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Could stem cells and a special diet ease autism symptoms? new trial aims to find out.

NCT ID NCT07546942

Disease control Sponsor: Black Tie Medical, Inc. 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a mix of treatments—including the patient's own stem cells, a strict keto diet, and a fecal transplant—can improve social skills, communication, and gut health in 50 teens and adults with autism. Participants must be stable on their current medications. The goal is to reduce autism-related challenges, not to cure the condition.

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 50 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

10 to 90 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: * ADS * Stable on current medications or therapy * With/wthout comorbid GI (gut/Axis) symptoms Exclusion Criteria: * Recent antiobiotics or probiotic therapy within 30 days * Severe GI disease or malnutrition * Recent major surgery that may interfere with study course * Other Med/Surgery issues that may preclude treatment with this protocol * Inability to perform the monitoring of FMT without supervision by qualfied Provider

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder Communication intestinal disorder learning disability

As listed by the trial registrant

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

Autism Autism spectral disorder Autism spectrum disorder

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Regenevita Health

    Hamilton, Montana, 59840, United States

  • Robert W. Alexander, MD, FICS

    Hamilton, Montana, 59840, United States

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