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GAIP ASD Research Study
Sponsor: Greater Atlanta Integrative Pediatrics
Summary
This clinical research study evaluates the safety and preliminary effects of AdiaVita (umbilical cord blood-derived stem cells and exosomes) combined with glutathione versus glutathione alone in people aged 3 and older with Autism Spectrum Disorder (ASD). In this randomized, participant-blinded crossover trial of about 100 participants, one group receives three monthly AdiaVita IV infusions plus glutathione, while the control group gets placebo saline infusions with the same glutathione regimen; the primary outcome is improvement on Autism Treatment Evaluation Checklist (ATEC) scores, with full safety follow-up through 12 months and optional crossover to AdiaVita for eligible controls. The treatment is investigational and not FDA-approved for autism, with no guaranteed benefit and risks including infusion reactions; participants pay $12,000 for the initial schedule, and all data remains confidential.
Official title: Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study
Key Details
Gender
All
Age Range
3 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-06-01
Completion Date
2027-06-30
Last Updated
2026-06-03
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 once monthly for 3 months (Initial Treatment Schedule)
Locations (2)
Greater Atlanta Integrative Pediatrics
Roswell, Georgia, United States
Greater Atlanta Integrative Pediatrics
Roswell, Georgia, United States