Autism Spectrum DisorderPhase 1NCT07304440
Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study
A Phase 1 study testing Umbilical Cord Blood-Derived Stem Cells and Exosomes and Glutathione in people with Autism Spectrum Disorder and Autism, run by Adia Med of Winter Park LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism, ASD
- What is being tested?
- Umbilical Cord Blood-Derived Stem Cells and Exosomes and Glutathione
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2026to 15 Jun 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Lyday Center
Green Bay, Wisconsin, 54311
Rhonda Hilgenberg, 9203843110, rhondah@thelydaycenter.com
Alina P, 9203013619, alinap@thelydaycenter.com
- Recruiting
Adia Med Of Winter Park
Winter Park, Florida, 32789
Dr Thomas MD, MD, 3212312843, research@adiamed.com
About this study
Official title: Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
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)
- Being tested
- Umbilical Cord Blood-Derived Stem Cells and Exosomes, Glutathione
- 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
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood-Derived Stem Cells and ExosomesBiological
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
GlutathioneDrug
Reduced L-glutathione administered Intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Glutathione with Stem Cells | Experimental | Not described Receives: Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes; Drug: Glutathione |
| Glutathione Only | Active comparator | Not described Receives: Drug: Glutathione |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at 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).
Measured: Baseline and Month 6
Secondary outcomes (3)
Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at 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).
Measured: Baseline and Month 3
Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at 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).
Measured: Baseline and Month 12
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Measured: Baseline through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 May 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adia Med of Winter Park LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304440
- Sponsor's protocol ID
- Adia Med ASD Research Study
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided