NCT07622316RecruitingPhase 1
GAIP ASD Research Study
Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 22 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Greater Atlanta Integrative Pediatrics
- Diseases
- Autism
- NCT number
- NCT07622316
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 100
- From 1 Jun 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion
Other illness
- Severe allergies to study products
- Significant uncontrolled medical conditions
- Malignancy history
Other
- Immunocompromised
- Pregnancy or breastfeeding (if applicable)
- Participation in another interventional trial within 30 days
Who the study is looking for
- 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
Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Greater Atlanta Integrative Pediatrics Coordinator of this site? Confirm its status | Roswell | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.