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Could stem cells help tiniest babies breathe easier?

NCT ID NCT07368088

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a single dose of stem cells (PNEUMOSTEM®) given into the windpipe of very premature babies with high blood pressure in their lungs. The goal is to see if it is safe and might improve breathing, reduce time on a ventilator, and lower the need for oxygen. Only 12 babies will take part, and they will be followed for several weeks to check for side effects and signs of improvement.

What this could mean

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

Active substance
PNEUMOSTEM® (umbilical cord blood-derived stem cells)
What this could lead to
If it works, this could point toward a treatment that helps premature babies with lung blood pressure problems breathe better and need less support.
What could go wrong
This is a very early, small trial (12 babies) testing safety first. It may not show clear benefit, and stem cell treatments carry unknown risks in fragile infants.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

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

1 day to 14 days

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: 1. Premature infants within 2 weeks of birth with a gestational age of 28 weeks or less or birth weight of less than 1,250g who require continuous invasive mechanical ventilation 2. When diagnosed with early pulmonary arterial hypertension satisfying condition ① or ② up to 14 days after birth: * When on or more of the following abnormal findings are present on echocardiography performed between 4 and 14 days after birth (findings at 1-3 days after birth correspond to early neonatal transition): 1. Sytemic or suprasystemic pulmonary artery pressure \>40mmHg(based on peak Doppler velocity of tricuspid regurgitation) 2. Right-to-left or bidirectional shunt through patent ductus arteriosus, foramen ovale, or atrial septal defect 3. Flattened interventricular septum or D-shaped left ventricle at end systole ② When receiving nitric oxide(NO) inhalation therapy for persistent pulmonary hypertension of the newborn(PPHN) within 3 days after birth Exclusion Criteria: 1. Those witth cyanotic congenital heart defects or acyanotic congenital heart defects causing heart failure, excluding patent ductus arteriosus in premature infatns 2. Those with severe pulmonary malformations such as congenital diaphragmatic hernia or congenital cystic lung disease 3. Those who underwent surgery within 72 hours before or after administration of the investigational cell product, or those for whom surgery is anticipated 4. Those who received surfactant within 24 hours prior to administration of the investigattional cell product 5. Those with chromosomal abnormalities accompanied by severe malformations(such as Edwards syndrome, Patau syndrome, Down syndrome, etc.) and severe congenital malformations(such as hydrocephalus, encephalocele, etc.) 6. Those with severe congenital infectious diseases(such as herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.) 7. Those with severe sepsis or shock due to active infection not adequately treated with antibiotics 8. Those who have a history of participation in other advanced regenerative medicine clinical studies or clinical trials 9. Others deemed inappropriate by tthe investigator to participate in this advanced regenerative medicine clinical study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

    Seoul, 06351, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.