Description

This study evaluates the safety and preliminary effectiveness of AdiaVita, an umbilical cord blood-derived stem cell and exosome product, when combined with glutathione for improving symptoms of Autism Spectrum Disorder in children ages 3-12. Participants are randomized to receive either glutathione alone or glutathione plus AdiaVita during the initial three-month treatment phase. Symptoms are measured using repeated Autism Treatment Evaluation Checklist assessments completed by both parents and therapists/teachers throughout the 24-month follow-up period. The primary outcome is change in total ATEC scores at Month 6, with secondary outcomes including safety, tolerability, quality of life, and overall wellness. Children in the glutathione-only group may enter a Phase II extension in which they later receive stem cell infusions at no additional cost if safety requirements are met at the six-month interim review. All clinical visits include physical exams, vitals, adverse event reviews, and post-infusion monitoring. Treatments involve monthly intravenous administration and twice-daily at-home topical glutathione during Phase One. Blood tests are completed prior to key visits to ensure medical stability, and serious adverse events trigger immediate medical attention and reporting. Risks include infusion-related discomfort, headache, fever, allergic reactions, or rare immune responses, with theoretical long-term risks noted. Potential benefits include improvement in social interaction, communication, and behavioral symptoms, although no benefits are guaranteed. Participation is voluntary and families may withdraw at any time, though study costs already paid are non-refundable. Data are stored securely with coded identifiers and only authorized parties may access identifiable information. Recruitment occurs through direct contact, clinic advertising, community outreach, and social media. Approximately 100 children from the Central Florida region are expected to participate and must have a confirmed ASD diagnosis prior to enrollment. Exclusion criteria include severe allergies to the study products, uncontrolled medical conditions, and recent participation in another interventional trial. No monetary incentives are offered, and families instead pay a fixed fee of $12,000 for Phase One, which covers all procedures and also includes Phase II if applicable. Outcomes will contribute to scientific knowledge regarding the safety and possible clinical utility of stem cell-based therapies for ASD.