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NCT07304440 · ClinicalTrials.gov registry record · Phase 1
Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
A Phase 1 study of Autism Spectrum Disorder and Autism, sponsored by Adia Med of Winter Park.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT07304440 is a Phase 1 study of Autism Spectrum Disorder and Autism that is actively recruiting participants, run by Adia Med of Winter Park. The registered enrollment target is 100 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07304440, a Phase 1 study of Autism Spectrum Disorder and Autism, is actively recruiting participants, sponsored by Adia Med of Winter Park.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Umbilical Cord Blood-Derived Stem Cells and Exosomes
- DRUG Glutathione
Study Locations (1)
Florida
- Adia Med Of Winter Park - Winter Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-01-12 |
| Est. Completion | 2028-06-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07304440
The ClinicalTrials.gov registry entry for NCT07304440 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (26% lower). The listed sponsor is Adia Med of Winter Park, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Umbilical Cord Blood-Derived Stem Cells and Exosomes is the first listed.
NCT07304440 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT07304440 about?
NCT07304440 is a clinical study titled "Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study". 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 m...
What is the current status of trial NCT07304440?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2026-01-12. Estimated completion is 2028-06-15.
What conditions does trial NCT07304440 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism, Autism Spectrum Disorder (ASD), ASD.
What interventions are being tested in trial NCT07304440?
The interventions under investigation include: Umbilical Cord Blood-Derived Stem Cells and Exosomes (BIOLOGICAL), Glutathione (DRUG).
Who is sponsoring clinical trial NCT07304440?
This trial is sponsored by Adia Med of Winter Park, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07304440 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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