NCT07304440 Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
| NCT ID | NCT07304440 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Adia Med of Winter Park LLC |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2028-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-05-01 with a primary completion date of 2028-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This 24-month study is testing whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, 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. After the initial three-month phase, children who received glutathione alone may cross over to receive AdiaVita infusions at no additional cost if safety checks at month 6 are satisfactory. Approximately 100 children with a confirmed autism diagnosis from the Central Florida area will take part. Participation is completely voluntary, and families may withdraw at any time.
Eligibility Criteria
Inclusion Criteria: * Age 3-12 years * Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2) * Parent/guardian willingness to consider experimental treatments and comply with study requirements * Ability to attend all scheduled visits * Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent Exclusion Criteria: * Severe allergies to study products * Significant uncontrolled medical conditions * Pregnancy or breastfeeding (if applicable) * Participation in another interventional trial within 30 days * Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07304440 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07304440 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07304440 currently recruiting?
Yes, NCT07304440 is actively recruiting participants. Contact the research team at research@adiamed.com for enrollment information.
Where is the NCT07304440 trial being conducted?
This trial is being conducted at Winter Park, United States.
Who is sponsoring the NCT07304440 clinical trial?
NCT07304440 is sponsored by Adia Med of Winter Park LLC. The trial plans to enroll 100 participants.