Recruiting
Phase 1
Phase 2

AdiaVita with Glutathione

Sponsor:

Adia Med of Winter Park LLC

Code:

NCT07304440

Conditions

Autism Spectrum Disorder

Autism

ASD

Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

Interventions

Umbilical Cord Blood-Derived Stem Cells and Exosomes

Glutathione

Study Details

Brief summary:

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.

Conditions

Autism Spectrum Disorder

Autism

ASD

Autism Spectrum Disorder (ASD)

Study ID

NCT07304440

Start date

May 1, 2026

Status verified date

Jun, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

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
  • Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent

Exclusion Criteria:

  • Severe allergies to study products
  • Significant uncontrolled medical conditions
  • Pregnancy or breastfeeding (if applicable)
  • Participation in another interventional trial within 30 days
  • Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening

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 (Phase I)

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

Locations

Adia Med Of Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Contacts

The Lyday Center

Recruiting

Green Bay, Wisconsin, United States, 54311

Contacts

Principal Investigator:

Tami Lyday, DO

More Information

Sponsor

Adia Med of Winter Park LLC

Last update posted

Aug 21, 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
  • MSCs
  • Mesenchymal stem cells
  • Regenerative medicine
  • Cellular therapy
  • Hematopoietic stem cells (HSCs)
  • Allogeneic stem cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Adia Med of Winter Park LLC on 2026-08-21.