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A second chance for the thymus: could reimplanting it during heart surgery shield immunity?

NCT ID NCT07799259

Disease control Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This pilot study tests whether putting back a child's own thymus tissue during heart surgery is safe and helps support the immune system. In some congenital heart disease surgeries, the thymus is removed to reach the heart, which may weaken immunity. Researchers will compare children who get the thymus reimplanted with those who do not, tracking safety, immune function, infections, and recovery for up to 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Autologous thymus transplant (reimplanting the child's own thymus tissue during heart surgery)
What this could lead to
If it works, this could lead to a way to preserve immune function in children with congenital heart disease who need thymus removal during surgery, potentially reducing infections and improving long-term health.
What could go wrong
This is a small pilot study with only 10 participants, so results may not apply broadly. The procedure carries surgical risks like infection, bleeding, or complications from the transplant itself, and it is not yet known if the thymus tissue will survive and function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 months to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart disease (CHD)

How to take part

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  1. The official record

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