A Phase 1/2 interventional study of Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells and Fecal Biomicrome Transplantation (FMT) in Autism Spectrum Disorder, Autism and Autism Spectral Disorder, sponsored by Black Tie Medical, Inc.. Enrolling by invitation at 2 sites in United States. Open to participants aged 10 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Black Tie Medical, Inc. · Phase 1/2, Interventional, and Treatment
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.
This refined protocol integrates the latest evidence for a multimodal intervention-autologous cSVF, cryopreserved autologous MSCs, FMT, and a structured ketogenic protocol program-for adolescent and adult ASD management.
Protocol Summary
Title:
A Phase 1-2 Randomized Controlled Trial Evaluating the Safety and Efficacy of Multimodal Therapy (Autologous cSVF + Cryopreserved Autologous MSCs, Fecal Microbiota Transplantation, Ketogenic Program Reset, and OT/PT Training) in Adolescents and Adults with Autism Spectrum Disorder (ASD-Multi-level scoring)
Sponsor: Blacktie Principal Investigator: Robert W. Alexander, MD, FICS Study Phase: Phase I/II Study Centers: 1-3 Clinical Applied Research Laboratories/academic centers with expertise in ASD, stem cell processing and utilization, plus gastroenterology/PMD consultants available for FMT in patient's locale
Compliance:
NIH and IRB oversight Informed consent for all participants
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Background and Rationale 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-may offer synergistic benefits for adolescents and adults with ASD.
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Objectives and Endpoints
Primary Objective:
Secondary Objectives:
Endpoints:
Study Design and Methodology
Study Population
Inclusion Criteria:
Exclusion Criteria:
Intervention Protocols 6.1 Autologous Cellular Stromal Vascular Fraction (cSVF)
Safety Monitoring Plan
Outcome Measures and Biomarker Assessments Domain Assessment Tools/Markers ASD Symptoms CARS, SRS, ABC, VABS-II; observational behavior, socialization changes, communication abilities, GI Symptoms Bristol Stool Scale; Management testing of bowel flora bacteria Metabolic Blood glucose, ketones, vitamin B6, dopamine Inflammation Fecal calprotectin, serum IgA, ESR/CRP Safety AE/SAE logs, laboratory monitoring
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Statistical Analysis Plan
Regulatory and Ethical Considerations
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 50 is close to the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Black Tie Medical, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
diet, bowel flora, autoimmune tracking, cSVF/MSC (cryo) multimodal approach
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
Isolation/concentration autologous MSCs derived from tSVF from each patient participant only
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
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
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)
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
Use of cSVF isolation and submission to FDA certified tissue/cell bank for subsequent use of autolgous patient only
Socialization Alterations
SRS-2 caregiver/teacher: Change in social behavior as measured by the Social Responsiveness Scale, Second Edition (SRS-2), a 65-item caregiver- and teacher-reported instrument scored on a scale of 0 to 195, where lower scores indicate better social functioning. SRS-2 assessments are completed at baseline, 3 months, 6 months, and 12 months to evaluate change over time.Time Frame: Baseline, 3 months, 6 months, and 12 months
Time frame: 1 year
Communication/Education Enhancement
PPVT-5 Peabody Picture Vocabulary testing: Change in receptive vocabulary and language comprehension as measured by the Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5). Standard scores range from approximately 40 to 160 (mean = 100, SD = 15), where higher scores indicate better vocabulary and language ability. Testing is administered at baseline, 3 months, 6 months, and 12 months.Time Frame: Baseline, 3 months, 6 months, and 12 months
Time frame: Months and 1 year
Gut-Brain Axis Improvement
GSRS Testing: Change in gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item patient- or caregiver-reported questionnaire. Scores range from 1 to 7 per item (total composite score 15-105), where lower scores indicate fewer or less severe GI symptoms. Assessed at baseline, 3 months, 6 months, and 12 months.Time Frame: Baseline, 3 months, 6 months, and 12 months
Time frame: 1 year
Plan to share: No
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Black Tie Medical, Inc.