Clinical Trial

GAIP ASD Research Study

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07622316
Lead Sponsor Greater Atlanta Integrative Pediatrics
Conditions Autism Spectrum Disorder, Autism, ASD, Autism Spectrum Disorder (ASD)
Enrollment 100 participants
Start Date 2026-06-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-03