Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-12
SponsorAdia Med of Winter Park LLC
About this trial
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.
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 once monthly for 3 months (Phase I)
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 Months 12 and 24
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, Month 12, and Month 243
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame
Baseline through Month 24Sponsors and contacts
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Source ClinicalTrials.gov