Autism Spectrum Disorder, Autism, ASD, Autism Spectrum Disorder (ASD)
Conditions
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
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.
Interventions
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
DRUGGlutathione
Reduced L-glutathione administered Intravenous infusion.
Sponsors
Adia Med of Winter Park LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3 | 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). |
| Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 12 | Baseline and 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). |
| Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events | Baseline through Month 12 | — |
Countries
United States
Contacts
CONTACTLarry Powalisz
Outcome results
None listed