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Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study
Sponsor: Adia Med of Winter Park LLC
Summary
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.
Official title: Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
Key Details
Gender
All
Age Range
3 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-05-01
Completion Date
2028-06-15
Last Updated
2026-09-22
Healthy Volunteers
No
Interventions
Umbilical Cord Blood-Derived Stem Cells and Exosomes
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Glutathione
Reduced L-glutathione administered Intravenous infusion.
Locations (2)
Adia Med Of Winter Park
Winter Park, Florida, United States
The Lyday Center
Green Bay, Wisconsin, United States