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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Adia Med of Winter Park LLC Academic / other |
| Locations | 2 sites (Winter Park, Florida and 1 other locations) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | June 15, 2028 |
| Study ends | June 15, 2028 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07304440 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
- Study coordinator: Larry Powalisz
- Email: research@adiamed.com
- Phone: 3217880850
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.