# 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.

> **NCT07546942** · PHASE1,PHASE2 · ENROLLING_BY_INVITATION · sponsor: **Black Tie Medical, Inc.** · enrollment: 50 (estimated)

## Conditions studied

- Autism Spectrum Disorder
- Autism
- Autism Spectral Disorder

## Interventions

- **PROCEDURE:** Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells
- **DIETARY_SUPPLEMENT:** Fecal Biomicrome Transplantation (FMT)
- **DIETARY_SUPPLEMENT:** Ketogenic RESET Diet Protocol
- **BEHAVIORAL:** Trial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patients
- **DIETARY_SUPPLEMENT:** FMT (Fecal Material Tranplantation)
- **BIOLOGICAL:** Use autologous cSVF + MSCs (cryo) for management of autoimmune component, anti-inflammatory and immune modulation

## Key facts

- **NCT ID:** NCT07546942
- **Lead sponsor:** Black Tie Medical, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ENROLLING_BY_INVITATION
- **Start date:** 2026-04-30
- **Primary completion:** 2030-06-01
- **Final completion:** 2030-08-14
- **Target enrollment:** 50 (ESTIMATED)
- **Last updated:** 2026-04-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07546942

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07546942, "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.". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT07546942. Licensed CC0.

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