Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

NCT07304440 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Adia Med ASD Research Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; ASD; Autism; Autism Spectrum Disorder (ASD)

Keywords

Glutathione; Intravenous glutathione; Glutathione therapy; Antioxidant therapy; Oxidative stress; Immune modulation; Anti-inflammatory therapy; Autism; Autism Spectrum Disorder; ASD; Autism symptoms; Stem cell therapy; MSCs; Mesenchymal stem cells; Regenerative medicine; Cellular therapy; Hematopoietic stem cells (HSCs); Allogeneic stem cells

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6

  The Autism Treatment Evaluation Checklist (ATEC) is a caregiver-completed questionnaire designed to evaluate treatment effectiveness in autism by assessing symptoms across four domains (Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior). Total ATEC scores range from 0 to 180, with higher scores indicating greater severity of autism symptoms (worse outcome) and lower scores indicating fewer symptoms (better outcome).

  Baseline and Month 6

Secondary Outcomes (3)

• Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3

  Baseline and Month 3

• Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Months 12 and 24

  Baseline, Month 12, and Month 24

• Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events

  Baseline through Month 24

Study Arms (2)

Glutathione with Stem Cells

EXPERIMENTAL

Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes; Drug: Glutathione

Glutathione Only

ACTIVE COMPARATOR

Drug: Glutathione

Interventions

Umbilical Cord Blood-Derived Stem Cells and Exosomes BIOLOGICAL

Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.

Glutathione with Stem Cells

Glutathione DRUG

Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Phase I)

Glutathione Only; Glutathione with Stem Cells

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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

You may not qualify if:

• Severe allergies to study products
• Significant uncontrolled medical conditions
• Pregnancy or breastfeeding (if applicable)
• Participation in another interventional trial within 30 days

Sponsors & Collaborators

• Adia Med of Winter Park LLC: lead

Study Sites (1)

Adia Med Of Winter Park

Winter Park, Florida, 32789, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Glutathione

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Larry Powalisz

CONTACT

3217880850; research@adiamed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)