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Therapeutic Solutions International Reports Amplification of Cancer Specific Immune Responses Using Second Generation Tumor Endothelial Targeting Vaccine StemVacs-V iPSC

Company Demonstrates Existing Platform Can Synergize with Multiple Antigen Specific Tumor Immunotherapies


https://www.prnewswire.com/news-release ... 06771.html


ELK CITY, Idaho, June 7, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported today potent synergy between its tumor blood vessel targeting StemVacs-V iPSC immunotherapy and several classical tumor specific therapeutic vaccines.

In a series of experiments tumor growth administration of dead tumor cells together with StemVacs-V resulted in potent immunological memory to the tumor cells, which could be transferred to immunologically naïve mice. Additionally, the experiments demonstrated killing tumor cells using conventional approaches such as chemotherapy, when performed together with StemVacs-V iPSC, led to the development of immunological memory towards the specific cancer.

"By targeting the blood vessels that feed the cancer, StemVacs-V iPSC causes enhanced necrotic cell death, which stimulates systemic immunity against the cancer throughout the whole body," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "We are extremely enthusiastic by the current data showing that our blood vessel targeting approach can be used to synergize with both cancer immunotherapies and non-immune therapies of cancer such as chemotherapy and radiation therapy."

Despite cancer immunotherapy being an over 100 billion dollar a year market in 2020, most cancers still do not respond to this approach. These are called "cold tumors." It is believed that by starving the cancer of its blood supply, StemVacs-V iPSC may convert cold tumors to immunotherapy sensitive "hot tumors."

"The potential implications of the current data, which is covered by our previously filed patents, include synergies with oncolytic viruses, checkpoint inhibitors, fractionated radiation therapy, antibodies, and chemotherapies," said Famela Ramos, Vice President of Business Development for Therapeutic Solutions International. "We are currently exploring numerous co-development partnerships."

"This new finding is extremely exciting because it opens the door to synergies with other immunotherapies such as CAR-T therapies, which although successful in liquid tumors, to date have not yielded promising results in solid and/or cold tumors," said Timothy Dixon, President and CEO of the Company. "Having SAB members such as Santosh Kesari and Francesco Marincola, who are at the forefront of cancer immunotherapy, significantly positions us to accelerate the development of our new approach which targets the "Achille's Heel of cancer."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

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Therapeutic Solutions International Spinoff Campbell Neurosciences Reports Reduction of Schizophrenia Activity in Mice Subsequent to Administration of Tolerogenic Dendritic Cells

Company Continues to Advance Technologies Described in its >1000 Claim Patent on Cellular Therapy for Schizophrenia

https://www.prnewswire.com/news-release ... 09916.html


ELK CITY, Idaho, June 10, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today that its subsidiary, Campbell Neurosciences, recently obtained data demonstrating that the administration of tolerogenic dendritic cells in an animal model of schizophrenia resulted in suppression of multiple neurological manifestations of the condition. Of great interest was the association between increased numbers of T regulatory cells and therapeutic activity. Previously the Company reported that administration of T regulatory cells are capable of suppressing schizophrenia.

"It is incredible to contemplate that immunological reactions such as the ability of tolerogenic dendritic cells to induce T regulatory cells can be used to treated neurological diseases. The interplay between the brain and the immune system is the foundation of Campbell Neurosciences, and I am very excited to lead the translation of this very relevant animal study into human clinical trials," stated Dr. James Veltmeyer, Chief Medical Officer of the Company.

Campbell Neurosciences was originally founded as a division of Therapeutic Solutions International and subsequently spun off as an independent company, which is focused on ending suicide using immunology and regenerative psychiatry. The company was founded by Kalina O'Connor, the President and CEO of the Company, whose mother, Kathleen O'Connor, and uncle, Hugh O'Connor (son of Carroll O'Connor), were victims of suicide.

"The only way to put an end to this silent epidemic of suicide is to aggressively approach it as a biological disease and not as a choice that people of weak minds make," said Ms. O'Connor. "I have three young kids; suicide is the second largest cause of death in young people. As a daughter of someone who was a victim of suicide, and as a mother now, I feel like not enough work is being done. That is why I am extremely grateful to our investors, our collaborators, and our team that every day is advancing knowledge to the biological causes of suicide."

Campbell Neuroscience's lead product is the Campbell Score, a clinically validated blood test for prediction of suicidal ideation. Additionally, the Company (TSOI) has 13 patent applications filed covering diagnostics and therapeutic solutions.

"Schizophrenia is a very peculiar disease which possesses numerous immunological connections," said Timothy Dixon, President and CEO of Therapeutic Solutions International. "There is much cross-fertilization that occurs between our two companies, especially from the sense that TSOI is focused on using the immune system to kill cancer, whereas Campbell is using the immune system to detect and to alter neuronal activities. Through these interactions we continually develop new ideas, experiments, patents, and ways of interpreting preclinical and clinical data. It is a real pleasure to collaborate with Campbell Neuroscience on this very important life issue."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

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Campbell Neurosciences Spin Off of Therapeutic Solutions Reports Synergistic Reduction of Schizophrenia in Animal Models using Low Dose Naltrexone and T Regulatory Cell Stimulation

Suicide Prevention Company Continues Experimental Validation of its >1000 Claim Patent on Application of Immunotherapy to Schizophrenia


https://www.prnewswire.com/news-release ... 13738.html


ELK CITY, Idaho, June 16, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported today new data validating claims in its previously filed patent application demonstrating potent synergy between low dose naltrexone and agents stimulating T regulatory cells.

In one set of experiments, interleukin-2, an FDA cleared cancer immunotherapy drug is combined with low dose naltrexone to potently reduce schizophrenic-like behavior in an animal model of the condition. Naltrexone is a medication approved by the Food and Drug Administration (FDA) to treat both opioid use disorder and alcohol use disorder as a medication-assisted treatment option. Studies also showed that low dose naltrexone synergizes with mesenchymal stem cells and myeloid suppressor cells, both cell types are capable of inducing the generation of T regulatory cells in vivo.

"Schizophrenia is a major cause of suicide and suicidal ideation for which no real treatments exist in patients that are refractory to electroconvulsive therapy," said Kalina O'Connor, President and CEO of Campbell Neurosciences. "We are actively working at refining our various approaches so that we may file an IND with the FDA in the near term."

"From a physician perspective, I am much more comfortable repositioning drugs that have already been demonstrated safe, as opposed to introducing novel and untested compositions of matter in patients," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The rapid rate of new findings by the Company is based upon a mechanistic-first approach, in which Campbell Scientists first started identifying cellular activities associated with reduction of schizophrenia, and subsequently began testing novel means of modulating the relevant cellular activities."

"The interplay between the immune system and nervous system is fascinating. The fact that immune modulation is associated with reduction in schizophrenic activities strongly supports the notion of the immune-brain interplay," said Timothy Dixon, President and CEO of Therapeutic Solutions International. "In my mind it is not a coincidence that out of all the systems of the body, only the brain and the immune system have the ability to tell between what is "self" and what is "non-self" and also to have memory. We are very excited about the work at Campbell, which will not only teach us how to modulate the brain with the immune system, but also how to modulate the immune system using neurological based approaches. The potency of this is difficult to overstate....imagine if we can generate immune stimulation by administration of select neuropeptides in order to biologically mimic, and amplify, the placebo effect."

About Therapeutic Solutions International, Inc.


Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

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Therapeutic Solutions International Demonstrates Potent Brain Protective Activity of JadiCells in Animal Model of Post-Covid-19 Neurological Damage

Clinical Stage Universal Donor Adult Stem Cell Therapy Shown to Block Reactive Astrogliosis and Reverse Neural Damage induced by SARS-CoV-2-like Inflammation


https://www.prnewswire.com/news-release ... 23081.html


ELK CITY, Idaho, June 30, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today new preclinical data demonstrating efficacy of its JadiCell Universal Donor stem cell in inhibiting and reversing neuroinflammation induced brain damage in a model representing post-COVID19 infection.

In a series of experiments, clinically relevant doses of JadiCell were capable of suppressing astrogliosis, a hallmark of inflammation induced brain damage, as well as reversing memory and cognitive deficits as assessed by the Morris Water Maze and the Modified Barnes Maze test, respectively. The experiments are part of a series of ongoing work in development of the JadiCells as a treatment for post-COVID brain damage.

"While we are in final steps with the FDA regarding the planned Phase III clinical trial of JadiCells for advanced COVID-19 patients, we are concurrently advancing our research into other areas of COVID-19 related medicine, such as the "post-COVID" syndrome" said Dr. James Veltmeyer, Chief Medical Officer of the Company.

In a double blind, placebo controlled clinical trial, the JadiCell was used to treat 12 patients, while 12 received placebo. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), event-free survival (P = .008), and time to recovery (P = .03). JadiCell infusions were shown safe and could be beneficial in treating subjects with COVID-19 ARDS. The published clinical trial may be seen at this link Umbilical cord mesenchymal stem cells for COVID–19 acute respiratory distress syndrome: A double–blind, phase 1/2a, randomized controlled trial - Lanzoni - 2021 - STEM CELLS Translational Medicine - Wiley Online Library.

"COVID-19 associated neuropathology is a highly underestimated problem, which unfortunately is believed to represent an exploding market opportunity" said Famela Ramos, Vice President of Business Development for the Company. "Through leveraging collaborators such as Dr. Santosh Kesari, one of the top clinical-trial Neurologists in the world, combined with our second-to-none regulatory and clinical trials experts, we are eager to address as many aspects as possible of this terrible disease."

Dr. Kesari, together with Board Member Dr. Thomas Ichim and Chief Scientific Officer Dr. Feng Lin recently published the rationale for utilization of mesenchymal stem cells for treatment of COVID-19 lung pathology1. Current data suggests that JadiCell possess superior activity to other mesenchymal stem cells in terms of reducing cytokine storm, assisting in pulmonary regeneration, and controlling pathological inflammation.

"At Therapeutic Solutions International we are committed to conquering the invisible enemy called COVID-19. Through combining our immunological, regenerative, and neurological expertise, we anticipate making significant progress in the neurological sequelae which is becoming more and more of a concern in COVID-19 survivors" stated Timothy Dixon, President and CEO of the Company.

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 Mesenchymal stem cells as living anti-inflammatory therapy for COVID-19 related acute respiratory distress syndrome (wjgnet.com)

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Therapeutic Solutions International Spin-Off Campbell Neurosciences Initiates Pilot Implementation of Campbell Score™ with California Concierge Medical & Wellness Inc.

https://www.prnewswire.com/news-release ... 24925.html


ELK CITY, Idaho, July 2, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today medical implementation of its Campbell Score™ blood-based suicide prediction marker in collaboration with the premiere San Diego personalized health center, Concierge Medical & Wellness Inc.

The Campbell Score™ was subject of a clinical trial1 which demonstrated patients with suicidal tendencies have a higher rating on the novel scale2. To the knowledge of the Company, the Campbell Score™ is the only subjective instrument in development capable of assisting psychiatrists in guiding frequency and intensity of their interventions.

"The Campbell Score™ is named after my mother, Kathleen Campbell, who was a victim of suicide. The goal of our Company is to create a world without suicide. The first step in this is quantifying risk of suicide in a scientific and objective manner," said Kalina O'Connor, President and CEO of Campbell Neurosciences. "We are extremely grateful that Chief Medical Officer, Dr. James Veltmeyer, volunteered for us to use his medical practice as the original launching pad for the Campbell Score™. Through initial implementation on a pilot basis, we can work on kinks in a real-life environment while we are concurrently working on launching a pivotal trial to apply for FDA clearance and eventual insurance reimbursement."

"Kalina O'Connor is a true inspiration. It is extremely rare to work with someone who can translate the suffering of a personal tragedy into a company that has a real shot at changing the way suicide is perceived by the medical community," said Dr. James Veltmeyer, Chief Medical Officer of the Company and Owner of California Concierge Medical & Wellness Inc. "I am proud to put my name and reputation behind this completely revolutionary approach to a terrible epidemic which is the number two cause of death in young people."

"At the end of the day, we are all in the field of biomedical sciences because we want to advance science and save lives," said Timothy Dixon, President and CEO of Therapeutic Solutions International and Chairman of Campbell Neurosciences. "It brings great joy to me and our shareholders that this new tool developed by our spin-off company is entering medical practice. I applaud Ms. O'Connor for her perseverance and leadership skills in taking this small step with Dr. Veltmeyer that we hope will be the basis for seeing suicide as a disease and not a choice."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 Correlation of Campbell Score With Suicidal Ideation - Full Text View - ClinicalTrials.gov
2 Therapeutic Solutions International Spin-Off Campbell Neurosciences Announces Positive Clinical Trial Results for Campbell Score Blood Based Suicide Prediction | BioSpace

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Therapeutic Solutions International Patents Modified StemVacs Dendritic Cell Immunotherapy to Suppress Parkinson's Disease in Animal Model

https://www.prnewswire.com/news-release ... 25958.html

ELK CITY, Idaho, July 6, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of a new patent and data utilizing "tolerogenic dendritic cells" obtained from umbilical cord blood for suppression of Parkinson's Disease in an animal model. The data, which was filed in a patent application, demonstrates that a specifically modified StemVacs dendritic cell is capable at suppressing brain inflammation, as well as preserving dopaminergic neurons in the brain. Parkinson's Disease is caused by death of dopaminergic neurons.

"Through collaboration with our spin-off company, Campbell Neurosciences, we are always learning how to expand the uses of technologies we are currently developing," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The original StemVacs product, which we generate under GMP and have used in preclinical and pilot clinical cases for cancer, can be modified, by addition of specific proteins, to act as a potent inhibitor of brain inflammation."

Recent studies suggest that Parkinson's has an immunological component [1-3]. The Company believes by concurrently repairing the abnormal immune response while providing regenerative cells such as stem cells is an ideal approach to attack this terrible disease which currently has no viable treatment.

"Immunotherapy is the future of medicine," said Feng Lin, MD, Ph.D., Chief Scientific Officer of the Company. "We are excited to use dendritic based immunotherapy such as StemVacs to not only trigger immune killing of cancer, but to also induce tolerogenic responses, which appear useful in neurodegenerative conditions."

"I am thankful to our advisors such as Dr's Santosh Kesari and Francesco Marincola, who through their curiosity and inquisitiveness, have created a culture of innovation in our Company, which allows for discoveries such as the one made today," said Timothy Dixon, President and CEO of the Company. "The current lines of investigation, if successful, could allow for novel therapeutic approaches to this terrible disease from which approximately 1 million Americans suffer from and cost the American healthcare system approximately 52 billion dollars a year[4]."

About Therapeutic Solutions International, Inc.


Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 Wang, B.Y., et al., Stress increases MHC-I expression in dopaminergic neurons and induces autoimmune activation in Parkinson's disease. Neural Regen Res, 2021. 16(12): p. 2521-2527.
2 Li, W., et al., Imbalance between T helper 1 and regulatory T cells plays a detrimental role in experimental Parkinson's disease in mice. J Int Med Res, 2021. 49(4): p. 300060521998471.
3 Seo, J., et al., Chronic Infiltration of T Lymphocytes into the Brain in a Non-human Primate Model of Parkinson's Disease. Neuroscience, 2020. 431: p. 73-85.
4 Parkinson's Disease Economic Burden on Patients, Families and the Federal Government Is $52 Billion, Doubling Previous Estimates | Parkinson's Disease (michaeljfox.org)

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Therapeutic Solutions International Spin-Off Campbell Neurosciences Explains Why Suicide is a Disease and How to Predict it in Newly Released Video

https://www.prnewswire.com/news-release ... 27904.html


ELK CITY, Idaho, July 8, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today that its Spin-Off Company, Campbell Neurosciences, released a video presentation describing its position and future directions in relation to diagnosis and prevention of suicide.

The video is available at the Campbell Neurosciences YouTube channel Suicide is a Disease: The Story of Campbell Neurosciences - YouTube




Suicide is the second leading cause of death in young people and is expected to have significantly increased since the beginning of the COVID-19 pandemic. The Company has developed a clinically-validated diagnostic test for suicidal ideations, the Campbell Score™ and a variety of intervention methodologies using regenerative and immune modulatory approaches.

"I am thankful for Howard Leonhardt, a serial inventor and entrepreneur, whose inventions have treated over 500,000 patients in 60 countries, Dr. James Veltmeyer our Chief Medical Officer, and Timothy Dixon, Chief Executive Officer of Therapeutic Solutions International, all of whom are featured in the video," said Kalina O'Connor, President and CEO of Campbell Neurosciences. "I am especially grateful to our numerous scientific collaborators, who believed in my vision of a molecular basis for suicide and worked with our team in making this a reality."

"It has truly been an honor to see the rapid progress Ms. O'Connor has been achieving with her team at Campbell Neurosciences. Progress that included TSOI filing more than 15 patients and licensing 10 of them to Campbell, completing 2 clinical trials, and recruiting top notch key opinion leaders," said Timothy Dixon, Chief Executive Officer of Therapeutic Solutions International. "I truly believe that by working with the brilliant business and scientific minds she has assembled, Ms. O'Connor will accomplish her dream of one day having a world without suicide."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

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Therapeutic Solutions International Reports Preclinical Efficacy of JadiCell Umbilical Cord Mesenchymal Stem Cells in Animal Model Resembling COVID-19 Delta Variant Associated Lung Pathology

https://www.prnewswire.com/news-release ... 41947.html


ELK CITY, Idaho, July 27, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported today preliminary data demonstrating administration of its universal donor adult stem cell product, JadiCell, reduced pulmonary pathology in an animal model replicating the severe inflammation observed in patients infected with the COVID-19 delta variant. In a series of experiments, mice were administered a synthetic version of viral compounds (Poly IC and spike protein) known to induce lung damage1 in a manner resembling uncontrolled COVID-19.

In contrast to other studies, the current experiments utilized significantly higher doses of the viral mimicking compounds in order to replicate infection with the delta variant. It is published that the delta variant evades various immune mechanisms of the body, therefore causing a significantly higher viral load as compared to the original virus2.

JadiCell administration resulted in significant reduction of lung injury based on preservation of lung function, reduction of inflammatory cells entering the lung, and suppression of specific proteins such as C5a which are associated with poor prognosis in COVID-19 patients3.

"Aside from its enhanced infectivity rate and ability to escape various immune mechanisms, little is known about the delta variant," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "Although the data reported today was based on animal studies, the significant suppression of lung damage, which we did not observe with other stem cells, supports the idea that the JadiCell may benefit patients with the delta variant."

In an FDA double blind, placebo controlled clinical trial the JadiCell was successful at substantially improving survival in end-stage patients with COVID-19 associated acute lung failure4. Specifically, treatment was associated with significantly improved patient survival (91% vs 42%).

"As a company we are committed to learning as much as we can about our cellular product from laboratory studies while we are concurrently in discussions with the FDA regarding our planned Phase III pivotal trial," said Timothy Dixon, President and CEO of the Company. "Given the unique ability of the JadiCell in animal studies to concurrently suppress cytokine storm while stimulating regenerative processes in the lung, combined with promising patient data, we are hopeful that our work will lead to a new weapon in our fight against this invisible enemy."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 Molecular mechanism of SARS-Cov-2 components caused ARDS in murine model | bioRxiv
2 Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization | Nature
3 Complement Anaphylatoxins and Inflammatory Cytokines as Prognostic Markers for COVID-19 Severity and In-Hospital Mortality (nih.gov)
4 Umbilical cord mesenchymal stem cells for COVID–19 acute respiratory distress syndrome: A double–blind, phase 1/2a, randomized controlled trial - Lanzoni - 2021 - STEM CELLS Translational Medicine - Wiley Online Library

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BIG NEWS 8/5/21 FDA Approval on Jadicells

Therapeutic Solutions International Receives FDA Clearance to Initiate Phase III Pivotal Registration Trial for JadiCell™ Universal Donor COVID-19 Therapy

Adult Stem Cell Therapy Previously Demonstrated to Block Inflammation While Regenerating Injured Tissue to Enter Final Phase of Testing


https://www.prnewswire.com/news-release ... 49316.html


ELK CITY, Idaho, Aug. 5, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today clearance from the Food and Drug Administration (FDA) to initiate a Phase III pivotal trial for registration of the Company's JadiCell™ universal donor stem cell as a treatment for COVID-19 associated lung failure.

In previous studies the Company has demonstrated the superior activity of JadiCell™ to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%1.

"We are thankful for the strong regulatory, basic research and translational team that has worked in successfully obtaining this FDA clearance," said Dr. Thomas E. Ichim, Director of the Company. "FDA clearance to initiate a Phase III clinical trial means we are at the last phase of development before commercially selling the product. This positions us in a highly exclusive place in that to our knowledge no other cells have this potent ability to concurrently suppress inflammation while restoring function of tissue damaged by SAR-CoV-2."

"Having personally seen the effects of JadiCells on patients, I have seen their clinical potential firsthand" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "I am very excited to enter the final step of clinical development before being able to provide these cells to the general population."

"Despite the initial promise of vaccine approaches, there exists a significant portion of the population refusing them and there are also patients in whom vaccines have failed to induce appropriate immunity. Once COVID-19 initiates its pathological cascade leading to lung failure, no therapies exist until now to address this population" said Famela Ramos, Vice President of Business Development. "We are looking forward to leveraging the current clearance not only for obtaining market registration but also for expanding into other COVID-19 related pathologies."

"Today marks a significant milestone in the growth of our Company as we have received the final regulatory clearance before final marketing approval," stated Timothy Dixon, President and CEO of Therapeutic Solutions International. "Successful completion of the agreed upon trial with the FDA will position the Company as a significant force in the global battle against this unseen enemy that to date has caused over 4.25 million deaths. We are extremely proud of our progress and vow to accelerate our work for humanity and for our shareholders."

About Therapeutic Solutions International, Inc.


Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 Umbilical cord mesenchymal stem cells for COVID–19 acute respiratory distress syndrome: A double–blind, phase 1/2a, randomized controlled trial - Lanzoni - 2021 - STEM CELLS Translational Medicine - Wiley Online Library

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Therapeutic Solutions International Completes FDA Requested Studies to Initiate JadiCell™ Chronic Traumatic Encephalopathy (CTE) Clinical Trial

Company Aims to Expand Clinical Trials of Universal Donor Stem Cell to Treat Military Veterans and Professional Athletes


https://www.prnewswire.com/news-release ... 50965.html


ELK CITY, Idaho, Aug. 9, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today successful completion of a series of preclinical experiments requested by the United States Food and Drug Administration (FDA) in order to begin Phase I/II clinical trials.

The Company, which possesses the only filed Investigational New Drug (IND) application for treatment of chronic traumatic encephalopathy (CTE) was requested by the FDA to perform a series of experiments confirming several of the known properties of the JadiCell™ stem cells. With the completion of these experiments, the Company is cautiously optimistic to be granted clearance to initiate this "first in class" new treatment approach for CTE.

"The fact that the FDA accepted our definition of CTE as diagnosed in living patients is in our opinion, a major breakthrough" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The experiments conducted demonstrate safety of the JadiCells™ in several different systems. We applaud the diligence and high level of scrutiny that the FDA has applied to our clinical trial and look forward to utilizing this novel approach to addressing this serious unmet medical need."

CTE is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe. TSOI has previously filed several patents in the area of CTE based on modulating the brain microenvironment to enhance receptivity of regenerative cells such as stem cells.

"Given the recent FDA clearance1 for us to initiate Phase III clinical trials in COVID-19 using the same cells, we are enthusiastic to cross pollinate information learned from each of the trials as they proceed" said Timothy Dixon, President and CEO of the Company. "It is our honor to develop potential treatments that may help, in addition to athletes, military veterans who have given their lives and their bodies for our Country."

About Therapeutic Solutions International, Inc.


Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 Therapeutic Solutions International Receives FDA Clearance to Initiate Phase III Pivotal Registration Trial for JadiCell™ Universal Donor COVID-19 Therapy

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