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RECRUITING Phase 1

Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

NCT07304440 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BIOLOGICAL Umbilical Cord Blood-Derived Stem Cells and Exosomes
  • DRUG Glutathione

Study Locations (1)

Florida

  • Adia Med Of Winter Park — Winter Park

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2026-01-12
Est. Completion 2028-06-15
Phase Phase 1

Sponsor

Adia Med of Winter Park

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07304440

The ClinicalTrials.gov registry entry for NCT07304440 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adia Med of Winter Park, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions — of which Umbilical Cord Blood-Derived Stem Cells and Exosomes is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07304440 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07304440 about?

NCT07304440 is a clinical study titled "Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study". 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 m...

What is the current status of trial NCT07304440?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2026-01-12. Estimated completion is 2028-06-15.

What conditions does trial NCT07304440 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism, Autism Spectrum Disorder (ASD), ASD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07304440?

The interventions under investigation include: Umbilical Cord Blood-Derived Stem Cells and Exosomes (BIOLOGICAL), Glutathione (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07304440?

This trial is sponsored by Adia Med of Winter Park, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07304440 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial