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by TimGDixon » Thu Dec 15, 2022 9:16 am
The cool thing about this product is its available right now at the Veltmeyer Institute of Advanced Biologics. Because the adjuvants described can be taken independently of the CBP we can provide a variety of immune stimulants and adjuvants pre and post intranasal delivery of the cbp.
QuadraMune is a preferred adjuvant and all four ingredients may be used together or alone. For example, 10 minutes prior to CBP administration the patient is pretreated with NeuroStilbene.
by TimGDixon » Thu Dec 15, 2022 5:52 am
https://patents.justia.com/patent/20220395540
TREATMENT OF COVID-19 LUNG INJURY USING UMBILICAL CORD PLASMA BASED COMPOSITIONS
Jun 9, 2021 - THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
by TimGDixon » Sat Dec 17, 2022 7:00 am
Nothing would make us happier than to tell you we were approved - this work requires great patience on management and shareholders alike - we are very anxious but we have to maintain our composure - FDA is not our enemy - we consider them partners and so we will remain patient with them.
"diagnosed with CTE. These are the first 5 living humans "
by TimGDixon » Fri Dec 16, 2022 9:26 am
curncman wrote: ?Fri Dec 16, 2022 8:39 am
That almost more than 70% reduction in IL-6 levels. I am guessing all 3 patients recovered from trauma and coma
These patients were not comatose. However, the three and the other two were all diagnosed with CTE. These are the first 5 living humans ever diagnosed with the disease.
https://forum.therapeuticsolutionsint.com/viewtopic.php?p=14179#p14179
NOT JUST ANOTHER PRETTY FACE Oh and a note to admin Famela Ramos is an officer at TSOI so don't delete--this time--
Famela Ramos – Vice President Business Development
Famela Ramos is a Nurse, a Researcher, and a Politician. Famela was running for Congress in the 53nd Congressional District. Ms. Ramos came to the United States from the Philippines at the age of two, when her father joined the United States Navy. Her parents worked tirelessly to support the family of 5 children, all of which became successful entrepreneurs and Government Employees. As a nurse, Famela has experience from the beginning of life, having practiced in pediatric nursing, to the end of life, having worked as a hospice nurse. Her excellence in nursing and research is attested by 7 peer reviewed publications that she collaborated with Academy and Industry in advancing cutting edge research in immunology and regenerative medicine.
The first paper, was a collaboration with the Moores Cancer Center and several biotechnology companies, describing the state of the art in cancer immunotherapy, and proposing future directions. The second paper discussed the possibility of stimulating regeneration of injured lung stem cells using specific types of laser and light based interventions, this was a collaboration between the University of Utah and the University of California, San Diego. The third paper, a collaboration between a nutraceutical company and Indiana University, demonstrated the beneficial effects of a nutritional supplement on circulating stem cells in healthy volunteers. The fourth publication was the first successful use of two different types of stem cells in a patient with heart failure, which resulted in a profound improvement. The fifth publication is a report of 114 patients that were treated with umbilical cord blood stem cells and demonstrated safety and signals of efficacy in collaboration with a Chinese Biotech company. The sixth publication was successful treatment of a spinal cord injury patient with stem cells. The seventh publication was the basis for an investigational new drug (IND) application to the FDA, describing use of fat stem cells to treat aplastic anemia.
Ms. Ramos has established the Right to Try Foundation, which assists companies in utilizing this new law that allows for accelerated patient access to experimental medication. Through this Foundation Ms Ramos facilitated the first utilization of a cancer vaccine in the United States, and has been assisting both public and private companies. Most recently the Foundation has collaborated on filing new patents for means of implementing the Right to Try Law. Ms. Ramos is a board member of Silent Voices, a Pregnancy Resource Center that provides counselling to woman in emergency pregnancies, alternatives to abortion, and for woman that do choose abortion, post abortion support. Ms. Ramos has been endorsed by business and community leaders as well as nationally known athletes including Dr. Peter Farrell, founder of Resmed, a $18 billion company, and Wes Chandler, an NFL Hall of Fame San Diego Charger.
by TimGDixon » Thu Dec 15, 2022 12:38 pm
Preferred embodiments herein are directed to a dendritic cell capable of stimulating natural killer cell activity and/or natural killer cell number in a host, said dendritic cell generated by the steps of: a) obtaining a monocytic cell; b) treating said monocytic cell in a manner to induce differentiation along the dendritic cell lineage; and c) exposing said dendritic cell to a stimulator of innate immune functions for a sufficient time and concentration to endow said dendritic cell ability to activate NK cells.
https://forum.therapeuticsolutionsint.com/viewtopic.php?p=14126#p14126
by TimGDixon » Thu Dec 15, 2022 9:16 am
The cool thing about this product is its available right now at the Veltmeyer Institute of Advanced Biologics. Because the adjuvants described can be taken independently of the CBP we can provide a variety of immune stimulants and adjuvants pre and post intranasal delivery of the cbp.
QuadraMune is a preferred adjuvant and all four ingredients may be used together or alone. For example, 10 minutes prior to CBP administration the patient is pretreated with NeuroStilbene.
However many polyphenols can be included, especially those analogues and derivatives of elagic acid.. see them in the lower right area of my white board in my hidden office....https://forum.therapeuticsolutionsint.com/viewtopic.php?p=14103#p14103
by TimGDixon » Sun Dec 11, 2022 7:05 pm
This really is the key in taking suicidal ideation, or the propensity towards it, and realigning it properly, by validating it as an immunological disease.
Campbell will soon start enrolling into a phase 3 with 300 patients this time. 100 control, 100 with suicidal ideation who did not act upon it, and 100 with suicidal ideation who did act upon it. We will complete the phase 3 using blood because we want consistency in all 3 phases. But post phase 3 we hope to be able to move to saliva based, and eventually a monitor like glucose. We can forever change the way suicidal ideation is viewed and change the way it is treated because the other 10 patents are all treatment based approaches for not only suicidal ideation but drug addictions, gambling, schizophrenia and hundreds of other neurological diseases.
1. A method of predicting propensity for suicide and/or suicidal ideation comprising the steps of: a) selecting a patient at potential risk of suicide/suicidal ideation; b) obtaining a biological fluid from said patient; c) analyzing immunological molecules and/or immunological cells from said patient; and d) making a prediction of suicidal risk/suicidal ideation based on immunological molecules/immunological cells.
by TimGDixon » Mon Dec 12, 2022 7:55 am
The Veltmeyer Stem Cell Therapeutic Protocol
Guest Columnist James D. Veltmeyer
Stem cell therapy is the future of medicine. However, why is it not revolutionizing medicine right now?
Let me explain.
Currently, the majority of medical interventions for chronic or degenerative diseases are based on treatment of symptoms. Stem cell therapy is a revolutionary type of medicine because it is based on regeneration of injured or aged tissues, thereby fixing the actual cause of the disease.
Although numerous clinical trials have demonstrated that adult stem cells are safe to administer, full demonstration of efficacy has not been achieved in large clinical trials. The reason for this is because conventional stem cell protocols provide the stem cells to patients without preparing the body for administration of the cells.
In many degenerative conditions, the underlying disease processes change the body such that when cells enter the body their therapeutic activity is minimized. This is because of various toxic agents which make the target tissue inhospitable for the stem cells.
The Veltmeyer Protocol involves utilization of various interventions before injection of stem cells such that the disease-induced elements which make the body hostile to stem cells are minimized.
According to the Veltmeyer Protocol, blood levels of these toxic agents associated with reduction of stem cell viability and activity are measured before stem cell therapy. Patients are placed on disease and patient specific interventions. Only when the patient’s body is ready to receive the stem cells because it has properly been detoxified, only then, are the stem cells administered. The problem is that when one administers stem cells but the body is full of toxicities, it becomes just like planting seeds on gravel…they just do not have a chance to function or to grow.
So let us give you one example of the Veltmeyer Protocol in action.
Take patients with heart failure. Many of them have high levels of inflammatory markers such as CRP, TNF-alpha. Some of them also have sleep apnea which is not treated, as well as an altered microbiome ( microbial environment ) characterized by dysbiosis ( a medical condition caused by microbial imbalances within the body ) and reduced alpha diversity index. In these patients, administration of stem cells intravenously usually results in the stem cells sticking to blood vessels all over the body…the stem cells being “consumed” by the inflammation, and the various factors made by the altered microbiome blocking the few stem cells left from exerting any type of therapeutic activity.
For this type of patient, upon intake we proceed to understand the various pathologies that are associated with his heart failure and address them. Once there is a sufficient reduction in all of these co-factors, then we administer stem cells. After stem cell administration, we continue the “detoxification” procedure and also assess regenerative potential through our proprietary test. In this way, we derive the optimum value of stem cell therapy.
It should be noted that T-regulatory cells are the body's unique defense mechanism against inflammation. The importance of these cells is seen most profoundly in patients with a genetic disease called IPEX who lack T-regulatory cells. Patients with this condition have multiple autoimmune diseases.
In patients with neurodegenerative diseases such as ALS ( Amyotrophic lateral sclerosis ), there is a correlation between survival and the number of T-regulatory cells that can actually produce nerve protective growth factors. In animal studies, direct administration of T-regulatory cells have been associated with disease remission or cure. Unfortunately, to date there is no easy way to generate patient specific T-regulatory cells. Therefore, we are extremely optimistic at our ability to naturally stimulate increases in T-regulatory cells through providing stem cells to our patients.
In the case of an ALS patient cited in a prior commentary, the improvement of her T-regulatory cells after stem cell therapy has been astounding, up from 47% to 77% post-JadiCell infusion treatment. Another case is that of a 5 1/2 year old boy diagnosed with autism who has literally not spoken a single word since birth. After JadiCell infusion, he is now actually talking for the first time in his life!
Of course, every individual is different and, obviously, results and progress will differ from person to person. Some individuals may need treatment for a short period of time and others perhaps for the rest of their lives. And, the treatment is not inexpensive and is normally not covered by health insurance. One of the main objectives of the Veltmeyer Institute of Advanced Biologics is to make stem cell therapy affordable and accessible to the vast majority of people needing such treatment. If we can reach this goal, we will have made another gigantic stride toward healing people of some of the most destructive diseases to plague mankind.
by TimGDixon » Sun Dec 11, 2022 8:41 am
I was just updating the IP list for CNSI and its nice to see that thus far 9 of the 11 patents licensed have published with one being granted a week or two ago. This is the new era on psychiatric illness. This is the new way forward.
Licensed Intellectual Property
CNSI has licensed from Therapeutic Solutions International, Inc., the following list of patent applications:
https://forum.therapeuticsolutionsint.com/viewtopic.php?p=13764#p13764
by TimGDixon » Sat Dec 10, 2022 9:07 am
we never talk about bringing more shareholder value? Is that a correct narrative? Let's see what we've done lately.
Res Nova Bio whom we have licensed the indication of breast cancer and sold them our IND for $200k and a patent licensing fee of $50,000 + annual minimum royalty of $10,000 + 10% of future revenue.
Breathe Biologics whom we have licensed the indication of COPD and sold them IND for $200k and a patent licensing fee of $50,000 + annual minimum royalty of $10,000 + 10% of future revenue.
Campbell Neurosciences whom we have licensed 11 patents to them for their programs. Just yesterday TSOI collected on licensing fees and opted to take more stock in Campbell increasing our holdings by 660,000 shares of common at $1.00 a share for a total of 15,660,000.
Allogen Biologics whom we have licensed manufacturing patent(s) to. Allo now has contracts with RENO, BRTH, and CNSI to provide the cells they will need bringing in several million dollars to ALLO. We own ALLO 100% and have no need to raise any capital because of cashflow from the 3 subs.
Next up is CTE and after that who knows - look at the pipeline. Lots of stuff to do that will bring value. However, the narrative outside this place is completely different as if we live in two distinctly different worlds. One that is real and one that is made up. Which world are you in?
“...my pathway led by confusion boats, mutiny from stern to bow... Ah, but I was so much older then I’m younger than that now...”
by TimGDixon » Wed Dec 07, 2022 6:43 am
noslippas808 wrote: ?Tue Dec 06, 2022 9:58 pm
TimGDixon wrote: ?Tue Dec 06, 2022 6:55 pm
noslippas808 wrote: ?Tue Dec 06, 2022 6:54 pm
can someone explain to me exactly why we have a billion more shares, what are we using them for, is this are final dilution?
see above
ok wait so i ask a serious question and i get "see above"???? none of what is above explains what the billion shares are for, and why we even need them ect..
This is what I said above "no dilution. these are treasury shares for s1 reserves required in our upcoming amended filing. routine biz kaikaina"
by TimGDixon » Tue Dec 06, 2022 4:57 pm
nirajpdl123 wrote: ?Tue Dec 06, 2022 3:08 pm
Hope you feel better, Tim. Wishing you a speedy recovery :)
Thanks nirajpdl123. Still sick but i'll be better soon.
by TimGDixon » Tue Dec 06, 2022 5:41 pm
whoa whoa whoa.. There are no leaks. No one knew of this outside me, tom, legal. The 8k was sent to edgarizer last night not last week. The sec found out when the edgarizer publsihed on edgar this afternoon. All that other talk has no bearing on this.
Therapeutic Solutions International Launches Spin-Off Breathe Biologics Aimed at Curing Chronic Obstructive Pulmonary Disease (COPD)
9:00 am ET November 9, 2022 (BusinessWire) Print
Therapeutic Solutions International (TSOI) announced today the launching of a spin-off company, Breathe Biologics, Inc., to commercialize technologies in the area of COPD.
Therapeutic Solutions International has licensed to Breathe Biologics assets in the COPD space including the Investigational New Drug Application (IND) which has been granted FDA number 28508. With the IND, the FDA assigned the stem cell therapy the new name of "Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection."
COPD is marked by lung inflammation and damage to alveoli -- the tiny air sacs in the lungs responsible for gas exchange. The precursor cells that line the alveoli, called alveolar epithelial progenitor cells, cannot adequately respond to this damage by generating enough new alveoli. JadiCells are mesenchymal stem cells (MSCs) -- a type of adult stem cell found in several tissues that can give rise to many different cell types. MSCs possess anti-inflammatory, neuroprotective, and regenerative properties that have made them increasingly popular as potential therapeutic avenues for some conditions.
"The effects of JadiCell on numerous types of inflammatory disease are profound. In my personal experience, in patients with COVID-19 under Right to Try and Emergency Use IND, the results are nothing short of miraculous," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "To date regenerative medicine has not been truly applied to the problem of COPD, I am excited to assist Breathe Biologics in accelerating this novel technology to address a significant unmet medical need."
"Through selecting opinion leaders in science and business and providing them with new and clinically applicable technologies I believe that we can extract significant value from our Innovation Factory at Therapeutic Solutions International," said Timothy Dixon, President, and CEO of the Company. "I look forward to the rapid commercialization of the JadiCell for COPD which we believe will have a significant impact on patients."
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.
The Veltmeyer Stem Cell Therapeutic Protocol
by
James D. Veltmeyer, MD
Stem cell therapy is the future of medicine. However, why is it not revolutionizing medicine right now?
Let me explain.
Currently, the majority of medical interventions for chronic or degenerative diseases are based on treatment of symptoms. Stem cell therapy is a revolutionary type of medicine because it is based on regeneration of injured or aged tissues, thereby fixing the actual cause of the disease.
Although numerous clinical trials have demonstrated that adult stem cells are safe to administer, full demonstration of efficacy has not been achieved in large clinical trials. The reason for this is because conventional stem cell protocols provide the stem cells to patients without preparing the body for administration of the cells.
In many degenerative conditions, the underlying disease processes change the body such that when cells enter the body their therapeutic activity is minimized. This is because of various toxic agents which make the target tissue inhospitable for the stem cells.
The Veltmeyer Protocol involves utilization of various interventions before injection of stem cells such that the disease-induced elements which make the body hostile to stem cells are minimized.
According to the Veltmeyer Protocol, blood levels of these toxic agents associated with reduction of stem cell viability and activity are measured before stem cell therapy. Patients are placed on disease and patient specific interventions. Only when the patient’s body is ready to receive the stem cells because it has properly been detoxified, only then, are the stem cells administered. The problem is that when one administers stem cells but the body is full of toxicities, it becomes just like planting seeds on gravel…they just do not have a chance to function or to grow.
So let us give you one example of the Veltmeyer Protocol in action.
Take patients with heart failure. Many of them have high levels of inflammatory markers such as CRP, TNF-alpha. Some of them also have sleep apnea which is not treated, as well as an altered microbiome ( microbial environment ) characterized by dysbiosis ( a medical condition caused by microbial imbalances within the body ) and reduced alpha diversity index. In these patients, administration of stem cells intravenously usually results in the stem cells sticking to blood vessels all over the body…the stem cells being “consumed” by the inflammation, and the various factors made by the altered microbiome blocking the few stem cells left from exerting any type of therapeutic activity.
For this type of patient, upon intake we proceed to understand the various pathologies that are associated with his heart failure and address them. Once there is a sufficient reduction in all of these co-factors, then we administer stem cells. After stem cell administration, we continue the “detoxification” procedure and also assess regenerative potential through our proprietary test. In this way, we derive the optimum value of stem cell therapy.
It should be noted that T-regulatory cells are the body's unique defense mechanism against inflammation. The importance of these cells is seen most profoundly in patients with a genetic disease called IPEX who lack T-regulatory cells. Patients with this condition have multiple autoimmune diseases.
In patients with neurodegenerative diseases such as ALS ( Amyotrophic lateral sclerosis ), there is a correlation between survival and the number of T-regulatory cells that can actually produce nerve protective growth factors. In animal studies, direct administration of T-regulatory cells have been associated with disease remission or cure. Unfortunately, to date there is no easy way to generate patient specific T-regulatory cells. Therefore, we are extremely optimistic at our ability to naturally stimulate increases in T-regulatory cells through providing stem cells to our patients.
In the case of an ALS patient cited in a prior commentary, the improvement of her T-regulatory cells after stem cell therapy has been astounding, up from 47% to 77% post-JadiCell infusion treatment. Another case is that of a 5 1/2 year old boy diagnosed with autism who has literally not spoken a single word since birth. After JadiCell infusion, he is now actually talking for the first time in his life!
Of course, every individual is different and, obviously, results and progress will differ from person to person. Some individuals may need treatment for a short period of time and others perhaps for the rest of their lives. And, the treatment is not inexpensive and is normally not covered by health insurance. One of the main objectives of the Veltmeyer Institute of Advanced Biologics is to make stem cell therapy affordable and accessible to the vast majority of people needing such treatment. If we can reach this goal, we will have made another gigantic stride toward healing people of some of the most destructive diseases to plague mankind.
what HAPPENS if
key words "FDA puts it very nicely. The product is the process." pg60-------------- IE patent for process
CAN YOU DIG IT?
https://www.docketalarm.com/cases/PTAB/IPR2021-01535/Restem_LLC_v._Jadi_Cell_LLC/10-05-2022-Petitioner/Exhibit-1083-Burger_Deposition_Transcript/
Jakes filing FINRA complaints---
by TimGDixon » Sat Dec 03, 2022 11:15 am ---Excerpts of thread
"As to fake news, or pump news. We've had it done several times over the past two years. Not to overlook that we have been through several finra investigations because people send complaints. The last one in March of this year cost the company more than 20k in legal fees. They (finra) wanted all backup to fully support the first 5 press releases of 2022. We provided everything they needed and today part of their investigation was over. Funny they didn't want to see any supporting data for the 63 press releases I issued in 2021. The other part of their investigation is ongoing as far as we know and that had to do with trading activity in TSOI. No one at tsoi has traded any tsoi stock so they're obviously looking at others."
"These are the releases.
03-10-22 Therapeutic Solutions International Granted Second United States Patent on QuadraMune® for Prevention, Inhibition, and Treatment of COVID-19
03-07-22 Therapeutic Solutions International Announces ApoptoCyte Procedure for Enhancing Stem Cell Activity
02-14-22 Therapeutic Solutions International Spin-Off Campbell Neurosciences Announces Positive Preclinical Safety and Efficacy Data Using CampbellCell™ for Treatment of Schizophrenia
02-07-22 Therapeutic Solutions International Announces Reduction of COVID-19 Associated Cognitive Decline by QuadraMune® Nutraceutical in Animal Model
01-03-22 Therapeutic Solutions International Reports Positive Clinical Data on QuadraMune® Reduction of SARS-CoV-2 Spike Protein Induced Inflammation"
by TimGDixon » Fri Dec 02, 2022 5:40 pm
Thanks you guys. I do have noodles hanging out with me. I slept from 6pm yesterday to 9:30am this morning. I haven't slept that much in 30 years. The Mrs is out of town to a funeral and gets home tomorrow. So I'm my own nurse and if I need a Dr I have James who will do house call :D
I didn't see any trading activity and just looked. Oh my. Only one person like that and where are his form4's? I'll be calling sec next if they don't appear. He's been selling all week and it's 2 days in form4. I've been waiting to burn his butt...
20% OFF SALE ALL PRODUCTS TSOI
by TimGDixon » Thu Nov 24, 2022 6:15 am
https://forum.therapeuticsolutionsint.com/viewtopic.php?t=481
When Justia publishes I will replace the text.
LITHIUM AS A MONOTHERAPY AND/OR STEM CELL ADJUVANT THERAPY FOR PULMONARY FIBROSIS
Abstract
Disclosed are compositions of matter, therapeutics, and protocols useful for reduction and/or reversion of pulmonary fibrosis. In one specific embodiment lithium chloride is administered together with a regenerative cell in a patient suffering from, or at risk of pulmonary fibrosis. In one embodiment said lithium chloride is administered as an adjuvant to a regenerative therapy, wherein said regenerative therapy is a gene therapy, a protein therapy, a cell therapy, or a tissue transplant. In one embodiment lithium chloride, or a salt thereof is utilized alone, or with a regenerative means, to evoke preservation and/or elongation of telomere length in pulmonary tissue.
Background/Summary
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/191,770 filed May 21, 2021, the entire contents of which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The invention pertains to the treatment, prevention, or amelioration of pulmonary fibrosis, using lithium as a therapeutic agent whether by itself or as a regenerative cell adjuvant.
BACKGROUND
[0003] It is recognized that coronaviruses (CoVs) are a single stranded positive sense RNA viruses which include four genera (alpha, beta, delta, and gamma) [1]. Infectivity of CoVs is mediated by the envelope spike (S) glycoprotein which binds to its cellular receptors angiotensin-converting enzyme 2 (ACE2) and dipeptidyl peptidase 4 (DPP4) for SARS-CoV and MERS-CoV, respectively [2, 3]. In the case of the novel COVID-19 virus, it is over 99% similar to SAR-CoV-2 which is a new type of beta genera. This is based on 10 sequenced samples collected from the original location of the outbreak [4]. SAR-2-CoV preferentially infects the type 2 pulmonary epithelial cells, in the lungs, which express ACE2 [5]. Immune responses to the family of coronaviruses are associated with induction of type 1 interferons, especially interferon beta, which originally was termed “MSC interferon”. Clinical trials are ongoing assessing intranasal interferon beta (https://pharmaphorum.com/news/synairgen ... d-19-drug/) for COVID-19. Interferons not only induce expression of genes that block viral replication, but also are responsible for stimulating natural killer (NK) cells, which selectively kill virally infected cells. Interestingly, exogenous allogeneic NK cells have been recently cleared by FDA for treatment of COVID-19 (https://techcrunch.com/2020/04/02/ventu ... -covid-19/). One ideal treatment for prevention of SARS-CoV-2 progression would be an agent which induces interferon production in the lung.
[0004] Mortality from COVID-19 is caused by acute respiratory distress syndrome (ARDS) [6, 7], which is caused by unrestrained cytokine release, also known as “cytokine storm”, and is characterized by fluid leakage, diffuse inflammation, and disseminated intravascular coagulation, all of which cause impaired alveolar gas exchange. Approximately 35-45% of patients with ARDS will die [8].
[0005] The feasibility of utilizing cell based approaches to ARDS has been demonstrated in animal models [9-11], in which researchers have shown reduction of pulmonary injury, water leakage, and neutrophil accumulation. Furthermore, analysis of 342 systemic infusions and 57 bronchial instillations (204 recipients) of cells of various origins for ARDS and other pulmonary issues demonstrated safety in early clinical trials [12, 13].
[0006] Unfortunately, to date, no treatments appear effective for Post-COVID associated pulmonary fibrosis.
by TimGDixon » Wed Nov 23, 2022 3:53 pm
I think this needs to be stickied indefinitely.
Item 8.01 Other Events – Letter to Shareholders and Interested Parties.
Dear Shareholders and all Interested Parties,
This letter is in response to the social media outpouring – much of it vitriolic and malicious - centered around ownership of certain important patent rights and a phase 3 IND. Therapeutic Solutions International, Inc. (“TSOI”) and its Board of Directors (“Board”) aim, herein, to set the record straight. To wit:
On September 29, 2021, an Inter Parties Review (IPR) was filed with the U.S. Patent and Trial Board between Restem LLC, and Jadi Cell LLC. On September 27, 2022 Dr. Amit Patel was deposed in this matter (see Exhibit Link # 99.1) and on August 26, Dr. Camillo Ricordi had his deposition taken. (see Exhibit Link # 99.12).
The Board has reviewed the transcripts of these two depositions as well as the rest of the filings and the following are the many discrepancies, inaccuracies, and potential perjurious items found therein. Included will be documents and references to prior TSOI SEC filings that directly contradict the deposition testimonies of these gentlemen, but also fly in the face of the libelous vitriol stated by certain anonymous (of course) social media disseminators:
Facts
In Nov-Dec 2020, Jadi Cell LLC (“JADI”), through their sole member, Dr. Amit Patel (“Patel”), approached TSOI through their director, Dr. Thomas Ichim (“Ichim”), about licensing JADI’s JadiCell mesenchymal stem cell (“Jadi Cell”) in the area of COVID-19 lung damage (US Patent 9,803,176 B2 (the “Patent”), and the drug master file (the Drug Master File), and master cell bank one (the “Master Cell Bank”) for all lung indications, including complications from COVID-19. This is a similar licensing arrangement that is for use of the same stem cell for CTE/TBI.
On February 9, 2021, Jadi Cell LLC accepted a $15,000,000 convertible promissory note (“CPN”) (see attached Exhibit # 99.13) for exclusive world-wide patent rights to US Patent 9,803,176 B2 (the “Patent”), and the drug master file (the Drug Master File), and master cell bank one (the “Master Cell Bank One”) for all lung indications, including complications from COVID-19.
During negotiations, Patel stated to Timothy Dixon (“Dixon”), CEO of TSOI, that part of what was being licensed included the Phase 2 Investigational New Drug Application (the “IND;” IND# 19757) that had been applied for as a Phase 3 study by University Miami (“UM”). It was presumed at this time that the IND lead investigator with UM, Dr. Camillo Ricordi (“Ricordi”), was being fully apprised of the status of TSOI and the License that had been granted in February 2021 and the promised IND transfer to TSOI, as well as unfettered access to the Master Cell Bank.
On or about August 18, 2021, a long-time requested meeting occurred involving Ricordi, Patel, Dixon, Ichim and others via Zoom conference call wherein Ricordi expressed surprise and “claimed” this was the first time he was hearing about TSOI and their exclusive world-wide patent license agreement (EPLA) with JADI. Unsurprisingly, Ricordi’s reactions to TSOI’s presence was unnerving for Dixon and Ichim given how long the EPLA was in existence and the parties’ established relationships. Why Dr. Patel and JADI kept TSOI’s existence, if true, from the IND filer and basis of the CPN-Lung and EPLA is a mystery that continues today, but assuredly contributes to Mr. Dixon and TSOI’s unrest and mistrust, as well as mindset for the character of the CPN at issue and all future dealings to date. One such result was Ricordi continually making threats through emails and tweets on multi-media about TSOI’s lack of rights and other caustic slander that further eroded TSOI’s confidence that the deal and consideration had truly been consummated.
After several months of request (initiated by 3rd parties with strong interest in seeing Phase 3 trials succeed), JADI finally agreed to putting the terms of the License granted in the CPN of Feb 2021, and a formal License Agreement was entered into on September 15, 2021, the stated intent being to definitively memorialize the Parties understanding under the License granted by the CPN. At this time, Dr. Ricordi became even more disruptive, if that’s possible. However, UM administrators took charge and SLOWLY kept negotiations for the IND advancing – up until the time JADI elected to demand $15,000,000 cash and denied promising to convert to shares of TSOI stock (on 2/9/2022, the first time JADI ever said they were not going to convert the shares), thus fulfilling Mr. Dixon, TSOI, and its counsel’s anticipation of shenanigans.
The reason the facts above are critical are that, until the IND was transferred to TSOI on 3/24/2022 via an IND Asset Transfer Agreement, as acknowledged by the FDA (see Exhibit 99.17), there is a question whether the 2/9/21 CPN was in full force and effect due to the failure of consideration to be exchanged (although the terms had been agreed to and consistently confirmed by the Parties for nearly the entirety of 2021 and as reflected in TSOI-JADI Settlement and Release Agreement dated 2/23/2022 (the “Settlement Agreement”). Indeed, the terms under the Settlement Agreement suggest the terms continue in force and effect; this ambiguity is the shared opinion of the CEO, the board, and counsel during all relevant times and went into the decision as to what needed to be reported in the financials. While it is true that TSOI moved forward in good faith reliance that JADI would be converting the shares similar to the prior CPN transaction related to CTE/TBI/Brain, it was not foreseen that JADI would not do so and would make a demand for $15,000,000.00 in cash less than ONE WEEK after UM executed an LOI with TSOI agreeing to finally transfer the IND and provide a certain number of expanded cGMP clinical grade JadiCells - this after 4 months of acrimonious negotiation - on 2/4/2022.
Of interest is the fact that on December 1, 2021, legal counsel for JADI sent the following email to UM included as attached exhibit (see attached Exhibit # 99) to purportedly assist in completing the negotiations for the IND transfer:
“Jadi Cell LLC (Jadi) would like to clarify and confirm the following:
Jadi hereby confirms that TSOI has the exclusive right to utilize the patent to commercialize products and services in the treatment of lung disease and to conduct research relating thereto. UofM is not permitted to proceed with phase 3 trials using its existing IND using the Jadi Cell in the absence of TSOI’s approval. The MTA originally granted to UofM does not contemplate a specific field of use, but obviously the MTA does not authorize UofM to proceed with the Phase 3 IND, use Jadi’s master cell bank or commercialize the cell in the lung disease treatment field outside of TSOI’s approval. Pursuant to UofM’s MTA with Jadi, UofM is required to provide Jadi with notice prior to publishing any information relating to the Jadi cell and must obtain Jadi’s consent to use of the Jadi cell in any clinical use, and we ask that such notifications be provided in the future. Jadi will provide all notices and requests received from UofM (for publication or clinical use of the Jadi cell) relating to the lung disease field of use to TSOI for its consideration.
Jadi’s strong preference is that UofM and TSOI reach an agreement regarding the phase 3 trial under UofM’s IND, and we expect both parties to be reasonable in their requests.”
Despite the above, once JADI sent notice of default to UM, all negotiations toward an IND transfer and assignment ended with UM stating they could not enter into any agreement with TSOI “without JADI’s permission.”
Needless to say, this led to correspondence from TSOI counsel that resulted in the Settlement Agreement of 2/23/2022 wherein JADI agreed to convert shares per license agreement that would be modeled upon the 2/9/2021 CPN (not retired since no longer considered applicable other than the terms and definitions of the patent license granted for lung indications) and EPLA of 9/15/2021 defining and describing terms of License pursuant to the CPN-Lung. In TSOI’s counsel’s opinion, the soonest effective date would be the execution of the Settlement Agreement and board resolution for share issuance of 2/23/2022 for purposes of booking the transaction in the financials for TSOI.
After the Settlement Agreement with JADI was completed and conveyed to UM, an IP Transfer Agreement (the IND) was executed between UM and TSOI on 3/24/2022.
The above is intended for the reviewer, shareholders, and demagogues to grasp the chaotic nature of these transactions, as well as the seeming dissonance with the actions and statements of Ricordi and Patel.
Testimony of Amit N. Patel
On September 27, 2022, Dr. Amit Patel was deposed in the matter of Restem LLC vs. Jadi Cell LLC. On Pg. 77 of his transcript, Dr. Patel states he was offered $15 million dollars for JadiCells approximately 2 years ago which would have been approximately August/September of 2020. In Nov-Dec 2020, Jadi, through their sole member, Dr. Amit Patel, approached TSOI through their director, Dr. Thomas Ichim, about licensing JADI’s JadiCell mesenchymal stem cell (“JadiCell”) in the area of COVID-19 lung damage (US Patent 9,803,176 B2 (the “Patent”), and the drug master file (the Drug Master File), and master cell bank one (the “Master Cell Bank One”) for all lung indications, including complications from COVID-19. This is a similar licensing arrangement that is for use of the same stem cell for CTE/TBI.
On pages 78 and 79 the discussion continues with Dr. Patel stating that the offer that preceded TSOIs was “left up in the air due to the IPR. That’s what was stated by the lawyers.” This is not possible as the IPR was not filed by Restem until September 29, 2021. By February 9, 2021, JadiCell LLC accepted a $15,000,000 convertible note (see attached Exhibit # 99.13) for exclusive world-wide patent rights to US Patent 9,803,176 B2 (the “Patent”), and the drug master file (the Drug Master File), and master cell bank one (the “Master Cell Bank One”) for all lung indications, including complications from COVID-19. Furthermore, in the Declaration given by Patel on Page 8 he states “For example, even before it issued, one company that learned of the patent application (that matured into the ‘176 Patent), and the associated technology, offered to purchase Jadi Cell, LLC (“Jadi Cell”) for 15 million dollars. At that time, the only patent or patent application Jadi Cell owned was the aforementioned application that matured into the ‘176 Patent.” (see Exhibit Link # 99.14) It would appear the prior fifteen million dollar offer was more like 5 years ago at minimum since the patent did not issue until 10-31-2017. There is no possible way that the filing of the IPR interfered in us issuing a convertible note for JadiCells as it did not exist at the time and would not exist for another seven months.
Later in same deposition Dr. Patel is asked on page 80 of his transcript how much TSOI paid for Jadi Cells, and Dr. Patel responded, “hundreds of thousands”. This too is incorrect as the convertible note clearly states JadiCell LLC received $15,000,000 worth of TSOI stock at a fixed price of $0.1004 which they have since cleared the stock which was underway at the exact time this deposition was taken.
Testimony of Camillo Ricordi
On August 26, 2022, Dr. Camillo Ricordi was also deposed and beginning on page 13 of his transcript he is asked if he has had any communication with Jadi Cell about his deposition and states the following “No, I didn’t. I didn’t communicate about this procedure or the deposition. I’ve been communicating in the past because this trial has been halted and we had all kind of difficulties moving forward to identify standing sources because when everyone — we had a Phase III trial approval FDA like a year ago or around a year ago and still we have been unable to move forward because when people come close and they see that there is a legal proceeding, they run in the opposite direction. I guess they don’t want to get involved. So practically we had very good results from the — spectacular results from the Phase I/IIA trial and then we obtained permission to move for a Phase III trial multisite and we were stuck and unable to save life and just witness the — COVID-19 to continue to unfold, but we were unable to help patients.”
On March 24, 2022, Office of Technology Transfer, University of Miami, and Therapeutic Solutions International, Inc. entered into an Asset Transfer and License Agreement. The material information relevant to public disclosure is the following: Within ten (10) days of the Effective Date, 1) TSOI shall make an initial payment of two hundred thousand dollars ($200,000) to UM; 2) Within six (6) months of the Effective Date, TSOI shall make a second payment of one million eight hundred thousand dollars ($1,800,000) (at the completion of the primary endpoint of the phase 2b/3 clinical trial specified in the IND or (ii) one (1) year from the Effective Date), and 3) TSOI shall make a final payment of two million dollars ($2,000,000). In turn, upon FDA approval of TSOI as Sponsor, TSOI will replace UM as Sponsor, receive all trial doses, and intends to appoint James Veltmeyer, MD, Chief Medical Officer as Principal Investigator (see Exhibit Link # 99.15).
Then on March 28, 2022, Dr. Ricordi sent a letter to FDA (see attached Exhibit # 99.16) stating that the IND has been transferred to TSOI and that TSOI is the new owner of IND 19757. On March 28, 2022, Dr. Thomas Ichim also sent a letter to US FDA notifying them of the IND transfer as well (see attached Exhibit # 99.17). On April 1, 2022, TSOI received notice from FDA that the IND had officially been transferred (see attached Exhibit # 99.18).
Despite all the above, Dr. Ricordi states that right up to August, 2022, “we have been unable to move forward because when people come close and they see that there is a legal proceeding, they run in the opposite direction.” At no time has this IPR interfered with TSOI moving forward.
On page 15 of his transcript he is asked about affiliations, advisory boards, institutions etc. that he is involved in and he provides a list of people and entities but fails to disclose his own relationship with Restem which includes using Restem’s mesenchymal stem cell in at least 3 patients (see Exhibit Link # 99.19) as well as an article published on Restem’s website (see Exhibit Link # 99.2) and scientific papers (see Exhibit Link # 99.21) he has co-authored with scientists from Restem. Oddly the lawyer representing Restem doesn’t seem to know they have a long-standing working relationship.
TSOI hopes and trusts that the above makes the facts and circumstances regarding this matter much clearer for all readers who wish to seek the truth.
Item 9.01 Financial Statements and Exhibits.
Exhibit Index: https://www.otcmarkets.com/filing/html? ... HlLxdw-B3h
(99) Email from W. Michael Black, legal counsel for JadiCell LLC.
(99.1) Patel Deposition Transcript - https://s3-us-west-1.amazonaws.com/ptab ... 535%2F1087
(99.12) Ricordi Deposition Transcript - https://s3-us-west-1.amazonaws.com/ptab ... 535%2F1085
(99.13) Convertible Note between TSOI and JadiCell LLC
(99.14) Declaration of Amit N. Patel - https://s3-us-west-1.amazonaws.com/ptab ... 535%2F2009
(99.15) Asset Transfer and License Agreement - https://www.sec.gov/ix?doc=/Archives/ed ... rm8-ka.htm
(99.16) Letter from Camillo Ricordi to FDA
(99.17) Letter from Thomas Ichim to FDA
(99.18) Letter from FDA to TSOI
(99.19) News article dated May 7, 2020 https://theamericanonews.com/2020/05/07 ... it-worked/
(99.2) Restem.com article published at https://restem.com/2020/05/07/3-miami-c ... l-therapy/
(99.21) Paper co-authored by Camillo Ricordi and Keith March from Restem https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299515/
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: October 24, 2022
THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.
By: /s/ Timothy Dixon By: /s/ Thomas Ichim
Timothy Dixon Thomas Ichim
Chief Executive Officer, Director Director
One could hope that I think CS is our front on that score
i THINK U missed the point its not the treatments--------
However we are living in very strange times. Truth is elusive, Ivermectin is bad, a joke (not now though), down is up, up is down. If the politically motivated MSMs ever covered TSOI I would be shocked. TSOI may for all you know be sending the MSM information in hopes of it being picked up, even a local news happy story would be great . BUT they are politically motivated and big Pharma is a major advertisement buyer and I forget the term pays for News broadcasts --ah yes sponsors the "News".
Long story short MSM are beholden to big pharma and policy / correct political views.
TSOI POST ABOUT TSOI WE LOVE TIM THE CEO TIM G DIXON. HE IS THE MAN
milly BillY TRILLY TSOI
Fascinating news a little more recent
I left out the middle and posted the money lines
Frank Ekejija – Chairman / President/ CEO
He takes over the appointment as Chairman/President/CEO of iBrands Corporation effective as of June 5. 2021.
http://www.ibrandscorporation.com/management/
nice post BBW
weasel FITZ thinks hes got Burger by the short hairs --but no wait-- that word I love HOWEVER page 56
BY MR. FITZPATRICK:
15 Q. Okay. And you are aware that
16 that's a ground for invalidity of a patent
17 claim, correct?
18 A. As you have described it -- as
19 you have just described it, yes. However,
20 Majore differs significantly from the
21 description in the patent, and Kita and
22 Phan described cells that have some
23 critical differences from the claimed
24 cells. So none of these three could be
25 considered to anticipate the claimed cells.
Page 57
1 S. Burger
2 Each of them is different in very
3 significant ways from the claimed cells.
4 Q. Well, I understand that that's
5 your opinion, but I guess really what I am
6 getting at is I would like to know what is
7 misleading or unscientific about relying on
8 Majore for an anticipation argument?
9 A. Because the method that is
10 described in Majore is completely different
11 from the method for isolation and culture
12 described in the patent and that's a
13 critical difference. Majore uses a fairly
14 traditional method for isolating cells from
15 umbilical cord tissue. Mixing up the cord
16 tissue and so forth. And I don't recall
17 whether Majore did a digestion stem or not.
18 We can look in the paper and check, but the
19 big difference is that Majore does not
20 place the subepithelial layer in contact
21 with the culture surface. With the culture
22 substrate. In other words, the plastic
23 inside of the culture vessel, whether it's
24 a dish or a flask. That's an absolutely
25 critical difference.
"FDA puts it very nicely. The product is the process" page 60
"But don't you see, the cells are
made in a fundamentally different way" page 58
https://www.docketalarm.com/cases/PTAB/IPR2021-01535/Restem_LLC_v._Jadi_Cell_LLC/10-05-2022-Petitioner/Exhibit-1083-Burger_Deposition_Transcript/
Fitzpatrick: paid weasel
Therapeutic Solutions International and Campbell Neurosciences Announce Preclinical Studies Showing Low Doses of FDA Cleared Immune Stimulant Interleukin-2 Reduces Inflammation Associated Depression in Animal Model
https://therapeuticsolutionsint.com/therapeutic-solutions-international-and-campbell-neurosciences-announce-preclinical-studies-showing-low-doses-of-fda-cleared-immune-stimulant-interleukin-2-reduces-inflammation-associated-depression-i/
the only good thing is the OS
whats next
by TimGDixon » Thu Nov 10, 2022 5:46 am
We have an awful lot going on but there is always opportunity to advance investigational products like StemVacs-P for Parkinson's Disease. I am getting ready to propose the following to the science team for comment/edit and eventual approval.
https://forum.therapeuticsolutionsint.com/viewtopic.php?t=445
Investigational New Drug Application (IND) which has been granted FDA number 28508. With the IND, the FDA assigned the stem cell therapy the new name of "Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection."
new S1 ----check your SEC filings on your trading platform it is there