<\/strong>Here, we explore why an intravenous infusion of a parent\u2019s Adipose-Derived Regenerative Cells (ADRCs)<\/a>, administered under the Federal Right to Try Act of 2017<\/a>, improved developmental progress in four children with diverse diagnoses. [1]<\/a> [2]<\/a><\/sup><\/p>\n
(Note: Quotes are summarized and lightly edited for clarity.) \u201cAbsolutely, the picture she made yesterday was really original\u2026not the rote pictures of hearts she\u2019s made the last months (love the love in the hearts, but it seemed she didn\u2019t have access to the rest of her experience).\u201d<\/p>\n Disorders of the Corpus Callosum<\/a> Rett Syndrome<\/a> Idiopathic Autism<\/a> Common Symptoms \u2013 Different Diagnoses – A New Cell-Assisted Therapeutic Approach <\/strong><\/p>\n \u201cAutism, or autism spectrum disorder (ASD), refers to a broad range of conditions characterized by challenges with social skills, repetitive behaviors, speech and nonverbal communication,\u201d according to Autism Speaks<\/a>.<\/p>\n Adipose Tissue and the ADRCs residing within it contain a heretofore well-kept secret that prophesies a new cell therapy-based standard of care for ASD. More on that in a moment; first, let\u2019s demystify developmental disabilities.<\/p>\n Contrary to conventional thought, a growing body of scientific evidence indicates that the Central Nervous System (CNS) alone does not cause ASD symptoms. Instead, researchers connect multiple body systems with developmental delays, seizures, and related health issues.<\/p>\n \u201cMany behaviors and physiologic imbalances are common in secondary or known-cause autism and idiopathic or unknown-cause autism<\/strong>.\u201d (Casanova et al. 2020)[3]<\/a><\/sup><\/p>\n ASD stymies neurologists, pediatricians, and basic scientists for an apparent reason: It involves not just one spectrum but also sub-spectrums, sub-sub-spectrums, and so on.<\/p>\n For example, \u201cRett syndrome is caused by mutations on the X chromosome on a gene called MECP2. There are more than 900 different mutations found on the MECP2 gene, most found in eight different \u2018hot spots\u2026\u2019, explains the International Rett Syndrome Foundation<\/a>.<\/p>\n Contrary to the drug development model, ADRCs are an \u201cadipopharmacy.\u201d<\/p>\n This mixed cell population uses natural intelligence (NI) to reverse the multiple dysregulations that cause the common ASD symptoms. From another angle, we have moved beyond the one-cell does-it-all paradigm. [7]<\/a> [8]<\/a> [9]<\/a><\/sup><\/p>\n <\/p>\n Notably, ADRCs \u201cdon\u2019t care\u201d about the cause, e.g., genetic, trauma, environmental, or brain malformation. \u00a0Our subcutaneous fat doesn\u2019t express these factors.<\/p>\n \u201cADRCs are smarter than we are; we just have to get out of the way and let them do their job,\u201d said one prominent stem cell researcher.<\/p>\n HYPOTHESIS – LINKING AT WITH FUNCTIONAL IMPROVEMENT IN ASD<\/strong><\/p>\n Just as music evokes an appropriate emotional response, a trend toward neurochemical balance and multisystem homeostasis, by definition, improves the quality of life for people with ASD-related functional deficits.<\/p>\n Ambrose Cell Therapy for ASD takes advantage of ADRCs\u2019 lead in keeping subcutaneous adipose tissue healthy, even later in life. The fact that we can maintain or gain weight when we are older proves this point. This attribute is undeterred by chronic diseases, genetics, and environmental factors.[13]<\/a> [14]<\/a> [15]<\/a><\/sup><\/p>\n ADIPOSE Tissue: The Body\u2019s Pipe Organ\u2014<\/strong><\/p>\n A January 2024 PubMed search discovered over 145,000 papers on the science of adipose tissue<\/a>. An understanding of the literature concludes that adipose tissue is the \u201cpipe organ\u201d of the body, including the brain.<\/p>\n Like the pipe organ imitates strings, horns, percussion, or wind instruments, adipose tissue (AT) functions as at least three bona fide organs.<\/p>\n From another angle, AT contains endothelial cells and endothelial progenitor cells (EPCs), which stimulate blood cell formation and vascular and immune health, all factors that contribute to neurologic health. [17]<\/a><\/sup><\/p>\n Did the investigators imagine their discovery would lead to a brighter future for Ann, Ashley, Sally, Becky, and others with developmental disorders?<\/p>\n Uncommon Causes \u2013 A Common Connection <\/strong><\/p>\n Peer-reviewed literature confirms an unexpected set of factors cause or contribute to ASD functional deficits, seizures, or inappropriate behaviors.<\/p>\n \u201cThe classical approach to autism spectrum disorders (ASD) is often limited to considering their neuro-functional aspects. However, recent scientific literature has shown that ASDs also affect many body systems and apparatuses such as the immune system, <\/em>the sensory-motor system<\/em><\/a>, and <\/em>the gut-brain axis<\/em><\/a>.<\/em><\/strong> The connective tissue, a common thread linking all these structures, may have a pathogenetic role in the multisystem <\/strong><\/em>involvement of ASD<\/em><\/strong>.\u201d\u00a0 (Zoccante et al Feb. 2022) [19]<\/a><\/sup><\/p>\n Connective tissue supports and protects our body\u2019s systems and organs. However, \u00a0connective tissue abnormalities lie at the heart of a wide range of diseases<\/a>.\u00a0 In his paper, Dr. Zoccante coined the term \u201cconnectiviome\u201d and included ASD in the connective tissue disorder spectrum.<\/p>\n The connectiviome theory begs the question: Can ADRCs that keep adipose connective tissue healthy be repurposed for treating ASD?\u00a0 But first, what other body systems connect to developmental delays?<\/p>\n THE AUTONOMIC NERVOUS SYSTEM AND THE CONNECTIVEIOME<\/strong><\/p>\n \u201cAutism spectrum disorder (ASD) is associated with atypical <\/strong><\/em>autonomic nervous system<\/em><\/strong><\/a> (ANS) function.<\/em><\/strong>\u201d<\/em> (Taylor et al. 2021) [20]<\/a><\/sup><\/p>\n Your autonomic (self-governing) nervous system controls unconscious processes such as breathing, heart rate, blood pressure, muscle control, and bladder and bowel function.<\/p>\n The ANS consists of two nervous systems that supply or restrain nervous energy (innervate):<\/p>\n In other words, the sympathetic and parasympathetic divisions work in concert to stimulate or inhibit various body processes.\u00a0 Their contrary but complementary functions help maintain whole-body balance or homeostasis, including in the gut.<\/p>\n Our SNS and PNS supply nerves to (innervate) connective tissue, including subcutaneous fat. Therefore, connective tissue health and disease are linked with ANS function or dysfunction.<\/p>\n Therein lies another notable connection between healthy fat and our ADRCs\u2019 potential to retune the autonomic nervous system.<\/p>\n ADRCS RESTORE ANS BALANCE<\/strong><\/p>\n Before cell therapy, Ashley and Ann displayed aggressive and repetitive behaviors, symptoms of sympathetic nervous system (SNS) hyper-arousal.<\/p>\n Following their intravenous delivery of ADRCs (ADRC-IV), their families shared their girl\u2019s sustained behavioral improvements:<\/p>\n ADRCs and the Second Brain \u2013 The Gut Microbiome <\/strong><\/p>\n Notably, the Vagus Nerve<\/a> (VN), which extends from the base of the brain to the stomach, regulates the gut-brain axis. Thus, by reactivating the VN (restoring vagal tone), ADRCs also restore gut microbiome homeostasis. [21]<\/a><\/sup><\/p>\n \u201cAnn\u2019s constipation is better,\u201d reported her mother four months after ADRC therapy.<\/p>\n These dramatic behavior changes indicate that their girls\u2019 parasympathetic nervous systems are more in tune with their environment. In addition, ADRCs restored Ann\u2019s brain-gut-adipose-tissue <\/strong>communication pathways.[22]<\/a><\/sup><\/p>\n Autonomic and Autoimmune Dysregulation<\/strong><\/p>\n Many people believe inflammation is the root of all physical and emotional evils. However, there is more to it than that.<\/p>\n An out-of-control autonomic stress response raises cortisol and adrenaline levels, lighting the inflammation fire. Then, the immune system throws gas on the flames, resulting in autoimmune diseases. [23]<\/a><\/sup><\/p>\n UC Davis Mind Institute studies find that ASD children have reduced immune system regulation, as well as shifts in their gut microbiome. A family history of autoimmune diseases adds fuel to the multisystem dysregulation blaze. [24]<\/a> [25]<\/a> [26]<\/a><\/sup><\/p>\n In sum, the connectiviome, autonomic dysfunction, and autoimmune dysregulation disconnect the CNS and other systems of the developmentally delayed. [27]<\/a><\/sup> There is still more to the multisystem dysregulation cacophony.<\/p>\n ADSC\u2019s immunomodulation mechanism plays a crucial role. They interact with immune cells, including T cells, B cells, macrophages, and dendritic cells, to modulate the immune response. [28]<\/a><\/sup><\/p>\n Neurochemical Imbalances<\/strong><\/p>\n The symphony\u2019s conductor directs the musicians so that their performance enlivens our emotions. However, while only one conductor leads a symphony, a group of conductors called neurochemicals <\/strong>orchestrates our brains and peripheral and autonomic nervous systems.<\/p>\n Strikingly, over 40 neurochemicals guide our nervous systems. Then, our nerves direct our muscles and organs.<\/p>\n Research has identified altered neurochemical pathways involved in Rett Syndrome, epilepsy, brain injury, and other diagnoses along the continuum. [29]<\/a><\/sup><\/p>\n \u201cIn this review, we aim to delineate the state-of-the-art main research findings about the neurochemical alterations in autism etiology…<\/em>\u201d (Marotta et al. 2020) [30]<\/a><\/sup><\/p>\n ADIPOSE TISSUE \u2013 OUR THIRD BRAIN<\/strong><\/p>\n \u201cAltogether, this may, like neuroendocrinology and neuroimmunology, open a novel field of research, neuroadipobiology<\/strong>. Its development may help humans stay lean, thoughtful, and noble.\u201d<\/em> (Emphasis added) [31]<\/a><\/sup><\/p>\n The literature suggests that ADRCs harness neuroadipobiology and reverse \u201cirreversible\u201d neurochemistry.<\/p>\n Neurotrophic Factors (NF)<\/strong><\/p>\n As a conductor directs the orchestra, NFs orchestrate our neurons\u2019 growth, survival, and repair. They feed molecular nutrients to the brain, nervous, vascular, and immune systems. [32]<\/a><\/sup><\/p>\n Examples:<\/p>\n ADRCs increase NF levels<\/strong><\/p>\n Ashley was at the 25th<\/sup> percentile of weight for her age, indicative of a lack of IGF-1 (insulin-like growth factor-1). She was also behind in school, suggesting reduced BDNF levels. [34]<\/a> [35]<\/a><\/sup><\/p>\n Within several months of her cell therapy, Ashley:<\/p>\n Ann\u2019s reading level \u201cimproved by a whole grade\u201d in the first five months of sixth grade,\u201d her mom said.<\/p>\n Sally\u2019s BMI (body mass index) was at the 15th<\/sup> percentile before her treatment. Four months after her treatment, she also reached the 95th<\/sup> percentile.<\/p>\n Ashley\u2019s, Ann\u2019s, and Sally\u2019s restored development after extended delays suggests that their respective parents\u2019 ADRCs increased IGF-1, BDNF, and other NFs.<\/p>\n Cell biology literature supports this theory.[37]<\/a> [38]<\/a> [39]<\/a> [40]<\/a> [41]<\/a><\/sup><\/p>\n Neurotransmitters<\/strong><\/p>\n Neurotransmitters carry messages from one nerve cell across to the next nerve, muscle, or gland cell, explains the Cleveland Clinic<\/a>.<\/p>\n Dozens of neurotransmitters riff back and forth, depending on the tone of life\u2019s music, like a jazz quartet in a jam session. Their proper balance creates a sense of well-being, energy, restfulness, excitement, relaxation, and so forth.<\/p>\n Example:<\/p>\n Gamma-aminobutyric acid (GABA) calms. Think of GABA as a mellow tune that helps you relax. On the opposite side of the coin, glutamate plays dance music.\u00a0\u00a0 But if the music blares, GABA levels reduce, and glutamate increases.<\/p>\n After cell therapy, their moms shared:<\/p>\n Neuropeptide Y (NPY) helps harmonize the central and peripheral nervous systems. It plays alongside GABA and glutamate. NPY\u2019s functions include controlling epileptic seizures<\/strong>. Research has shown a significant reduction in NPY levels during the delayed post-seizure recovery (postictal period). [47]<\/a><\/sup><\/p>\n Lest we undervalue Ann\u2019s dramatic improvement, even if imperfect, several seizures per day or \u201cseizure clusters\u201d increase the risk of sudden unexplained death (SUND) by 2.5 times.<\/u><\/em>[48]<\/a><\/sup><\/p>\n Neuroendocrine hormones<\/strong><\/p>\n \u201cThe central neuroendocrine systems are responsible for the control of homeostatic processes in the body, including reproduction, growth, metabolism and energy balance, and stress responsiveness.\u201d<\/em> (Gore 2010) [49]<\/a><\/sup><\/p>\n Example:<\/p>\n Dopamine, norepinephrine, and epinephrine maintain homeostasis through the autonomic nervous system.<\/p>\n This continuous balancing act between dopamine and adrenal hormones also plays a role in your fight-or-flight response.<\/p>\n After ADRC therapy:<\/p>\n Neurochemical Summary<\/strong><\/p>\n ADRCs\u2019 treasure trove of signaling molecules, hormones, growth factors, and neurotrophic factors helps:<\/p>\n Conclusion<\/strong><\/p>\n Ambrose Cell Therapy has demonstrated with four ASD patients with different diagnoses that a single infusion of a parent\u2019s ADRCs made a profound difference in their developmental progress and quality of life. These strong signals of safety and effectiveness call for continued investigation and therapy under the Federal Right to Try Act of 2017<\/a>.<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.24.2″ text_font_size=”14px” text_line_height=”1.6em” custom_padding=”0px|||||” global_module=”7842″ global_colors_info=”{}”][\/et_pb_text][et_pb_text _builder_version=”4.24.2″ text_font_size=”80%” text_line_height=”1.5em” global_colors_info=”{}”][1]<\/a> Kesten S, Fraser JK. Autologous Adipose Derived Regenerative Cells: A Platform for Therapeutic Applications. Surg Technol Int. 2016 Oct 26;29:38-44.<\/p>\n [2]<\/a> Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use \u2013 Compliance Policy<\/a><\/p>\n [3]<\/a> Casanova MF et al. Editorial: Secondary vs. Idiopathic Autism. Front Psychiatry. 2020 Apr 14;11:297.<\/p>\n [4]<\/a> Clarke C, Evans J, Brogan K. Treatment Emergent Violence To Self And Others; A Literature Review of Neuropsychiatric Adverse Reactions For Antidepressant And Neuroleptic Psychiatric Drugs And General Medications. Adv Mind Body Med. 2019 Winter;33(1):4-21.<\/p>\n [5]<\/a> \u00a0<\/strong>Moore TJ et al. (2010) Prescription Drugs Associated with Reports of Violence Towards Others. PLoS ONE 5(12): e15337.<\/p>\n [6]<\/a> Spencer D et al. Psychotropic medication use and polypharmacy in children with autism spectrum disorders. Pediatrics. 2013 Nov;132(5):833-40. doi: 10.1542\/peds.2012-3774. Epub 2013 Oct 21. PMID: 24144704; PMCID: PMC3813388.<\/p>\n [7]<\/a> Alshoubaki YK et al. Modulation of the Activity of Stem and Progenitor Cells by Immune Cells. Stem Cells Transl Med. 2022 Mar 31;11(3):248-258<\/p>\n [8]<\/a> Caplan AI. Mesenchymal Stem Cells: Time to Change the Name! Stem Cells Transl Med. 2017 Jun;6(6):1445-1451.<\/p>\n [9]<\/a> Zeni\u0107 L et al. Medicinal signaling cells niche in stromal vascular fraction from lipoaspirate and microfragmented counterpart. Croat Med J. 2022 Jun 22;63(3):265-272.<\/p>\n [10]<\/a> Chugani, Diane C et al. Autism Spectrum Disorders<\/em>\u00a0(New York,\u00a02011;\u00a0online edn,\u00a0Oxford Academic, 1 Sept. 2012),<\/p>\n [11]<\/a> Zoccante L et al. The “Connectivome Theory”: A New Model to Understand Autism Spectrum Disorders. Front Psychiatry. 2022 Feb 7;12:794516.<\/p>\n [12]<\/a> Booth A et al. Adipose tissue: an endocrine organ playing a role in metabolic regulation. Horm Mol Biol Clin Investig. 2016 Apr 1;26(1):25-42.<\/p>\n [13]<\/a> Perin EC, Willerson JT. Buying new soul. J Am Coll Cardiol. 2012 Nov 20;60(21):2250-1.<\/p>\n
Rasmussen’s Encephalitis<\/a>
\u201cAnn\u2019s imagination has been back in full force. She would play, but it seems she\u2019s more imaginative. Do you agree, Mom? \u201c![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2024\/03\/Ellas-Drawings-600x451.jpg\")
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\u201cBecky is walking all over the place. I let her decide where she is going unless we are running late, and then I hold her hand. She is doing so well.\u201d![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2024\/03\/Becky-walking-with-Dad-600x450.jpeg\")
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\u201cSally has been very engaged. There are moments throughout the day when she is completely engaged, making eye contact and smiling, and she even finds things funny now.\u201d![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2024\/03\/Rapid-change-sequence-for-Eleanor-600x458.png\")
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\u201cAshley is more complimentary and appreciative, overall, more alive!\u201d![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2024\/03\/Eva-hugging-Mom-450x600.jpeg\")
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Yet pharma and biotech focus on their unvaried one drug, one disease (or symptom) model. ASD\u2019s diversity of causes and range of symptoms makes that approach unworkable. Additionally, the prescribed drugs often come with black box warnings, a multitude of potential side effects, and unpredictable interactions. [4]<\/a> [5]<\/a> [6]<\/a><\/sup><\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2024\/03\/Adipopharmacy-600x390.png\")
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\u201cIn my eyes and ears, the organ is the King of Instruments.\u201d
<\/strong>– Wolfgang Amadeus Mozart<\/em><\/strong><\/p>\n\n
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In 2001, UCLA and University of Pittsburgh researchers unveiled a pool of multipotent cells in adipose tissue.[18]<\/a><\/sup> (Zuk et al. 2001) \u00a0More than twenty years of research and over 115,000 publications<\/a> followed their seminal paper.<\/p>\n\n
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The adipose tissue as a third brain <\/strong>(Chaldakov et al. 2009) connects the adipose tissue secretome with neurochemical, ANS, and multisystem harmony.<\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2024\/03\/Neuroadipobiology-600x450.jpeg\")
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