Therapeutic Solutions International Inc (OTCMKTS: TSOI) operating out of Elk City, Idaho is a biotech focused on immune modulation for the treatment of several specific diseases. The Company is developing a range of immune-modulatory agents to target certain cancers, schizophrenia, suicidal ideation, traumatic brain injury, and for daily health. TSOI has been producing high quality nutraceuticals. Its current flagship product, QuadraMune®, a multi-patented synergistic blend of pterostilbene, sulforaphane, epigallocatechingallate, and thymoquinone. QuadraMune has been shown to increase Natural Killer Cell activity and healthy Cytokine production. The Company’s synergistic blend of ingredients helps the immune system fight off common and complex ailments and promote healthy T Cell activity. Recently the Company was approved to sell certain nutraceuticals on the Amazon Platform. 

TSOI nutraceuticals some of which are for sale on Amazon include: ProJuvenol® is a patented, (US No.: 9,682,047) and powerful synergistic blend of complex anti-aging ingredients in capsules. NanoStilbene® is an easily absorbed nanoemulsion of nanoparticle pterostilbene derived from the ‘047 patent. DermalStilbene is a topical form of pterostilbene delivered via spray application onto skin, derived from the ‘047 patent. IsoStilbene an injectable formulation of pterostilbene is available by prescription only, derived from the ‘047 patent. NeuroStilbene is an intranasal form of pterostilbene delivered via spray application inside the nostril, derived from the ‘047 patent. NanoPSA is a blend of NanoStilbene® and Broccoli Sprout Extract (BSE) providing 74mg of BSE and 125mg of our patented NanoStilbene, a proprietary formulation of nanoparticle pterostilbene. NLRP3 Trifecta is a two-product combo and consists of one bottle of NanoPSA and one bottle of GTE-50 green tea extract. QuadraMune® is a multi-patented synergistic blend of pterostilbene, sulforaphane, epigallocatechingallate, and thymoquinone. 

TSOI has filed numerous IND’s including: 

• Treatment of Metastatic Breast Cancer by StemVacs-V Cancer Immunotherapeutic IND transferred to Res Nova Bio,Inc. 
• Safety, Feasibility, and Immunomodulatory Activities of StemVacs in Patients with Advanced Solid Tumors IND # 17448 
• Umbilical Cord-derived Mesenchymal Stem Cells for Patients with COVID-19 (“UC-MSC for COVID-19”) IND # 19757 
• Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy Patients IND # 27377 
• JadiCell Therapy for COPD IND transferred to Breathe Biologics, Inc. 

TSOI obtained exclusive rights to a patented adult stem cell for development of therapeutics in the area of chronic traumatic encephalopathy (CTE) and traumatic brain injury (TBI) and Lung Pathology (LP). The stem cell licensed, termed “JadiCell” is unique in that it possesses features of mesenchymal stem cells, however, outperforms these cells in terms of a) enhanced growth factor production; b) augmented ability to secrete exosomes; and c) superior angiogenic and neurogenic ability. TSOI has also 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. On March 4, 2021, the Company received an IND Serial # 27377 for a clinical trial of 10 patients with CTE. 

TSOI is led by its CEO Timothy Dixon who has serves as Chairman of Campbell Neurosciences, Inc., Allogen Biologics, Inc., Res Nov Bio, Inc., and Breathe Biologics, Inc., all subsidiaries of TSOI. Mr. Dixon has produced many educational DVD’s used by dental professionals worldwide on the subject of parafunctional control, migraine prevention, therapeutic Botox injections, migraine pathophysiology, dental sleep medicine, and other therapeutic protocols. Mr. Dixon also has extensive experience in dealing with corporate compliance matters with the U.S. Food and Drug Administration, (FDA) as well as many international regulatory bodies. Mr. Dixon is the inventor and co-inventor of 70+ patents and patents pending. TSOI has also assembled an impressive executive management team. 

Historic day for $tsoi …the patent for our phase 3 clinical trial was upheld….https://t.co/fzZ8bPMTuH

— Dr. Thomas Ichim (@exosome) April 19, 2023

On August 4th, 2021, TSOI reported clearance from the 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 under IND # 19757. In previous studies TSOI 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%. The Company also recently announced the launching of Phase III for IND # 19757 with Biorasi LLC, a global, full-service CRO, who will run the clinical trial. 

In addition, TSOI has filed data with the FDA, as part of IND #17448, which demonstrated that treatment of cancer patients with StemVacs™ resulted in enhanced activity of a type of immunological cell called “natural killer” cells, otherwise known as “NK cells.”TSOI has also developed an allogenic version of StemVacs and has filed patents to cover activating universal donor immune system cells called dendritic cells in a manner so that upon injection they reprogram the body’s NK cells. TSOI also filed a patent application covering the use of JadiCells™ for treatment of epilepsy and associated conditions. 

TSOI is up big on Thursday, April 20 after the Company reported the filing of a new Phase III clinical trial application with the FDA for use of its JadiCell adult stem cells in treatment of acute respiratory distress syndrome (ARDS). This investigational drug application (IND) is based on the Company’s existing data and experiences associated with its Phase III clinical trial in the area of COVID-19 associated ARDS. 

Acute respiratory distress syndrome (ARDS) is a serious lung condition that causes low blood oxygen. People who develop ARDS are usually ill due to another disease or a major injury. In ARDS, fluid builds up inside the tiny air sacs of the lungs, and surfactant breaks down. ARDS afflicts approximately 190,000 Americans a year and is the market for ARDS is expected to reach $19.5 billion by 2029. 

This decision comes after a published decision from the U.S. Patent Trial and Appeal Board to uphold validity of Patent 9,803,176 B2 after an Inter Partes Review initiated by Restem, LLC3. This patent, which is exclusively licensed to Therapeutic Solutions International for lung and brain indications, covers composition of matter of the JadiCells, which have previously been published to be 100% effective in COVID-19 induced ARDS patients under 85 years of age. 

Dr. James Veltmeyer, Principle Investigator of the Study stated: “The Company has stayed a steady course in accomplishing its milestones of in-licensing an advanced cell therapeutic product, filing additional patents surrounding it, demonstrating in animal models and various clinical situations benefits of the product, and now taking the next step in product development by filing for entry into the ARDS patient population, which presents a significantly greater market than COVID-19 induced ARDS.”  

TSOI CEO Timothy Dixon stated: “We are happy to report the decision of our medical advisors to support entry of our adult stem cell based product into the greater patient population of ARDS/ We have numerous physicians eager to join the new trial, including ones who have previously witnessed significant patient improvement in previous clinical uses of our cells.” 

When I was appointed CEO of Medistem, the stock was at 7 cents…we sold the company at $1.35

Proud to be CEO of Campbell Neurosciences….I will create even greater success ….for patients and shareholders $TSOI

This is a video from the Medistem dayshttps://t.co/30fxhjksQY

— Dr. Thomas Ichim (@exosome) April 8, 2023

For More on TSOI Subscribe Right Now!

Currently trading at a $10 million market valuation TSOI os is 2,811,224,943 as of April 18. TSOI is an SEC filer and fully reporting and the Company gets its filings out on time filings its latest 10k on March 29, same as last year. While the Company brough in about $200k from its nutraceuticals like QuadraMune selling Amazon, they continue to lose money, however TSOI has a manageable debt load of under $3 million. TSOI is an exciting story developing in small caps with a long history of big moves and a significant shareholder base looking for a breakout into copperland. Newsytrends is currently on the hunt for the next big penny stock winner. Subscribe today by entering your email below.