Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 3 to 12

Do AdiaVita stem cells plus glutathione help kids with autism more than glutathione alone?

Official title: Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

Run by Adia Med of Winter Park LLC · NCT07304440 · Data updated 2026-11-12

This 12-month study tests whether adding AdiaVita stem cells and exosomes to glutathione helps children aged 3–12 with autism more than glutathione alone.

More Autism trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages3 Years to 12 Years
SexAll
Enrollment100 (estimated)
SponsorAdia Med of Winter Park LLC
Academic / other
Locations2 sites (Winter Park, Florida and 1 other locations)
StatusRecruiting
StartedMay 1, 2026
Main results expectedJune 15, 2028
Study endsJune 15, 2028
Registry record updatedSeptember 22, 2026
Trial IDNCT07304440 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 3–12 years with a confirmed autism spectrum disorder diagnosis who can attend all visits and can cover the study fee.

Probably not a fit

Children with severe allergies to study products, significant uncontrolled medical conditions, or prior stem cell or glutathione therapies may be unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase 1 trial randomizes about 100 children with confirmed autism to two groups. One group receives monthly IV AdiaVita plus IV glutathione for 3 months, while the control group receives IV glutathione plus a saline placebo for 2 months; both groups use a topical glutathione spray at home. Autism symptoms are tracked using the Autism Treatment Evaluation Checklist (ATEC) completed by parents and by a clinician or teacher, with safety monitored through 12 months. A potential crossover allows initial glutathione-only participants to receive AdiaVita if they remain medically stable. Participation requires a study fee of $12,000 and adherence to visits and procedures.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option that may improve autism symptoms in children when added to glutathione therapy.

How similar studies have gone: Earlier studies of glutathione and stem cell–based approaches in autism have shown mixed results; this study explores a combination therapy in a randomized design.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 3-12 years
* Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2)
* Parent/guardian willingness to consider experimental treatments and comply with study requirements
* Ability to attend all scheduled visits
* Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent

Exclusion Criteria:

* Severe allergies to study products
* Significant uncontrolled medical conditions
* Pregnancy or breastfeeding (if applicable)
* Participation in another interventional trial within 30 days
* Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening

Where it's running

  • Adia Med Of Winter Park
    Winter Park, Florida, United States
    Recruiting
  • The Lyday Center
    Green Bay, Wisconsin, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.