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.

Enrolling by invitation · Phase 1/Phase 2

Conditions studied: Autism Spectrum Disorder, Autism, Autism Spectral Disorder

In brief

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.

Key facts

Study ID

NCT07546942

Run by

Black Tie Medical, Inc.

People needed

50

Starts

2026-04-30

Expected to finish

2030-08-14

Last updated by the study team

2026-04-27

Who can join

Age: 10 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ADS
• Stable on current medications or therapy
• With/wthout comorbid GI (gut/Axis) symptoms

You may not qualify if…

• Recent antiobiotics or probiotic therapy within 30 days
• Severe GI disease or malnutrition
• Recent major surgery that may interfere with study course
• Other Med/Surgery issues that may preclude treatment with this protocol
• Inability to perform the monitoring of FMT without supervision by qualfied Provider

Where it is running

• Regenevita Health — Hamilton, Montana, United States
• Robert W. Alexander, MD, FICS — Hamilton, Montana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.