About this trial
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 criteria
Qualifiers
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
Disqualifiers
Severe allergies to study products
Significant uncontrolled medical conditions
Immunocompromised
Malignancy history
Trial design
Treatments tested in this trial
- Umbilical Cord Blood-Derived Stem Cells and Exosomes
- Glutathione