NCT07622316 · Greater Atlanta Integrative Pediatrics
GAIP ASD Research Study
What this study is about
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).
View original scientific description
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.
Interventions
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)
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Roswell, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations