GAIP ASD Research Study

Part of paid clinical trials in Roswell, Georgia.

Sponsor: Greater Atlanta Integrative Pediatrics
Study ID: NCT07622316
Phase: PHASE1
Status: Recruiting

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Conditions

ASD
Autism
Autism Spectrum Disorder
Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex: ALL
Age: 3 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Umbilical Cord Blood-Derived Stem Cells and Exosomes — BIOLOGICAL
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Glutathione — DRUG
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)

Study Details

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.