| NCT ID | NCT07622316 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Greater Atlanta Integrative Pediatrics |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Maia Gaither, MD
PRINCIPAL INVESTIGATOR
Greater Atlanta Integrative Pediatrics
Frequently Asked Questions
Who can join the NCT07622316 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07622316 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07622316 currently recruiting?
Yes, NCT07622316 is actively recruiting participants. Contact the research team at intakes@gaipeds.com for enrollment information.
Where is the NCT07622316 trial being conducted?
This trial is being conducted at Roswell, United States, Roswell, United States.
Who is sponsoring the NCT07622316 clinical trial?
NCT07622316 is sponsored by Greater Atlanta Integrative Pediatrics. The principal investigator is Maia Gaither, MD at Greater Atlanta Integrative Pediatrics. The trial plans to enroll 100 participants.