Update From The God Himself - Dr. Takashi Tsuji

ZP31

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My hairline doesn't have another year.
If your hairline is THAT fucked up then shave it to a 1 guard, grow a beard and move the f*** on. Stop torturing yourself looking at this forum everyday when you know damn well you won’t be able to get this treatment for at least 3-5 more years.
 

Marcaronii

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If your hairline is THAT fucked up then shave it to a 1 guard, grow a beard and move the f*** on. Stop torturing yourself looking at this forum everyday when you know damn well you won’t be able to get this treatment for at least 3-5 more years.
Then why are you here?
 

ZP31

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Then why are you here?
We’re all here for the same reason. The difference between you and me is that I’ve accepted what is happening to my hair and am not going to let it ruin me.

My hairline has not receeded to the point where it needs to be shaved yet. What I’m saying is, don’t pout to people that you “don’t have another year” to wait for a treatment. No one gives a f***, and sadly that’s the reality of being a man, but you’ve got to handle it like one.
 

Marcaronii

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We’re all here for the same reason. The difference between you and me is that I’ve accepted what is happening to my hair and am not going to let it ruin me.

My hairline has not receeded to the point where it needs to be shaved yet. What I’m saying is, don’t pout to people that you “don’t have another year” to wait for a treatment. No one gives a f***, and sadly that’s the reality of being a man, but you’ve got to handle it like one.
Tl;dr. :D
 

Dogma

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com·mer·cial·ize
Dictionary result for commercialize

verb
  1. manage or exploit (an organization, activity, etc.) in a way designed to make a profit.
Hey hey you cant change the rules now you just said if they commercialize not this full commercialization term sh*t and they have stated they will only be doing so many the first year they think they will be out which is 2020. I dont know that they will make it or not but if they do sell the treatment in 2020 to anybody though for a profit then in 2020 I dont mind if you room with me in my new 3 story $350g house but the basement is mine. Wait is the basement furnished?
Yeah see the problem is that’s not contextual, I made it explicitly clear that because of Japan’s new stem cell regulations they could maybe sell to a few lucky individuals before the end of the phase 2, but that is not full commercialization ( I would actually argue that that isn’t even really commercialization in any pedantic sense of the word, and more so fundraising to finish the phase 2 and have more funds for the phase 3, Which means those few purchases made by said lucky individuals would not be revenue but reinvested into the clinical process a.k.a. not profit for the time being), and if I make the bet I make the terms especially when we are talking about a new gray area in Japan for the lucky few, compared to Full access to the therapy, with multiple clinics around the world looking to purchase their rights to sell the therapy ( completion of phase 3 required), implementation of mass production of any technology/materials necessary to meet consumer demands = full commercialization.
 

H

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so have you read this anywhere or is it just brain dead pure speculation? if it is so then it would be just a normal phase 2 with the exception of them making money. it can't be this f*****g hard to actually dig up the proper information about this law. what i heard is that a lot of people go for medical tourism to japan to get stem cell treatments etc, if it were just a very restrictive and ofr some lucky ones this would simply not be possible.

also your incoherent mubo jumbo about a phase 3, that is not even listed here

https://www.caladrius.com/wp-content/uploads/2018/05/Sietsema-et-al.-2018-RAPS.pdf

can you provide sources for your claims? for example that phase 3!!! is required for a full release in japan even though there is literally nothing to find online and in the picture from the length it clearly says one study is required then conditional release(with no claims of what you said either) and then reapplication and release. absolutely no word of a phase 3 study and Im pretty sure no completion of 3 is required so thats the point. so either provide sources for your claims or go away

nobody actually understands this law and everyone is just autistically speculating about it. can someone please figure out how this actually works? unbelievable.
Dogma is just pissed I took him up on a bet for his house lol so now the coward is trying to set up new terms to cover his ***
 

megadyptes

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Old information!

In a recent paper co-authored by Tsuji (entitled: "Functional ectodermal organ regeneration as the next generation of organ replacement therapy" (2019)) it is stated that: "The regeneration of hair follicles using our organ germ method is now being investigated in a pre-clinical study to cure patients suffering from androgenic alopecia, with an aim of conducting clinical trials in 2020."

In previous papers by Tsuji suggested it was going to be this year. For instance, in the paper "Organ regeneration based on developmental biology: past and future" (2015) the authors said: "The regeneration of hair follicles using our organ germ method is now under translational research to cure alopecia patients with a goal of conducting clinical trials in 2019 in Japan, which will be the first attempt worldwide".

Which means this is delayed for at least another year, which makes 2020 success less likely.
 
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Marcaronii

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New information!

In a recent paper co-authored by Tsuji (entitled: "Functional ectodermal organ regeneration as the next generation of organ replacement therapy" (2019)) it is stated that: "The regeneration of hair follicles using our organ germ method is now being investigated in a pre-clinical study to cure patients suffering from androgenic alopecia, with an aim of conducting clinical trials in 2020."

In previous papers by Tsuji suggested it was going to be this year. For instance, in the paper "Organ regeneration based on developmental biology: past and future" (2015) the authors said: "The regeneration of hair follicles using our organ germ method is now under translational research to cure alopecia patients with a goal of conducting clinical trials in 2019 in Japan, which will be the first attempt worldwide".

Which means this is delayed for at least another year, which makes 2020 success less likely.
This is old information. Lol.
 

Dogma

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so have you read this anywhere or is it just brain dead pure speculation? if it is so then it would be just a normal phase 2 with the exception of them making money. it can't be this f*****g hard to actually dig up the proper information about this law. what i heard is that a lot of people go for medical tourism to japan to get stem cell treatments etc, if it were just a very restrictive and ofr some lucky ones this would simply not be possible.

also your incoherent mubo jumbo about a phase 3, that is not even listed here

https://www.caladrius.com/wp-content/uploads/2018/05/Sietsema-et-al.-2018-RAPS.pdf

can you provide sources for your claims? for example that phase 3!!! is required for a full release in japan even though there is literally nothing to find online and in the picture from the length it clearly says one study is required then conditional release(with no claims of what you said either) and then reapplication and release. absolutely no word of a phase 3 study and Im pretty sure no completion of 3 is required so thats the point. so either provide sources for your claims or go away

nobody actually understands this law and everyone is just autistically speculating about it. can someone please figure out how this actually works? unbelievable.

“ The Japanese want to be the regenerative medicine center of the world,” said Colin Lee Novick, managing director of the CJ Partners biotech consulting firm in Tokyo. “To be able to do that, they need to entice companies to come to Japan, and they need to entice their own pharmaceutical companies to license in and obtain the best.”
The “regen” boom in Japan is based on a series of reforms and new laws for pharmaceuticals, but especially the landmark Pharmaceuticals and Medical Devices Act (PMD Act) and the Act on the Safety of Regenerative Medicine. The result is the ability to offer conditional marketing approval for a regen so it can move more quickly to commercialization – an approval process widely seen as the fastest in the world. Regens also benefit from what is known as the Sakigake Package of policy changes, which speed up the introduction of innovative medical products. The package focuses on everything from basic research to clinical research/trials, approval reviews, safety measures, insurance coverage, improvement of infrastructure and the environment for corporate activities, and global expansion. It includes a designation system that promotes R&D in Japan aimed at early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines. It also includes a scheme for rapid authorization of unapproved drugs, which speeds the practical application of unapproved/off-label use of drugs for serious and life-threatening diseases.
https://hbr.org/sponsored/2018/02/h...ities-in-the-field-of-regenerative-medicine-2

Major Changes to Medical Device Registration Process in Japan
https://www.emergobyul.com/blog/2014/11/major-changes-medical-device-registration-process-japan

New regulations accelerating the approval of regenerative therapeutics in Japan took effect November 25, 2014. The significance of these regulations is that they allow companies to receive conditional marketing approval and commercialize regenerative medicine products while clinical trials continue through the later stages ( A.k.a. phase IIb and more importantly: phase III mumbo-jumbo)

Similarly, the PMD Act introduces a specific regulatory framework for regenerative medicine products. Under the PMD Act, conditional and time-limited marketing approval can be given to a regenerative medicine product after exploratory clinical trials have demonstrated probable benefit and proven safety (aka phase I and II). According to these new laws, once a company has demonstrated safety and basic efficiency data in humans and has the cell product manufactured to the standards described within the Pharmaceutical and Medical Devices (PMD) Act, the cell therapy can be given conditional approval for up to seven years. This allows for commercial use with data reporting requirements and potential for national insurance coverage.

The intent of the laws is to accelerate the commercialization of cell therapeutics within Japan by allowing companies to benefit from conditional marketing authorization. Therefore, cell therapies that show safety and probable efficacy during Phase I and Phase II trials can get conditional approval for up to seven years, during which time:

1) Larger-scale, later-stage clinical trials are performed (AKA PHASE III!)
2) Revenue from the cell therapy is pursued within the Japanese market

During the seven-year conditional approval period, companies must continue to submit clinical trial data to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and subsequently apply for final marketing approval or withdraw the product within seven years. ( The product can gain revenue within the seven years evidently after a phase to safety confirmation, it’s most likely that most of that if not all of the revenue is going to be put towards completing the phase III [ largest scale and latest stage of any clinical trial, other than manufacturing, distribution which is contingent on the completion of the phase III] and compiling, qualifying and quantifying all of the data for submission, which if goes smoothly the product gets the full “stamp of approval“ full commercialization and other developed countries will likely now consider it a viable treatment fully tested and approved.)
https://bioinformant.com/japan-accelerated-approvals-of-cell-therapies/
 
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soull

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“ The Japanese want to be the regenerative medicine center of the world,” said Colin Lee Novick, managing director of the CJ Partners biotech consulting firm in Tokyo. “To be able to do that, they need to entice companies to come to Japan, and they need to entice their own pharmaceutical companies to license in and obtain the best.”
The “regen” boom in Japan is based on a series of reforms and new laws for pharmaceuticals, but especially the landmark Pharmaceuticals and Medical Devices Act (PMD Act) and the Act on the Safety of Regenerative Medicine. The result is the ability to offer conditional marketing approval for a regen so it can move more quickly to commercialization – an approval process widely seen as the fastest in the world. Regens also benefit from what is known as the Sakigake Package of policy changes, which speed up the introduction of innovative medical products. The package focuses on everything from basic research to clinical research/trials, approval reviews, safety measures, insurance coverage, improvement of infrastructure and the environment for corporate activities, and global expansion. It includes a designation system that promotes R&D in Japan aimed at early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines. It also includes a scheme for rapid authorization of unapproved drugs, which speeds the practical application of unapproved/off-label use of drugs for serious and life-threatening diseases.
https://hbr.org/sponsored/2018/02/h...ities-in-the-field-of-regenerative-medicine-2

Major Changes to Medical Device Registration Process in Japan
https://www.emergobyul.com/blog/2014/11/major-changes-medical-device-registration-process-japan

New regulations accelerating the approval of regenerative therapeutics in Japan took effect November 25, 2014. The significance of these regulations is that they allow companies to receive conditional marketing approval and commercialize regenerative medicine products while clinical trials continue through the later stages ( A.k.a. phase IIb and more importantly: phase III mumbo-jumbo)

Similarly, the PMD Act introduces a specific regulatory framework for regenerative medicine products. Under the PMD Act, conditional and time-limited marketing approval can be given to a regenerative medicine product after exploratory clinical trials have demonstrated probable benefit and proven safety (aka phase I and II). According to these new laws, once a company has demonstrated safety and basic efficiency data in humans and has the cell product manufactured to the standards described within the Pharmaceutical and Medical Devices (PMD) Act, the cell therapy can be given conditional approval for up to seven years. This allows for commercial use with data reporting requirements and potential for national insurance coverage.

The intent of the laws is to accelerate the commercialization of cell therapeutics within Japan by allowing companies to benefit from conditional marketing authorization. Therefore, cell therapies that show safety and probable efficacy during Phase I and Phase II trials can get conditional approval for up to seven years, during which time:

1) Larger-scale, later-stage clinical trials are performed (AKA PHASE III!)
2) Revenue from the cell therapy is pursued within the Japanese market

During the seven-year conditional approval period, companies must continue to submit clinical trial data to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and subsequently apply for final marketing approval or withdraw the product within seven years. ( The product can gain revenue within the seven years evidently after a phase to safety confirmation, it’s most likely that most of that if not all of the revenue is going to be put towards completing the phase III [ largest scale and latest stage of any clinical trial, other than manufacturing, distribution contingent on the completion of the phase III] and compiling, qualifying and quantifying all of the data for submission, which if goes smoothly the product gets the full “stamp of approval“ full commercialization and other developed countries will likely now consider it a viable treatment fully tested and approved.)
https://bioinformant.com/japan-accelerated-approvals-of-cell-therapies/


Very interesting, the question is whether it would be possiblefor a foreigner to perform this technique.
 

Dogma

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nobody actually understands this law and everyone is just autistically speculating about it. can someone please figure out how this actually works? unbelievable.

2014 Japan initiated the two acts:
  • Act on the Safety of Regenerative Medicine (Law No. 85/2013)
  • Pharmaceuticals and Medical Device (PMD) Act (Law No. 84/2013)
- The aim of the first act was to accelerate the clinical application and commercialization of innovative regenerative medicine therapies. It covers clinical research and medical practice using processed cells and specifies the procedure required for clearance to administer cell procedures to humans. These guidelines are very important to the use the cells within clinical stages.

- as I showed above the second act (PMD) is the specific legislation that allows conditional marketing as long as efficacy and safety data is shown in early clinical phases. As I have been saying over and over again, is that enough sources and information for you?
 

Dogma

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Very interesting, the question is whether it would be possiblefor a foreigner to perform this technique.
After a phase 3 yes, but during the conditional seven-year marketing period after phase II confirms safety and efficiently it clearly states it will Allow the product access to the “Japanese market“, that is a direct statement from more than one source but I’m going to assume that the Japanese market pretty much unanimously consists of Japanese citizens. I would consider that a fair and rational assumption. However we all know damn well money talks, if you have multi millions you can pick any clinical trial right now for any condition bring all of the equipment and surgeons down to the Bahamas where they have very little medical regulation but great facilities and have the experimental therapy performed… So is it crazy to assume that if you are capable and willing of paying quadruple the standard price or make an offer they cannot refuse they will not allow a foreigner to receive early access in the Japanese market? The only question is if that would be antithetical to the PMD act, and thereby damage their full approval process well they are in the conditional phase.
 

Dogma

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Finally a constructive discussion. Thank You for your effort!
I have been repeatedly explaining this over and over again, I’m pretty well versed in clinical trial processes and cellular research ( to a lesser extent), because I suffer from quadriplegia which is A catastrophic condition. But after the arrogance exhibited in that man’s post, I decided to finally put the kibosh in place, and provide sources and direct quotes to substantiate everything I’ve been saying.

bboy also brought these specific acts out earlier ( although he didn’t copy a key summaries of each act), and he copied and paste did direct quotes from the interview with Dr. Tsuji which clearly indicates that they are behind compared to when that interview took place courtesy of the moderators of this website, and the 2020 date is purely observed by them for the Japanese market on most certainly within the PMD seven year conditional release phase
 
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soull

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After a phase 3 yes, but during the conditional seven-year marketing period after phase II confirms safety and efficiently it clearly states it will Allow the product access to the “Japanese market“, that is a direct statement from more than one source but I’m going to assume that the Japanese market pretty much unanimously consists of Japanese citizens. I would consider that a fair and rational assumption. However we all know damn well money talks, if you have multi millions you can pick any clinical trial right now for any condition bring all of the equipment and surgeons down to the Bahamas where they have very little medical regulation but great facilities and have the experimental therapy performed… So is it crazy to assume that if you are capable and willing of paying quadruple the standard price or make an offer they cannot refuse they will not allow a foreigner to receive early access in the Japanese market? The only question is if that would be antithetical to the PMD act, and thereby damage their full approval process well they are in the conditional phase.


Hopefully with Replicel not have to wait so long.....:(:(
 
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