Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study (NCT07304440) | Clinical Trial Compass
RecruitingPhase 1/2
Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
United States100 participantsStarted 2026-05-01
Plain-language summary
This 24-month study is testing whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy helps improve autism symptoms in children ages 3-12 more than glutathione alone. Children will be randomly placed into one of two groups for the first three months: one group receives glutathione only, and the other receives glutathione plus monthly intravenous AdiaVita infusions. Both groups also use topical glutathione cream twice daily at home. Autism symptoms will be tracked over two years using the Autism Treatment Evaluation Checklist (ATEC) filled out by parents and by therapists or teachers. Safety, side effects, quality of life, and overall well-being will be closely monitored through regular clinic visits, physical exams, blood tests, and adverse event reporting. After the initial three-month phase, children who received glutathione alone may cross over to receive AdiaVita infusions at no additional cost if safety checks at month 6 are satisfactory. Approximately 100 children with a confirmed autism diagnosis from the Central Florida area will take part. Participation is completely voluntary, and families may withdraw at any time.
Who can participate
Age range
3 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 1/2, which means it's still in early stages — what does that tell us about how much is known so far about whether this treatment is safe and effective for someone with ASD?
2The main thing this study is measuring is a change in the Autism Treatment Evaluation Checklist score after 6 months — can you help me understand what that checklist actually captures, and whether that lines up with the specific challenges we most want to address?
3Since this is a recruiting study at a specific clinic in Winter Park, what would participation actually look like day-to-day — how many visits, how far, and how much time would this take over those 6 months?
4Before considering a Phase 1/2 trial, are there established or standard treatments for ASD that we haven't fully tried yet, and would it make more sense to explore those first?
5What questions would you want answered about this study's design or the researchers running it before you'd feel comfortable recommending we look into it further?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6