Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study

Phase 1RecruitingNCT07304440

Adia Med of Winter Park LLC100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Autism Spectrum Disorder Autism ASD Autism Spectrum Disorder (ASD)

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 6

Secondary Outcomes

Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3

Time frame: Baseline and Month 3

Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 12

Time frame: Baseline and Month 12

Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events

Time frame: Baseline through Month 12