259
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Conditions: Congenital Heart Disease (CHD)
Sex: All
Ages: 2 Months – 2 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Presence of severe non-cardiac congenital anomalies.
* Parent or guardians who refuse to consent.
Source: ClinicalTrials.gov (NCT07799259). StuddyBuddy aggregates publicly available trial information.