About this trial

This clinical research study evaluates the safety and preliminary effects of AdiaVita (umbilical cord blood-derived stem cells and exosomes) combined with glutathione versus glutathione alone in people aged 3 and older with Autism Spectrum Disorder (ASD). In this randomized, participant-blinded crossover trial of about 100 participants, one group receives three monthly AdiaVita IV infusions plus glutathione, while the control group gets placebo saline infusions with the same glutathione regimen; the primary outcome is improvement on Autism Treatment Evaluation Checklist (ATEC) scores, with full safety follow-up through 12 months and optional crossover to AdiaVita for eligible controls. The treatment is investigational and not FDA-approved for autism, with no guaranteed benefit and risks including infusion reactions; participants pay $12,000 for the initial schedule, and all data remains confidential.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 3 years and up

Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2 or its equivalent)

Parent/guardian willingness to consider experimental treatments and comply with study requirements

Ability to obtain required bloodwork

Disqualifiers

Severe allergies to study products

Significant uncontrolled medical conditions

Immunocompromised

Malignancy history

Trial design

Design model

Crossover

Treatments tested in this trial

Umbilical Cord Blood-Derived Stem Cells and Exosomes
Biological/Vaccine
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Glutathione
Drug
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)

Treatment groups

100 Participants

are divided into 2 treatment groups

Group 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 6

Secondary 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 3

2

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, Month 12

3

Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events

Time frame

Baseline through Month 12

GAIP ASD Research Study

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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