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.

Part of paid clinical trials in Hamilton, Montana.

Sponsor: Black Tie Medical, Inc.
Study ID: NCT07546942
Phase: PHASE1/PHASE2
Status: Enrolling By Invitation

Conditions

Autism
Autism Spectral Disorder
Autism Spectrum Disorder

Eligibility Criteria

Sex: ALL
Age: 10 Years - 90 Years
Healthy Volunteers: Not accepted

Interventions

Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells — PROCEDURE
Isolation/concentration autologous MSCs derived from tSVF from each patient participant only
Fecal Biomicrome Transplantation (FMT) — DIETARY_SUPPLEMENT
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 — DIETARY_SUPPLEMENT
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 — BEHAVIORAL
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) — DIETARY_SUPPLEMENT
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 — BIOLOGICAL
Use of cSVF isolation and submission to FDA certified tissue/cell bank for subsequent use of autolgous patient only

Study Details

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.