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: 2

Brief Summary

This 12-month study tests whether AdiaVita (umbilical cord blood-derived stem cells and exosomes) plus glutathione improves autism symptoms more than glutathione alone in children ages 3-12. About 100 children with confirmed autism will be randomly assigned to one of two groups. One group receives monthly IV AdiaVita plus IV glutathione for 3 months. The other group receives IV glutathione plus a saline placebo infusion for 2 months. Both groups also use a topical glutathione spray twice a day at home. Symptoms are tracked with the Autism Treatment Evaluation Checklist (ATEC), completed by a parent and by a therapist or teacher. Safety is monitored at clinic visits through Month 12. Children who first receive glutathione only, may crossover to receive AdiaVita at no extra cost if they stay medically stable and their family agrees. Participation is voluntary. The study fee is $12,000.

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 Month 12

  Baseline and Month 12

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

  Baseline through Month 12

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.

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
• Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent

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
• 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

Sponsors & Collaborators

• Adia Med of Winter Park LLC: lead

Study Sites (2)

Adia Med Of Winter Park

Winter Park, Florida, 32789, United States

RECRUITING

The Lyday Center

Green Bay, Wisconsin, 54311, 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: September 22, 2026

Record last verified: 2026-06

Locations

US (2)