100 Participants Needed

Glutathione + Stem Cells for Autism

LP
Overseen ByLarry Powalisz
Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Adia Med of Winter Park LLC
Must be taking: Glutathione
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?

The trial aims to determine if combining AdiaVita, a stem cell-derived product, with glutathione can improve autism symptoms in children ages 3-12 more effectively than glutathione alone. Children will be randomly assigned to receive either only glutathione or glutathione plus monthly AdiaVita infusions for the first three months. Participants must have a confirmed autism diagnosis and be able to attend regular clinic visits. The study will monitor symptom improvements over two years, focusing on safety, side effects, and quality of life. Families may choose to leave the trial at any time. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works and measure its effectiveness in an initial group, offering participants the chance to contribute to groundbreaking autism research.

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

Research shows that stem cell therapy for children with autism, such as AdiaVita, might be safe. A review of several studies suggests it could be both safe and effective, but ongoing research continues to expand understanding. As with any treatment, monitoring for side effects remains important.

For glutathione, studies indicate it is generally safe. In one study, some children experienced minor stomach upset, but no serious side effects occurred. This suggests that most people tolerate glutathione well.

These treatments have shown promising safety results, but individual experiences can differ. It's always important to consult a healthcare provider about any concerns before joining a trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for autism because they offer innovative approaches that differ from standard therapies, such as behavioral interventions and medications like Risperidone and Aripiprazole. The combination of Glutathione with stem cells is unique because it targets oxidative stress and cellular repair, which are not typically addressed by existing treatments. Glutathione alone acts as a powerful antioxidant, helping to reduce oxidative stress, a factor often elevated in individuals with autism. The addition of stem cells could potentially enhance neurodevelopmental repair and improve overall brain function, offering a novel pathway for therapeutic intervention.

What evidence suggests that this trial's treatments could be effective for autism?

Research has shown that stem cell therapy, such as AdiaVita, may help improve autism symptoms. In earlier studies, about 90% of children with autism improved after receiving stem cell therapy. Specifically, one study found that children who received stem cells had much lower scores on the Childhood Autism Rating Scale compared to those who did not. Additionally, around 70% of children improved in key autism symptoms when treated with products like AdiaVita, made from cord blood. In this trial, participants will receive either Glutathione with Stem Cells or Glutathione Only. These findings suggest that combining AdiaVita with glutathione therapy might enhance treatment effectiveness for children with autism.16789

Are You a Good Fit for This Trial?

This study is for children aged 3-12 with a confirmed diagnosis of Autism Spectrum Disorder (ASD). They must be able to attend all scheduled visits and have parents or guardians willing to consider experimental treatments and comply with the study's requirements.

Inclusion Criteria

My guardian is open to experimental treatments and will follow study rules.
I am between 3 and 12 years old.
I have been diagnosed with ASD based on DSM-5 and ADOS-2.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either glutathione alone or glutathione plus AdiaVita during the initial three-month treatment phase

12 weeks
Monthly intravenous administration and twice-daily at-home topical glutathione

Crossover/Extension

Children in the glutathione-only group may cross over to receive AdiaVita infusions if safety checks at month 6 are satisfactory

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment using repeated Autism Treatment Evaluation Checklist assessments

24 months
Regular clinic visits, physical exams, blood tests, and adverse event reporting

What Are the Treatments Tested in This Trial?

Interventions

  • AdiaVita
  • Glutathione

Trial Overview

The trial is testing AdiaVita, an umbilical cord blood-derived stem cell and exosome product, combined with glutathione therapy. Over two years, it will compare improvements in autism symptoms between those receiving both treatments versus glutathione alone.

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?

Adia Med of Winter Park LLC

Lead Sponsor

Citations

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

The primary outcome is change in total ATEC scores at Month 6, with secondary outcomes including safety, tolerability, quality of life, and ...

Efficacy and Safety of Stem Cell Therapy in Children With ...

Data showed that the Childhood Autism Rating Scale score of stem cell group was striking lower than the control group (WMD: −5.96; 95%CI [−8.87, ...

Stem Cell Therapy for Autism and Success Rate After ...

83.3% experienced improvement in half or more of the assessed symptoms. Most commonly improved areas included. Stem Cells in Autism: Results, % ...

Examining the Success Rate of Stem Cell Therapy for Autism

According to research studies, stem cell therapy for Autism Spectrum Disorder (ASD) has demonstrated a success rate of around 90% in improving the condition.

Results from the Duke ACT Study of Cord Blood for Autism

In that study, approximately 70% of the children had improvement in one or more core symptoms of autism. Importantly, children with non-verbal IQs (NVIQ) over ...

Adia Med begins autism stem cell trial recruitment

Study in Winter Park will follow 100 children with autism ages 3-12 for 24 months, comparing glutathione alone to added AdiaVita stem cell ...

Stem Cell Therapy in Autism Spectrum Disorders

The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with autism spectrum disorders.

What is the Success Rate of Stem Cell Therapy for Autism?

Numerous case studies have documented positive outcomes following stem cell therapy for individuals with autism.

Alarming Aspect Of Stem Cell Therapy As Autism Treatment

The short answer is NO!!! The alarming aspect of this potential therapeutic proposal is the promise of significant clinical improvements in children who ...