Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-12
SponsorAdia Med of Winter Park LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe allergies to study products
Significant uncontrolled medical conditions
Pregnancy or breastfeeding (if applicable)
Participation in another interventional trial within 30 days
Trial design
Design model
Crossover
Treatments tested in this trial
Umbilical Cord Blood-Derived Stem Cells and Exosomes
Biological/VaccineIntravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Glutathione
DrugReduced L-glutathione administered Intravenous infusion.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Glutathione with Stem CellsExperimental treatment 2 interventions
Group B: Glutathione OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline and Month 6Secondary outcomes
1
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).
Time frame
Baseline and Month 32
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).
Time frame
Baseline and Month 123
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame
Baseline through Month 12Sponsors and contacts
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Source ClinicalTrials.gov