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Bone marrow stem cells injected for autism: first human safety test begins

NCT ID NCT07177677

Disease control Sponsor: Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial will test the safety of a single intravenous dose of stem cells derived from human bone marrow in 42 people aged 6 and older with autism spectrum disorder. Participants will receive one of three different doses. The study will monitor for side effects and also look for any signs of improvement in behavior and social skills, but it is too early to know if the treatment works.

What this could mean

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

Active substance
human bone marrow mesenchymal stem cells (hBMMSC)
What this could lead to
If safe and effective, this could point toward a new way to ease core autism symptoms, though it is not a cure.
What could go wrong
This is a very early phase 1 trial with only 42 people, focused on safety. It is too soon to know if it works, and stem cell treatments carry risks like allergic reactions or infection.

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 42 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

6 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: * Male or female ≥6 years old * Body weight ≥ 17 kg * Meets the diagnostic criteria for Autism Spectrum Disorder (ASD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and confirmed by the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2) * Has either not received any psychotropic medication in the three months prior to enrollment or has been on a stable regimen of psychotropic medication for at least three months * The subject and/or their legal guardian(s) agree to participate in the trial and provide signed informed consent. Exclusion Criteria: * Inability of the subject or their guardian to sufficiently understand instructions in Chinese * Active infection (viral, bacterial, fungal, or mycobacterial) * A confirmed diagnosis of Rett syndrome, childhood disintegrative disorder, fragile X syndrome, or other genetic/metabolic diseases that may impact cognitive development * History of epileptic seizures within 6 months prior to enrollment * History of suicide attempts/self-harm, presentation of suicidal ideation, or being judged as the risk of suicidal by the investigator * Severe hematologic diseases or active malignancy * Severe hepatic or renal disease * Participation in a drug clinical trial within 3 months prior to enrollment (unless beyond the protocol-defined wash-out period) or participation in any other stem cell study within the past year * A positive skin test result * Any other condition which, in the opinion of the investigator, would make the subject unsuitable for participation in this study

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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