GAIP ASD Research Study

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3+
SponsorGreater Atlanta Integrative Pediatrics

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

Treatment groups

100 Participants
are divided into 2 treatment groups