In December 2017, Jeff’s spine surgery gone wrong resulted in an SCI and paraplegia. His extended hospitalization led to an abscessed colon requiring an ileostomy.\u00a0 Compounding matters, he lived with T2 diabetes.<\/p>\n
Jeff complained of neck and back pain, neuropathy, scar pain from the ileostomy, claw toes, spasticity, poor balance, diabetes T2, shoulder immobility, and erectile dysfunction (ED).\u00a0 He took seven meds to manage his symptoms, including opioids.<\/p>\n
Our in-depth review of published SCI stem cell therapy studies yielded positive results. Thus, AMBROSE curated the literature and developed a personalized protocol<\/a> for Jeff.<\/p>\n The treatment strategy was unconventional. Rather than only targeting the spinal cord lesion, the AMBROSE medical team addressed Jeff’s array of complaints in a single procedure using a Master Protocol<\/a>.<\/p>\n In essence, AMBROSE designed one overarching protocol to treat multiple issues in a single treatment including the injury site, using adipose-derived regenerative cells (ADRCs). Our treatment team then personalizes it for each patient.<\/p>\n Importantly, our previous group’s prior successes using a Master Protocol with over 300 patients living with diverse chronic conditions supported our hypothesis. \u00a0(Okyanos Cell Therapy, Bahamas 2014- 2017).<\/p>\n In addition:<\/p>\n Hypothesis Hence, patients suffer from an array of secondary complications.<\/p>\n Further, the overwhelming insult suppresses spinal cord regeneration, limiting functional recovery. Thus, the expected window of improvement for SCI patients is ~12 months.<\/p>\n As an example, Jeff’s symptoms included 24\/7 scar pain, neuropathy, bilateral spasticity, bowel and bladder issues, ED, and impaired balance. At 11 months post-injury, Jeff and his physiatrist recognized his progress had leveled off.<\/p>\n Yet, drug discovery focuses on a single mechanism of action to repair the injury site or suppress a symptom. Put differently, the pharma model of one drug, gene, or cell type to treat a disease has made little progress in improving the prognosis for patients living with spinal cord injuries. This approach neglects a deep body of literature documenting the multiple factors and resulting comorbidities that combine to handicap patients like Jeff.<\/p>\n Multiple Mechanisms of ADRCs ADRCs home to sites of inflammation and secrete hundreds of bioactive molecules that are anti-inflammatory, immuno-modulatory, angiogenic, anti-apoptotic, and wound healing.<\/p>\n ADRCs work through cell-to-cell communication or the paracrine effect.<\/p>\n Beyond wound healing mechanisms, ADRCs restore cellular, systemic, and tissue equilibrium (multisystem homeostasis). [10]<\/a> [11]<\/a><\/sup><\/p>\n In Jeff’s recovery, the restoration of multisystem homeostasis included improved balance, pain scores, bladder, and bowel function, as well as a significant reduction in spasticity. \u00a0The net result was an elimination of all drugs, engaging in hardcore gym workouts, a return to racing, learning to fly helicopters and scuba diving, plus playing golf three times a week. \u00a0Though not cured or asymptomatic, Jeff is real-world evidence that ADRCs extended Jeff’s recovery window.<\/p>\n In sum, our preliminary evidence indicates that ADRCs can extend or restart the neurologic window of recovery by restoring multisystem homeostasis.<\/p>\n Why Adipose Tissue? \u00a0<\/strong>Why ADRCs<\/strong><\/p>\n A<\/u>dipose-D<\/u>erived R<\/u>egenerative C<\/u>ells (ADRCs) are the designation for a clinical-grade preparation of stromal vascular fraction (SVF), a heterogeneous population of cells residing on the outer lining of the capillaries in adipose tissue. The cell mix includes MSCs, endothelial cells (ECs), endothelial progenitor cells (EPCs), fibroblasts, T-regulatory cells (Tregs), macrophages, and other immune cells (leukocytes).[13]<\/sup><\/a><\/p>\n ADRCs secrete significantly higher amounts of trophic factors compared to Adipose-Derived MSCs (ADSCs).[14]<\/a> Therefore, the ADRC secretome amplifies the MOAs of ADSCs, including but not limited to:<\/p>\n Human studies show ADRCs:<\/p>\n Notably, a close relationship exists between revascularization and improved functional outcomes after SCI. First, a well-vascularized lesion provides a permissive microenvironment for local tissue survival\u00a0and nerve regeneration. Improved capillary blood flow, angiogenesis, and B-SC-B integrity facilitate functional recovery.[15]<\/sup><\/a> [16]<\/sup><\/a><\/p>\n Neurotrophic factors BDNF:<\/p>\n A recent discovery of neuro-immune cells in ADRCs connects their role in enhancing neuroplasticity.[22]<\/sup><\/a> [23]<\/sup><\/a><\/p>\n Safety <\/p>\n [\/et_pb_text][et_pb_divider color=”RGBA(0,0,0,0)” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.16″ text_font_size=”80%” text_line_height=”1.3em” background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”]<\/p>\n [1]<\/a> Chen et al Transplantation of mesenchymal stem cells for spinal cord injury: a systematic review and network meta\u2011analysis J Transl Med (2021) 19:178<\/p>\n [2]<\/a> Cherian C et al. Autologous, micro-fragmented adipose tissue as a treatment for chronic shoulder pain in a wheelchair using individual with spinal cord injury: a case report Spinal Cord Series and Cases\u00a0(2019) 5:46<\/p>\n [3]<\/a> Huang S-H, Wu S-H, Lee S-S, Chang K-P, Chai C-Y, Yeh J-L, et al. (2015) Fat Grafting in Burn Scar Alleviates Neuropathic Pain via Anti- Inflammation Effect in Scar and Spinal Cord. PLoS ONE 10(9): e0137563<\/p>\n [4]<\/a> A Nguyen, A et al Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) 69, 170e179<\/p>\n [5]<\/a> Guo et al Stromal vascular fraction: A regenerative reality? Part 2: Current concepts and review of the literature Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) 69, 180e188<\/p>\n [6]<\/sup><\/a> Sun et al. Multiple organ dysfunction and systemic inflammation after spinal cord injury: a complex relationship Journal of Neuroinflammation (2016) 13:260<\/p>\n [7]<\/a> B. Perrouin-Verbe, C. Lefevre, P. Kieny, R. Gross, B. Reiss, M. Le Fort, Spinal cord injury: A multisystem\u00a0physiological impairment\/dysfunction, Revue Neurologique, Volume 177, Issue 5, 2021, Pages 594 605,<\/p>\n [8]<\/a> Marion et al. Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury\u2014Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study JOURNAL OF NEUROTRAUMA 34:2883\u20132891 (October 15, 2017)<\/p>\n [9]<\/a> Caplan A I Mesenchymal Stem Cells: Time to Change the Name! STEM CELLS TRANSLATIONALMEDICINE 2017; 6:1445\u20131451<\/p>\n [10]<\/a> Visoso F. J. et al Mesenchymal Stem Cells in Homeostasis and Systemic Diseases: Hypothesis, Evidences, and Therapeutic Opportunities Int. J. Mol. Sci. 2019, 20, 3738<\/p>\n [11]<\/a> Morris, M.E. et al. (2015), Systemically Delivered Adipose Stromal Vascular Fraction Cells Disseminate to Peripheral Artery Walls and Reduce Vasomotor Tone Through a CD11b+<\/sup>\u00a0Cell-Dependent Mechanism. STEM CELLS Translational Medicine, 4: 369-380.<\/p>\n [12]<\/a> Perin EC and Willerson JT Buying New Soul J Am Coll Cardiol. 2012;60(21):2250-2251<\/p>\n [13]<\/a>S Kesten and JK Fraser Autologous Adipose Derived Regenerative Cells: A Platform for Therapeutic Applications Advanced Wound Healing Surgical Technology International XXIX<\/p>\n [14]<\/a> Hirosi Y et al. Comparison of trophic factors secreted from human adipose-derived stromal vascular fraction with those from adipose-derived stromal\/ stem cells in the same individuals<\/p>\n [15]<\/sup><\/a>Yao C, Cao X and Yu B (2021) Revascularization After Traumatic Spinal Cord Injury. Front. Physiol. 12:631500.<\/p>\n [16]<\/a> Numan MT et al. Autologous Adipose Stem Cell Therapy for Autonomic Nervous System Dysfunction in Two Young\u00a0Patients. Stem Cells and Development\u00a02017\u00a026:6,\u00a0391-393<\/p>\n [17]<\/a> Razavi, Shahnaz et al. \u201cNeurotrophic Factors and Their Effects in the Treatment of Multiple Sclerosis.\u201d\u00a0Advanced\u00a0<\/em>Biomedical Research<\/em>\u00a04 (2015): 53.\u00a0PMC<\/em>. Web. 28 Sept. 2018.<\/p>\n [18]<\/a> J. K. Huang et al Myelin Regeneration in Multiple Sclerosis: Targeting. Endogenous Stem Cells., The American\u00a0Society for Experimental NeuroTherapeutics, Inc. 2011<\/p>\n [19]<\/a> T Lopatina et al. (2011) Adipose-Derived Stem Cells Stimulate Regeneration of Peripheral Nerves: BDNF Secreted by These Cells Promotes Nerve Healing and Axon Growth De Novo. PLoS ONE 6(3): e178991<\/p>\n [20]<\/a> S.\u00a0 Seigo et al, Uncultured adipose-derived regenerative cells promote peripheral nerve regeneration, Journal of Orthopaedic Science, Volume 18, Issue 1,2013, Pages 145-151<\/p>\n [21]<\/a> Xu et al Brain-derived neurotrophic factor reduces inflammation and hippocampal apoptosis in experimental Streptococcus pneumoniae meningitis Journal of Neuroinflammation (2017) 14:156<\/p>\n [22]<\/a> O\u2019Reilly ML and Tom VJ (2020) Neuroimmune System as a Driving Force for Plasticity Following CNS Injury. Front. Cell. Neurosci. 14:187.<\/p>\n [23]<\/a> Blaszkiewicz, M., Wood, E., Koizar, S.\u00a0et al.<\/em>\u00a0The involvement of neuroimmune cells in adipose innervation.\u00a0Mol Med<\/em>\u00a026,\u00a0<\/strong>126 (2020)<\/p>\n [24]<\/a> Lorem Cytori, Inc Unpublished internal data<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Footer CTA” _builder_version=”4.15.1″ _module_preset=”6ea0bfdb-1736-47ec-a731-c9b3bd89f568″ global_module=”317″ saved_tabs=”all” global_colors_info=”{}”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” background_blend=”multiply” width=”50%” max_width=”80%” custom_padding=”|||” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”3%” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_text_color=”#FFFFFF” header_text_color=”#FFFFFF” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.16″ parallax=”on” custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_button button_url=”https:\/\/ambrosecelltherapy.com\/contact\/” button_text=”Learn More” button_alignment=”center” _builder_version=”4.16″ _module_preset=”default” background_layout=”dark” custom_margin=”30px||||false|false” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Background: In December 2018, AMBROSE Cell Therapy pioneered a novel protocol for Jeff, a patient living with a spinal cord injury. Jeff’s 14-month patient-reported outcome chronicled significant improvements in symptoms, function, and quality of life. In December 2017, Jeff’s spine surgery gone wrong resulted in an SCI and paraplegia. His extended hospitalization led to an […]<\/p>\n","protected":false},"author":8,"featured_media":8900,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":" Many sources of stem cells exist, not all of them are created equal. At AMBROSE, having examined these various sources and their functions, our interest is in the adult stem cells found in adipose tissue (fat).\u00a0<\/p> Adipose-derived stem and regenerative cells (ADRCs) are scientifically validated to be more accessible, abundant and potent than the stem cell populations from bone marrow and umbilical cord blood. They also have an advantaged mix of cell types to rescue, repair and regenerate damaged tissues, organs and the systems\u2014vascular, immune and endocrine (hormones)\u2014of our bodies. In addition, the factors of age-related declines in yield and potency that are found in the in the bone marrow are not observed in ADRCS. [i]<\/a> [ii]<\/a> [iii]<\/a><\/p> The term stem cell<\/em> first appeared in the scientific literature some 150 years ago in the works of the eminent German biologist Ernst Haeckel (Haeckel, 1868). Haeckel, a major supporter of Darwin\u2019s theory of evolution, drew a number of branching trees to represent the evolution of organisms by descent from common ancestors and called these trees \u2018\u2018Stammba \u0308 ume\u2019\u2019 (German for family trees or \u2018\u2018stem trees\u2019\u2019). In this context, Haeckel used the term \u2018\u2018Stammzelle\u2019\u2019 (German for stem cell) to describe these cells as the most basic cells in our body and from which all other cells are developed.<\/p> Embryonic stem cells (ESCs)\u2014of which there are between 50 and 150\u2014are developmental cells, meaning they develop into all of the cell lines of our body and those cells replicate. They are referred to as \u201ctotipotent stem cells,\u201d being the only cells capable of giving rise to all cell types necessary to develop an embryo into a fully formed body.<\/p> ESCs can develop into each of the more than 200 cell types of the adult\u00a0body\u00a0when given sufficient and necessary stimulation for a specific cell type, however ethical and medical concerns surround their use. Due to this they have been the subject of only a small number of human trials and are illegal to use in nearly all developed countries including the US.<\/p> The term \u201cadult stem cell\u201d is cause for some confusion, as these are the cells we are born with. Adults and infants alike possess the same \u201cadult\u201d stem cells. Thus, a more accurate and descriptive name for these cells might be \u201crepair cells,\u201d for this is their function in a fully developed body. Adult stem cells do not grow a new heart, brain, or bones\u2014they are purposed to keep what we have in good repair.<\/p> The history of adult stem cell research began in the 1950s, when researchers discovered that the bone marrow contains at least two kinds of stem cells. The first population, called hematopoietic stem cells (HSCs), forms all the types of blood cells in the body. HSCs make up approximately 99.9% of the stem cells in bone marrow and, as they are blood forming stem cells, they are used to treat blood cancers. Umbilical cord blood stem cells are also virtually all HSCs and have been approved for use to treat blood cancers as well.[iv]<\/a> There are stem cells in the umbilical cord tissue but as they are small in number per gram it is necessary to grow them out in a dish (culture).<\/p> The second population found in bone marrow is the mesenchymal stem cell (MSC).<\/p> The origin of the concept of a \u201cmesenchymal\u201d stem cell goes back to the pioneering experiments of Tavassoli and Crosby in the 1960s.[v]<\/a> In 1991, Prof. Arnold Caplan from Case-Western University named the MSC. [vi]<\/a> According to a Medline search, there are now over 49,000 published papers on MSCs and they have been used in over 700 clinical trials. In 2016, Dr. Caplan, in MSCs\u2014The Sentinel and Safe-Guards of Injury<\/em>[vii]<\/a>\u00a0 proposed renaming mesenchymal stem cells to \u201cmedicinal signaling cells\u201d due to their function of repairing through cell-to-cell communication or the \u201cparacrine effect.\u201d<\/p> There is more to fat than meets the eye. Whereas many researchers focus solely on the MSCs found in bone marrow, fat, umbilical cord, placenta, dental pulp and so on, in fat they are not unlike a lead singer in a band whose music is enriched and enhanced by backup singers and the other musicians. There are many other cell types in fat that work together, and we call these \u201cregenerative cells.\u201d<\/p> Adipose tissue functions as a protected reservoir of stem and regenerative cells throughout one\u2019s life. The studies using bone marrow mononuclear cells (BMNCs) for bone marrow found a steep drop-off in efficacy after the age of 62.[viii]<\/sup><\/a><\/p> Another advantage of fat as a cell source lies in the fact that there are up to 2,500 times more MSCs in a gram of adipose tissue vs a gram of bone marrow. [ix]<\/a><\/p> Fat-derived regenerative cells were first discovered in 1964 by Martin Rodbell who, using an enzyme and a centrifuge, successfully liberated a mixed population of cells from the adipose tissue of a mouse. Research on adult stem cells took a quantum leap forward in 2001, when Patricia Zuk PhD, Dr. Marc Hedrick and others working in the labs of UCLA, published a paper in Tissue Engineering discussing their discovery that mesenchymal stem cells (MSCs) reside alongside other regenerative cells in our fat<\/a>.[x]<\/a> With that a new era in medicine had begun.<\/p> Adult stem cells from different cells sources work for different indications including certain blood cancers for bone marrow and umbilical cord stem cells. Bone marrow stem cells have been shown to be most effective in orthopedic and cardiac cell therapy in middle-aged or younger patients due to the declining number and potency as we age. Conversely, ADRCs are accessible, abundant and potent later in life and hence hold the most promise for age-related degenerative diseases.<\/p> [i]<\/a> A Nguyen, A et al Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) 69, 170e179<\/p> [ii]<\/a>Guo et al Stromal vascular fraction: A regenerative reality? Part 2: Current concepts and review of the literature Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) 69, 180e188<\/p> [iii]<\/a>JK Fraser PhD and S Kesten MD Autologous Adipose Derived Regenerative Cells: A platform for therapeutic applications Advanced Wound Healing Surgical Technology International XXIX<\/p> [iv]<\/a>C Dessels et al Factors Influencing the Umbilical Cord Blood Stem Cell Industry: An Evolving Treatment Landscape Stem Cells Translational Medicine April 2018<\/p> [v]<\/a>Tavassoli M, Crosby WH. Transplantation of marrow to extramedullary sites.\u00a0Science.\u00a01968;161:54\u201356.<\/p> [vi]<\/a> A. I. Caplan, Mesenchymal stem cells,\u00a0Journal of Orthopaedic Research, vol. 9, no. 5, pp. 641\u2013650, 1991<\/p> [vii]<\/a> A.I. Caplan MSCs \u2013 The Sentinel and Safe-Guards of Injury J. Cell. Physiol. 231: 1413\u20131416, 2016. \u00a02015 Wiley Periodicals, Inc<\/p> [viii]<\/a> J Willerson and E Perin Buying New Soul Journal of American College of Cardiology. 2012;60(21):2250-2251.<\/p>\n
<\/strong>A wide gap exists between the known pathophysiology of spinal cord injury and the standard of care being relied upon to treat it. Specifically, the damage to the cord incites multisystem dysregulation, including immune, endothelial, metabolic, mitochondrial, and autonomic dysfunction. [6]<\/sup><\/a> [7]<\/sup><\/a> [8]<\/sup><\/a><\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2021\/10\/Multisystem-Dysfunction-1024x437.jpg\")
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<\/strong>In contrast, ADRCs have multiple mechanisms of action (MOAs) targeting all the factors involved in a chronic condition, including multisystem dysregulation. [9]<\/sup><\/a><\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2021\/10\/Process-of-Repair-1024x442.jpg\")
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<\/strong>Unlike other tissue sources of adult stem cells, e.g., bone marrow, ADRCs remain accessible, abundant, and potent throughout one’s life. [12]<\/a><\/sup> Following liposuction, the Celution\u2122 Cell Processing System (Lorem Cytori, Inc.) centrifuges the lipoaspirate and prepares the ADRCs.<\/p>\n![\"\"](\"https:\/\/ambrosecelltherapy.com\/wp-content\/uploads\/2021\/10\/cell-preparation-600x193.jpg\")
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<\/strong>ADRCs deliver neurotrophic factors (NTFs) to the CNS, PNS, and ANS. Just as fertilizers keep plants healthy and growing, NTFs stimulate the development of new brain cells, brain cell connections, and nerves.
One such trophic factor is the brain-derived neurotrophic factor or BDNF.<\/p>\n\n
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<\/strong>Since 2007, no ADRC-related adverse events have been reported.[24]<\/sup><\/a><\/p>\nAMBROSE Cell Therapy<\/h1>\n
Your Right to Try<\/span><\/h3>\n
What is a Stem Cell?<\/strong><\/h3>
Embryonic Stem Cells<\/strong><\/h3>
Adult Stem Cells<\/strong><\/h3>
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<\/a>MSCs are non-blood cell-making stem cells found in every tissue of our bodies. They make up a rare proportion of the\u00a0population in the bone marrow and can differentiate into bone, cartilage and fat cells. The early adult stem cell research focused on bone marrow source but one key problem arose: The quantity and potency of bone marrow stem cells decline with age as well as in the presence of chronic diseases.<\/p>Advantages of Adipose Tissue<\/strong><\/h3>
Different Cells, Different Jobs<\/strong><\/h3>