Black Tie Medical, Inc.
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.
This refined protocol integrates the latest evidence for a multimodal intervention-autologous cSVF, cryopreserved autologous MSCs, FMT, and a structured ketogenic protocol program-for adolescent and adult ASD management. 1. Protocol Summary Title: A Phase 1-2 Randomized Controlled Trial Evaluating the Safety and Efficacy of Multimodal Therapy (Autologous cSVF + Cryopreserved Autologous MSCs, Fecal Microbiota Transplantation, Ketogenic Program Reset, and OT/PT Training) in Adolescents and Adults with Autism Spectrum Disorder (ASD-Multi-level scoring) Sponsor: Blacktie Principal Inv…
Inclusion Criteria: * ADS * Stable on current medications or therapy * With/wthout comorbid GI (gut/Axis) symptoms Exclusion Criteria: * 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
Isolation/concentration autologous MSCs derived from tSVF from each patient participant only
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
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
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)
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 of cSVF isolation and submission to FDA certified tissue/cell bank for subsequent use of autolgous patient only
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