GAIP ASD Research Study (NCT07622316)
Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- Greater Atlanta Integrative Pediatrics โ Roswell, Georgia
- Greater Atlanta Integrative Pediatrics โ Roswell, Georgia
๐ 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.
๐ฐ 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.
More studies in Autism Spectrum Disorder
- Improving the Part C Early Intervention Service Delivery System for Children With ASD โ Chicago, Illinois
- Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism โ Philadelphia, Pennsylvania
- Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder โ New Haven, Connecticut
- PRISM Intervention Study โ Los Angeles, California
- ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD) โ Dothan, Alabama
- MTT for Children With ASD Who Have Gastrointestinal Disorders โ Tempe, Arizona
Explore by condition: All Autism Spectrum Disorder clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.