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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.
Sponsor: Black Tie Medical, Inc.
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.
Official title: Autism Spectral Disorder (ASD) In Adolescent-Adults Treated by Multimodal Protocol: IV Autologous cSVF, Interval IV Autologous MSCs (Cryopreserved), Strick Ketogenic Diet RESET Program, and Fecal Microbiota Transplantation (FMT)
Key Details
Gender
All
Age Range
10 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-04-30
Completion Date
2030-08-14
Last Updated
2026-04-27
Healthy Volunteers
No
Interventions
Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells
Isolation/concentration autologous MSCs derived from tSVF from each patient participant only
Fecal Biomicrome Transplantation (FMT)
Novel Biome Protocol for elimination of patient's gut flora, replacement oral transplantation with a known flora common to restore the brain-gut balance in ASD patients
Ketogenic RESET Diet Protocol
Limited timeframe strick ketogenic diet for RESET of insulin resistance in form of high animal derived protein, high animal derived fat, low carbohydrate diet for 90 days, then standard ketogenic diet as tolerated
Trial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patients
GI Axis modification of bowel flora (FMT); Diet modification to permit mild ketosis in patient; cellular modification with use of cSVF and MSCs (autologous only)
FMT (Fecal Material Tranplantation)
Converting diet from patient selection which complies with the needs to change the GI-Axis to accommodate bowel changes and restoration of a normal bowel flora
Use autologous cSVF + MSCs (cryo) for management of autoimmune component, anti-inflammatory and immune modulation
Use of cSVF isolation and submission to FDA certified tissue/cell bank for subsequent use of autolgous patient only
Locations (2)
Regenevita Health
Hamilton, Montana, United States
Robert W. Alexander, MD, FICS
Hamilton, Montana, United States