Tsuji's Timetable Of 2020 Likely Refers To Final Marketing After Studies Are Finished.
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Baldybald1
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Me too
If we get in the clinical trial then yes
If we get in the clinical trial then yes
We all know that Japan has enacted a law which allows cell-based therapies to come to market after phase 1 if the treatment demonstrates safety and efficacy in phase 1. Researchers still have to continue phase 2 and phase 3 studies and then approval would go widespread.
Let's assume Dr. Tsuji's phase 1 human study start sometime in 2017 and finishes sometime in 2018. If it proves safe and effective in phase 1 AND if Tsuji's treatment qualifies as the type of cell-based therapy that can go to market after successful phase 1 testing then Tsuji might be legally able to release it in 2018, and the 2020 date might actual refer to later widespread release after completing ALL studies.
I'm not saying that this is the way it is; I'm just saying that if Tsuji's treatment qualifies as one of the types of cell-based treatment that can be marketed after a successful phase 1 study then this could possibly happen.
I just sent an email to Dr. Tsuji asking him about this.
If he responds I'll share his response with everyone. But I've never communicated with him before. If anyone is in direct email contact with Dr. Tsuji and Kyocera maybe that poster could also run this by Dr. Tsuji and Kyocera. I think we should be trying to get Dr Tsuji and Kycera interested in releasing their treatment after a successful phase 1 study if their treatment qualifies for that.
I don't know about the rest of you but I've had all the fun I can stand with hair loss. I'd like this nightmare over already.
Let's assume Dr. Tsuji's phase 1 human study start sometime in 2017 and finishes sometime in 2018. If it proves safe and effective in phase 1 AND if Tsuji's treatment qualifies as the type of cell-based therapy that can go to market after successful phase 1 testing then Tsuji might be legally able to release it in 2018, and the 2020 date might actual refer to later widespread release after completing ALL studies.
I'm not saying that this is the way it is; I'm just saying that if Tsuji's treatment qualifies as one of the types of cell-based treatment that can be marketed after a successful phase 1 study then this could possibly happen.
I just sent an email to Dr. Tsuji asking him about this.
If he responds I'll share his response with everyone. But I've never communicated with him before. If anyone is in direct email contact with Dr. Tsuji and Kyocera maybe that poster could also run this by Dr. Tsuji and Kyocera. I think we should be trying to get Dr Tsuji and Kycera interested in releasing their treatment after a successful phase 1 study if their treatment qualifies for that.
I don't know about the rest of you but I've had all the fun I can stand with hair loss. I'd like this nightmare over already.
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constrictedvoid
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I don't really think that's likely to work. More importantly, if it indeed releases in 2020, I think we should be first in line. I feel this forum should make some contact with them to ensure that we will be able to be some of the first people who are treated. I think many users here want this more heavily than some random people in Japan. I'm willing to pay twice the cost of a regular hair transplant and spend months in Japan, and I'm a dense NW2... The earlier that issue is brought up, the better, IMO.
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- 35
Pal,
You've got it all wrong.
The trials ain't starting in 2017.
They haven't even managed yet to amplify epithelial stem cells, for Allah's sake.
Tone it down, man.
Be patient and save as much money as possible.
That's all I had to say.
Over and out!
You've got it all wrong.
The trials ain't starting in 2017.
They haven't even managed yet to amplify epithelial stem cells, for Allah's sake.
Tone it down, man.
Be patient and save as much money as possible.
That's all I had to say.
Over and out!
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japan is always in the first line of treatment , they have approved dutasteride for hairloss .
It will never be approved in the US or europe
It will never be approved in the US or europe
For Allah's sake pal, doesn't this solve the amplification of epithelial stem cells problem?
http://emboj.embopress.org/content/early/2016/12/09/embj.201694902.abstract
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Baldybald1
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Very interesting!
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Nope!
A phase 1 human study, including data collection, only takes about a year and a half if everyone is organized.
And like I said, in Japan they can market some cell-based therapies after successful completion of phase 1 studies.
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Mate this isn't just about data collection, there are still obstacles they haven't overcome. If I remember correctly they were still trying to find out how to culture epithelial stem cells without losing "intrinsic properties". Don't ask me what that means (cause I don't know), I am just echoing from news I read here before.
Point is you can't test something before it's been completed.
Even if it doesn't work, who's going to stop them from selling it in the US?
https://www.scientificamerican.com/article/unproved-stem-cell-clinics-proliferate-in-the-u-s/
I'm not your mate, dude. I'm exclusively attracted to women.
That aside, new discoveries are made every day. I understand that there's still a piece of the puzzle missing and I think they'll have that sorted out <1 year.
If it works the way Tsuji claims, they could sell the procedure in various countries including the USA and without FDA approval. FDA approval would be nice for them have, and they surely will seek approval especially if it works, but I don't believe it's a major show-stopper the way some people think it is.
Baldybald1
Established Member
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Nameless could be right. I remember few years ago that tsuji said they will begin the clinical trial in 2020 and now they say the production will be in 2020. My point is that they may using this technique just for back up in case things got delayed
Some time ago I also remember them saying they would start clinical trials in 2020. And now they appear to have changed that. Now they appear to be saying they'll market it in 2020. I think maybe they revised the date to a sooner date because they see themselves, and other research teams, closing in on solutions to the amplification of epithelial cells problem faster than they originally anticipated.
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