Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

This 24-month study is for children aged 3 to 12 with Autism Spectrum Disorder (ASD). It's testing if adding AdiaVita, a product made from umbilical cord blood stem cells and exosomes, to glutathione therapy can improve autism symptoms more than glutathione alone. You would be randomly assigned to one of two groups for the first three months: one receiving glutathione only, and the other receiving glutathione plus monthly intravenous (into a vein) AdiaVita. Both groups also use a topical glutathione cream at home. The study will track changes in autism symptoms using a parent-filled checklist (ATEC) and assessments from therapists or teachers. The main goal is to see how much the ATEC score changes after six months. This study is currently unclear on its recruitment status.

Study design
This is an interventional study with 100 planned participants, randomly assigned to receive either glutathione alone or glutathione plus AdiaVita during the initial three-month treatment phase.
What's involved
You would need to attend all scheduled visits, which include physical exams, vital sign checks, and adverse event reviews. Treatments involve monthly intravenous infusions and twice-daily at-home topical glutathione during the first three months.
Compensation
You would be responsible for a $12,000 study fee plus bloodwork costs, if applicable.
Follow-up
Participants will be followed for 24 months, with the primary outcome measured at Month 6.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07304440

Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

Recruiting
PHASE1Ages 3–12InterventionalTreatment
Adia Med of Winter Park LLC
~100 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Umbilical Cord Blood-Derived Stem Cells and ExosomesGlutathione

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6
Measured over Baseline and Month 6
Autism Spectrum Disorder
Autism
ASD
Autism Spectrum Disorder (ASD)

NCT07304440

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Adia Med Of Winter Park

    Winter Park, Floridastudy coordinator listed

    Recruiting

  • The Lyday Center

    Green Bay, Wisconsinstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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
  • Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6Baseline and Month 6

    The Autism Treatment Evaluation Checklist (ATEC) is a caregiver-completed questionnaire designed to evaluate treatment effectiveness in autism by assessing symptoms across four domains (Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). Total ATEC scores range from 0 to 180, with higher scores indicating greater severity of autism symptoms (worse outcome) and lower scores indicating fewer symptoms (better outcome).