GAIP ASD Research Study

The study evaluates the safety and preliminary effects of combining AdiaVita, an umbilical cord blood-derived stem cell and exosome product, with glutathione in individuals aged 3 years and older diagnosed with Autism Spectrum Disorder (ASD). Researchers will compare participants receiving AdiaVita plus glutathione against participants receiving glutathione alone using changes in Autism Treatment Evaluation Checklist (ATEC) scores as the primary outcome measure. The study is designed as a randomized, participant-blinded crossover trial with approximately 100 participants recruited primarily from the Atlanta metropolitan area and nationwide. Participants will undergo a 12-month study timeline that includes screening, three months of active treatment, six-month primary endpoint evaluation, and 12-month safety follow-up. Those assigned to the glutathione-only arm may later cross over to receive AdiaVita treatments if they meet specified safety and stability criteria. The protocol cites prior cord blood studies suggesting favorable safety profiles in pediatric ASD populations, though the treatment remains investigational and not FDA-approved for autism. Inclusion criteria require a confirmed ASD diagnosis, the ability to attend scheduled visits, and willingness from parents or guardians to comply with study procedures. Exclusion criteria include uncontrolled medical conditions, immunocompromised status, pregnancy, recent participation in another interventional trial, and unstable medication regimens. Participants in the active treatment arm receive monthly intravenous infusions of AdiaVita and escalating doses of glutathione over three months along with twice-daily transdermal glutathione sprays administered at home. The control arm receives placebo saline infusions combined with the same glutathione regimen and home spray schedule. Study assessments include repeated ATEC evaluations completed independently by parents and therapists or teachers, along with physical exams, laboratory testing, and monitoring for adverse events. Safety oversight includes post-infusion observation periods, predefined stopping criteria, and monitoring by an independent Data Safety Monitoring Board (DSMB). Potential risks described in the protocol include infusion reactions, allergic responses, blood draw complications, theoretical immune effects, and unknown long-term risks. The protocol states that there is no guaranteed therapeutic benefit for participants and that the study is exploratory rather than designed to prove efficacy. Participant confidentiality will be protected through coded study identifiers, encrypted electronic systems, restricted data access, and de-identified publication of results. The study is funded through participant payments totaling $12,000 for the initial treatment schedule, with crossover treatments provided at no additional cost for eligible participants.

• Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3 [Time frame: Baseline and Month 3]
• Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 12 [Time frame: Baseline, Month 12]
• Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events [Time frame: Baseline through Month 12]