Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

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TimGDixon
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Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

Post by TimGDixon »

I thought you all might like to know that a little while ago FDA called me to issue our IND# 27377 for Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy Patients .

This is just the start but its another stroke in our masterpiece we are painting - we had a great end of the day thanks to all you askslappers....

This is the original press release,

Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using Clinically Validated JadiCell® Universal Donor Stem Cell
December 17, 2020 09:00 ET | Source: Therapeutic Solutions International, Inc.

OCEANSIDE, Calif., Dec. 17, 2020 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of an Investigational New Drug (IND) application seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for treatment of Chronic Traumatic Encephalopathy (CTE) patients with JadiCells™.

The JadiCell is a type of umbilical cord derived mesenchymal stem cell which possesses superior therapeutic activity as compared to other stem cell types based on laboratory and clinical studies. The JadiCell was recently reported to possess therapeutic activity against COVID-19 in a recently published clinical trial1. The Company previously obtained an exclusive license for use of JadiCells for CTE and Traumatic Brain Injury (TBI)2,3.

“My team and myself are extremely excited about the potential of using our unique novel cell therapy for treatment of CTE, which is the cause of countless deaths, as well as chronic disabilities” said Dr. Amit Patel, inventor of the JadiCell. “Having worked over the past several years with the multidisciplinary team assembled by Timothy Dixon, I look forward to progress in this area of medicine, for which currently there are limited options.”

Chronic Traumatic Encephalopathy (CTE) is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players4. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe. TSOI has previously filed several patents in the area of CTE based on modulating the brain microenvironment to enhance receptivity of regenerative cells such as stem cells.

Suicide is a major cause of death in military veterans, approximately 20 deaths per day5. It is widely known that TBI and CTE are associated with increased propensity for suicide6,7. Furthermore, studies show that cytokines associated with brain inflammation, such as IL-6 and TNF-alpha are found in higher levels in patients with suicidal tendencies8.

“To our knowledge, this is the first therapeutic intervention addressing CTE using stem cells and we are tremendously excited to finally move into clinical testing for this terrible disease that not only affects athletes but our military and law enforcement as well” said Timothy Dixon, President and CEO of the Company. “Having worked over the last 2 years in developing the preclinical data supporting this IND, we are extremely pleased to file this new drug application today.”

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 and Campbell Neurosciences at https://www.campbellneurosciences.com
1 https://papers.ssrn.com/sol3/papers.cfm ... id=3696875
2 https://www.globenewswire.com/news-rele ... uries.html
3 https://patents.google.com/patent/US9803176?oq=9803176
4 https://www.nytimes.com/interactive/201 ... l-cte.html
5 https://en.wikipedia.org/wiki/United_St ... an_suicide
6 https://www.psychcongress.com/news/trau ... sk-suicide
7 https://sbindependent.org/nfl-athletes- ... d-suicide/
8 https://www.ncbi.nlm.nih.gov/pubmed/20951793
Therapeutic Solutions International, Inc.
ir@tsoimail.com
Jamesy
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

Post by Jamesy »

This is wonderful news! Thank you for sharing Tim! Every day is rainbows when you know what you are holding, despite what the market says. Your transparency and communication are almost as invaluable as your science.
rrao11
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

Post by rrao11 »

Woo hoo! Congratulations! Hello NFL, EFL, BOXING, MMF, Veterans, accident victims, and everyone else who suffers and needs help with CTE/TBI

Go $TSOI
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TimGDixon
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

Post by TimGDixon »

Thanks everyone - this is a big deal. This isn't permission to begin yet but we're in line now. No one has ever filed an IND to treat CTE. The only way you get the diagnosis is post-mortem, until now because we are proposing within our IND a method of diagnosis. No promises here but i am going to try and obtain non-dilutive funds for this IND and i think there are plenty of places to look. I was starting to think we got caught in the paper IND covid trap like celz did but we're in you guys and the rest is just Q&A time with FDA until they say yes.
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TimGDixon
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

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I'm sorry it took so long because it was all my fault i sent the original filing to the wrong address - its the same building suite but i sent to central document room not Therapeutic Biological Products Document Room and they couldn't walk it across the room i guess - i got tired of waiting on them and printed new books (3 of them 3-ring) and sent them to the correct address - don't know whatever happened to first one - probably in an Indiana Jones box somewhere.

For a Drug:

Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266


For a Therapeutic Biological Product:

Food and Drug Administration
Center for Drug Evaluation and Research
Therapeutic Biological Products Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266
Jamesy
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

Post by Jamesy »

TimGDixon wrote: Fri Mar 05, 2021 2:52 pm Thanks everyone - this is a big deal. This isn't permission to begin yet but we're in line now. No one has ever filed an IND to treat CTE. The only way you get the diagnosis is post-mortem, until now because we are proposing within our IND a method of diagnosis. No promises here but i am going to try and obtain non-dilutive funds for this IND and i think there are plenty of places to look. I was starting to think we got caught in the paper IND covid trap like celz did but we're in you guys and the rest is just Q&A time with FDA until they say yes.
Hey Tim,
How are you planning on doing the diagnosing as it normally occurs post-mortem? Could there be an argument for applying prior to diagnosis in order to avoid or diminish reduced brain atrophy?
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TimGDixon
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

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The question is a good one. To begin with, Chronic traumatic encephalopathy (CTE) is the term used to describe brain degeneration that's likely caused by repeated head traumas seen on autopsy. Although formal diagnosis is made after death, criteria have been developed which tightly correlate with post-mortem findings. Based on behavioral and laboratory abnormalities, we have proposed a clinical trial in patients with advanced symptoms of CTE, as identified based on multiple concussions, behavioral markers and proprietary biomarkers.

Major components to neurodegeneration associated with CTE include hyperproduction of inflammatory cytokines, reduction in T regulatory cells, and augmented oxidative stress.

Mesenchymal stem cells (MSC) have been reported by numerous groups as possessing anti-inflammatory and neuroregenerative activity. The JadiCell is a newly discovered MSC originating from the umbilical cord, which has demonstrated potent anti-inflammatory activity in vitro and in vivo. Strikingly, in a double blind, placebo controlled clinical trial, administration of 100 million JadiCells intravenously resulted in 91% of patients surviving at 28 days, whereas in the placebo group only 42% survived.

The current study will assess primary safety and secondary efficacy endpoints for treatment of 10 patients with advanced CTE using a dose of 100 million JadiCells intravenously. Patients will be assessed at 1, 3, and 6 months for behavioral improvement, reduction in inflammatory cytokines, and changes on brain imaging.

And so this study will provide proof of concept for expanded studies using regenerative approaches.
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TimGDixon
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

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BTW this was better than spending 1300 bucks and the post has already had 200 views and is all over SM - man you guys/gals are great and i doubt a single MM knows hahahaha :lol: :lol: :lol: :lol:
Jamesy
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

Post by Jamesy »

TimGDixon wrote: Fri Mar 05, 2021 4:05 pm The question is a good one. To begin with, Chronic traumatic encephalopathy (CTE) is the term used to describe brain degeneration that's likely caused by repeated head traumas seen on autopsy. Although formal diagnosis is made after death, criteria have been developed which tightly correlate with post-mortem findings. Based on behavioral and laboratory abnormalities, we have proposed a clinical trial in patients with advanced symptoms of CTE, as identified based on multiple concussions, behavioral markers and proprietary biomarkers.

Major components to neurodegeneration associated with CTE include hyperproduction of inflammatory cytokines, reduction in T regulatory cells, and augmented oxidative stress.

Mesenchymal stem cells (MSC) have been reported by numerous groups as possessing anti-inflammatory and neuroregenerative activity. The JadiCell is a newly discovered MSC originating from the umbilical cord, which has demonstrated potent anti-inflammatory activity in vitro and in vivo. Strikingly, in a double blind, placebo controlled clinical trial, administration of 100 million JadiCells intravenously resulted in 91% of patients surviving at 28 days, whereas in the placebo group only 42% survived.

The current study will assess primary safety and secondary efficacy endpoints for treatment of 10 patients with advanced CTE using a dose of 100 million JadiCells intravenously. Patients will be assessed at 1, 3, and 6 months for behavioral improvement, reduction in inflammatory cytokines, and changes on brain imaging.

And so this study will provide proof of concept for expanded studies using regenerative approaches.
Thanks for the information! If the results and efficacy even slightly mimic that of the Jadicell's previous performance from the covid study; this is going to be incredibly significant and game-changing!
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TimGDixon
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Re: Investigation of Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Chronic Traumatic Encephalopathy

Post by TimGDixon »

Thats what we think and hope for Jamesy.
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