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Cord blood stem cells trialed for autism – but Don't get your hopes up yet

NCT ID NCT07622316

Disease control Sponsor: Greater Atlanta Integrative Pediatrics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a combination of umbilical cord stem cells and glutathione can safely improve autism symptoms in 100 people aged 3 and older. Participants receive either the stem cell product plus glutathione, or a placebo plus glutathione, with the option to switch groups later. The main goal is to check safety and see if symptoms improve on a standard autism checklist. However, the treatment is not FDA-approved, costs $12,000, and this early-stage trial cannot guarantee any benefit.

What this could mean

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

Active substance
umbilical cord blood-derived stem cells and exosomes (AdiaVita) plus glutathione
What this could lead to
If it works, this could point toward a treatment that reduces autism symptoms for some children and adults.
What could go wrong
This is a very early Phase 1 trial focused on safety, not proof of effectiveness. The treatment is not FDA-approved for autism, costs $12,000, and carries risks like 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

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

Participants

About 100 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

3 years and older

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: * Age 3 years and up * Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2 or its equivalent) * Parent/guardian willingness to consider experimental treatments and comply with study requirements * Ability to obtain required bloodwork * Ability to attend all scheduled visits Exclusion Criteria: * Severe allergies to study products * Significant uncontrolled medical conditions * Immunocompromised * Malignancy history * Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion * Pregnancy or breastfeeding (if applicable) * Participation in another interventional trial within 30 days

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Conditions

The condition(s) this trial relates to.

atrial septal defect autism autism spectrum disorder

As listed by the trial registrant

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

ASD Autism Autism spectrum disorder Autism spectrum disorder (ASD)

How to take part

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

  1. The places running it

    2 sites. 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

  • Greater Atlanta Integrative Pediatrics

    RECRUITING

    Roswell, Georgia, 30076, United States

  • Greater Atlanta Integrative Pediatrics

    RECRUITING

    Roswell, Georgia, 30076, United States

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