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.

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 Investigator: Robert W. Alexander, MD, FICS Study Phase: Phase I/II Study Centers: 1-3 Clinical Applied Research Laboratories/academic centers with expertise in ASD, stem cell processing and utilization, plus gastroenterology/PMD consultants available for FMT in patient's locale Compliance: NIH and IRB oversight Informed consent for all participants \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 2. Background and Rationale 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-may offer synergistic benefits for adolescents and adults with ASD. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 3. Objectives and Endpoints Primary Objective: • Evaluate the safety and tolerability of the multimodal interventions compared to current standard of care (SOC) for supportive therapy. Secondary Objectives: • Assess changes in ASD core symptoms, GI function, behavioral and social outcomes, and quality of life. Endpoints: * Incidence of adverse events (AEs) and serious adverse events (SAEs) * Change in validated ASD and GI symptom scales (CARS, VABS-II, GSRS, SRS, ABC) * Microbiome diversity and metabolic biomarker changes * Assessed performance and QoL evaluations 4. Study Design and Methodology * Design: Multi-disciplined, open labelled, controlled, parallel-group (1:1:1), tracked for cellular and biologics used, open-label, including tracking of diet/OT-PT * Sample Size: 50 participants (range ages 10-90, DSM-5 ASD diagnosis) * Randomization: Stratified by age, sex, and baseline GI symptoms, Socialization * Interim Analysis: Futility analysis at 50% enrollment 5. Study Population Inclusion Criteria: * Age 10-90 years, DSM-5 ASD diagnosis * Stable on current medications (if so treated at time of selection) * With/without comorbid GI symptoms Exclusion Criteria: * Recent antibiotics/probiotics * Severe GI trial.show_full_description

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