GAIP ASD Research Study

What Was Tested

The trial (phase 1) is built around Glutathione.

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).

It had two arms (groups): Glutathione with Stem Cells (experimental) and Glutathione Only (active comparator).

The registry classes the interventions as biological and drug.

More on the Plan

The study evaluates the safety and preliminary effects of combining AdiaVita, an umbilical cord blood-derived stem cell and exosome product, with glutathione in individuals aged 3 years and older diagnosed with Autism Spectrum Disorder (ASD).

Researchers will compare participants receiving AdiaVita plus glutathione against participants receiving glutathione alone using changes in Autism Treatment Evaluation Checklist (ATEC) scores as the primary outcome measure.

Participants will undergo a 12-month study timeline that includes screening, three months of active treatment, six-month primary endpoint evaluation, and 12-month safety follow-up.

Those assigned to the glutathione-only arm may later cross over to receive AdiaVita treatments if they meet specified safety and stability criteria.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 3 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Ability to attend all scheduled visits.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: severe allergies to study products; malignancy history; pregnancy or breastfeeding (if applicable).

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Glutathione and who got the comparison, which limits bias.

Each person switched between Glutathione and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2026-06-01 with completion listed for 2026-12-31.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6 (time frame: Baseline and Month 6).

It also tracked 3 secondary outcomes, for example Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3, Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 12 and Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glutathione in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.