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Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study

Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

Who can join

Ages 3 to 12 · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

This 12-month study tests whether AdiaVita (umbilical cord blood-derived stem cells and exosomes) plus glutathione improves autism symptoms more than glutathione alone in children ages 3-12. About 100 children with confirmed autism will be randomly assigned to one of two groups. One group receives monthly IV AdiaVita plus IV glutathione for 3 months. The other group receives IV glutathione plus a saline placebo infusion for 2 months. Both groups also use a topical glutathione spray twice a day at home. Symptoms are tracked with the Autism Treatment Evaluation Checklist (ATEC), completed by a parent and by a therapist or teacher. Safety is monitored at clinic visits through Month 12. Children who first receive glutathione only, may crossover to receive AdiaVita at no extra cost if they stay medically stable and their family agrees. Participation is voluntary. The study fee is $12,000.

What is being tested

• Umbilical Cord Blood-Derived Stem Cells and Exosomes (biological)
• Glutathione (drug)

Sponsor: Adia Med of Winter Park LLC · Participants: 100 · Started: May 1, 2026

Contact the study team

• Larry Powalisz · Phone: 3217880850

Official record on ClinicalTrials.gov — NCT07304440

Locations in the U.S.

Conditions

• Autism Spectrum Disorder
• Autism

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.