Study of AdiaVita Stem Cell Therapy Plus Glutathione for Improving Autism Symptoms in Children Ages 3 to 12

What this Trial Is About

Researchers are studying whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy improves autism symptoms in children aged 3 to 12 better than glutathione alone. This 24-month study focuses on children with confirmed Autism Spectrum Disorder ASD and aims to assess changes in autism symptoms, safety, quality of life, and overall well-being. The study includes a randomized, crossover design with two treatment groups during the initial three months. Participants are randomly assigned to receive either glutathione alone or glutathione plus monthly intravenous AdiaVita infusions during the first three months. Both groups apply topical glutathione cream twice daily at home. After the initial phase, children in the glutathione-only group may cross over to receive AdiaVita infusions if safety checks at month 6 are satisfactory. The study tracks symptoms using the Autism Treatment Evaluation Checklist ATEC completed by parents and therapists or teachers over the two-year period. Throughout the study, participants attend regular clinic visits for physical exams, vital signs monitoring, blood tests, and adverse event reporting. Safety and side effects are closely monitored, with serious events receiving immediate attention. Families will complete ATEC assessments at multiple time points to measure changes in autism symptoms. Participation is voluntary, with costs covering the first phase and extension. Data are securely stored with privacy protections, and families may withdraw at any time.

Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study