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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder; Autism; ASD; Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes; Drug: Glutathione

Detailed Description

This study evaluates the safety and preliminary effectiveness of AdiaVita, an umbilical cord blood-derived stem cell and exosome product, when combined with glutathione for improving symptoms of Autism Spectrum Disorder in children ages 3-12. Participants are randomized to receive either glutathione alone or glutathione plus AdiaVita during the initial three-month treatment phase. Symptoms are measured using repeated Autism Treatment Evaluation Checklist assessments completed by both parents and therapists/teachers throughout the 24-month follow-up period. The primary outcome is change in total ATEC scores at Month 6, with secondary outcomes including safety, tolerability, quality of life, and overall wellness. Children in the glutathione-only group may enter a Phase II extension in which they later receive stem cell infusions at no additional cost if safety requirements are met at the six-month interim review. All clinical visits include physical exams, vitals, adverse event reviews, and post-infusion monitoring. Treatments involve monthly intravenous administration and twice-daily at-home topical glutathione during Phase One. Blood tests are completed prior to key visits to ensure medical stability, and serious adverse events trigger immediate medical attention and reporting. Risks include infusion-related discomfort, headache, fever, allergic reactions, or rare immune responses, with theoretical long-term risks noted. Potential benefits include improvement in social interaction, communication, and behavioral symptoms, although no benefits are guaranteed. Participation is voluntary and families may withdraw at any time, though study costs already paid are non-refundable. Data are stored securely with coded identifiers and only authorized parties may access identifiable information. Recruitment occurs through direct contact, clinic advertising, community outreach, and social media. Approximately 100 children Nation Wide are expected to participate and must have a confirmed ASD diagnosis prior to enrollment. Exclusion criteria include severe allergies to the study products, uncontrolled medical conditions, and recent participation in another interventional trial. No monetary incentives are offered, and families instead pay a fixed fee of $12,000 for Phase One, which covers all procedures and also includes Phase II if applicable. Outcomes will contribute to scientific knowledge regarding the safety and possible clinical utility of stem cell-based therapies for ASD.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Winter Park, Florida, United States, 32789
      • Adia Med Of Winter Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glutathione with Stem Cells	Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes; Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.; Drug: Glutathione; Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Phase I)
Active Comparator: Glutathione Only	Drug: Glutathione; Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Phase I)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events		Baseline through Month 24
Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3	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 3
Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Months 12 and 24	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, Month 12, and Month 24

Collaborators and Investigators

• Sponsor: Adia Med of Winter Park LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Oxidative stress; ASD; Autism; Autism Spectrum Disorder; Mesenchymal stem cells; Glutathione; Regenerative medicine; Cellular therapy; MSCs; Immune modulation; Stem cell therapy; Antioxidant therapy; Allogeneic stem cells; Anti-inflammatory therapy; Intravenous glutathione; Glutathione therapy; Autism symptoms; Hematopoietic stem cells (HSCs)
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Glutathione
• Other Study ID Numbers: Adia Med ASD Research Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No