Congenital Heart Disease (CHD)ATTTNCT07799259
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
A study testing Autologous Thymus Transplant in people with Congenital Heart Disease (CHD), run by Children's Hospital Medical Center, Cincinnati.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Autologous Thymus Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Autologous Thymus Transplant in CHD Patients With no Congenital Athymia - 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.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Autologous Thymus Transplant
- Keywords
- pediatric congenital heart disease, congenital heart disease, Autologous thymus transplantation
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Thymus TransplantProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Intervention | Experimental | Not described Receives: Procedure: Autologous Thymus Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment (approximately 24 months).
Secondary outcomes (8)
Incidence of Postoperative Infections
Number and type of postoperative infections documented in the medical record.
Measured: Within 12 months after surgery
Length of Hospital Stay
Total number of days from surgery to hospital discharge.
Measured: 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.
Measured: 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.
Measured: 12 months after surgery.
Rate of Overall Survival
Survival status of study participants
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1, 3, 6, 12, and 24 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Moore, PhD, MBA, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799259
- Sponsor's protocol ID
- 2025-0551
- Acronym
- ATTT
- Status last verified
- Nov 2026
- First submitted
- 24 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Thymus Transplant in CHD Patients With no Congenital Athymia - A Pilot Study
- ClinicalTrials.gov ID
- NCT07799259
- Acronym / sponsor ID
- ATTT / 2025-0551
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- pediatric congenital heart disease, congenital heart disease, Autologous thymus transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Intervention | Experimental | Procedure: Autologous Thymus Transplant |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Thymus TransplantAutologous 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. | Procedure or surgery | Surgical Intervention |
Primary outcome
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).
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.
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.
8 secondary outcomes
Incidence of Postoperative Infections
Time frame: Within 12 months after surgery
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.
Number of Participants with Postoperative Complications
Time frame: Within 12 months after surgery.
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Score
Time frame: 12 months after surgery.
Rate of Overall Survival
Time frame: 24 months after surgery
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
Change From Baseline in Immune Cell Functional Assay Results
Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery.
Change From Baseline in Immune-Related Gene Expression Levels
Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease (CHD)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolina Moore, PhD, MBA principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Thymus Transplant in people with Congenital Heart Disease (CHD), run by Children's Hospital Medical Center, Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Cope (513-636-9537, Hannah.Cope@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complications from Autologous Thymus Reimplantation (time frame: Within 30 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.