NEWS 10/11/21

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trader32176
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NEWS 10/11/21

Post by trader32176 »

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

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

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


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

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

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

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

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

About Therapeutic Solutions International, Inc.

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

ir@tsoimail.com

SOURCE Therapeutic Solutions International
Related Links

https://therapeuticsolutionsint.com
RR19
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Re: NEWS 10/11/21

Post by RR19 »

Hi Tim, Great News, congrats to all of us here.

1) when the news said, we started to produce these cells internally, did you mean we built our own lab rather than giving it to some pharma?

2) If yes, will you be allowed to share some inside pictures of the production facility to us, I am excited.

3) are there more and more RTTs coming your way recently? Is the word being spread really fast.

4) a patent on production procedures, this never heard of, amazing job Tim and team .
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TimGDixon
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Re: NEWS 10/11/21

Post by TimGDixon »

Hey RR19 - no we have not build a production facility yet. We are saying in our research lab we were able to produce this technology and write all the SOP's. Now we will endeavor to build a cGMP Cellular Facility that can not only produce JadiCells but all of our cell lines. The future is very exciting.
RR19 wrote: Mon Oct 11, 2021 6:14 am Hi Tim, Great News, congrats to all of us here.

1) when the news said, we started to produce these cells internally, did you mean we built our own lab rather than giving it to some pharma?

2) If yes, will you be allowed to share some inside pictures of the production facility to us, I am excited.

3) are there more and more RTTs coming your way recently? Is the word being spread really fast.

4) a patent on production procedures, this never heard of, amazing job Tim and team .
retsehc
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Joined: Thu Aug 20, 2020 2:41 pm

Re: NEWS 10/11/21

Post by retsehc »

Hi Tim, good news this morning.

Wondering how much $ is needed to build a cGMP Cellular Facility and how long would it take to build and be functional?

Thanks!
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TimGDixon
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Re: NEWS 10/11/21

Post by TimGDixon »

On the low end around $2 million but thats subject to many things. Construction is modular (which can be expanded) and the manufacturer is an hour away from us and time to ship, uncrate and assemble is probably a week or two and then certification - likely looking at 60 days.
retsehc wrote: Mon Oct 11, 2021 12:01 pm Hi Tim, good news this morning.

Wondering how much $ is needed to build a cGMP Cellular Facility and how long would it take to build and be functional?

Thanks!
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TimGDixon
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Re: NEWS 10/11/21

Post by TimGDixon »

Here is today's abstract. This patent makes 1000 claims spanning 245 pages and using 118,435 words.

Umbilical Cord Derived Regenerative and Immune Modulatory Stem Cell Populations
The present invention 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.
curncman
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Re: NEWS 10/11/21

Post by curncman »

Tim congratulations on delivering and leading the way in introducing for new line of medicine in the form of JADICELLS for pulmonary , cardiovascular, Diabetes and LUNG regeneration therapy in US. Its better that as American Company lead the way in tis space and set the order from cGMP to patient bedside. Kudos to you and your team of Docs for their GUTS and SCIENCE to come up with JADICELLS functional and manufacturing lab in short period of time with minimum funding for the benefit of all suffering patients. Hope this JADICELLS cure is going to heal so many patient lives and give them back their health unless they chose to create the Disturbance-In-Ease with their food or eating habits in future.

Having said that is cGMP facility need to be ready before we can attempt to go for EUA or Initiate Conduct of Phase trial? just asking. Also I hope FUNDING is next prerogative for TSOI to move forward to become next BIG PHARAOH in town!
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TimGDixon
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Re: NEWS 10/11/21

Post by TimGDixon »

Everyone is asking the same thing and I have tried my best to answer. EUA has nothing to do with the actual Phase 3 with the caveat that P3 allows us to request EUA. They are completely separate things. All of these smarty pants who think they know what we are planning, where we are going and how its going to end are living in fantasy land. Unless you have located my top secret underground bunker and have listening devices in place haven't a clue whats discussed behind closed doors and yet they all claim to have intimate knowledge about all of this is very amusing but completely wrong. OOOOOH Merck has a pill. Wow I'm impressed. Wow i'm askeered... puhleeeeeease... JadiCell is not about covid-19 - covid-19 is just a vehicle to prove their safety and efficacy. If we wanted to we could out-license jadi to a majorly owned subsidiary and raise money all day long and eventually that will flow back to the parent. We have dozens of patents we could do the same thing with and all the bellyachers and whiners and bashers and haters can't do one damn thing about it. TSOI is not some one trick pony... we prefer to keep everything in house.
curncman wrote: Tue Oct 12, 2021 3:54 am Tim congratulations on delivering and leading the way in introducing for new line of medicine in the form of JADICELLS for pulmonary , cardiovascular, Diabetes and LUNG regeneration therapy in US. Its better that as American Company lead the way in tis space and set the order from cGMP to patient bedside. Kudos to you and your team of Docs for their GUTS and SCIENCE to come up with JADICELLS functional and manufacturing lab in short period of time with minimum funding for the benefit of all suffering patients. Hope this JADICELLS cure is going to heal so many patient lives and give them back their health unless they chose to create the Disturbance-In-Ease with their food or eating habits in future.

Having said that is cGMP facility need to be ready before we can attempt to go for EUA or Initiate Conduct of Phase trial? just asking. Also I hope FUNDING is next prerogative for TSOI to move forward to become next BIG PHARAOH in town!
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TimGDixon
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Re: NEWS 10/11/21

Post by TimGDixon »

Heres some news - Elk City is 24f this morning... guess I better climb out of my underground bunker and head to soCal and eat avocados and carne asada burritos...in my top secret underground lab

Heres a rare photo taken of me exiting the bunker... it must be somewhere on the other side of the river...

IMG_8579.JPG
IMG_8579.JPG (10.75 MiB) Viewed 289 times
lampspost
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Re: NEWS 10/11/21

Post by lampspost »

Ha Ha Looks pretty darn nice. Never been a fly fisherman but cant beat the solitude I am sure. Hang in there Tim. Just keep the boat pointed toward shore and you will get there.
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