RecruitingPhase 1Phase 2NCT07304440

Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study


Sponsor

Adia Med of Winter Park LLC

Enrollment

100 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 12 Years

Inclusion Criteria4

  • 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

Exclusion Criteria4

  • Severe allergies to study products
  • Significant uncontrolled medical conditions
  • Pregnancy or breastfeeding (if applicable)
  • Participation in another interventional trial within 30 days

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Interventions

BIOLOGICALUmbilical Cord Blood-Derived Stem Cells and Exosomes

Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.

DRUGGlutathione

Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Phase I)


Locations(1)

Adia Med Of Winter Park

Winter Park, Florida, United States

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NCT07304440


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