GAIP ASD Research Study
Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study
Greater Atlanta Integrative Pediatrics
100 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Age 3 years and up
- Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2 or its equivalent)
- Parent/guardian willingness to consider experimental treatments and comply with study requirements
- Ability to obtain required bloodwork
- Ability to attend all scheduled visits
Exclusion Criteria7
- Severe allergies to study products
- Significant uncontrolled medical conditions
- Immunocompromised
- Malignancy history
- Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion
- Pregnancy or breastfeeding (if applicable)
- Participation in another interventional trial within 30 days
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07622316