Stem cell infusions plus glutathione for people with autism spectrum disorder
Tests cord blood stem cells with glutathione in people with autism spectrum disorder.
Plain-language title generated from the registry record
Registry title: GAIP ASD Research Study
Key facts
- Where
- Roswell, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Greater Atlanta Integrative PediatricsRoswell, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Greater Atlanta Integrative Pediatrics
- Trial code
- NCT07622316
- Record updated
- 3 June 2026
- Original description
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.Read full original descriptionShow less
Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research 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.
Inclusion: 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: Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion; Severe allergies to study products; Significant uncontrolled medical conditions; Malignancy history; Immunocompromised; Pregnancy or breastfeeding (if applicable); Participation in another interventional trial within 30 days.