Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

Recruiting now · Phase 1/Phase 2

Conditions studied: Autism Spectrum Disorder, Autism, ASD, Autism Spectrum Disorder (ASD)

In brief

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.

Key facts

Study ID

NCT07304440

Run by

Adia Med of Winter Park LLC

People needed

100

Starts

2026-05-01

Expected to finish

2028-06-15

Last updated by the study team

2026-06-17

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Adia Med Of Winter Park — Winter Park, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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