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GAIP ASD Research Study
Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study
Who can join
Ages 3 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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.
What is being tested
- Umbilical Cord Blood-Derived Stem Cells and Exosomes (biological)
- Glutathione (drug)
Sponsor: Greater Atlanta Integrative Pediatrics · Participants: 100 · Started: Jun 1, 2026
Contact the study team
- Maia Gaither, MD · Phone: 4047513693
- Amy Westmoreland, MSN · Phone: 4047513693
Official record on ClinicalTrials.gov — NCT07622316
Locations in the U.S.
| Georgia | Greater Atlanta Integrative Pediatrics, Roswell Greater Atlanta Integrative Pediatrics, Roswell |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.