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 | Enrolling By Invitation Phase 1 DMC FDA Drug

• 1 other identifier: GARM-Autism Adults
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Autism Spectral Disorder; Autism Spectrum Disorder; Autism

Keywords

Socialization; Learning Disability; Situational awareness and communication; Bowel dysfunction (flora correction); cSVF and Cryopreserved MSCs (autologous)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Months and 1 year

Secondary Outcomes (1)

• Gut-Brain Axis Improvement

  1 year

Study Arms (1)

ASD behavior, learning, communication and diet

EXPERIMENTAL

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

Interventions

Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells PROCEDURE

Isolation/concentration autologous MSCs derived from tSVF from each patient participant only

ASD behavior, learning, communication and diet

Fecal Biomicrome Transplantation (FMT) DIETARY_SUPPLEMENT

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

ASD behavior, learning, communication and diet

Ketogenic RESET Diet Protocol DIETARY_SUPPLEMENT

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

ASD behavior, learning, communication and diet

Trial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patients BEHAVIORAL

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)

ASD behavior, learning, communication and diet

FMT (Fecal Material Tranplantation) DIETARY_SUPPLEMENT

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

ASD behavior, learning, communication and diet

Use autologous cSVF + MSCs (cryo) for management of autoimmune component, anti-inflammatory and immune modulation BIOLOGICAL

Use of cSVF isolation and submission to FDA certified tissue/cell bank for subsequent use of autolgous patient only

ASD behavior, learning, communication and diet

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ADS
• Stable on current medications or therapy
• With/wthout comorbid GI (gut/Axis) symptoms

You may not qualify if:

• Recent antiobiotics or probiotic therapy within 30 days
• Severe GI disease or malnutrition
• Recent major surgery that may interfere with study course
• Other Med/Surgery issues that may preclude treatment with this protocol
• Inability to perform the monitoring of FMT without supervision by qualfied Provider

Sponsors & Collaborators

• Black Tie Medical, Inc.: lead

Study Sites (2)

Regenevita Health

Hamilton, Montana, 59840, United States

Location

Robert W. Alexander, MD, FICS

Hamilton, Montana, 59840, United States

Location

Related Publications (19)

• Alexander, Robert W. Overview of COVID-19 Lung Damage Clinical Trial NCT#04326036 Using Cellular Stromal Vascular Fraction (cSVF) and Functional Respiratory Imaging (FRI) Analysis of Pulmonary Injury & Post-Viral (SARS-Cov-2) Adult Respiratory Distress Syndrome (ARDS). Ann Stem Cell Res Ther. 2020; 4(1): 1039.

  BACKGROUND

• Alexander, Robert W. Overview of Cellular Stromal Vascular Fraction (cSVF) & Biocellular Uses of Stem/Stromal Cells and Matrix (tSVF + HD-PRP) in Regenerative Medicine, Aesthetic Medicine and Plastic Surgery. J. Stem Cell Res Dev Ther. 2019; 4:1-15.

  BACKGROUND

• Alexander, Robert W., Everts, Peter A. Understanding Communication Between Cellular Stromal Vascular Fraction (cSVF), Mesenchymal Stem Cells (MSC), Pericytes, Blood Derivative (HD PRP): Mechanisms in Inflammation and Immune Modulation. 2026; J Stem Cell Res. 7(1)-81. DOI:http:doi.org/10.52793/JSCR.2026.7(7(1)-81.

  BACKGROUND

• Liu, S., Li, E. et al. The gut microbiota regulates autism-like behavior by mediating vitamin B6 in EphB6-deficient mice. Microbiome. 2020; 8: 120.

  BACKGROUND

• Sharon, G., Cruz, N.J., et al. Human gut microbiome from autism spectrum disorder promote behavioral symptoms in mice. Microbiome. 2019; 7: 3.

  BACKGROUND

• Zuo, T., Kamm, M.A. et al. Fecal microbiota transplantation: indications, methods, evidence and future directions. Microbiome. 2017; 5:24.

  BACKGROUND

• Effects, methods and limits of cryopreservation on mesenchymal stem cells. Stem Cell Res Ther. 2024; 5-24.

  BACKGROUND

• Principles and Protocols for Post-Cryopreservation Quality Evaluation of Stem Cells in Novel Biomedicine. Cells. 2022; 11(9): 1563

  BACKGROUND

• Quintero, A.J., et al. Evaluating the quality of studies reporting on clinical application of stromal vascular fraction: A systematic review and proposed reporting guidlines (CLINIC-STRA-SVF), J Transl Med. 2023; 21:456.

  BACKGROUND

• Wragg, N.M. et al. Intern J Mol Sci. 2020: 21(22): 8579.

  BACKGROUND

• Bradstreet, J.J. et al. Cell Transplant. 2014: 23:1 suppl): 105-112

  BACKGROUND

• Chez, MG, et al. Stem Cells Transl Med. 2018: 7(7): 636-647

  BACKGROUND

• Brinkman FSL, Winsor GL, Done RE, Filloux A, Francis VI, Goldberg JB, Greenberg EP, Han K, Hancock REW, Haney CH, Haussler S, Klockgether J, Lamont IL, Levesque RC, Lory S, Nikel PI, Porter SL, Scurlock MW, Schweizer HP, Tummler B, Wang M, Welch M. The Pseudomonas aeruginosa whole genome sequence: A 20th anniversary celebration. Adv Microb Physiol. 2021;79:25-88. doi: 10.1016/bs.ampbs.2021.07.001. Epub 2021 Nov 16.

  PMID: 34836612 BACKGROUND

• Quintero, A. J. et al. Evaluating the quality of studies reporting on clinical applications of stromal vascular fraction: A systematic review and proposed reporting guideline (CLINIC-STRA-SVF). J Transl Med. 2023; 21: 456.

  BACKGROUND

• Nguyen, Thanh L., Nguyen, H.P, et al. Outcomes of autologous bone marrow mononuclear cell administration combined with educational intervention in the treatment of autism spectrum disorder: a randomize, open label, controlled phase II clinical trial. Stem Cell Res Ther. 2025; 15(1):404

  BACKGROUND

• Nagpal, R., Neth, B.J et al. Modified Mediterranean-ketogenic diet modulates gut microbiome and short-chain fatty acids in association with alzheimer's disease markers in subjects with mild cognitive impairment. EBioMedicine. 2019: 47:529-542.

  BACKGROUND

• Kang, D.W., Adams, JB, et al. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptom: an open label study. Microbiome. 2017: 5 :10

  BACKGROUND

• Galipeau, J, et al. J Translat Med, 2019: 17:397

  BACKGROUND

• Xie, Y et al. Stem Cell Therapy in the Treatment of Patient with Autism Spectrum Disorder: a Systematic Review and Meta-analysis. Stem Cell Rev Rep. 2021; 17(5): 1769-1780.

  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Learning Disabilities; Communication; Intestinal Diseases

Interventions

Fecal Microbiota Transplantation; Anti-Inflammatory Agents; Immunomodulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Immune System Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional use of autolgous cSVF and MSCs; Diet modifications, OT/PT learning and training

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 23, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): August 14, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)