Recruiting
Phase 1

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 12-month study tests whether AdiaVita (umbilical cord blood-derived stem cells and exosomes) plus glutathione improves autism symptoms more than glutathione alone in children ages 3-12. About 100 children with confirmed autism will be randomly assigned to one of two groups. One group receives monthly IV AdiaVita plus IV glutathione for 3 months. The other group receives IV glutathione plus a saline placebo infusion for 2 months. Both groups also use a topical glutathione spray twice a day at home. Symptoms are tracked with the Autism Treatment Evaluation Checklist (ATEC), completed by a parent and by a therapist or teacher. Safety is monitored at clinic visits through Month 12. Children who first receive glutathione only, may crossover to receive AdiaVita at no extra cost if they stay medically stable and their family agrees. Participation is voluntary. The study fee is $12,000.

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.

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

Larry Powalisz

3217880850research@adiamed.com

Locations

Adia Med Of Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Dr Thomas MD, MD

3212312843research@adiamed.com

The Lyday Center

Recruiting

Green Bay, Wisconsin, United States, 54311

Contacts

Rhonda Hilgenberg

9203843110rhondah@thelydaycenter.com

Alina P

9203013619alinap@thelydaycenter.com

Principal Investigator:

Tami Lyday, DO

More Information

Sponsor

Adia Med of Winter Park LLC

Last update posted

Sep 22, 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 2026-10-23. This information was provided to ClinicalTrials.gov by Adia Med of Winter Park LLC on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.