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GAIP ASD Research Study

RecruitingPhase 1Ages 3 Years - anyAllGreater Atlanta Integrative Pediatrics
NCT07622316 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Severe allergies to study products * Significant uncontrolled medical conditions * Immunocompromised * Malignancy history * Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion * Pregnancy or breastfeeding (if applicable) * Participation in another interventional trial within 30 days
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What it tests

  • Umbilical Cord Blood-Derived Stem Cells and Exosomes
  • Glutathione
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Where

2 sites
Greater Atlanta Integrative Pediatrics
Roswell, United States
Greater Atlanta Integrative Pediatrics
Roswell, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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