True words - even cell therapies need to be tested systematically in vivo.
These lab grown skins and organs on chips are very very very... very simplified systems.
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Update From The God Himself - Dr. Takashi Tsuji
- Thread starter kingjohn
- Start date
True words - even cell therapies need to be tested systematically in vivo.
These lab grown skins and organs on chips are very very very... very simplified systems.
How do you guys know that Dr.Tsuji will start trials in March? I emailed Organ-technol recently, telling them I'd like to be a subject. They replied that "The method of recruiting clients and clinical trials or subjects are undecided now." By the way, because my English is not good, I don't know what do these words exactly mean: "We hope to confirm our progress on our new HP new arrivals and media etc. I am sorry to hear that you will respond to your expectations,"
I'm guessing HP means home page on the organ technologies website.. perhaps they'll post something soon?
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Tsuji ain't a normal hair transplant surgeon...he wants to clone and implement those hair minimalinvasive, not just butchering like an oldschool surgeon. Don't forget that his method will provide much higher density that couldn't be achieved by other methods
I am quite confident re Tsuji.
However, as somebody already pointed out, will non Japanese be able to get this treatment?
Has somebody detailed knowledge of the regulatory requirements?
Its no good if the technology is perfect, price is acceptable but the regulator specifies that only people from Japan are allowed to be treated.
However, as somebody already pointed out, will non Japanese be able to get this treatment?
Has somebody detailed knowledge of the regulatory requirements?
Its no good if the technology is perfect, price is acceptable but the regulator specifies that only people from Japan are allowed to be treated.
Lets wish the regulator wont be that strict...
I never want to be the obnoxious, cynic that we are oh so privy to running into on these forums (especially potentially optimistic research threads), but everyone must understand - I would hope this is self-explanatory - that if they begin human trials in 2019, in no way shape or form does that mean that anyone other than the Japanese folk Lucky enough to get into the clinical trial will get anywhere near the procedure/treatment for: optimistically three years, realistically five (the administrative Overlook in Japan is not quite as stringent as the US otherwise it would be optimistically five realistically 8 to 10 with a high probability of failing due to funding dwindling, with investors the slightest hiccup in the research will decimate investment into the work [also a huge problem is most investors are laymen looking for that easily understandable magic bullet, and are all too eager to jump ship when they realize their uninformed fantasy is not realistic and will not lead them to quick and easy riches]).
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It is not a Tsuji paper.
It's a Jahoda-Christiano paper.
It's been already discussed.
I hope this time you won't go berserk, pal.
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You know nobody knows! What are you asking?
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I made a short calculation. It is arround 74.394%
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Even if this came out in the hypothetical case of the year "2020" and was suitable for my economic and health, I would wait a few years before doing anything to be able to observe clearly. As an entrepreneur I think they think as a company too and want to get profit as soon as possible. It's the only thing I can think of.
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When I mean to wait I mean my. When I said they want to getbenefits as soon as possible I mean them, as a company Iimagine they want to get benefits as soon as possible. With thisI want to say that no one knows for now!
I thought that would be blatantly obvious… My point is that just because they are starting a clinical trial this year does not mean we are anywhere near receiving it as a treatment, a phase 1 alone can take three years. People were sounding off at this announcement ( that should be treated with exultation) as if this means we will be able to have a treatment by the end of the year, in fact it’s very common for people to say that Tsuji will have a
‘cure“ by 2020, no he will start clinical trials by 2020. You are right 2025 would be amazing, no question I’m just setting the record straight that there will be no treatment in 2020 on the market from Tsuji at best by the end of next year he will be going through the end results of a phase 1, hopefully with great success MAYBE starting the early processes of a phase II.
What’s hilarious is the people that dislike what I wrote, very curious maybe what I said is so blatantly obvious that they are perturbed because there’s no point in saying it… But from what I had seen on this fourm, it’s very common for people to literally believe that Tsuji Will have a treatment/cure by 2020 when his team said that they would start human trials by 2020 ( according to reports/articles no direct statement from Tsuji himself), starting human trails means a long way from market that is all... that is reality. And it’s actually important to inform people who are uninformed, so that at the end of 2020 when he doesn’t release anything they don’t all start going on about how it was yet another farce, snake oil, etc.
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Absolutely impossible… This is what I mean people actually believe this ( I know you literally state hypothetically, but ever since he announced that he would be starting human trails by 2020 many people interpreted that as if his work would be available by 2020) , the man and his team are literally just starting human trials! In fact they haven’t started yet, they hope the first phase will be started closer to the end of 2019 or the latest early 2020. Their product/treatment will be in clinical trials, nowhere near market release, the only people that are going to receive it are the people that get into the clinical trials (lucky bastards). Now after a phase II is completed, if you have a lot of money in many cases you can buy your way into receiving the product before it is cleared by the governing administration ( I looked into this for autologous neural cells for spinal injury, $500,000 per injection four injections a year for two years for a total of $4 million just for the stem cells, not including The additional medical expenses, surgery, intensive physiotherapy, etc. Obviously this is far more intensive than androgenic alopecia, I’m merely using it as an example to show what kind of “clientele” buy their way into clinical trials/advance treatments long before they are released to the general public).
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I just want to reiterate this is fantastic news, they overcame the hurdles that were preventing them from progressing to human trials and are potentially on a trajectory to start human trials in 2019, earlier than they expected. Amazing! Just understand that clinical trials take an exorbitant amount of time and money. And are very volatile, meaning they could lose their primary investors/source of funding from anything that could be interpreted as risk/potential failure. Now with a reputable head researcher Behind the science, it’s almost guaranteed to get picked up by someone else but that means months or even years of limbo.
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Friend, they had clearly stated they aimed at an early 2019 commencing trial.
And conditional commercialization by late 2020.
Those are their words. What you say is pulled right out of your ***.
Tut mir leid!
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It is a cellular-based technology, in Japan they are one of the few if not the only country that actually has a separate oversight committee for pharmaceuticals and stem cell-based technology. In Japan Cellular research if it successfully goes through a phase II they can begin “commercialization“ and offering it to people, however I do believe they have to continue on and finish the phase III. As it stands right now they haven’t even started a Phase I human trail, which is going to take no less than a year and naturally the second phase takes longer as it is bigger, it is more focussed on safety with placebo groups to analyze efficiency as well. I would bet my house they can’t get two clinical faces done by next year.
The only caveat is, in Japan I believe they can offer the treatment to people as long as the phase II has demonstrated significant safety profiling, meaning that it actually doesn’t even have to be fully completed… And this is a cosmetic therapy, hardly invasive. So say the safety aspect was rocksolid, technically they could begin offering the treatment before the full completion of the second phase clinical trial, as patients we wouldn’t have a full assessment for efficacy and there would likely be a tremendous marked up and waiting list. So even if all of that were to go through smoothly I would not consider that “commercialization“.
Just google Tsuji and/or Riken and you will find multiple websites talking about commercializing a treatment by 2020, none of which get a statement from Dr. Tsuji making such a claim. And no it’s not something I made up, in fact they said they hope to start human trials by 2019 http://www.asahi.com/ajw/articles/AJ201806050032.html apparently that is a direct statement from the scientist working on the technology. And this forum is rife with people believing that this technology will be on the market by 2020, not necessarily to their own fault many articles are made making such overzealous statements.
“This is a ridiculous comparison“ in case you didn’t read I clearly established that it was not a comparison: “Obviously this is far more intensive than androgenic alopecia... merely using it as an example“. Literally any treatment that is in early development (Phase I or II, if you want to buy your way in it’s going to cost you tens of thousands to hundreds of thousands of dollars, this is just common knowledge regardless of the condition, The markup will be exorbitant.