GAIP ASD Research Study

June 1, 2026 updated by: Greater Atlanta Integrative Pediatrics

Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study evaluates the safety and preliminary effects of combining AdiaVita, an umbilical cord blood-derived stem cell and exosome product, with glutathione in individuals aged 3 years and older diagnosed with Autism Spectrum Disorder (ASD). Researchers will compare participants receiving AdiaVita plus glutathione against participants receiving glutathione alone using changes in Autism Treatment Evaluation Checklist (ATEC) scores as the primary outcome measure. The study is designed as a randomized, participant-blinded crossover trial with approximately 100 participants recruited primarily from the Atlanta metropolitan area and nationwide. Participants will undergo a 12-month study timeline that includes screening, three months of active treatment, six-month primary endpoint evaluation, and 12-month safety follow-up. Those assigned to the glutathione-only arm may later cross over to receive AdiaVita treatments if they meet specified safety and stability criteria. The protocol cites prior cord blood studies suggesting favorable safety profiles in pediatric ASD populations, though the treatment remains investigational and not FDA-approved for autism. Inclusion criteria require a confirmed ASD diagnosis, the ability to attend scheduled visits, and willingness from parents or guardians to comply with study procedures. Exclusion criteria include uncontrolled medical conditions, immunocompromised status, pregnancy, recent participation in another interventional trial, and unstable medication regimens. Participants in the active treatment arm receive monthly intravenous infusions of AdiaVita and escalating doses of glutathione over three months along with twice-daily transdermal glutathione sprays administered at home. The control arm receives placebo saline infusions combined with the same glutathione regimen and home spray schedule. Study assessments include repeated ATEC evaluations completed independently by parents and therapists or teachers, along with physical exams, laboratory testing, and monitoring for adverse events. Safety oversight includes post-infusion observation periods, predefined stopping criteria, and monitoring by an independent Data Safety Monitoring Board (DSMB). Potential risks described in the protocol include infusion reactions, allergic responses, blood draw complications, theoretical immune effects, and unknown long-term risks. The protocol states that there is no guaranteed therapeutic benefit for participants and that the study is exploratory rather than designed to prove efficacy. Participant confidentiality will be protected through coded study identifiers, encrypted electronic systems, restricted data access, and de-identified publication of results. The study is funded through participant payments totaling $12,000 for the initial treatment schedule, with crossover treatments provided at no additional cost for eligible participants.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Recruiting
        • Greater Atlanta Integrative Pediatrics
        • Contact:
        • Contact:
          • Phone Number: 4047513693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 (Initial Treatment Schedule)
Active Comparator: Glutathione Only
Drug: Glutathione
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greater Atlanta Integrative Pediatrics

Investigators

  • Principal Investigator: Maia Gaither, MD, Greater Atlanta Integrative Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB2605MG-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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