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.
Public ClinicalTrials.gov record NCT07546942. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Autism Spectral Disorder (ASD) In Adolescent-Adults Treated by Multimodal Protocol: IV Autologous cSVF, Interval IV Autologous MSCs (Cryopreserved), Strick Ketogenic Diet RESET Program, and Fecal Microbiota Transplantation (FMT)
Study identification
- NCT ID
- NCT07546942
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Black Tie Medical, Inc.
- Industry
- Enrollment
- 50 participants
Conditions and interventions
Interventions
- Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells Procedure
- FMT (Fecal Material Tranplantation) Dietary Supplement
- Fecal Biomicrome Transplantation (FMT) Dietary Supplement
- Ketogenic RESET Diet Protocol Dietary Supplement
- Trial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patients Behavioral
- Use autologous cSVF + MSCs (cryo) for management of autoimmune component, anti-inflammatory and immune modulation Biological
Procedure · Dietary Supplement · Behavioral + 1 more
Eligibility (public fields only)
- Age range
- 10 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 29, 2026
- Primary completion
- May 31, 2030
- Completion
- Aug 13, 2030
- Last update posted
- Apr 26, 2026
2026 – 2030
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regenevita Health | Hamilton | Montana | 59840 | — |
| Robert W. Alexander, MD, FICS | Hamilton | Montana | 59840 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07546942, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2026 · Synced May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07546942 live on ClinicalTrials.gov.