GAIP ASD Research Study
Recruiting now · Phase 1
Conditions studied: Autism Spectrum Disorder, Autism, ASD, Autism Spectrum Disorder (ASD)
In brief
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.
Key facts
- Study ID
- NCT07622316
- Run by
- Greater Atlanta Integrative Pediatrics
- People needed
- 100
- Starts
- 2026-06-01
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-06-03
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Greater Atlanta Integrative Pediatrics — Roswell, Georgia, United States (enrolling)
- Greater Atlanta Integrative Pediatrics — Roswell, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.