Actively Recruiting
Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
Led by Adia Med of Winter Park LLC · Updated on 2026-06-08
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding AdiaVita, a product derived from umbilical cord blood stem cells and exosomes, to glutathione therapy can better improve symptoms of Autism Spectrum Disorder (ASD) in children aged 3 to 12 compared to glutathione alone. The study is designed as a 24-month research trial involving about 100 children with confirmed ASD diagnoses. The main goal is to observe changes in autism symptoms using the Autism Treatment Evaluation Checklist (ATEC) at six months, with additional focus on safety, quality of life, and overall well-being. Participants are randomly assigned to one of two groups for the first three months: one group receives glutathione alone, and the other receives glutathione plus monthly intravenous infusions of AdiaVita. Both groups use topical glutathione cream twice daily at home. After three months, children initially receiving only glutathione may switch to the combined treatment if safety checks at six months are satisfactory. The study includes physical exams, blood tests, and monitoring for side effects throughout. During the trial, children will have regular clinic visits for assessments including physical exams, blood tests, and adverse event reporting. Autism symptoms are tracked by parents and therapists or teachers using the ATEC at multiple points over two years. Safety and tolerability are closely monitored with immediate attention to any serious adverse events. Participation is voluntary, with secure data handling and ongoing evaluation over the full 24-month period.
CONDITIONS
Brief Title
Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3-12 years
- Confirmed Autism Spectrum Disorder diagnosis using DSM-5 criteria supported by ADOS-2
- Parent or guardian willing to consider experimental treatments and follow study requirements
- Ability to attend all scheduled visits
You will not qualify if you...
- Severe allergies to study products
- Significant uncontrolled medical conditions
- Pregnancy or breastfeeding (if applicable)
- Participation in another interventional trial within 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive monthly intravenous infusions of glutathione with or without umbilical cord blood-derived stem cells and exosomes during the initial three-month treatment phase. They also apply topical glutathione twice daily at home during this period.
Monthly visits for 3 months with additional daily at-home treatment
Duration - 24 months
Participants are monitored over a 24-month period with repeated assessments of Autism Treatment Evaluation Checklist scores, physical exams, vital checks, and safety evaluations to track symptoms, tolerability, and overall wellness.
Multiple visits at baseline, Month 3, Month 6, Month 12, and Month 24
Trial Site Locations
Total: 1 location
1
Adia Med Of Winter Park
Winter Park, Florida, United States, 32789
Actively Recruiting
Research Team
L
Larry Powalisz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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