Clinical Trial

Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.

Study acronym: GARM-Autism
Enrolling by Invitation Phase 1/2
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-16.
Trial Details
NCT Number NCT07546942
Lead Sponsor Black Tie Medical, Inc.
Conditions Autism Spectrum Disorder, Autism, Autism Spectral Disorder
Enrollment 50 participants
Start Date 2026-04-30
Primary Completion 2030-06-01 (estimated)
Study Completion 2030-08-14 (estimated)
Updated on ClinicalTrials.gov 2026-04-27