Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
that and 30 MILLY plus volume
62..5 % increase will spread the joy
LIKE WISE TT CALLED IT
YOU CALLED IT YOOP
Type into the search. I will admit it can be hard to find specific items there
You are able to READ the forum No? You do not have to join to READ the forum.
Well its yer lucky day! No need to buy from those sneaky 3rd party peeps, U2 can by Quad direct and find out the great things about Quad. Also please read the forum there are testimonials buried about same. (unfortunately not under a testimonials heading )
https://www.youcanordernow.com/
Very nice! I will take some NS right now as a toast. And as a testimonial for NanoStilbene PKE; I am convinced It works for me in several ways.
AGREED uptrend coming soon load the TSOI boat
Tim Dixon plans to work until called home, never retire.
TSOI is looking to change
The future is almost here! Can't be clueless about how all these TSOI patents and new subsidiaries are really starting to erase any doubt! This is gonna be priceless science when it's all said and done with! Hat's off to Tim and Tom's hard work!
PLEASE READ FOR YOURSELF TSOI FORUM
yes naturally Tim will sell shares for a low PPS toe GHS rather than wait for say .10 WITH plenty of time to do so.
I think not . Also 18 months to go to get the money no rush.
https://forum.therapeuticsolutionsint.com/viewtopic.php?p=17240#p17240
nice pipeline page for TSOI
https://therapeuticsolutionsint.com/pipeline/
Ray Grimm, Jr.
Chief Executive Officer
Chief Operating Officer
A veteran entrepreneur with over 45 years experience building some of the top nutritional and wellness companies in Direct Sales history, Ray has what many consider to be the Midas touch creating multimillion dollar brands starting companies, three of which exceeded 50-100 million in annual revenues within their first five years.
https://forum.therapeuticsolutionsint.com/viewtopic.php?p=16339#p16339
And you know this for a fact because--------
by TimGDixon » Fri Feb 10, 2023 7:34 am
Let me see if i can help you better understand.
Patel's patent (US Patent 9,803,176 B2) is a "composition of matter" patent that describes and teaches how to obtain a population of cells through a process. The '176 patent does not teach how to use them. TSOI owns the only "use" patents filed within our two fields which are organ based, the brain and lung. Within those organs we have identified diseases that are applicable or amenable to stem cell intervention.
For example in Patent Publication number: 20220125852 we have identified 373 neurodegenerative diseases we believe can be treated by administration of jadicells. If we wanted to, we could subsequently file hundreds of new individual use patents like I did recently with Epilepsy. Epilepsy is one of the 373 diseases in claim #6 of the above.
So, as you can see there is much more here than meets the eye. I tend to agree with my kaikaina that Restem likely had no idea we had filed all the use patents (19 of them thus far) when they filed the IPR.
https://forum.therapeuticsolutionsint.com/memberlist.php?mode=viewprofile&u=58
money line
"From preliminary data in patients, and also in our laboratory research, it appears that this marker may be predictive for efficacy of other stem cells besides JadiCells."
Therapeutic Solutions International Identifies Novel Cellular Marker Associated with Therapeutic Response to JadiCell Stem Cell Treatment
9:00 am ET January 9, 2023 (BusinessWire) Print
Therapeutic Solutions International (TSOI) announced today identification and patent filing of a previously unexpected discovery that responsiveness to JadiCell stem cell therapy appears to correlate with alternations of a specific type of B cell producing the cytokine interleukin-10 and possessing unique surface markers.
These types of B cells, which are related to a cell type previously associated with pregnancy, appear to play a role in controlling pathological immunity, as well as producing factors that may be involved in healing injured tissues.
Therapeutic Solutions International has a Phase III clinical trial ongoing for COVID-19 acute respiratory distress syndrome (ARDS) and has been granted IND numbers for use of JadiCells in Chronic Obstructive Pulmonary Disease (COPD) and Chronic Traumatic Encephalopathy. Additionally, the Company has active, ongoing, collaborations with physicians to provide the cells under Emergency IND and Right to Try.
"As a Principal Investigator for these clinical trials, it is difficult to overstate how important it is to possess a marker that appears to predict responsiveness to our stem cell therapy," said Dr. James Veltmeyer, Chief Medical Officer of the Company, and co-inventor of the patent. "From preliminary data in patients, and also in our laboratory research, it appears that this marker may be predictive for efficacy of other stem cells besides JadiCells."
"The field of biotechnology in general is aiming for the Holy Grail called 'Personalized Medicine'. The findings disclosed today, we feel, bring Personalized Medicine to the area of Regenerative Medicine and Regenerative Psychiatry," said Timothy Dixon, President, and CEO of the Company and co-inventor. "Significant sums of money are routinely spent on clinical trials that do not provide efficacy data. Many believe that this occurs simply because we are not choosing the right patients. It is reasonable to believe that if today's results are reproducible on a larger scale, we will possess a new tool to advance the field of stem cell sciences."
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230109005494/en/
Great EOW GOOOOOO TSOI---------- Bang Zoom
I only wish the good doctor might have mentioned TSOI .
Given?? like a gift or a perhaps a bonus. I am pretty sure they are paid like this and its not enough 4 milly x.006 and this is looking to be a BillY company. CEOs get paid a lot and most if not all CEOs are not doing hands on reserch AND manufacturing product and doing the filings and ETC. Ditto. Tom (the hit man) Given indeed!
poor choice of word but that's not what folks go by the from 4 is what folks go by. I had never seen this site b4 but then again I dont get out much
https://www.conferencecalltranscripts.org/summary/?id=11659250
I am not doubting your support Yooperman
Transaction Code Transaction
A Grant, award, or other acquisition
of securities from the company
(such as an option)
K Equity swaps and similar hedging
transactions
P Purchase of securities on an
exchange or from another person
S Sale of securities on an exchange
or to another person
D Sale or transfer of securities
back to the company
F Payment of exercise price or tax
liability using portion of securities
received from the company
M Exercise or conversion of
derivative security received from
the company (such as an option)
G Gift of securities by or to the
insider
V A transaction voluntarily reported
on Form 4
J Other (accompanied by a footnote describing the transaction)
Thomas Ichim, a director of THERAPEUTIC SOLUTIONS INTERNATIONAL, INC., recently acquired 4,000,000 shares of the company. The buys took place at $0.01 per share, on December 30, 2022. Ichim now owns 118,000,000 shares of the company. Ichim operates out of Oceanside, CA.
The above information was disclosed in a filing to the SEC. To see the filing, click here.
https://newsfilter.io/a/738aeba68f290059cc2a97bd6a43772b
Timothy G Dixon, a major owner of THERAPEUTIC SOLUTIONS INTERNATIONAL, INC. and THERAPEUTIC SOLUTIONS INTERNATIONAL, INC.'s President & CEO and a director of the company, recently acquired 4,000,000 shares of the company. The buys took place at $0.01 per share, on December 30, 2022. Dixon now owns 284,911,471 shares of the company. Dixon operates out of Oceanside, CA.
https://newsfilter.io/a/46ff2dd3bfc828f371d0de993cd4c54c
Tim has stated ad nauseum to all who DD no RS while he is CEO
agreed It does not look like it will go below .005 by much there are bids stacked to ward off the small investors dumping and jane at .0047 no telling how many shares hidden
Dr Thomas Ichim
note to admin this is Thomas E.Ichim, Ph.D. – Director ---TSOI
Dr. Ichim was appointed to the Board of Directors on January 22, 2016. Dr. Ichim is a seasoned biotechnology entrepreneur with a track record of scientific excellence. He has founded/co-founded several companies including Batu Biologics, Inc., Medvax Pharma Corp, ToleroTech Inc, bioRASI, and OncoMune LLC. To date, he has published 121 peer-reviewed articles and is co-editor of the textbooks “RNA Interference: From Bench to Clinical Translation” and “Immuno-Oncology Text Book.”
I paper I published on how the $TSOI #cancer #immunotherapy works
oncotarget.com
Induction and characterization of anti-tumor endothelium immunity elicited by ValloVax therapeutic...
https://doi.org/10.18632/oncotarget.15563 Samuel C. Wagner, Thomas E. Ichim, Vladimir Bogin, Wei-Ping Min,
https://www.oncotarget.com/article/15563/text/
by TimGDixon » Fri Dec 16, 2022 7:34 am
TimGDixon wrote: ?Sat Dec 03, 2022 11:18 am
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
This is getting pretty old all this chatter about us treating patients under Right To Try and eIND. Below in bold and quoted is the exact wording of the request we received from FINRA and our response. If any of you have an issue with this I suggest you copy and paste this and ask FINRA if this is how we responded. For anyone to suggest we lied well check your source because if we are liars then we lied to FINRA didn't we? In total 5 retired Navy SEALS from San Diego have been treated but as of our response we only had data on the first 3 so don't start with that either.
FINRA request: “As discussed, I was hoping to obtain the following information and copies of the following studies/results:”
1. Clinical Trial Results/Other Study Results for:
a. The Treatment of “No Option” Patients with JadiCell Stem Cell Therapy announced by TSOI on December 30, 2021.
Please note that while the Company has an FDA cleared Phase III clinical trial for COVID-19 treatment using JadiCell, and the patients mentioned in the press release were treated under the “Right to Try” Law which allows for “no option” patients to receive an experimental drug. The fact that the patients were treated under this exception was stated in the press release.
Below is a description of the patients treated at a high level. More information is available upon request.
JadiCell is a licensed patent from JadiCell LLC and TSO issued and granted on October 31, 2017 as U.S. Patent No.: 9,803,176
METHODS AND COMPOSITIONS FOR THE CLINICAL DERIVATION OF AN ALLOGENIC CELL AND THERAPEUTIC USES
by TimGDixon » Sun Dec 18, 2022 8:36 am
This is your protection.
1. On November 14, 2022, the Company filed a patent application titled “Treatment of Chronic Obstructive Pulmonary Disease with Myeloid Derived Suppressor Cells” which discloses compositions of matter, protocols, and treatment means for prevention and/or reversing Chronic Obstructive Pulmonary Disease (COPD) using myeloid derived suppressor cells as a monotherapy or adjuvant therapy. In one embodiment umbilical cord low density myeloid cells are expanded using interleukin-3 and GM-CSF and administered in an allogeneic manner to a mammal suffering from COPD. In some embodiments combinations of myeloid derived suppressor cells and mesenchymal stem cells are disclosed.
2. On October 24, 2022, the Company filed a patent application titled “Mesenchymal Stem Cell Therapy of Epilepsy and Seizure Disorders” which discloses novel compositions of matter and treatment methods for reducing and/or reversing epilepsy through administration of mesenchymal stem cells in order to induce immune modulation and/or regenerative processes. In one embodiment umbilical cord mesenchymal stem cells are administered to a patient suffering from epilepsy at a concentration and frequency sufficient to inhibit neuronal hyperactivation and/or reduce neuroinflammatory status of the patient.
3. On October 03, 2022, the Company filed a patent application titled “Stimulation of Pulmonary Regenerative Exosomes by Mesenchymal Stem Cells and Derivatives Thereof” which discloses therapeutic means for pulmonary degenerative conditions through the administration of mesenchymal stem cells in order to induce regenerative exosomes from dendritic cells expressing CD103. In one embodiment cultures of mesenchymal stem cells with dendritic cell progenitors are disclosed wherein said mesenchymal stem cells induce a modulation of STAT3 signaling in said dendritic cell endowing a regenerative property to said dendritic cells and exosomes derived from said cells.
4. On September 19, 2022, the Company filed a patent application titled “Treatment of Bipolar Disorder Using Mesenchymal Stem Cells and Modification of Mesenchymal Stem Cells” that discloses the utilization of mesenchymal stem cells, exosomes from mesenchymal stem cells, conditioned media from mesenchymal stem cells, apoptotic bodies from mesenchymal stem cells, and modified mesenchymal stem cells for treatment of bipolar disorder. In one embodiment mesenchymal stem cells isolated from umbilical cord tissue are treated with carbon monoxide at a concentration sufficient to induce activation of heme-oxygenase I and infused into a patient at risk or suffering from bipolar disorder.
5. On September 12, 2022, the Company filed a patent application titled “Treatment of COPD by Stimulation of Stem Cell Mobilization” which discloses means of inducing pulmonary regeneration and/or protection from oxidative stress by stimulation of endogenous stem cell mobilization together with one or more inhibitors of NF-kappa B and/or one or more inhibitors of oxidative stress. The invention discloses the unexpected finding that G-CSF administration enhances oxidative stress and pulmonary damage, however, coadministration with pterostilbene, results in synergistic suppression of COPD pathology.
6. On August 12, 2022, the Company filed a patent application titled “Treatment of Chronic Obstructive Pulmonary Disease by Mesenchymal Stem Cell Apoptotic Bodies and Compositions Thereof” that discloses means, treatments and compositions of matter useful for treatment of chronic obstructive pulmonary disease (COPD). In one embodiment the invention provides the administration of mesenchymal stem cell apoptotic bodies alone or in combination with “regenerative adjuvants” to prevent and/or reverse reduction in lung function associated with COPD. In other embodiments the invention teaches the utilization of stem cell apoptotic bodies for induction of pulmonary regeneration directly or indirectly.
7. On July 29, 2022, the Company filed a patent application titled “Gene Modified iPSC Derived Cellular Compositions for Regeneration and Immune Modulation” that disclosed cells and cellular compositions useful for treatment of degenerative and/or autoimmune diseases derived from gene edited/gene modified pluripotent stem cells. In one embodiment pluripotent stem cell such as inducible pluripotent stem cells are gene modified to express tissue associated transcription factors such as pdx-1 if endodermal tissue is desired and cells are differentiated into regenerative-type cells such as along the mesenchymal lineage. In one embodiment the invention teaches transfection with IL-27 to induce expression of coinhibitory molecules for suppression of autoimmunity. In some embodiments the invention provides generation of iPSC derived MSC which cannot stimulate inflammation due to gene-editing based removal of inflammatory associated transcription factors.
8. On May 12, 2022, the Company filed a patent application titled “Inhibition and Reversion of Chronic Obstructive Pulmonary Disease (COPD) by Endothelial Cell Regeneration” that teaches means, treatment methods, and compositions of matter useful for prevention and/or reversion of chronic obstructive pulmonary disease (COPD). In one embodiment the invention provides the administration of mesenchymal stem cells and exosome thereof as a means of augmenting endogenous endothelial regeneration and/or endothelial regeneration stimulated by exogenous means. In some embodiments the invention provides administration of allogeneic mesenchymal stem cells together with autologous endothelial progenitor cells and/or mobilization of said autologous endothelial progenitor cells.
9. On March 7, 2022, the Company filed a patent application titled “Treatment of Trauma Associated Cognitive Dysfunction Using Mesenchymal Stem Cell Apoptotic Bodies and Compositions Thereof” which teaches means, treatments and compositions of matter useful for treatment of chemotherapy/radiotherapy associated cognitive dysfunction. In one embodiment the invention provides the administration of mesenchymal stem cell apoptotic bodies alone or in combination with “regenerative adjuvants” to prevent and/or reverse cognitive dysfunction associated with chemotherapy and/or radiation therapy. In other embodiments the invention teaches the utilization of stem cell apoptotic bodies for induction of neuroregeneration directly or indirectly.
10. On October 11, 2021, the Company filed a patent application titled “Umbilical Cord Derived Regenerative and Immune Modulatory Stem Cell Populations” which provides universal donor cellular populations derived from umbilical cords possessing ability to elicit immune modulation and evoke regeneration when administered into a mammalian host. Generation of cellular products for clinical use are provided including methodologies of expansion, characterization, and means of therapeutic implementation.
11. On October 4, 2021, the Company filed a patent application titled “Reduction of Neutrophil Extracellular Trap formation by Mesenchymal Stem Cells and their Exosomes” that disclosed methods of reducing lung inflammation in acute respiratory distress syndrome elicited by various factors such as COVID-19 infection by reduction of neutrophil extracellular trap formation through administration of mesenchymal stem cells and/or exosomes thereof. The invention provides means of inhibiting neutrophil release of extracellular traps by mesenchymal stem cells and/or exosomes derived from said mesenchymal stem cells. Additionally, synergies are provided between mesenchymal stem cells and/or exosomes derived from mesenchymal stem cells and agents approaches which reduce neutrophil extracellular trap formation.
12. On September 22, 2021, the Company filed a patent application titled “Stimulation of Mesenchymal Stem Cell Therapeutic Activities by T Regulatory Cells” teaches novel means of enhancing mesenchymal stem cell regenerative activities including, intra alia, production from pulmonary leakage and suppression of scar tissue formation by co-administration with T regulatory cells. In some embodiments the invention provides an interaction between T regulatory cells and mesenchymal stem cells in which T regulatory cells stimulate upregulation of mesenchymal stem cell activity in a GITR dependent manner.
13. On August 23, 2021, the Company filed a patent application titled “Umbilical Cord Mesenchymal Stem Cells for Treatment of Chronic Obstructive Pulmonary Disease and Lung Degeneration” that discloses means of treating lung degenerative diseases including chronic obstructive pulmonary disease (CODP) using umbilical cord mesenchymal stem cells such as JadiCells alone, and/or using said cells under conditions that are activated in order to endow enhanced regenerative activity. In one embodiment said activation of said mesenchymal stem cells is performed through stimulation with a toll like receptor agonist at a concentration and duration sufficient to induce a >50% increase in keratinocyte growth factor expression from said stem cells. In another embodiment the invention provides the use of JadiCells as a means of producing exosomes, wherein said exosomes possess therapeutic properties capable of reducing inflammation, fibrosis and degeneration associated with COPD, as well as stimulation of regenerative activity. In some JadiCells are activated by a treatment with Activated Protein C.
14. On August 18, 2021, the Company filed a patent application titled “Enhancement of Umbilical Cord Mesenchymal Stem Cell Therapeutic Activity by Stimulators of T Regulatory Cells and/or Cells Expressing CD73” that teaches compositions of matter and protocols useful for treatment of COVID-19 and/or other inflammatory pathologies through stimulation of T regulatory cells and/or T cells expressing CD73 using administration of umbilical cord derived mesenchymal stem cells such as JadiCells. In one embodiment dosage of JadiCells needed to treat a patient is determined by the increase of T regulatory cells and/or CD73 expressing cells that are increased in number and/or activity subsequent to a test dose of JadiCells. In another embodiment stimulators of T regulatory cells and/or CD73 expressing T cells are utilized together with JadiCells in order to augment therapeutic activity. In some embodiments administration of JadiCell is performed with low dose interleukin-2 as a treatment for COVID-19 or other inflammatory related pathologies.
15. On August 11, 2021, the Company filed a patent application titled “Induction of Neurogenesis using Umbilical Cord Derived Mesenchymal Stem Cells and Derivatives Thereof” that disclosed compositions of matter and protocols useful for treatment of neurological dysfunctions through stimulation of adult neurogenesis using administration of umbilical cord derived mesenchymal stem cells such as JadiCells. In one embodiment viral induced neuropathy is reduced by administration of JadiCells to stimulate neurogenesis. In another embodiment the neurogenic activity of selective serotonin reuptake inhibitors is enhanced by administration of JadiCells. In some embodiments administration of JadiCell exosomes, conditioned media, microvesicles and/or apoptotic bodies is utilized to stimulate neurogenesis.
16. On July 6, 2021, the Company filed a patent application titled “Treatment of Parkinson’s Disease by Immune Modulation and Regenerative Means” in which we describe and disclose means, methods and compositions of matter for treatment Parkinson’s Disease through concurrent immune modulation and regenerative means. In one embodiment Parkinson’s Disease is treated by augmentation of T regulatory cell numbers and/or activity while concurrently providing regenerative cells such as mesenchymal stem cells, and/or dopamine secreting cells. In one embodiment administration of immunoglobulins such as IVIG together with low dose interleukin-2 and/or low dose naltrexone is disclosed as a preparatory means prior to administration of therapeutic cells such as stem cells. Other therapeutic means utilized in an adjuvant manner are also provided for hormonal rebalancing, transcranial magnetic stimulation, and deep brain stimulation.
17. On May 21, 2021, the Company filed a patent application titled “Lithium as a Monotherapy and/or Stem Cell Adjuvant Therapy for Pulmonary Fibrosis” that disclosed 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. In one embodiment the invention teaches administration of umbilical cord mesenchymal stem cells (MSC) and/or products derived from said cells in order to induce an inhibition of natural or pathological reduction of telomere length, to preserve telomere length or to enhance telomere length. In one embodiment the MSC described in the invention as useful are umbilical cord derived MSC. Published on November 24, 2022 https://patents.justia.com/patent/20220370561
18. On October 27, 2020, the Company filed a patent application titled “Protection/Regeneration of Neurological Function by Endothelial Protection/Rejuvenation” using Stem Cells for Treatment of Conditions such as Chronic Traumatic Encephalopathy and Schizophrenia” which therapeutic compounds, protocols, and compositions of matter useful for treatment of neurological conditions. In one embodiment the invention teaches the treatment of chronic traumatic encephalopathy (CTE) through protecting/regenerating the endothelial by administration of cells such as stem cells. In one embodiment stem cells are administered in order to protect the endothelium from apoptosis and to preserve the blood brain barrier. In another embodiment stem cells are administered together with endothelial progenitor cells in order to regenerate neural endothelium. In other embodiments preservation of brain integrity in conditions of degeneration is accomplished by administration of stem cells and/or endothelial cells. Published on April 28, 2022 https://patents.justia.com/patent/20220125852
19. On September 14, 2020, the Company filed a patent application titled “Immunotherapy of Schizophrenia and Schizophrenia Associated Suicidal Ideation/Suicide” Disclosed are methods, means, and protocols of modifying the immune system so as to induce an immunologically tolerant state insofar as T regulatory cell number and/or activity is augmented in a patient suffering from schizophrenia. In one embodiment T regulatory cells are administered to the patient from exogenous sources, be they allogeneic or autologous. In other embodiments, T regulatory cells are generated endogenously through administration of immature dendritic cells, mesenchymal stem cells, and/or pharmaceutical means.
by TimGDixon » Sun Dec 18, 2022 7:45 am
curncman wrote: ?Sun Dec 18, 2022 12:32 am
Tim ...Let me wrap by head around this whole gamut of things that are happening around us:
1) RESTEM LLC vs Patel & Camillo Ricardo claiming that they are ORIGINAL OWNERS of PATENT ON JADICELLS
2) The Outcome this lawsuit may not see the light until 5-6 years from now.
3) until then TSOI shall continue and conclude and commercialize JADICELLS after phase 3 approval
4) In case on adverse decision by court granting the PATENT to RESTEM LLC then , does TSOI have to negotiate with RESTEM LLC on the using the procedure of generation of mother cell lot ?
5) TSOI has patents on USE OF JADICELLS in lung and brain. so anyone using JADICELLS with IV has to pay the royalties to TSOI unless they chose to inject JADICELLS into organ (which is very expensive)
6) TSOI receives how much royalties on usage of JADICELLS any of the organs for regeneration/rujuvenation ?
I am thinking TSOI has already devised alternate plans to generate JADICELLS from allogeneic STEMVACS platform (based on dendritic cells from blood) , But will those cells can match the properties and efficacy of JADICELLS motherlot derived from UC ?
Just rambling here.... thanks in advance
1. No. Patel is the sole inventor of 9,803,176.
2. It could take years, yes.
3. Nothing about this IPR changes anything for us. Our phase 3 for Covid-19 ARDS, and as amended, does not rely upon 9,803,176, as TSOI will be using her own patent when it comes time for BLA.
4. No. TSOI doesn't have to negotiate with anyone. Even if Restem prevails all they will do is cause the patent to go into public domain which would allow even you to obtain a population of cells and if you did and administered them by IV then TSOI will sue you or anyone else who attempts to use Jadi's IV.
5. Our position is you will need a license from TSOI to use Jadi's by way of IV.
6. TSOI is the only licensed company and there won't be any others.
TSOI has unfettered access to Master Cell Bank One and we can request aliquot's of cells any time we want, in fact i am getting ready to do just that. We can then either start a new cell bank or we can simply expand the aliquots, assay them, vial them, and cryopreserve them. We can also generate brand new cells from fresh umbilical cord. Or we can use our iPSC manufactured cell.
There is a lot of misinformation being disseminated out there - don't believe a word of it. You want answers for *yourself* come ask me, but don't carry water for those scumbuckets of social media. They can just read what we have to say and suck it up.
by TimGDixon » Sat Dec 17, 2022 9:06 pm
ND2020 wrote: ?Sat Dec 17, 2022 8:51 pm
TimGDixon wrote: ?Sat Dec 17, 2022 8:33 pm
I'll tell you what thats some funny stuff all that patel rehab going on. Bomb around the neck...
Yep, that's what it looks like. Could it be CELZ? Would rather not speculate ;) ...
Its strange is all I can say. Yeah we're a little pissed off at amit and camillo and have every reason to be but that doesn't mean we want JadiCell to be invalidated and it won't be - if you read burger then you know our position. We conducted our own internal investigation in anticipation of filing an amicus curiae but discovered we were blocked, but needless to say our own knowledge and investigation came to the exact same conclusion as burger.
So what was the purpose? The laundry isn't done yet.
For all of your edification I will state this once again. The 176' patent only teaches how you obtain a population of the "claimed" cells. It does not teach how to use them. Only TSOI has "use" patents and all of those use patents lock up the lung. You cannot use jadi's in IV administration without the lung. Suppose Patel licensed someone tomorrow the heart, as long as they inject the organ and stay away from IV I will ignore them, put Jadi's in an IV and we will sue the crap out of you. If you could invalidate and turn jadi public domain you may be able to obtain a population of cells but how are you going to use them? Yes direct organ injection works well, but it's very expensive, and clinical trials would be hard because of placebo, yet it can be done, but in the end the procedure costs more than the cells. Maybe Restem didn't understand that.
by TimGDixon » Sat Dec 17, 2022 8:03 pm
This isn't that at all. We have a regular contact at FDA that Tom calls every other week and so far its not cleared. On the other we could get an email notice on any given day as well.
by TimGDixon » Sat Dec 17, 2022 8:53 pm
We have a very good, high level relationship with fda for being a very small firm. Do you remember the eIND we did earlier ( https://therapeuticsolutionsint.com/the ... ical-tria/ ) this year. We were at the highest levels on that one and the Director of the Office of Tissues and Advanced Therapies (OTAT) gave the OK personally on that one and in fact requested we do dose escalation for that patient, increasing to three transfusions, which is a departure from whats been cleared for phase 3 at two transfusions. We will find out when we find out. I have sitting here a brand spanking new IND for all etiology ARDS ready to be filed if for any reason they shoot our amendment down.
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