100 Participants NeededMy employer runs this trial

Stem Cells + Glutathione for Autism

AW
MG
Overseen ByMaia Gaither, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: Greater Atlanta Integrative Pediatrics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the safety and effectiveness of combining stem cells with a natural antioxidant called glutathione for people with Autism Spectrum Disorder (ASD). Participants will receive either the stem cell treatment (AdiaVita, which includes umbilical cord blood-derived stem cells and exosomes) with glutathione or glutathione alone to assess improvements in autism-related behaviors. Individuals diagnosed with ASD and open to experimental treatments may be suitable candidates. The trial is experimental and involves potential risks, such as reactions to infusions. Participants must cover some costs and attend regular study visits. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but it requires a stable medication regimen without frequent changes or missed doses in the 30 days before starting. It's best to discuss your specific situation with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatments using stem cells from umbilical cord blood, such as AdiaVita, are under investigation for their potential to manage autism symptoms. These stem cells might adjust or repair the immune system in individuals with autism. However, since this trial is in its early stages, the safety of using AdiaVita with glutathione, an antioxidant, remains unclear.

Earlier studies indicate that people generally tolerated similar stem cell treatments well. Some experienced mild reactions during infusion, but these were not serious. As safety information continues to be gathered, staying updated as more research emerges is important. Those considering participation should discuss potential risks and benefits with a healthcare provider.12345

Why are researchers excited about this trial's treatments?

Most treatments for autism focus on behavioral therapy or medications to manage symptoms. But AdiaVita offers a different approach by using umbilical cord blood-derived stem cells and exosomes. Researchers are excited because this treatment could potentially address the underlying biological aspects of autism, rather than just the surface symptoms. The combination of stem cells with glutathione is thought to promote brain repair and reduce inflammation, which could lead to more comprehensive improvements in autism symptoms. This innovative approach provides a fresh perspective on how we might better help those with autism.

What evidence suggests that this trial's treatments could be effective for Autism Spectrum Disorder?

Research has shown that stem cells from umbilical cord blood, like those in AdiaVita, might help with autism spectrum disorder (ASD). These stem cells could manage the body's immune system and reduce inflammation, potentially improving ASD symptoms. In previous studies, about 70% of children experienced improvements in key autism symptoms after receiving similar treatments. This trial will compare two treatment arms: one where participants receive Glutathione with Stem Cells, and another where participants receive Glutathione Only. Additionally, mesenchymal stem cells and their tiny particles that facilitate cell communication have shown potential in enhancing social skills and emotional expression in people with ASD. While these results are encouraging, it is important to note that this treatment is still under study and not yet approved by the FDA for autism.678910

Who Is on the Research Team?

MG

Maia Gaither, MD

Principal Investigator

Greater Atlanta Integrative Pediatrics

Are You a Good Fit for This Trial?

This trial is for people aged 3 and older who have been diagnosed with Autism Spectrum Disorder (ASD).

Inclusion Criteria

Ability to obtain required bloodwork
Ability to attend all scheduled visits
I am at least 3 years old.
See 2 more

Exclusion Criteria

Pregnancy or breastfeeding (if applicable)
Participation in another interventional trial within 30 days
Significant uncontrolled medical conditions
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly intravenous infusions of AdiaVita and escalating doses of glutathione over three months

12 weeks
3 visits (in-person)

Primary Endpoint Evaluation

Evaluation of treatment effectiveness using ATEC scores at Month 6

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Crossover (optional)

Eligible participants in the control arm may receive AdiaVita treatments

What Are the Treatments Tested in This Trial?

Interventions

  • AdiaVita (umbilical cord blood-derived stem cells and exosomes)
  • Glutathione

Trial Overview

The study compares the safety and effects of AdiaVita (umbilical cord blood stem cells and exosomes) plus glutathione versus glutathione alone in children and adults with ASD. Participants are randomly assigned to each group, with an option to switch treatments later.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Glutathione with Stem CellsExperimental Treatment2 Interventions
Group II: Glutathione OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Greater Atlanta Integrative Pediatrics

Lead Sponsor

Citations

NCT07243561 | Prospective Clinical Study on Human ...

This clinical study aims can safely and effectively improve core symptoms in children aged 3-7 years with autism spectrum disorder (ASD). It is a 24-week, ...

Stem Cell Therapy and Models for Autism Spectrum Disorder

The rationale behind umbilical cord blood-derived stem cells for ASD is that these stem cells may modulate immune responses, reduce inflammation, and promote ...

International Journal of Molecular Medicine

Recently, mesenchymal stem cells (MSCs) and their derived exosomes (MSC‑Exos) have emerged as promising candidates for ASD therapy owing to ...

Glutathione + Stem Cells for Autism · Info for Participants

Additionally, around 70% of children improved in key autism symptoms when treated with products like AdiaVita, made from cord blood. In this trial, participants ...

GAIP ASD Research Study - ICH GCP

The study evaluates the safety and preliminary effects of combining AdiaVita, an umbilical cord blood-derived stem cell and exosome

Study Details | NCT07622316 | GAIP ASD Research Study

The study evaluates the safety and preliminary effects of combining AdiaVita, an umbilical cord blood-derived stem cell and exosome product, ...

Adia MED of Winter Park LLC Autism Spectrum Disorder ...

This study evaluates the safety and preliminary effectiveness of AdiaVita, an umbilical cord blood-derived stem cell and exosome product, when ...

Adia MED of Winter Park LLC Autism Spectrum Disorder ...

Potential improvement in autism symptoms through access to experimental stem cell therapy. Children in the initial glutathione-only group can receive AdiaVita ...

Stem Cell-Derived Exosomes in Autism Spectrum Disorder

This review article describes the potential role of exosomes in alleviating ASD symptoms. Keywords: exosomes, stem cells, translational approach ...

title NOW RECRUITING: AUTISM STEM CELL RESEARCH ...

... Umbilical cord blood-derived stem cells and exosomes (AdiaVita) ✓ Glutathione support This study is designed to evaluate safety and gather ...