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.

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.

Conditions

• Autism Spectrum Disorder
• Autism
• Autism Spectral Disorder

Interventions

PROCEDURE

Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells

Isolation/concentration autologous MSCs derived from tSVF from each patient participant only

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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

BEHAVIORAL

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)

DIETARY_SUPPLEMENT

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

BIOLOGICAL

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

Sponsors & Collaborators

• Black Tie Medical, Inc.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2030-06-01

Completion

2030-08-14

FDA Drug

Yes

Countries

• United States

Study Locations