Study of AdiaVita Stem Cells Combined with Glutathione for Autism Spectrum Disorder in Children and Adults

What this Trial Is About

Researchers are studying the safety and early effects of combining AdiaVita, a stem cell and exosome product derived from umbilical cord blood, with glutathione in people aged 3 years and older who have Autism Spectrum Disorder ASD. This randomized, participant-blinded crossover trial compares the combination treatment against glutathione alone, focusing on changes in Autism Treatment Evaluation Checklist ATEC scores. The study will include about 100 participants and follows them for 12 months, including screening, treatment, and safety monitoring phases. The treatment is investigational and not approved by the FDA for autism, with some risks such as infusion reactions and no guaranteed benefits. Participants in the active group receive three monthly intravenous infusions of AdiaVita along with escalating doses of glutathione, plus twice-daily transdermal glutathione sprays at home. The control group receives placebo saline infusions with the same glutathione regimen and spray schedule. After six months, participants in the glutathione-only group who meet safety and stability criteria may cross over to receive AdiaVita treatments. The study includes screening, three months of treatment, a six-month primary endpoint evaluation, and a 12-month safety follow-up. During the study, parents and therapists independently complete ATEC evaluations at various timepoints to assess treatment impact. Participants also undergo physical exams, laboratory tests, and monitoring for adverse events. Safety is overseen by an independent board with observation after infusions and predefined stopping rules. Confidentiality is maintained through coded identifiers and secure data systems. Participation costs 12,000 for the initial schedule, while crossover treatments are provided at no extra cost for eligible participants.

GAIP ASD Research Study