Adia MED of Winter Park LLC Autism Spectrum Disorder Research Trial
Phase 1/2
100
about 2.4 years
3–12
1 site in FL
What this study is about
This trial is testing whether adding AdiaVita, a treatment made from umbilical cord blood stem cells and exosomes, to glutathione therapy helps improve autism symptoms in children ages 3-12 more than glutathione alone. Children will be randomly placed into one of two groups for the first three months: one group receives glutathione only, and the other receives glutathione plus monthly intravenous AdiaVita infusions. Both groups also use topical glutathione cream twice daily at home. Autism symptoms will be tracked over two years using the Autism Treatment Evaluation Checklist (ATEC) filled out by parents and by therapists or teachers. Safety, side effects, quality of life, and overall well-being will be closely monitored through regular clinic visits, physical exams, blood tests, and adverse event reporting.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Umbilical Cord Blood-Derived Stem Cells and Exosomes
- 2.Take Glutathione
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
glutathione
intravenous
Primary: Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6
Secondary: Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3, Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Months 12 and 24, Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Psychiatry / Mental Health