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Could stem cells save Babies' brains after oxygen loss?

NCT ID NCT07018739

Disease control Sponsor: Mahidol University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 03, 2026 · Updated 8 times

Summary

This study tests whether adding stem cells to standard cooling therapy helps newborns with brain injury from lack of oxygen at birth. Forty infants will receive either stem cells from donated placentas or a placebo. Researchers will track death and developmental delays for up to two years.

What this could mean

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

Active substance
Wharton's jelly-derived mesenchymal stem cells (MSCs)
What this could lead to
If it works, this could point toward a treatment that reduces the risk of death or long-term disability in newborns with brain injury from oxygen loss.
What could go wrong
This is an early Phase 1/2 trial with only 40 infants, so results are preliminary. The stem cell approach may not improve outcomes over cooling alone, and there are risks like infection or infusion reactions.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 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 2033

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

4 to 9 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: * Term and late-preterm infants (gestational age ≥34 weeks) * Diagnosed with moderate to severe HIE based on modified Sarnat staging * Received TH per standard protocol * Parental consent obtained Exclusion Criteria: * Major congenital anomalies or genetic syndromes * Severe sepsis or active infection * Severe coagulopathy or bleeding disorders * Multi-organ failure

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia brain injury perinatal asphyxia

As listed by the trial registrant

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

Brain injuries, hypoxic-ischemic Hypoxic-ischemic encephalopathy, neonatal

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

  • Siriraj Hospital, Mahidol University

    Bangkok, 10700, Thailand

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