GAIP ASD Research Study

NCT07622316 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BB2605MG-205
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical research study evaluates the safety and preliminary effects of AdiaVita (umbilical cord blood-derived stem cells and exosomes) combined with glutathione versus glutathione alone in people aged 3 and older with Autism Spectrum Disorder (ASD). In this randomized, participant-blinded crossover trial of about 100 participants, one group receives three monthly AdiaVita IV infusions plus glutathione, while the control group gets placebo saline infusions with the same glutathione regimen; the primary outcome is improvement on Autism Treatment Evaluation Checklist (ATEC) scores, with full safety follow-up through 12 months and optional crossover to AdiaVita for eligible controls. The treatment is investigational and not FDA-approved for autism, with no guaranteed benefit and risks including infusion reactions; participants pay $12,000 for the initial schedule, and all data remains confidential.

Conditions

Autism Spectrum Disorder; Autism; ASD; 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; Regenerative medicine; Allogeneic stem cells; Cellular therapy

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, 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 once monthly for 3 months (Initial Treatment Schedule)

Glutathione Only; Glutathione with Stem Cells

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 3 years and up
• Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2 or its equivalent)
• Parent/guardian willingness to consider experimental treatments and comply with study requirements
• Ability to obtain required bloodwork
• Ability to attend all scheduled visits

You may not qualify if:

• Severe allergies to study products
• Significant uncontrolled medical conditions
• Immunocompromised
• Malignancy history
• Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion
• Pregnancy or breastfeeding (if applicable)
• Participation in another interventional trial within 30 days

Sponsors & Collaborators

• Greater Atlanta Integrative Pediatrics: lead

Study Sites (2)

Greater Atlanta Integrative Pediatrics

Roswell, Georgia, 30076, United States

RECRUITING

Greater Atlanta Integrative Pediatrics

Roswell, Georgia, 30076, 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

Study Officials

• Maia Gaither, MD

  Greater Atlanta Integrative Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maia Gaither, MD

CONTACT

4047513693; intakes@gaipeds.com

Amy Westmoreland, MSN

CONTACT

4047513693; intakes@gaipeds.com

Study Design

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

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)