NCT07546942Enrolling by invitationPhase 1/2
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 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)
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 4 Apr 2026
- Start date
- 30 Apr 2026
- Primary completion date
- 1 Jun 2030
- Lead sponsor
- Black Tie Medical, Inc.
- Diseases
- Autism
- NCT number
- NCT07546942
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From 30 Apr 2026 to the primary completion date, 1 Jun 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent antiobiotics or probiotic therapy within 30 days
- Recent major surgery that may interfere with study course
- Other Med/Surgery issues that may preclude treatment with this protocol
Other illness
- Severe GI disease or malnutrition
Other
- Inability to perform the monitoring of FMT without supervision by qualfied Provider
Who the study is looking for
- ADS
- Stable on current medications or therapy
- With/wthout comorbid GI (gut/Axis) symptoms
Age in the registry: 10 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regenevita Health Coordinator of this site? Confirm its status | Hamilton | United States | Unknown status |
| Robert W. Alexander, MD, FICS Coordinator of this site? Confirm its status | Hamilton | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.