NCT07304440RecruitingPhase 1
Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
This 12-month study tests whether AdiaVita (umbilical cord blood-derived stem cells and exosomes) plus glutathione improves autism symptoms more than glutathione alone in children ages 3-12. About 100 children with confirmed autism will be randomly assigned to one of two groups. One group receives monthly IV AdiaVita plus IV glutathione for 3 months. The other group receives IV glutathione plus a saline placebo infusion for 2 months. Both groups also use a topical glutathione spray twice a day at home. Symptoms are tracked with the Autism Treatment Evaluation Checklist (ATEC), completed by a parent and by a therapist or teacher. Safety is monitored at clinic visits through Month 12. Children who first receive glutathione only, may crossover to receive AdiaVita at no extra cost if they stay medically stable and their family agrees. Participation is voluntary. The study fee is $12,000.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 12 Dec 2025
- Start date
- 1 May 2026
- Primary completion date
- 15 Jun 2028
- Lead sponsor
- Adia Med of Winter Park LLC
- Diseases
- Autism
- NCT number
- NCT07304440
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 100
- From 1 May 2026 to the primary completion date, 15 Jun 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Severe allergies to study products
- Significant uncontrolled medical conditions
Other
- Pregnancy or breastfeeding (if applicable)
- Participation in another interventional trial within 30 days
Who the study is looking for
- 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
Age in the registry: 3 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Lyday Center Coordinator of this site? Confirm its status | Green Bay | United States | Recruiting |
| Adia Med Of Winter Park Coordinator of this site? Confirm its status | Winter Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.