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NCT Number: NCT07799259

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

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.

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

2 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Rate of Complications from Autologous Thymus Reimplantation

    Time frame: Within 30 days after surgery

    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).

  2. Rate of Success of Thymus Reimplantation

    Time frame: Baseline, 6 months, and 12 months after surgery

    Evidence of immune reconstitution based on T-cell counts, recent thymic emigrants (TREC assays), T-cell repertoire diversity, and T-cell functional assessments.

  3. Number of Enrolled Participants

    Time frame: From enrollment to the end of treatment (approximately 24 months).

    Percentage of eligible patients who enroll in the study compared with those approached and eligible.

Secondary outcomes

  1. Incidence of Postoperative Infections

    Time frame: Within 12 months after surgery

    Number and type of postoperative infections documented in the medical record.

  2. Length of Hospital Stay

    Time frame: Total number of days spent in the hospital from surgery to discharge assessed up to 30 days post-surgery.

    Total number of days from surgery to hospital discharge.

  3. Number of Participants with Postoperative Complications

    Time frame: Within 12 months after surgery.

    Incidence and severity of postoperative complications, including wound infections, respiratory infections, systemic infections, bleeding, and graft-related adverse events.

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

    Time frame: 12 months after surgery.

    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.

  5. Rate of Overall Survival

    Time frame: 24 months after surgery

    Survival status of study participants

  6. Change From Baseline in T-cell, B-cell, and NK-cell Subset Frequencies

    Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery

    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.

  7. Change From Baseline in Immune Cell Functional Assay Results

    Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery.

    Changes in immune cell function assessed by validated functional assays, including measures of immune cell activity and responsiveness.

  8. Change From Baseline in Immune-Related Gene Expression Levels

    Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery.

    Changes in expression levels of immune-related genes measured using gene expression analyses of peripheral blood samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Cope

CONTACT

[email protected]

513-636-9537

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Autologous Thymus Transplant in CHD Patients With no Congenital Athymia - A Pilot Study

Acronym: ATTT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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