Back to search results

GAIP ASD Research Study: Umbilical Cord Blood-Derived Stem Cells and Glutathione for Autism

This study is looking at the safety and early effects of a treatment called AdiaVita, which uses umbilical cord blood-derived stem cells and exosomes, when combined with glutathione. It's for people aged 3 and older who have Autism Spectrum Disorder (ASD). You would either receive AdiaVita infusions plus glutathione, or a placebo (inactive) saline infusion plus glutathione. Researchers will compare how these groups change on the Autism Treatment Evaluation Checklist (ATEC) scores. About 100 participants are planned, and the study is currently recruiting. You need a confirmed ASD diagnosis and the ability to attend study visits.

Study design
This is a randomized, participant-blinded crossover trial involving about 100 participants. One group receives AdiaVita plus glutathione, and the other receives a placebo plus glutathione.
What's involved
You would have three months of active treatment, followed by evaluations at 6 months and safety follow-ups for 12 months. This includes scheduled visits and required bloodwork.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a full safety follow-up through 12 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07622316

GAIP ASD Research Study

Recruiting
PHASE1Ages 3+InterventionalTreatment
Greater Atlanta Integrative Pediatrics
~100 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Umbilical Cord Blood-Derived Stem Cells and ExosomesGlutathione

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6
Measured over Baseline and Month 6

Conditions

Autism Spectrum Disorder
Autism
ASD
Autism Spectrum Disorder (ASD)

Explore related trials

Autism Spectrum Disorder

NCT07622316

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Greater Atlanta Integrative Pediatrics

    Roswell, Georgiastudy coordinator listed

    Recruiting

  • Greater Atlanta Integrative Pediatrics

    Roswell, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Maia Gaither, MD · PRINCIPAL_INVESTIGATOR · Greater Atlanta Integrative Pediatrics

Who to contact

Maia Gaither, MD
[email protected]
4047513693
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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

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

What this trial measures

  • Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6Baseline and Month 6

    The Autism Treatment Evaluation Checklist (ATEC) is a caregiver-completed questionnaire designed to evaluate treatment effectiveness in autism by assessing symptoms across four domains (Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). Total ATEC scores range from 0 to 180, with higher scores indicating greater severity of autism symptoms (worse outcome) and lower scores indicating fewer symptoms (better outcome).