Therapeutic Solutions International Files Comprehensive Campbell Platform™ Patent for Stem Cell Immunotherapy of Schizophrenia
Campbell Neurosciences Division Continues Groundbreaking Work Based on Treating Suicide as a Biological Disease OCEANSIDE, Calif., Sept. 14, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today filing of a landmark patent, with over 1000 claims, covering stem cell based immunotherapy of schizophrenia, one of the significant causes of suicide. The patent, based on years of biochemical, neurological and cellular research by the inventors covers utilization of various stem cell types, as well as cellular immunotherapies, nutraceuticals, and small molecules, for reducing symptoms and increasing treatment responsiveness in schizophrenic patients.
"Schizophrenia, despite affecting approximately 1% of the population, is still treated in a very empirical manner with little understanding of the molecular mechanisms of the disease or the currently used treatments" said Kalina O'Conner, Director of Campbell Neurosciences and co-inventor of the patent. "We are proud to have developed a novel, science-based, platform for therapeutic intervention which is grounded in objective assessment and intervention methods."
The Campbell Platform™ is an extension of earlier work described by the Company as the Campbell Score™, in which inflammatory markers, exosomes, and imaging technologies are initially used to provide an integrative means of evaluating disease status. Once the unique aspects of each patient's disease are understood, a personalized approach is developed to address their own unique needs.
"The JadiCell has been demonstrated to possess exceptional anti-inflammatory and immune modulatory activity. We are extremely excited to apply these properties to the area of neurology" said Dr. Amit Patel, co-inventor of the patent, and inventor of the JadiCell. "Having exclusively licensed certain neurologically related aspects of the JadiCell Universal donor stem cell technology to the Company, I am excited about these new developments and strongly support the current work in progress associated with suicide, brain injury, and chronic traumatic encephalopathy."
In December 2018 Therapeutic Solutions International signed an agreement with Jadi Cell LLC for licensing of the JadiCell universal donor adult stem cell, as covered in US Patent No.: 9,803,176 B2 for use in Chronic Traumatic Encephalopathy (CTE), and Traumatic Brain Injury (TBI)1.
"It is truly amazing to see the dedication of our Team and Scientific Advisors at rapidly translating ideas to patents, to preclinical research and to INDs" said Timothy Dixon, President and CEO of the Company, as well as co-inventor of the recently filed patent. "By working with scientific/medical leaders, such as Dr. Amit Patel, the first person to inject stem cells into the human heart, we are always pushing the limits of science and coming up with approaches that one day will help patients. Being Suicide Prevention Month, we especially remember the memory of Kathleen Campbell, mother of Kalina O'Conner, a victim of suicide in whose name we started Campbell Neurosciences NEWS 8/28/20
Therapeutic Solutions International Reports Synergistic Suppression of Suicide-Associated Neuroinflammatory Pathway by QuadraMune™ and Minocycline
Campbell Neurosciences Division Continues its Mission of "Treating Suicide as a Biological Disease" OCEANSIDE, Calif., Aug. 28, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), reported filing a patent on new data showing synergy between QuadraMune™ and Minocycline in generating a type of immune cell termed T regulatory cell.
T regulatory cells suppress pathological inflammation, including interleukin-6, which is associated with suicidal ideation, as well as risk of COVID-19 associated death.
QuadraMune™ is a nutraceutical developed by the Company which is currently in a clinical trial for prevention of COVID-19. Minocycline is an antibiotic that is approved by the FDA.
"The recent data supports initiation of clinical trials combining QuadraMune and Minocycline for reduction of suicidal ideations and hopefully preventing suicides" said Kalina O'Connor, Director of the Campbell Neurosciences Division of Therapeutic Solutions International and co-inventor of the patent. "I am thankful to Mr. Dixon and the team at TSOI for having the courage to attack suicide as a biological disease."
Campbell Neurosciences was formed as a Division of the Company to address suicide from an immunological perspective. The company is named after Kathleen Campbell, the mother of Kalina O'Connor, who was a victim of suicide.
"The potent generation of T regulatory cells by the combination of QuadraMune™ and Minocycline suggests that the therapeutic effects of the combination may be long lasting due to the fact that T regulatory cells have a long life in the body and can replicate" said Famela Ramos, Director of Business Development. "The ability of the T regulatory cells generated to suppress interleukin-6 and macrophage activation supports the possible use of this combination for other neurogenerative diseases associated with inflammation."
"By combining quantitative measurements such as the Campbell Score™, with practical interventions such as QuadraMune™ with adjuvants such as Minocycline, we believe that we are primed for initiating a new way of treating suicide based on objective immunology and not speculation" said Timothy Dixon, President and CEO of the Company and co-inventor of the patent. "We thank our Scientific Advisory Board for their leadership in stimulating us to explore this fascinating and underdeveloped area of medicine." NEWS 8/21/20
Therapeutic Solutions International Files Patent on Campbell Score™:
The First Quantitative Tool for Assessment of Suicidal Propensity based on Immunological Markers
Ending the Stigma of Suicide OCEANSIDE, Calif., Aug. 21, 2020 /PRNewswire/ -- Therapeutics Solutions International, Inc., (OTC Markets: TSOI), announced today filing a patent covering immunological means of quantifying risk of suicide. One embodiment of the patent is the Campbell Score™, a proprietary means of predicting risk of suicide based on assessment of immunological parameters from the blood of the patient.
"Since the beginning of time, suicide has been treated as a stigma, with victims being called 'selfish' and 'choosing the easy way out.' I am proud of the team and scientific advisors of Therapeutic Solutions International who have initiated the process of using solid science to establish suicide as an immunological disease," said Kalina O'Connor, Director of the Campbell Neurosciences Division of the Company and co-inventor of the patent. "By activating immune cells outside of the body using neurological chemicals, we can put our fingers on the pulse of the brain-immune interaction, which appears to be one of the critical factors controlling risk of suicide."
Kalina O'Connor's mother Kathleen Campbell was a victim of suicide. The name Campbell Score™ was chosen in her honor.
"It is estimated that a minimum of 1.5 million people will die from suicide in 2020. Furthermore, this is the second biggest cause of death for young people in the USA. At present the only means of evaluating suicidal tendencies are through questionnaires, which are often unreliable due to patient reluctance to share relevant information," said Famela Ramos, former Congressional Candidate, co-inventor on the patent and Director of Business Development. "Working with the Team assembled by Ms. O'Connor, including internationally renowned inventor Howard Leonhardt and psychologist Erin Ferma, positions the Company to initiate the paradigm shift needed to change the way we look at suicide."
"The potential of immune hyperactivation being related to suicidal risk has been known for decades. In the beginning days of cancer immunotherapy, observations were made that hyperactivation of immunity led to suicidal thoughts," stated Dr. James Veltmeyer, Chief Medical Officer of the Company and co-inventor of the patent. "It is of great interest to the Company to explore using agents such as QuadraMune™ in patients with inflammation associated suicidal ideations given that QuadraMune™ reduces interleukin-6, which is one of the components of the Campbell Score™."
"We are extremely thankful for our advisors and collaborators, and especially to Ms. O'Connor whose labor of love for her late mother has stimulated such scientific progress," said Timothy Dixon, President and CEO of the Company and co-inventor. "Given that we are already running a COVID-19 prevention trial using QuadraMune™, it will be exciting to explore the use of QuadraMune™ for prevention of suicidal ideations and to document reduction of the Campbell Score™ in clinical trials. NEWS 8/11/20
Therapeutic Solutions International Launches Campbell Neurosciences Division aimed at Biologically Identifying and Repairing Suicide-Prone Brains
Company Leverages Existing Immunology and Regenerative Medicine Intellectual Property to Attack Second Leading Cause of Death in Young People OCEANSIDE, Calif., Aug. 11, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today formation of Campbell Neurosciences, a new division of the Company dedicated to approaching suicide as a biological disorder and developing science-based diagnostic tools and interventions.
The Division will be headed by Kalina O'Connor, and is named after her mother, Kathleen Campbell, who was a victim of suicide. Ms. O'Connor has previously worked in the area of drug and alcohol rehabilitation, as well as assisting the Company in its basic research and development.
Howard Leonhardt, a serial inventor and entrepreneur, whose inventions have treated over 500,000 patients in 60 countries will serve as Advisor to the Division. Additionally, Dr. Erin Ferma, a forensic psychologist with over 15 years clinical experience will provide input on clinical trial design and practical implementation of the technologies under development. Former Congressional Candidate and Director of Business Development, Famela Ramos, will oversee operations.
"I am honored to be working with Timothy Dixon, a modern-day renaissance man, and the team at Therapeutic Solutions International. This organization has developed products and conducted successful preclinical and clinical trials on approaches which can modulate biological pathways linked to suicide" said Ms. O'Connor. "By leveraging existing findings and developing new intellectual property, we believe we are in the position to offer for the first time a suicide risk score which is based on science and not psychological self-assessment. Combined with identifying risk, we seek to develop various therapeutic approaches."
Previous studies have shown correlations between inflammatory cytokines in the blood and suicide. The causative effects of these molecules on suicidal ideation is seen in cancer patients who take similar molecules for hyperstimulation of immunity, which also results in suicidal ideation. Products developed by Therapeutic Solutions International such as NeuroStilbene™, NanoStilbene™ and QuadraMune™ have been shown to reduce inflammatory markers.
"It is extremely exciting to be at the ground floor of a paradigm shift" said Howard Leonhardt. "I look forward to assisting the Company in accelerating solutions for this terrible condition. Additionally, we will explore synergistic interaction with various companies form the Leonhardt Ventures portfolio."
"Suicide has historically been treated as a stigma. With increasing advancement of science, we realize it is a biological abnormality and should be addressed the same way we address other conditions" said Timothy Dixon, President and CEO of the Company. "Psychiatry is the only discipline of medicine that does not base its drug prescriptions by detailed evaluation of the organ they are treating. It is interesting that only in psychiatry that treatments are given without actually assessing physical changes that the intervention is accomplishing. Technologies we are developing will provide a biological basis for the practice of psychiatry as it relates to suicide prevention." Suicide is a Major Problem: In 2017, in the USA, suicide was the second leading cause of death among individuals between the ages of 10 and 34, with twice as many suicides as there were homicides . Suicide is significantly more prevalent in veterans, in which approximately 20 deaths per day occur .
New Approaches are Needed: Psychotherapy and current drug interventions have not significantly reduced the rate of suicide. In fact, suicide rates have increased approximately 60% since 1981 .
Suicide is not only Mental: Suicidal ideation and suicide have been associated with inborn genetic components  as well as various forms of inflammation that occur as a result of brain injury . In some situations, depression or other pathological mental states have been shown to induce inflammation , which is subsequently associated with suicidal ideation and suicide .
Inflammation is a Major Cause of Suicide: Molecular signals which in healthy individuals are associated with the body fighting disease, such as TNF-alpha, are turned on by the brain when they are needed, and turned off when the disease has been defeated. In patients with suicidal ideation, these signals are turned on at a low level without being turned off. It is known that these “inflammatory signals”, otherwise known as “inflammatory cytokines” are associated with depression based human studies in which inflammatory signals were artificially manufactured and administered in patients to fight cancer and treated patients became depressed . Additionally, studies show that patients who are successfully treated for depression have a reduction in inflammatory signals in the blood [9, 10]. Furthermore, various cofactors known to increase suicide rates such as drug abuse , alcoholism , and brain injury , have been shown to increase inflammatory signaling.
1. Analysis of what is happening in blood. Proprietary algorithm utilizing already available blood tests to establish patients at risk of suicide (Doctor or rehab facility sends to us lab results from Quest and we plug into our computer and give risk score)
2. Analysis of what is happening in brain. Brain produces very small particles called exosomes that we can isolate, and they tell us how much inflammation is happening specifically in brain. Additionally, when appropriate, imaging studies using fMRI and various dyes to detect specific areas of brain atrophy and/or inflammation
3. Analysis of what is happening in the gut. Analysis of the microbiome in gut suggests overall inflammation in body
4. Analysis of suicide associated gene. Several gene polymorphisms have been shown to be associated with suicide.
The above physical findings are utilized to develop a suicide risk score, as well as to establish a baseline for intervention. In some situations physicians will only be interested in attaining our suicide risk score and they will perform their own interventions. We are the only group to have developed a suicide risk score based on medical and not psychological findings.
1. Clinical trial of QuadraMune™, clinically validated to reduces biomarkers associated with suicide risk
2. Broad acting anti-inflammatory natural interventions. Intravenous vitamin C, vitamin D, fish oil, quercetin, micronutrients.
3. Specific anti-inflammatory antibodies. Anti-TNF, anti-IL-17, anti-IL21
4. Microbiome modulators. Probiotics, prebiotics, fecal transplants
5. Cell based therapies. Autologous bone marrow
6. Transcranial Magnetic Stimulation. Various studies have shown ability to reduce neural inflammation and augment brain regeneration using this approach.
1. Understanding intellectual property landscape around our broad ideas of diagnosis and treatment. Filing new patents and/or licensing.
2. Creation of a “Central Core” which analyzes data and provides patient specific recommendations together with the input from the health care professional
3. Selling subscriptions to medical professionals, drug rehab clinics, etc.
 Juengst et al. Exploratory associations with tumor necrosis factor-a, disinhibition and suicidal endorsement after traumatic brain injury. Brain Behav Immun. 2014 Oct;41:134-43.
 Zhu et al. Neuroinflammation caused by mental stress: the effect of chronic restraint stress and acute repeated social defeat stress in mice. Neurol Res. 2019 Aug;41(8):762-769
 O'Donovan et al. Suicidal ideation is associated with elevated inflammation in patients with major depressive disorder. Depress Anxiety. 2013 Apr;30(4):307-14.
 Illman et al. Are inflammatory cytokines the common link between cancer-associated cachexia and depression? J Support Oncol. 2005 Jan-Feb;3(1):37-50.
 Lanquillon et al. Cytokine production and treatment response in major depressive disorder. Neuropsychopharmacology. 2000 Apr;22(4):370-9.
 Chen et al. Rapid inflammation modulation and antidepressant efficacy of a low-dose ketamine infusion in treatment-resistant depression: A randomized, double-blind control study. Psychiatry Res. 2018 Nov;269:207-211.
 Kapasi et al. Morphine stimulates mesangial cell TNF-alpha and nitrite production. Inflammation. 2000 Oct;24(5):463-76.
 Valles et al. Chronic ethanol treatment enhances inflammatory mediators and cell death in the brain and in astrocytes. Brain Pathol. 2004;14:365–371.
 Yang et al. Serum macrophage migration inhibitory factor concentrations correlate with prognosis of traumatic brain injury. Clin Chim Acta. 2017 Jun;469:99-104. NEWS 8/5/20
Therapeutic Solutions International Reports Reduction of Inflammation Associated Memory Impairment by QuadraMune™ Administration
Animal Data has Potential Implications for Ongoing COVID-19 Prevention Study
Company Continues Quest to Dominate Intellectual Property Regarding COVID-19 Associated Pathologies OCEANSIDE, Calif., Aug. 5, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today filing of a patent on new data demonstrating memory-protective effects of QuadraMune™ in an animal model of inflammation associated memory loss.
Animals were treated with QuadraMune™ for 3 days and exposed to lipopolysaccharide, which serves as an inflammatory stimulus. Subsequently, the ability of animals to remember a submerged platform was assessed. In agreement with previously published studies, lipopolysaccharide administration resulted in approximately 57% reduction in memory. Animals which received QuadraMune had restoration of memory activity. Additionally, it was demonstrated that QuadraMune™ reduced the presence of proteins associated with inflammation in the brain, termed cytokines.
"The current data is an extension of our ongoing obsession with identifying mechanisms by which QuadraMune™ works and expanding its potential for other diseases. It is known that conditions such as Alzheimer's Disease, Multiple Sclerosis and Parkinson's Disease are all associated with brain inflammation [1, 2]," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The same cytokines, such as interleukin 6, that we are reducing with QuadraMune™ in the brain, are associated with COVID-19 severity . Studies show that viral infections in general, and especially the SARS-CoV-2 virus, can cause memory impairment. It will be interesting to explore whether QuadraMune™ may have therapeutic effects in this arena."
QuadraMune™ is comprised of green tea extract, pterostilbene, nigella sativa, and sulforaphane. Studies published in the peer-reviewed literature have shown that these ingredients by themselves possess anti-inflammatory [4-7], neuroprotective [8-13], and immune stimulatory properties [14-17].
"It has not escaped us that mental health issues such as dementia and depression are associated with inflammatory cytokines [18, 19]. We are currently investigating the possibility of utilizing QuadraMune™ or similar formulations for psychiatric indications," said Famela Ramos, director of business development and co-inventor on the patent.
"I am very thankful for our scientific advisory board, and our research collaborators who are working tirelessly to advance QuadraMune™ into new indications, as well as identifying mechanisms of action," said Timothy Dixon, President and CEO of the Company. "We plan to continue expanding our collaborations and strengthening our science and portfolio, because at the end of the day, the best marketing is when the science speaks for itself." NEWS 7/28/20
Therapeutic Solutions International Files Patent on Ability of QuadraMune Ingredient Pterostilbene to Reduce Inflammation while Stimulating Brain Protective Biological Pathways
Mechanistic Studies Continuing on QuadraMune™ a COVID19 Candidate in Clinical Trial
Company Continues Quest to Dominate Intellectual Property Regarding COVID-19 Associated Pathologies OCEANSIDE, Calif., July 28, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), reported new data demonstrating that the blueberry derived compound pterostilbene possesses numerous brain protective and potentially brain regenerative activities. Pterostilbene is one of four ingredients which comprise QuadraMune™, a nutraceutical being developed by the Company which is currently in a clinical trial for prevention of COVID-19. Information on the clinical trial can be found on the Government Clinical Trials website https://clinicaltrials.gov/ct2/show/NCT04421391.
"These new data confirm previous findings published on pterostilbene and also reveal novel therapeutic properties of this naturally occurring nutrient," said Dr. James Veltmeyer, Chief Medical Officer of the Company and Voted Top Doctor of San Diego. "By continually investigating mechanisms of action of our products, our ambition is to ensure we have support of the top medical and scientific leaders. In my opinion, many times, it does not matter how good your product is, what matters is that you have scientific basis for why it works. This is especially important in the current age of molecular medicine."
The data disclosed by the Company indicates:
a) pterostilbene suppresses inflammatory cytokines TNF-alpha, IL-1 beta and IL-6;
b) pterostilbene inhibits death of neurons caused by inflammatory mediators;
c) pterostilbene stimulates production of regenerative factors from cells in the brain such as BDNF, NGF, FGF-1, and FGF-2; and
d) pterostilbene allows/enhances proliferation of endogenous brain stem cells.
"The importance of possessing a deep scientific understanding of your product can be seen in the example of nutraceuticals which ended up obtaining regulatory clearance as drugs," said Timothy Dixon, President and CEO of Therapeutic Solutions International. "For example, Lovaza and Vascepa are both fish oil based products which have been developed scientifically and FDA approved through clinical trials. Lovaza, which is sold by GSK, had sales of approximately 1 billion per year and is used for reduction of triglycerides.1 Vascepa, sold by Amarin, had sales in 2019 of 410 million and is used to prevent heart attacks.2 We believe that similar developmental pathways may be possible with several of our existing products."
The Company is currently pursuing FDA clearance for its cell therapy produce StemVacs, for which an IND number was previously granted. The Company's in-licensed stem cell, the JadiCell has FDA clearance for other indications.
R & D Products listed below are in different stages of development :
Cellular Products StemVacs http://stemvacs.com/
sRNA augmented stem cells http://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/78834511/therapeutic-solutions-international-expands-chroni
JadiCell MSCs https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/78853508/therapeutic-solutions-international-signs-agreemen
Autologous Neurogenic Stem Cell banking http://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/79022244/therapeutic-solutions-international-continues-to-e
"Educated" Monocytes / Projenitors https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/79095195/therapeutic-solutions-international-continues-to-e Nutraceutical Products
NanoStilbene PKE http://mynanostilbene.com/
Nano Cannabidiol http://www.youcanordernow.com/Nano-Cannabidiol-12ml-w-glass-eyedropper_p_30.html
Alpha Lipoic Acid https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/78013140/therapeutic-solutions-international-develops-micro
Cancer Metabolic DeTox http://www.marketwired.com/press-release/therapeutic-solutions-files-new-patent-on-targeting-tumor-microenvironment-through-nutraceutical-otc-pink-tsoi-2215015.htm
Nano PSA https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/80285424/therapeutic-solutions-international-develops-gluco?_ga=2.179046118.372974125.1561310240-1993038973.1559041875
Nano Myros https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/80311774/therapeutic-solutions-international-develops-adjuv
Nano Myros w/ Cannabidiol http://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/80328380/therapeutic-solutions-international-adds-nano-cann
NLRP3 Trifecta http://www.youcanordernow.com/NLRP3-Trifecta_p_33.html
NanoStilbene / EGCg https://board.therapeuticsolutionsint.com/viewtopic.php?f=3&t=36&p=1270#p1270
LymphoBoost http://www.marketwired.com/press-release/therapeutic-solutions-files-new-patent-on-augmentation-anti-tumor-immunity-mifepristone-otc-pink-tsoi-2217703.htm 4 Cellular, 3 Nutraceuticals, 1 Pharmaceutical licensed to Pan Am Cancer Treatment Center
StemVacs, innaMune, MemoryMune, BRS-001, Cancer Metabolic DeTox, NanoStilbene, IsoStilbene, LymphoBoost
Pan Am Cancer Treatment Center Tour Video
https://www.youtube.com/watch?v=rWgJLRCICa8&feature=youtu.be Distribution 5/6/19
Therapeutic Solutions International Awards Distribution of NanoStilbene and Nano Cannabidiol in Mexico to Immun ET Laboratories, LLC.
Immun ET labeled
Therapeutic Solutions International Enters Into Multi-million Dollar Master Sales Agreement With Tiva Bio
Therapeutic Solutions International Enters Into Multi-million Dollar Master Sales Agreement With WCTE, Inc.
Therapeutic Solutions International Enters into Multi-Million Dollar Master Sales Agreement with Publicly Traded iBrands Corporation
Proprietary Nano Particle Cannabidiol based products to be sold through iBrands Farms
iBrands Corporation Adds Immune Booster To Nutraceutical Product Line
iBrands Farms labeled
https://www.ibrandsfarms.com/product-category/nutraceuticals/ Patent Info https://therapeuticsolutionsint.com/patents/ SS AS 3,505,000,000 https://therapeuticsolutionsint.com/security-details/
Held at DTC
SEC Filings https://www.sec.gov/cgi-bin/browse-edgar?CIK=0001419051&action=getcompany
E Commerce Sites
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