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.

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.

Timeline

Start

2026-04-30

Primary completion

2030-06-01

Completion

2030-08-14

Publications

• Background 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 Li Y, Luo ZY, Hu YY, Bi YW, Yang JM, Zou WJ, Song YL, Li S, Shen T, Li SJ, Huang L, Zhou AJ, Gao TM, Li JM. The gut microbiota regulates autism-like behavior by mediating vitamin B6 homeostasis in EphB6-deficient mice. Microbiome. 2020 Aug 20;8(1):120. doi: 10.1186/s40168-020-00884-z.
• Background Sharon G, Cruz NJ, Kang DW, Gandal MJ, Wang B, Kim YM, Zink EM, Casey CP, Taylor BC, Lane CJ, Bramer LM, Isern NG, Hoyt DW, Noecker C, Sweredoski MJ, Moradian A, Borenstein E, Jansson JK, Knight R, Metz TO, Lois C, Geschwind DH, Krajmalnik-Brown R, Mazmanian SK. Human Gut Microbiota from Autism Spectrum Disorder Promote Behavioral Symptoms in Mice. Cell. 2019 May 30;177(6):1600-1618.e17. doi: 10.1016/j.cell.2019.05.004.
• Background Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1.
• Background Wang J, Li R. Effects, methods and limits of the cryopreservation on mesenchymal stem cells. Stem Cell Res Ther. 2024 Sep 29;15(1):337. doi: 10.1186/s13287-024-03954-3.
• Background Xie J, Ekpo MD, Xiao J, Zhao H, Bai X, Liang Y, Zhao G, Liu D, Tan S. Principles and Protocols For Post-Cryopreservation Quality Evaluation of Stem Cells in Novel Biomedicine. Front Pharmacol. 2022 May 3;13:907943. doi: 10.3389/fphar.2022.907943. eCollection 2022.
• Background Ferreira MY, Carvalho Junior JDC, Ferreira LM. Evaluating the quality of studies reporting on clinical applications of stromal vascular fraction: A systematic review and proposed reporting guidelines (CLINIC-STRA-SVF). Regen Ther. 2023 Aug 26;24:332-342. doi: 10.1016/j.reth.2023.08.003. eCollection 2023 Dec.
• Background Wragg NM, Tampakis D, Stolzing A. Cryopreservation of Mesenchymal Stem Cells Using Medical Grade Ice Nucleation Inducer. Int J Mol Sci. 2020 Nov 13;21(22):8579. doi: 10.3390/ijms21228579.
• Background Bradstreet, J.J. et al. Cell Transplant. 2014: 23:1 suppl): 105-112
• Background Park EH, Lim HS, Lee S, Roh K, Seo KW, Kang KS, Shin K. Intravenous Infusion of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in Rheumatoid Arthritis: A Phase Ia Clinical Trial. Stem Cells Transl Med. 2018 Sep;7(9):636-642. doi: 10.1002/sctm.18-0031. Epub 2018 Aug 15.
• 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.
• Background Nguyen LT, Nguyen PM, Nguyen HP, Bui HT, Dao LTM, Van Pham M, Hoang CK, Nguyen PT, Nguyen TTP, Nguyen ATP, Hoang VT, Bui HTP, Vuong NK, Van Ngo D. Outcomes of autologous bone marrow mononuclear cell administration combined with educational intervention in the treatment of autism spectrum disorder: a randomized, open-label, controlled phase II clinical trial. Stem Cell Res Ther. 2025 May 30;16(1):268. doi: 10.1186/s13287-025-04404-4.
• Background Nagpal R, Neth BJ, Wang S, Craft S, Yadav H. 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 Sep;47:529-542. doi: 10.1016/j.ebiom.2019.08.032. Epub 2019 Aug 30.
• Background Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7.
• Background Galipeau, J, et al. J Translat Med, 2019: 17:397
• Background Villarreal-Martinez L, Gonzalez-Martinez G, Saenz-Flores M, Bautista-Gomez AJ, Gonzalez-Martinez A, Ortiz-Castillo M, Robles-Saenz DA, Garza-Lopez E. Stem Cell Therapy in the Treatment of Patients With Autism Spectrum Disorder: a Systematic Review and Meta-analysis. Stem Cell Rev Rep. 2022 Jan;18(1):155-164. doi: 10.1007/s12015-021-10257-0. Epub 2021 Sep 13.

Drugs

Indications