News Portal

trader32176
Posts: 3538
Joined: Fri Jun 26, 2020 5:22 am

Re: News Portal

Post by trader32176 »

Therapeutic Solutions International Successfully Treats Veteran Navy SEAL Suffering from Chronic Traumatic Encephalopathy with JadiCell™ Adult Stem Cells Under Right to Try Law

FDA Phase III COVID-19 Clinical Trial Company Offers Pro Bono Cell Therapy for Veterans at Risk


https://www.prnewswire.com/news-release ... 75088.html


ELK CITY, Idaho, Sept. 13, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today successful treatment of a United States Navy SEAL Veteran suffering from Chronic Traumatic Encephalopathy (CTE). The patient received 2 injections of the JadiCell adult stem cells, no treatment associated adverse events were noted.

The cells were provided under a newly initiated program under which Therapeutic Solutions International provides access to its technologies Pro Bono, to members of the Armed Forces who have defended the United States.

"We are 100% committed to performing proper clinical trials, as seen by the recent Phase III clearance to utilize these cells in patients with COVID-19 ARDS. We are also working with the FDA to launch our Phase I/II trial in CTE," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "With a suicide rate of 20 veterans per day, it is imperative that we vigorously explore novel therapeutic strategies in patients for which other approaches have failed or don't exist. Given the excellent safety profile of these cells, and promising preclinical data, in our opinion it would be criminal not to provide access to these cells under very specific circumstances."

CTE is caused by repeated injuries to the brain causing chronic inflammation, deterioration of neuronal communication, and death of brain cells. These culminate in various symptomologies including depression, violence, and suicidality.

"My father was a combat veteran Marine of WWII and Korea; I fully understand the extreme sacrifices made by members of our Armed Forces in the defense of our Freedom, our Nation, and our National Security," said Timothy Dixon, President and CEO of the Company. "We are a Company that is proud of being in a position to give something back to the bravest segment of our society."

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/

ir@tsoimail.com

SOURCE Therapeutic Solutions International
Related Links

therapeuticsolutionsint.com
trader32176
Posts: 3538
Joined: Fri Jun 26, 2020 5:22 am

Re: News Portal

Post by trader32176 »

Therapeutic Solutions International Identifies and Files Patent on Combination Effects Between its Nutraceutical QuadraMune™ and Ivermectin in Animal Models of COVID-19 Pathology

Company Developing Phase III Stem Cell Therapy for COVID-19 Advances Natural Approaches Towards Controlling Pandemic


https://www.prnewswire.com/news-release ... 78661.html


ELK CITY, Idaho, Sept. 16, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported today new data demonstrating positive effects when its commercially available nutraceutical, QuadraMune™, is administered together with ivermectin in animals suffering from similar biological processes as those elicited by a COVID-19 infection.

In a series of experiments, it was demonstrated that ivermectin alone has a marginal effect at reducing inflammation in the lungs, whereas this effect is markedly increased when QuadraMune™ is co-administered. The Company also observed enhanced innate immune system activity, specifically stimulation of natural killer cells (NK cells), as well as elicitation of NK memory-like activities when QuadraMune™ was combined with ivermectin.

"It is fundamentally important that we continue exploring molecular mechanisms of how various approaches to COVID-19 function at a cellular and immunological level," said Dr. James Veltmeyer, Chief Medical Officer, and co-inventor on the patent. "QuadraMune™ has previously been shown to enhance immunity and suppress inflammation in pilot clinical trials and we are pleased to report this new promising animal data which has clinical implications."

"The great advancements we are making on the Phase III JadiCell Program are fundamentally important, however, JadiCells are more aimed towards advanced COVID-19, when lung damage to some extent has already occurred," said Wais Kaihani, consultant to the Company and coinventor on the patent. "We are exploring various potential strategies to address patients at the earlier stage of the COVID-19 continuum."

"We are currently in discussions with various medical groups to potentially initiate combination trials between ivermectin and QuadraMune," stated Timothy Dixon, President and CEO of the Company and co-inventor on the patent. "To our knowledge this is the first detailed exploration of ivermectin having lung protective activities, which makes this a very interesting finding according to our collaborators."

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/

ir@tsoimail.com

SOURCE Therapeutic Solutions International
Related Links

http://www.therapeuticsolutionsint.com
trader32176
Posts: 3538
Joined: Fri Jun 26, 2020 5:22 am

Re: News Portal

Post by trader32176 »

Therapeutic Solutions International Discovers and Files Patent on Novel Cellular Therapy Combination for Augmentation of Lung Repair in COVID-19 Model

Exogenous T Regulatory Cells Demonstrated to Augment Activity of JadiCell Universal Donor Stem Cells Cleared for FDA Phase III Trials in COVID-19


https://www.prnewswire.com/news-release ... 82566.html


ELK CITY, Idaho, Sept. 22, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today novel data and filing of a patent demonstrating synergistic suppression of lung injury and acceleration of lung regeneration by combining T regulatory cells and JadiCells.

In a series of experiments synergistic suppression of lung damage was observed in the endotoxin and Poly (IC) models when umbilical cord blood T regulatory cells were co-administered with JadiCells. Furthermore, blockade of GITR, a member of the TNF receptor superfamily, resulted in suppression of synergy, suggesting a molecular mechanism of this interaction.

"I believe science does not stop and cannot be stopped. Therefore, as a Company, we are always seeking new ways of enhancing efficacy of our therapies, as well as elucidating molecular mechanisms causing our therapies to work," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The current discovery provides for novel means of suppressing lung damage, as well as preventing long term-scarring which is a major issue in certain COVID-19 patients."

Lung damage after COVID-19 is believed to be caused by deposition of scar tissue in the functional areas of the lung, which has been quantified to cause dysfunctional breathing for as long as 9 months after infection1. JadiCells, as well as QuadraMune®, a commercially available nutraceutical developed by the Company have been shown to reduce lung scarring in other experiments.

"As the COVID-19 pandemic continues its merciless progression, it is becoming more and more important to create second and third generation approaches," said Famela Ramos, Vice President of Business Development. "Today's findings open the door not only towards new approaches but also towards alternative means of manipulating JadiCells using the newly discovered importance of the GITR pathway."

"We are currently continuing experiments to try to identify other molecular switches which can be used to not only enhance JadiCell activity but also activity of numerous other types of stem cells," said Timothy Dixon, President and CEO of the Company and co-inventor of patent. "As we are preparing to initiate the recently cleared FDA Phase III trial on COVID-19 patients, we wish to know as many details as possible about our cells in order to capture as much value as possible from the planned clinical trial."

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 Study confirms longer-term lung damage after COVID-19 (newswise.com)

ir@tsoimail.com

SOURCE Therapeutic Solutions International
Related Links

https://therapeuticsolutionsint.com
trader32176
Posts: 3538
Joined: Fri Jun 26, 2020 5:22 am

Re: News Portal

Post by trader32176 »

Therapeutic Solutions International Discusses Claims of Possible COVID-19 Suppressive Activity of QuadraMune™ Ingredients by Independent Universities Made After Patent Filing

Company with Stem Cell in FDA Cleared Phase III COVID-19 Clinical Trial Comments on Scientific Support for Nutraceutical Already on the Market


https://www.prnewswire.com/news-release ... 85491.html


ELK CITY, Idaho, Sept. 27, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI).

On May 5th, 2020, Therapeutic Solutions International publicly announced their production and patent filing's for QuadraMune™, a nutraceutical developed with the aim of naturally modulating susceptibility, immunity, and inflammation in the context of COVID-191.

On November 24th, 2020, TSOI announced results of a clinical trial demonstrating in healthy volunteers that QuadraMune™ increases natural killer cell activity2. Natural killer cells are believed to be part of the body's "innate" immune response to viral infections such as SARS-CoV-2, the causative agent of COVID-19.

On December 1st, 2020, TSOI reported the results of another clinical trial in which QuadraMune™ was shown to increase interleukin 2, a protein associated with T cell responses3. T cells are considered the "adaptive" arm of the immune system and are needed for creation of immunological memory to prevent re-infections.

Following TSOI's initial research, there have been multiple studies published in peer-reviewed journals by independent academic institutions supporting the individual ingredients in QuadraMune™, which are listed below by ingredients.

To our knowledge, QuadraMune™ is the only nutraceutical on the market with this level of independent scientific support for its potential use in COVID-19.

QuadraMune™ Ingredient #1: Pterostilbene:


- November 11th, 2020. Researchers at the University of Ha'il, Saudi Arabia, used computer modeling to screen 200,000 natural compounds for the ability to block interaction between SARS-CoV2 Spike Protein and ACE2 receptor. They found pterostilbene to be the top 2 blocker of this interaction, which is critical for the virus to infect cells4.

- July 10th, 2021. Researchers at the University of Groningen in the Netherlands reported "resveratrol and its metabolically more stable structural analog, pterostilbene, exhibit potent antiviral properties against SARS-CoV-2 in vitro5."

QuadraMune Ingredient #2: Thymoquinone:

- July 12th, 2020. Researchers at University of Casablanca, Morocco reported thymoquinone may have inhibitory activities against SARS CoV2 protease. Activity of the protease is needed for the virus to replicate6.

- November 3rd, 2020. Scientists at University of Dalian, China, demonstrated thymoquinone prevents kidney damage in a mouse model of systemic inflammation resembling COVID-197.

- March 3rd, 2021. A paper from the Graduate School of Pharmaceutical Sciences in South Korea entitled "Revisiting pharmacological potentials of Nigella sativa seed: A promising option for COVID-19 prevention and cure" described why thymoquinone, the active ingredient in Nigella Sativa seeds possesses numerous therapeutic properties making it an ideal adjuvant or monotherapy for COVID-198.

- September 6th, 2021. A randomized clinical trial with 173 COVID-19 patients revealed that 62% of patients who received nigella sativa oil (source of thymoquinone) recovered, whereas only 36% recovered who received placebo9. The study was a collaboration between multiple hospitals in Saudi Arabia.

QuadraMune Ingredient #3: Epigallocatechin-3-gallate (EGCG)


- Sept 3rd, 2020. Researchers from Yonsei University in South Korea demonstrated EGCG inhibits SARS-CoV-2 proliferation. They demonstrated mechanistically that this process worked through suppression of 3CL-proteins, which the virus uses to generate its protein components after it has infected cells10. These findings were replicated by two independent groups11,12.

- April 13th, 2021. A study led by a group of scientists from the Paul-Ehrlich-Institute at the Department of Virology in Germany showed that EGCG suppressed SARS-CoV-2 virus in vitro13. This was replicated by independent groups14,15.

- August 10th, 2021. Researchers at the Russian Academy of Sciences reported EGCG suppresses original and SARS-CoV-2 variant (mutant) virus replication16. This data was independently verified17.

QuadraMune Ingredient #4: Sulforaphane

- March 25th, 2021. Scientists from John Hopkins published that sulforaphane reduces proliferation of SARS-CoV-2 in the laboratory, as well as in mice18.

- July 8th, 2021. Researchers at University of Ferrara, Italy published that sulforaphane decreases toxic cytokines produced by lung cells in response to parts of the SARS-CoV-1 virus19.

Timothy Dixon, President and CEO of Therapeutic Solutions International, stated, "the fact that there was no mention of COVID-19 altering activity of any of the QuadraMune™ ingredients prior to our patent filing, and that now these ingredients are being actively investigated as possible therapies speaks volumes about the wisdom of our scientific team and our advisors who have worked tirelessly at developing QuadraMune™, as well as advancing its science. With the rise of the new variants, as well as realization of the problem of "long hauler" pathologies, we believe that there is an increasing need for natural approaches towards this pandemic."

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 Leverages Filed and Issued Intellectual Property to Develop COVID-19 Nutraceutical Candidate: QuadraMune™ | BioSpace
2 QuadraMune™ Synergizes with Metformin to Stimulate Anti-Viral Defenses in Pilot Clinical Trial (prnewswire.com)
3 Therapeutic Solutions International Announces Positive QuadraMune™ Clinical Trial Data (prnewswire.com)
4 Molecular basis for drug repurposing to study the interface of the S protein in SARS-CoV-2 and human ACE2 through docking, characterization, and molecular dynamics for natural drug candidates | SpringerLink
5 Viruses | Free Full-Text | Resveratrol and Pterostilbene Inhibit SARS-CoV-2 Replication in Air–Liquid Interface Cultured Human Primary Bronchial Epithelial Cells (mdpi.com)
6 In Silico Investigation of the SARS CoV2 Protease with Thymoquinone, the Major Constituent of Nigella Sativa | Bentham Science (eurekaselect.com)
7 Effect of Thymoquinone on Acute Kidney Injury Induced by Sepsis in BALB/c Mice (hindawi.com)
8 Revisiting pharmacological potentials of Nigella sativa seed: A promising option for COVID–19 prevention and cure - Islam - 2021 - Phytotherapy Research - Wiley Online Library
9 Nigella sativa for the treatment of COVID-19: An open-label randomized controlled clinical trial – ScienceDirect
10 Tea Polyphenols EGCG and Theaflavin Inhibit the Activity of SARS-CoV-2 3CL-Protease In Vitro (hindawi.com)
11 The inhibitory effects of PGG and EGCG against the SARS-CoV-2 3C-like protease – ScienceDirect
12 Epigallocatechin-3-gallate, an active ingredient of Traditional Chinese Medicines, inhibits the 3CLpro activity of SARS-CoV-2 – ScienceDirect
13 The green tea catechin epigallocatechin gallate inhibits SARS-CoV-2 infection | Microbiology Society (microbiologyresearch.org)
14 Epigallocatechin Gallate Inhibits the Uridylate-Specific Endoribonuclease Nsp15 and Efficiently Neutralizes the SARS-CoV-2 Strain | Journal of Agricultural and Food Chemistry (acs.org)
15 Molecules | Free Full-Text | Antiviral Effects of Green Tea EGCG and Its Potential Application against COVID-19 (mdpi.com)
16 EGCG as an anti-SARS-CoV-2 agent: Preventive versus therapeutic potential against original and mutant virus – ScienceDirect
17 Epigallocatechin gallate from green tea effectively blocks infection of SARS-CoV-2 and new variants by inhibiting spike binding to ACE2 receptor | Cell & Bioscience | Full Text (biomedcentral.com)
18 Sulforaphane exhibits in vitro and in vivo antiviral activity against pandemic SARS-CoV-2 and seasonal HCoV-OC43 coronaviruses | bioRxiv
19 Sulforaphane inhibits the expression of interleukin-6 and interleukin-8 induced in bronchial epithelial IB3-1 cells by exposure to the SARS-CoV-2 Spike protein - ScienceDirect

ir@tsoimail.com

SOURCE Therapeutic Solutions International
Related Links

therapeuticsolutionsint.com
trader32176
Posts: 3538
Joined: Fri Jun 26, 2020 5:22 am

Re: News Portal

Post by trader32176 »

Therapeutic Solutions International Utilizes Mesenchymal Stem Cell Exosomes to Effectively Suppress Neutrophil Extracellular Trap Production

Patent Filed on Potential Solution to Cause of Major Inflammatory Pathologies


https://www.prnewswire.com/news-release ... 91625.html


ELK CITY, Idaho, Oct. 4, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI) announced today laboratory data demonstrating that exosomes produced by JadiCells™, the Company's Phase III cell therapy candidate for COVID-19 and other lung pathology, as well as mesenchymal stem cells proprietary to the Company, can suppress the production of neutrophil extracellular traps.

Neutrophil extracellular traps are a network of extracellular DNA, histones, and enzymes that cause inflammation. In healthy individuals, neutrophil extracellular traps are very useful in fighting bacterial infections. Unfortunately, in conditions such as COVID-19, atherosclerosis, cancer, and various autoimmune diseases, neutrophil extracellular traps are considered to play a major role in disease initiation and progression1.

In a series of experiments JadiCells and other mesenchymal stem cells were stimulated using agents that replicate biological "danger signals". It was observed that the cells produced exosomes, which when added to neutrophils, would inhibit the production of neutrophil extracellular traps. The experimental data is part of a patent application that was submitted today.

"Due to the small size of exosomes, their ease of production, and the fact that they are made from stem cells that are recognized by the FDA, we anticipate rapid translation of this new approach into potential treatments for a variety of inflammation associated conditions," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "Preliminary data suggests that the exosomes themselves possess potent lung protective activity in animal models of lung injury simple to COVID-19. This gets us excited because it opens the possibility for increasing our product pipeline."

"The lifeblood of our Company is the germination of thought into working applications. The findings described today are particularly exciting to us because they point to a potentially new mechanism by which stem cells, and the exosomes they produce, affect inflammation," said Timothy Dixon, President and CEO of the Company and co-inventor. "By targeting broadly acting molecular targets we have the opportunity to develop First in Class approaches towards diseases, which have significant possibility of sale or partnership with Big Pharma."

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 Jorge and Kubes. An emerging role for neutrophil extracellular traps in noninfectious disease. Nat Med. 2017 Mar 7;23(3):279-287

ir@tsoimail.com

SOURCE Therapeutic Solutions International
Related Links

therapeuticsolutionsint.com
trader32176
Posts: 3538
Joined: Fri Jun 26, 2020 5:22 am

Re: News Portal

Post by trader32176 »

Therapeutic Solutions International Announces Initiation of JadiCell™ Manufacturing Program to Address Upcoming FDA Phase III Trial and Emergency Use Requests

Company Files Over One Thousand Claim Manufacturing Patent and Begins Pilot Production Runs


https://www.prnewswire.com/news-release ... 96937.html


ELK CITY, Idaho, Oct. 11, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI) announced today initiation of pilot batch production of JadiCells, its umbilical cord stem cell product cleared by the FDA to enter Phase III clinical trials for COVID-19.

Company scientists have successfully reproduced manufacturing protocols described in the issued US patent # 9,803,176 B2 which is exclusively licensed for pulmonary indications, chronic traumatic encephalopathy, and traumatic brain injury. Additionally, the Company has filed an extensive patent covering novel manufacturing procedures as well as "second generation" JadiCells.

"Seeing myself as a man of science, the fact that we have successfully reproduced in our own hands the isolation and scalable generation of JadiCells, according to the protocols used in previously published clinical trials, is a fundamental milestone" said Dr. Thomas Ichim, Board Member of the Company, and co-inventor of the manufacturing patent. "As we prepare to launch the Phase III clinical trial in COVID-19 we need to ensure that manufacturing procedures utilized are practical and economical. The data generated by the team, as well as the various advancements that we have filed intellectual property on significantly reduce the cost of production."

Cellular therapies are characterized by extremely high costs and need for complicated procedures during manufacturing, transportation, and administration. Therapeutic Solutions International aims to increase the practicality and reduce barriers to entry for physicians wishing to utilize this "living medicine" in their patients.

"Due to the enormous interest in utilizing JadiCells domestically under the Right to Try Law and domestically and internationally under Emergency Use Authorization, as well as our upcoming Phase III clinical trial, we have decided as a Company to initiate internal manufacturing" said Timothy Dixon, President and CEO of the Company and co-inventor of the patent. "I am thankful for the efforts of our team in developing and validating the numerous Standard Operating Procedures associated with cell manufacturing, as well their innovations which have led to, in my opinion, an unparalleled patent being filed."

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/

ir@tsoimail.com

SOURCE Therapeutic Solutions International
Related Links

https://therapeuticsolutionsint.com
trader32176
Posts: 3538
Joined: Fri Jun 26, 2020 5:22 am

Re: News Portal

Post by trader32176 »

Therapeutic Solutions International Announces Formation of Allogen Biologics Inc.

Wholly Owned Subsidiary Created for Manufacturing of JadiCell™ and StemVacs™ Clinical Stage Cell Therapeutics


https://www.einpresswire.com/article/55 ... logics-inc


OCEANSIDE, CA, USA, October 18, 2021
/EINPresswire.com/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI) announced today the formation of Allogen Biologics Inc, a wholly owned subsidiary of the Company.

Last week the Company successfully initiated production of its first pilot batch production of JadiCells ™ under Good Manufacturing Practices in anticipation for uses such as Emergency Use Authorization requests, Right To Try, and our upcoming CTE clinical trial. Allogen Biologics will be led by Dr. Thomas Ichim, currently a board member of Therapeutic Solutions International. Dr. Ichim is an industry veteran with four cleared INDs, over 200 patents and patent applications, and over 120 peer reviewed papers.

Allogen Biologics will house intellectual property and Standard Operating Procedures related to generation of the Company’s existing and anticipated cellular therapeutics.

The JadiCell™ is a universal donor stem cell that has recently been cleared by the FDA to begin Phase III clinical trials of COVID-19. Under the Right to Try Law, companies are permitted to administer and charge for experimental therapeutics if no other treatment options exist. The Company has recently treated a Navy SEAL under this exemption.

“As we advance our cellular therapeutic products, the need for flexibility and manufacturing has become more and more apparent. By controlling our own manufacturing, we believe the Company is in a significantly better position to advance its objectives and reduce costs of production” said Timothy Dixon, President and CEO of Therapeutic Solutions International and Chairman of Allogen Biologics. “Dr. Ichim is one of the most accomplish developers of cellular therapies in regenerative medicine and immunology and we are honored for him to lead Allogen Biologics.”

“Timothy Dixon is a true visionary and innovator” said Dr. Thomas Ichim. “Though his efforts, and the work of his advisors such as Francesco Marincola from Gilead, Santosh Kesari from John Wayne Cancer Center, and Boris Reznik from Venvalo, Timothy Dixon has developed multiple drug candidates and nutraceuticals for a variety of therapeutic indications. I am excited to increase my involvement with Timothy and his world-class team.”

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/

Timothy Dixon
Therapeutic Solutions International, Inc.
ir@therapeuticsolutionsint.com
Visit us on social media:
Facebook
Twitter
Post Reply