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Multimodal Interventions for Autism

(GARM-Autism Trial)

Enrolling by invitation at 1 trial location
Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Black Tie Medical, Inc.
Must not be taking: Antibiotics, Probiotics
Disqualifiers: Severe GI disease, Malnutrition, others
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?

Autism spectrum disorder (ASD) is a neurodevelopmental condition with core deficits in social communication and behavior, often accompanied by gastrointestinal (GI) and metabolic dysfunction. Emerging evidence supports the role of neuroinflammation (including autoimmune components), gut-brain axis disruption, and metabolic dysregulation in ASD pathophysiology. Multimodal interventions targeting these pathways-using autologous cSVF, cryopreserved MSCs, FMT, and dietary modulation-intent is that these multimodal interventions may offer synergistic benefits for adolescents and adults with ASD.

Are You a Good Fit for This Trial?

Inclusion Criteria

* ADS
I have been stable on my current medications or therapy.
I may or may not have digestive or gut-related symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multimodal interventions including autologous cSVF, cryopreserved MSCs, FMT, and ketogenic diet

12 months
Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
2 visits (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous cSVF + MSCs (cryo)
  • FMT (Fecal Material Transplantation)
  • Ketogenic RESET Diet Protocol

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ASD behavior, learning, communication and dietExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Black Tie Medical, Inc.

Lead Sponsor

Trials
2
Recruited
110+

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