Autism Spectrum Disorder Clinical Trials

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Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Adia Med Of Winter Park
RECRUITING
Winter Park
Contact Information
Primary
Larry Powalisz
ceo@adiamed.com
3212312843
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 100
Treatments
Experimental: Glutathione with Stem Cells
Active_comparator: Glutathione Only
Related Therapeutic Areas
Sponsors
Leads: Adia Med of Winter Park LLC

This content was sourced from clinicaltrials.gov