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New treatment option for Autism Spectrum Disorder
Official title Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
ClinicalTrials.gov ID: NCT07304440
What this study is testing
What is Umbilical Cord Blood-Derived Stem Cells and Exosomes?
Umbilical Cord Blood-Derived Stem Cells and Exosomes is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for autism spectrum disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 12
You may be able to join if
- 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
You likely can't join if
- Severe allergies to study products
- Significant uncontrolled medical conditions
- Pregnancy or breastfeeding (if applicable)
- Participation in another treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Winter Park, Florida, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winter Park, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.