๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-01

GAIP ASD Research Study (NCT07622316)

Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Greater Atlanta Integrative Pediatrics

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Greater Atlanta Integrative Pediatrics โ€” Roswell, Georgia

Age range: 3 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Greater Atlanta Integrative Pediatrics โ€” Roswell, Georgia
  • Greater Atlanta Integrative Pediatrics โ€” Roswell, Georgia

๐Ÿ“ž Contact the Study Coordinator

Phone: (404) 751-3693

Email: intakes@gaipeds.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—