Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

Part of paid clinical trials in Winter Park, Florida.

Sponsor: Adia Med of Winter Park LLC
Study ID: NCT07304440
Phase: PHASE1/PHASE2
Status: Recruiting

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Conditions

ASD
Autism
Autism Spectrum Disorder
Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex: ALL
Age: 3 Years - 12 Years
Healthy Volunteers: Not accepted

Interventions

Umbilical Cord Blood-Derived Stem Cells and Exosomes — BIOLOGICAL
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Glutathione — DRUG
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Phase I)

Study Details

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.