Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study

NCT07799259 | Not Yet Recruiting

• 1 other identifier: 2025-0551
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Congenital Heart Disease (CHD)

Keywords

pediatric congenital heart disease; congenital heart disease; Autologous thymus transplantation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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).

Secondary Outcomes (8)

• Incidence of Postoperative Infections

  Within 12 months after surgery

• Length of Hospital Stay

  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

  Within 12 months after surgery.

• Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Score

  12 months after surgery.

• Rate of Overall Survival

  24 months after surgery

Study Arms (1)

Surgical Intervention

EXPERIMENTAL

Procedure: Autologous Thymus Transplant

Interventions

Autologous Thymus Transplant PROCEDURE

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.

Surgical Intervention

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Carolina Moore, PhD, MBA

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Cope

CONTACT

513-636-9537; Hannah.Cope@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share