Autism Spectrum Disorder Clinical Trials

Find Autism Spectrum Disorder Clinical Trials Near You

Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Greater Atlanta Integrative Pediatrics
RECRUITING
Roswell
Greater Atlanta Integrative Pediatrics
RECRUITING
Roswell
Contact Information
Primary
Maia Gaither, MD
intakes@gaipeds.com
4047513693
Backup
Amy Westmoreland, MSN
intakes@gaipeds.com
4047513693
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 100
Treatments
Experimental: Glutathione with Stem Cells
Active_comparator: Glutathione Only
Related Therapeutic Areas
Sponsors
Leads: Greater Atlanta Integrative Pediatrics

This content was sourced from clinicaltrials.gov