drugset / Trial / NCT07304440

Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study

NCT07304440 ↗

Phase 1 Recruiting 100 enrolled Adia Med of Winter Park LLC
RandomizedCrossoverSingle-blindTreatment

Summary

This 12-month study tests whether AdiaVita (umbilical cord blood-derived stem cells and exosomes) plus glutathione improves autism symptoms more than glutathione alone in children ages 3-12. About 100 children with confirmed autism will be randomly assigned to one of two groups. One group receives monthly IV AdiaVita plus IV glutathione for 3 months. The other group receives IV glutathione plus a saline placebo infusion for 2 months. Both groups also use a topical glutathione spray twice a day at home. Symptoms are tracked with the Autism Treatment Evaluation Checklist (ATEC), completed by a parent and by a therapist or teacher. Safety is monitored at clinic visits through Month 12. Children who first receive glutathione only, may crossover to receive AdiaVita at no extra cost if they stay medically stable and their family agrees. Participation is voluntary. The study fee is $12,000.

Timeline

Start
2026-05-01
Primary completion
2028-06-15
Completion
2028-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject AdiaVita Cell therapy — Intravenous
Background Glutathione Peptide — Intravenous

Indications