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RECRUITING Phase 1 ClinicalTrials.gov

Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study

Sponsor: Adia Med of Winter Park LLC • ClinicalTrials.gov ID: NCT07304440

Registry updated: 2026-09-22
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Description

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.

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.

Eligibility criteria

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

Conditions

Autism Spectrum Disorder Autism ASD Autism Spectrum Disorder (ASD)

Locations

  • Adia Med Of Winter Park — Winter Park, Florida, United States
  • The Lyday Center — Green Bay, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record