RecruitingPhase 1NCT07622316

GAIP ASD Research Study

Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study


Sponsor

Greater Atlanta Integrative Pediatrics

Enrollment

100 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Glutathione and a biological treatment called Umbilical Cord Blood-Derived Stem Cells and Exosomes for people with asd, autism, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 3 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUmbilical Cord Blood-Derived Stem Cells and Exosomes

Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.

DRUGGlutathione

Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)


Locations(2)

Greater Atlanta Integrative Pediatrics

Roswell, Georgia, United States

Greater Atlanta Integrative Pediatrics

Roswell, Georgia, United States

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NCT07622316


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