Stem cells, gut bacteria transplant and ketogenic diet for autism in teens and adults
Tests stem cells, fecal transplant and a ketogenic diet in autistic adolescents and adults.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Hamilton, United StatesSee the 2 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 90 years old?
Source: NCT07546942, who can take part
Where in United States
- Regenevita HealthHamilton, United StatesNo longer taking part
- Robert W. Alexander, MD, FICSHamilton, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Black Tie Medical, Inc.
- Trial code
- NCT07546942
- Record updated
- 27 April 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: ADS; Stable on current medications or therapy; With/wthout comorbid GI (gut/Axis) symptoms.
Exclusion: 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; Severe GI disease or malnutrition; Inability to perform the monitoring of FMT without supervision by qualfied Provider.