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Tsuji's Timetable Of 2020 Likely Refers To Final Marketing After Studies Are Finished.
- Thread starter nameless
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Sorry dude, but it's wishful thinking.
They've openly said that they begin trials in 2018 as that's when not only Organ Tech, but the other two will be ready. It will take at least 2 years to complete up to Phase II, which is what makes a 2020 release date possible given Japan's stem-cell laws.
Apparently, some bill passed in the US that I think is a rough equivalent to the Japanese laws? That would be good, because it would probably give them more incentive to begin trials outside of Japan sooner.
They've openly said that they begin trials in 2018 as that's when not only Organ Tech, but the other two will be ready. It will take at least 2 years to complete up to Phase II, which is what makes a 2020 release date possible given Japan's stem-cell laws.
Apparently, some bill passed in the US that I think is a rough equivalent to the Japanese laws? That would be good, because it would probably give them more incentive to begin trials outside of Japan sooner.
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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
Why?
http://emboj.embopress.org/content/early/2016/12/09/embj.201694902.abstract
Why?
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Do you actually believe he bothered to even read it?
So why he said "nope" then if he didn't read that paper?
Because he's one of these guys who says being bald is no big deal and there are "plenty of hot bald guys" because apparently a gay man's opinion on what men are or aren't "hot" is relevant to straight men.
He said and still says that there is no way this will be out in 2020, despite everything being on track for it.
He's also contradicted his own beliefs numerous times
These kinds of guys are narcissists, dude. They don't want a solution as bad as you do; they want it more. Narcissists hate it when they aren't the ones in control and baldness is something that they can't control, so the coping method is to try and tell yourself it's not a problem because you will be f*****g awesome even without hair. That's what leads to what I call "the naysayer circle jerk." You only find these forums and are reading new research if you go looking for it. Anyone who is here is bothered by hairloss — period. However, if you find even ONE other voice telling you what you want to hear in the sea of people telling you the truth you don't want to accept (you're going bald and will look like sh*t) that one person saying "It's no big deal; these treatments won't work out and we don't need them anyway" that person is your best friend now because they feed your narcissistic delusion. That's why all the naysayers stick together and give each other the thumbs up.
The one thing they will never let themselves be, though? Wrong. Guys like Foucault will still being saying even when they see hair sprouting out of human scalps in 2018 that it's not gonna work out, there's no way it'll be out in 2020, etc. Meanwhile they'll be the first ones booking the plane ticket when the time comes.
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maybe he was trying to undermine u but instead got knocked off after reading the paper.
anyway, got to admit one thing, lots of researches going on so what do u think guys Is total fix around the corner?
the one important thing that i noticed during male pattern baldness is the decrease in the thickness of the scalp, and it is seen only in the affected areas so epithelial cells must have an important role in this.
Do u think Histogen, replicel, tsuji may use this new discovery to increase the efficacy of their products?
they should according to my belief because the main culprit is skull expansion and decrease in the thickness of scalp, hormones and receptors are only the driving factors. Since we cannot do anything about skull expansion, we can increase the skin thickness to cope up with scalp expansion.
that's how the cure shall be found
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First and foremost, I happen to have read the abstract. I can't read the whole paper, though.
Furthermore, I can't extract much info from the abstract alone.
Nonetheless,
• The term HFSC is different from the terms "epithelial stem cells" or "derma papilla stem cells", that Tsuji's team used in their papers, but I'm guessing it includes both types. Still, a grey area.
• The word "expansion" is used instead of proliferation/amplification in the specific paper, which makes it a little vague to me. What do they mean by the word "expansion"? Do you know?
• In the experiment, murine stem cells were used, not human. That's a huge difference, trust me!
Consequently, in my opinion, this paper is NO f-ing breakthrough!
My condolences to your unjustifiable allegria.
Bis bald,
.A research team is already working on improving scalp skin thickness to treat hair loss.
The treatment is called Kerastem.
They're adding a layer of fat (with ADSCs) to the scalp.
Kerastem might give good improvement for more people than minoxidil + finasteride does.
Kerastem is in phase 2 studies in America right now.
http://ir.cytori.com/investor-relat...-Trial-for-Early-Stage-Hair-Loss/default.aspx
I read a news article that indicated the 21st Century Cures Act would allow some treatments to come to market after phase 2 if there's an unmet need and if there's other evidence to support that the treatment is safe and effective. Phase 3 would take place while the treatment is already in the marketplace. I don't know if this provision of th 21st Century Cures Act will apply to hair loss treatments but it might. If that provision of the 21st Century Cures Act could be used to speed the approval process for hair loss treatments then Kerastem could hit the market in 2018.
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Unfortunately, you're probably right. But at least the case for a 2020 release is strong.
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go to this link
https://www.gourmetstylewellness.com/intera...e-21st-century-cures-act.102509/#post-1402144
this act will definitely speed up things for us.
thanx for the reply @nameless
i want to ask how effective is kerastem's method
I'll gather some info on Kerastem but first I want to give you a link to a very recent article which confirms my statement that marketing of a drug can be sped up in cases where there is an unmet need.
https://www.statnews.com/2016/12/01/21st-century-cures-act-fda-approval/
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hair loss cure is an unmet need (sighs) i hope they understand this
Blackber
Experienced Member
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Not too effective. Several members got the procedure done, myself included, and no one has had any regrowth maintenance. I wouldn't count on Kerastem for anything.
Thanks for the update.
It looks like Kerastem is not the partial breakthrough I hoped it might be.
The drug companies most certainly understand it.
This is important because the drug companies could request speedier release (bypassing phase 3 until after marketing) for their hair loss treatments with the FDA, and the FDA would need a good reason to reject that request. And if there's nothing in the 21st Century Cures Act that specifically excludes treatments for things like hair loss from utilizing that provision the FDA likely would not have a good reason to reject that request. And if there's nothing in the Cures Act that specifically excludes treatments for things like hair loss from utilizing that provision then FDA could be forced (by court order) to allow companies to use that provision for hair loss treatments.
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then we can safely conclude one bird down
thanx for the feedback
the sooner we know the truth the better it is
Looking forward to histogen and replicel.
21st cure act approval, stem cell therapy, phase 3 trials,(coincidence? hell no) things are lining up
it seems that the progress is very slow but will help us in the long run
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Why did they use murine stem cells not human?
IMO this is the only good issue that Foucaltll raised.
All of his other reasons for rejecting the study posted earlier are lousy reasons. They don't even merit a response IMO.
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Hun, I'm a medical student.
What's your qualification?
I'm so fed up with people having no f-ing idea but being argumentative, whatsoever.
There are posters here who write like 6 posts/day on average for 4 months in a row or claim that cutaneous epithelial cells depend on atmospheric oxygen (which is written in wikipedia; how lame!!!) and I'm the one who's called names.
Ok, hun, this paper is a breakthrough. Because of it, Riken-Kyocera are launching a Phase I trial next year.
Happy?
Now, live your life!
Or if you can't, find a Doctor. Most of "qualified" posters in here really need one.