- Reaction score
- 419
Yeah you clearly don't actually know what you're talking about. You're just pulling reasons out of your *** based on your own gut feelings.
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Regular Tsuji Updates... Unfortunately They Are In Japanese!
- Thread starter Ted Buckland
- Start date
Your replies kill me lmao
- Reaction score
- 3,025
I don't think that's true at all.
Here's his most recent study from 2016:
http://advances.sciencemag.org/content/2/4/e1500887.full
To quote:
To generate various epithelia from iPS cells, we first developed a CDB transplantation method as an in vivo transplantation model. To form the complete three-germ-layer epithelial tissue from iPS cells, we established iPS cells from murine gingiva.
To be clear, that means they started off with mouse gum tissue, created iPS cells (induced pluripotent stem cells), and used those to create hair follicles, which they reimplanted into other mice.
It's mice top to bottom.
All his studies are listed here:
http://www.cdb.riken.jp/en/research/laboratory/tsuji.html
Here is his other famous hair study from 2012:
https://www.nature.com/articles/ncomms1784
Again all mouse top to bottom.
Am I missing something? I concede I have only skimmed his research, but I see no mention of human hair tissue.
You don't need to be so upset. I'm just saying you're probably going to have to be a little more patient than they are suggesting in their marketing. If he has cloned a human hair follicle more recently (ie. this year) it's possible he hasn't published because he doesn't want to give away the secret, since it's now a commercial property.
But he was quite willing to publicly state in July that his big project was working on a better method of stem cell multiplication at that point. He hasn't really been very "private" about things. I find it hard to believe they wouldn't be blasting it out in their marketing that he has cloned human hairs if he already had. They obviously want as much publicity as they can get.
- Reaction score
- 3,025
You can read the current state of Tsuji's published research (as of summer last year) on mice in the post above.
In 2014, one of RIken's lead researchers was busted for "falsely manipulated research findings" which shows they are not above f*****g up or making false claims:
https://www.bioinformant.com/stem-c...ized-market-for-ips-cell-therapy-development/
To follow an example of how stem cell projects, proceed, we can look at their macular degeneration research which is farther ahead. In 2015 Riken started a much simpler trial of using stem cells to treat macular degeneration. The trial was put on hold for two years after they found concerning mutations in the stem cell derivatives.
https://ipscell.com/2017/02/japan-ips-cell-trial-vision-start-new-incarnation/
They restarted this initiative with a research study in just 5 preliminary patients in 2017 (2 years lost since that "glitch" and still not close to a marketable end product). They will need to now monitor those 5 patients for a given time frame to prove it is safe before offering it more broadly, and even then it will be probably a few hundred patients next, not general wide release.
I don't know why you guys think this is such an easy problem to solve, that Riken has a perfect track record, or that the Japanese government won't still require clinical trials. We can see from their macular degeneration project which is much simpler just how slowly this stuff moves, especially when real world problems start popping up along the way.
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They're 100% sure it'll work on humans because of the quote you just typed out. The safety data is something I don't understand, I don't think Tsuji would've forgotten one of the most important things and that's the clinical trials, obviously they have to prove safety but to what extent? "Oh my bad forgot we had to prove safety, 2020 is no longer feasible, we'll do 2025."
Hey man I think you're sort of right but Shiseido has nothing to do with Riken or Tsuji.
- Reaction score
- 3,025
Oh wow Ted. I found the article by searching that quote. The quote was referencing his 2012 study here:
https://www.nature.com/articles/ncomms1784
I take it back! I didn't know he had done this already. I had only reviewed his 2016 one in detail, thinking that was his most recent research, and that was purely in mice.
That's really good. Fantastic.
Sorry for being so negative. I was inadequately informed. I still think 2019/2020 is an optimistic target and I have been trying to find some more info on their stem cell law and what safety data it requires. From what I see of their macular degeneration study, they are still having to go through standard trials to get stepwise approval. It's taking years for that, and that's much simpler than hair.
- Reaction score
- 1,709
No dude Tsuji f*****g sucks; he doesn't care about us at all. He's been using government and private funding to give nude mice the sickest hairstyles scientifically possible.
MOHAWK
A RAT TAIL ON A MOUSE - IS IT POSSIBLE??? HAS SCIENCE GONE TOO FAR??
f*** you Tsuji, these mice are getting laid while we are suffering. Thanks for giving them OUR follicles.
Thanks for nothing.
- Reaction score
- 3,025
Found the information on the laws in Japan.
https://www.nature.com/nm/journal/v19/n5/pdf/nm0513-510.pdf?origin=ppub
I have free access, so I'll post the relevant quotes:
Under the Pharmaceutical Affairs Law as it
currently stands, regenerative therapies, like
small-molecule drugs, must undergo three
phases of costly and cumbersome clinical trials
to get approval by Japan’s Pharmaceutical and
Medical Devices Agency.
The proposed amendments to the
pharmaceutical law will create a new, separate
approval channel for regenerative medicine.
Rather than using phased clinical trials,
companies will have to demonstrate efficacy
in pilot studies of as few as ten patients in one
study, if the change is dramatic enough, or a few
hundred when improvement is more marginal.
According to Toshio Miyata, deputy director
of the Evaluation and Licensing Division at
the Pharmaceutical and Food Safety Bureau
in Tokyo, if efficacy can be “surmised,” the
treatment will be approved for marketing. At
that stage, the treatment could be approved for
commercial use and, crucially for such expensive
treatments, for national insurance coverage.
With the bar for regenerative therapies
dramatically lowered by requiring only limited
safety and efficacy data—and essentially doing
away with the need for high-powered phase
3 trials—the amendments’ architects say it
will be possible to get a stem cell treatment to
the market in just three years, rather than the
typical six or more. The law should also give
local producers of regenerative medicine an
edge even over those selling stem cell therapies
in South Korea, where an accelerated system has
helped companies get more stem cell treatments
on the market than any other country (see Nat.
Med. 18, 329, 2012). “It’s bold,” says Yoshihide
Esaki, director of Bio-Industry Division, a
bureau of the Ministry of Economy, Trade
and Industry based in Tokyo, which promoted
legislation calling for the update.
Following approval, there will be a postmarket
surveillance period of five to seven years,
after which the treatment will be evaluated again
for safety and efficacy. Every patient must be
entered in a registry during that period, says
Miyata. If the therapies prove inefficacious or
unsafe, approval can be withdrawn.
According to that, it seems they are saying the law requires a 3 year process to prove safety, which is the bare minimum of what I think reasonably makes sense. Think about it, would you want tumors popping all over your scalp from stem cells going wrong?
Then there is another 5-7 year monitoring period where every single patient who gets the treatment must be registered and monitored and until that period passes, the approval is "conditional" and can be revoked if problems arise.
From that and what they are doing currently, I can only assume when they say "it will be available in 2020" they mean for the 10-100 or so initial test patients they will start with. Otherwise the timeline still doesn't add up.
If that is what they mean, then 2023 would be the likely earliest possible start of broad availability. But even then, given that all patients for the next 5-7 years would need to be registered and monitored, I'm not sure if they'd even let foreigners get the treatment. How would they monitor someone in Brazil or Egypt after he flew home?
If that's again the case, then we'd be looking at 2028-2030 for non-Japanese, assuming it all goes smoothly.
https://www.nature.com/nm/journal/v19/n5/pdf/nm0513-510.pdf?origin=ppub
I have free access, so I'll post the relevant quotes:
Under the Pharmaceutical Affairs Law as it
currently stands, regenerative therapies, like
small-molecule drugs, must undergo three
phases of costly and cumbersome clinical trials
to get approval by Japan’s Pharmaceutical and
Medical Devices Agency.
The proposed amendments to the
pharmaceutical law will create a new, separate
approval channel for regenerative medicine.
Rather than using phased clinical trials,
companies will have to demonstrate efficacy
in pilot studies of as few as ten patients in one
study, if the change is dramatic enough, or a few
hundred when improvement is more marginal.
According to Toshio Miyata, deputy director
of the Evaluation and Licensing Division at
the Pharmaceutical and Food Safety Bureau
in Tokyo, if efficacy can be “surmised,” the
treatment will be approved for marketing. At
that stage, the treatment could be approved for
commercial use and, crucially for such expensive
treatments, for national insurance coverage.
With the bar for regenerative therapies
dramatically lowered by requiring only limited
safety and efficacy data—and essentially doing
away with the need for high-powered phase
3 trials—the amendments’ architects say it
will be possible to get a stem cell treatment to
the market in just three years, rather than the
typical six or more. The law should also give
local producers of regenerative medicine an
edge even over those selling stem cell therapies
in South Korea, where an accelerated system has
helped companies get more stem cell treatments
on the market than any other country (see Nat.
Med. 18, 329, 2012). “It’s bold,” says Yoshihide
Esaki, director of Bio-Industry Division, a
bureau of the Ministry of Economy, Trade
and Industry based in Tokyo, which promoted
legislation calling for the update.
Following approval, there will be a postmarket
surveillance period of five to seven years,
after which the treatment will be evaluated again
for safety and efficacy. Every patient must be
entered in a registry during that period, says
Miyata. If the therapies prove inefficacious or
unsafe, approval can be withdrawn.
According to that, it seems they are saying the law requires a 3 year process to prove safety, which is the bare minimum of what I think reasonably makes sense. Think about it, would you want tumors popping all over your scalp from stem cells going wrong?
Then there is another 5-7 year monitoring period where every single patient who gets the treatment must be registered and monitored and until that period passes, the approval is "conditional" and can be revoked if problems arise.
From that and what they are doing currently, I can only assume when they say "it will be available in 2020" they mean for the 10-100 or so initial test patients they will start with. Otherwise the timeline still doesn't add up.
If that is what they mean, then 2023 would be the likely earliest possible start of broad availability. But even then, given that all patients for the next 5-7 years would need to be registered and monitored, I'm not sure if they'd even let foreigners get the treatment. How would they monitor someone in Brazil or Egypt after he flew home?
If that's again the case, then we'd be looking at 2028-2030 for non-Japanese, assuming it all goes smoothly.
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- Reaction score
- 3,025
If that's the case, and there's no bullshit here, then there must something I'm not getting about the law. Because the law still implies a small group needs to be studied first, and that article from Nature implies it should be for 3 years at the soonest ...
I am looking but can't find anything that says they are doing away with ALL clinical trials or considering one year data sufficient. The only way I can see they could make that target is if they were permitted to only submit one year of data.
Blackber
Experienced Member
- Reaction score
- 604
A chart explaining the new approval process in Japan has been posted on this site numerous times. Yes, it's POSSIBLE for this treatment to be approved by 2020, and yes they've said they're on schedule but no one can tell the future.
The whole point of new stem cell treatment regulations is because stem cells (when developed properly) are more safe than conventional medicines because they use the patient's own cells.
My personal opinion is that it won't be available until 2021-2022, but how you can say this guy is a snake oil salesman and talk about them in a derogatory way when you haven't even read his studies or know anything about the new regulations is a little ridiculous....
- Reaction score
- 3,025
You can read about the two year delay they had on macular degeneration here:
An operation on a second patient was called off because a number of minor genetic mutations had crept into his iPS cells during processing, and uncontrolled growth—cancer—has been a worry with such cells. “These changes do not directly induce cancer, but we wanted to make safety the first priority,” Yamanaka says. Also, Takahashi says, AMD drugs had stabilized the patient’s condition so there was no urgency in subjecting him to the risks of surgery, which include hemorrhaging and retinal damage.
http://www.sciencemag.org/news/2017...therapy-proves-safe-will-it-ever-be-effective
All induced pluripotent stem cells run the risk of turning into cancer. This cancer risk is not a joke. That led to a two year delay in their study. I still don't see how the Japanese government isn't going to want safety data when this is a known risk. If you find my lack of knowledge on the Japanese law "ridiculous", then please, share your expertise.http://www.sciencemag.org/news/2017...therapy-proves-safe-will-it-ever-be-effective
- Reaction score
- 3,025
Ahh maybe. That's a trick that would buy them a few months. If they start trials in early 2018, then 2021 is still "2020". That would mean they'd have to start trials on around 10-100 guys in the next 4 months....
Last I heard, 4 months ago they were still working on their cell multiplication technique.
- Reaction score
- 3,025
Sort of. What he's done is pretty exciting. Got it with what you mean on the dates.
But as for the timeline, unless I'm misinterpreting the law, it's going to be likely 3 years of 10-100 patients first. THEN 5-7 years of time where every patient who gets it must be registered and monitored for follow up. The approval is then conditional on what happens to those 5-7 years worth of patients.
I can't see how they would take Europeans and North Americans for the 5-7 years of registered and monitoring. How would they guarantee someone from England would come back in 5-7 years for checkups? They simply couldn't. Japanese guys would be no problem for this, since they can monitor them as locals. But foreigners? Impossible.
Their macular degeneration studies have been for Japanese citizens only.
That would mean for non-Japanese, it will take 8-10 years after the first hair is implanted in the first human.
- Reaction score
- 3,025
It was stated as part of the law from what I read there. Conditional approval is based on registration and monitoring of all patients during the 5-7 year period. After those 5-7 years, they review all the patients who had the procedure, and check for any changes in their health due to the treatment. Their regulatory body requires this information for submission and review in order to either grant or revoke permanent approval.
How could that process possibly include non-Japanese?
You absolutely COULD move to Japan...
- Reaction score
- 1,321
Crap. I'm going to have to reread the research results. I don't recall they were using pluripotent SCs. Even at that the cloning process involves in vitro multiplication so one would think aberrations would be easily detected and eliminated before transplantation. And, I can only speculate about the possibility but perhaps genetic analysis would be done in cell populations to detect any anaplasia. Too, once production testing gets rolling, normal cellular turnover could reveal consequences quickly. It would be insane if the uncontrolled cell growth, aka cancer, was a wild proliferation of follicles that covered every inch of your body.
If that's the risk I can almost gaurantee you that the risk would be so small and the people that would get cancer from this treatment would have a very high chance of getting cancer without this treatment.
- Reaction score
- 507
Jesus bro calm the f*** down lol
"f*** you pussy c*** wagon go home f*** you" just give it a minute lmao
- Reaction score
- 820
Hello! I am Fuji Maru Kagurazaka.
I live in Tokyo, Japan. Thank you.
Sometimes the translation function seems to mischief.
I will not confuse the forum with my unintended sentences.
Japanese and English are completely different languages, and they do not have any similarities.
We expect to begin clinical trials for humans in 2018, as described on the Organ Technologies Inc. web site.
I think it is March 2019 at the latest.
This is related to the fiscal year of Japan.
In 2030, regardless of whether they are Japanese or foreigners, everyone should be in the age of receiving this treatment.
2030 is such a meaning.
I am sorry for the confusion.
I live in Tokyo, Japan. Thank you.
Sometimes the translation function seems to mischief.
I will not confuse the forum with my unintended sentences.
Japanese and English are completely different languages, and they do not have any similarities.
We expect to begin clinical trials for humans in 2018, as described on the Organ Technologies Inc. web site.
I think it is March 2019 at the latest.
This is related to the fiscal year of Japan.
In 2030, regardless of whether they are Japanese or foreigners, everyone should be in the age of receiving this treatment.
2030 is such a meaning.
I am sorry for the confusion.
- Reaction score
- 1,531
I still don't get what he's trying to say here with that year 2030
thomps1523
Established Member
- Reaction score
- 298
Yeah is he jesting the treatment will be available in other countries, or that they are restricting the treatment to only residents of Japan until 2030?
NorwoodGuardian
Established Member
- Reaction score
- 184
f*** you they have mentioned before to treat about 10000 patients in the first year of commercialization and commercialization is 2020 and you still think you are Mr.Smart who found something that Tsuji team has never considered. f*** you your f*****g retarded.