Recruiting
Phase 1

AdiaVita & Glutathione

Sponsor:

Greater Atlanta Integrative Pediatrics

Code:

NCT07622316

Conditions

Autism Spectrum Disorder

Autism

ASD

Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Interventions

Umbilical Cord Blood-Derived Stem Cells and Exosomes

Glutathione

Study Details

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)

Study ID

NCT07622316

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Glutathione with Stem Cells

active comparator: Glutathione Only

Interventions

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.

Glutathione

Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)

Primary outcome measure

  • Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6 [ Time Frame: Baseline and Month 6 ]

Central Contacts and Locations

Central contacts

Maia Gaither, MD

4047513693intakes@gaipeds.com

Amy Westmoreland, MSN

4047513693intakes@gaipeds.com

Locations

Greater Atlanta Integrative Pediatrics

Recruiting

Roswell, Georgia, United States, 30076

Contacts

Maia Gaither, MD

4047513693heal@gaipeds.com

Amy Westmoreland, MSN

4047513693intakes@gaipeds.com

Principal Investigator:

Maia Gaither, MD

Greater Atlanta Integrative Pediatrics

Recruiting

Roswell, Georgia, United States, 30076

Contacts

Maia Gaither, MD

intakes@gaipeds.com

4047513693

More Information

Sponsor

Greater Atlanta Integrative Pediatrics

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Greater Atlanta Integrative Pediatrics on 2026-06-03.