Tissuse And J. Hewitt: Smart Hair Transplant Trial In 2019!
- Thread starter RolfLeeBuckler
- Start date
The company hasn't released any new info yet but based on what the CEO said in his last update I think we COULD be about 3 months away from the trial starting. In his last update the CEO said that the disaster with the cell company he was trying to work with delayed things by about 6 months. Since that trial was supposed to start BY December 2019 that means that he COULD be able to start a trial by roughly June of 2020. After all, 6 months from December 1, 2019 is June 1, 2020.
I’ll believe it when I see it. Don’t trust anything this CEO says anymore.
TissUse has a contract with J Hewitt. TissUse needs to profit off of their technology and see whether it's successful. So it doesn't add up that J Hewitt would be able to sit around for long doing nothing. They have to do a trial and they have to do it soon.
Desmond_84
Established Member
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Tsuji and TissUse will take at least 5 years to come to market if they start their trials today. Neither have conducted a Proof of Concept or Phase 1 trial. You need to finish Phase 2 to commercialise
Where have you been Desmond? You don't have to do that in Japan anymore with stem cell treatments. They can get interim approval and commercialize immediately after phase 1 thanks to the law they passed years ago. Catch up, man.
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Desmond_84
Established Member
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As far as I'm aware only 3 therapies have gone through the conditional approval process and all 3 conducted a small Phase 1 safety trial followed by a Phase 2 proof of concept. Although Phase 2 only lasts 6 - 12 months, patients need to be assessed for a good 6 months after the Phase 1 first in man safety trial. Add in analysing data, Clinical trial approval from Japans health ministry, tweaking the study protocol, etc....you are looking at 3 years minimum if it was a simple therapy like Shiseido.
Tsuji and TissUse on the other hand are infinitely more complex as they're engineering mini organs for transplantation. You can most certainly expect some tweaks and unforseen delays along the way.
Lets not forget Shiseido's Phase 2 trial took 3 years and study results still hasn't been published. They were also aiming for conditional approval.
Tsuji and TissUse on the other hand are infinitely more complex as they're engineering mini organs for transplantation. You can most certainly expect some tweaks and unforseen delays along the way.
Lets not forget Shiseido's Phase 2 trial took 3 years and study results still hasn't been published. They were also aiming for conditional approval.
"It is five years since Japan passed laws regulating stem-cell clinics; in that time, some 3,700 treatments have received the green light. From Hokkaido to the islands of Okinawa, companies in Japan can extract stem cells from skin biopsies and use them in injections for complex conditions such as heart disease.
But the vast majority of these therapies have not passed a randomized, controlled, double-blind clinical trial, the global standard to prove that interventions are safe and effective, and the foundation for most medical regulation. Instead, Japan’s 2014 Act on the Safety of Regenerative Medicine and a second law, the 2014 Pharmaceutical and Medical Device Act, provide a fast track to market approval."
https://www.nature.com/articles/d41586-019-02844-6
A recently approved stem cell treatment approved before trial data was even published:
"The clinical trials that demonstrated efficacy were based on only 13 participants. There was no control group and the trial data remain unpublished."
https://www.nature.com/articles/d41586-019-00332-5
But the vast majority of these therapies have not passed a randomized, controlled, double-blind clinical trial, the global standard to prove that interventions are safe and effective, and the foundation for most medical regulation. Instead, Japan’s 2014 Act on the Safety of Regenerative Medicine and a second law, the 2014 Pharmaceutical and Medical Device Act, provide a fast track to market approval."
https://www.nature.com/articles/d41586-019-02844-6
A recently approved stem cell treatment approved before trial data was even published:
"The clinical trials that demonstrated efficacy were based on only 13 participants. There was no control group and the trial data remain unpublished."
https://www.nature.com/articles/d41586-019-00332-5
In a recent email I've been able to see, TissUse said they still expect to have trials conducted this year and that the procedure will reach "market maturity" within a few years. Market maturity is when sales begin to grow at a decreasing rate. If that's really what they expect, then I interpret that as they expect to commercialize it very quickly after the first trials are completed (if successful). They also hinted at pursuing trials and commercialization in Europe again.
Take gay tsuji and tissuse and shove them both where it stinks. This year will not end without either me or my family are dead. In a third world country where anything kills everyone. I regret listening to this sh*t for the last decade only for everything to end like that. Just a f***** japanese wannabe and some handicapped companies who are not even serious about anything. Just a wasted lifetime without a fucken meaning.
but sure:
“gay tsuji will save us all”.
but sure:
“gay tsuji will save us all”.
You need a life. Wait for tsuji. He will get ya one for sure.
“suck my tsuji .. Roll It And Suck It”.
Desmond_84
Established Member
- Reaction score
- 359
If this was the case and you could launch a stem cell therapy with a single phase trial and 13 participants, Shiseido should have launched their product in 2018, yet here we are, 4 years have passed and we are still waiting.
They may have meant something else by “market maturity”. I find it hard to believe that sales would already be declining a couple years from now.
Probably. Don't know what, though. Sloppy, unclear words as usual.
Still, though, if trials are done this calendar year, and the results are satisfactory and a company or companies want to sell it publicly, there's really no reason it couldn't be available next year. How long wait times are is another story.
That’s the dream, but we’ll see. Been awfully dead around here lately in terms of updates or news.
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- 984
Follicle Thought
March 4, 2020
Update on J Hewitt SHT Trial
So, I’ve heard from J Hewitt CEO Jon Knight today who reached out to me by email after reading some of the comments here.
He too, like everyone else is disappointed by the disruption of the projected trial timeline. But, he’s still pursuing the goal of a SHT trial in Japan and wanted me to reiterate a few things here.
For starters. most people are unaware that Jon Knight/J Hewitt literally invented PRP/Vampire Filler as an aesthetic treatment in Japan in 2005, this was verified in a court case which took place in 2019 involving two other British companies. Knight wanted to emphasize this in response to particular comments which were undermining the caliber of his company. To be fair, that treatment has now created billions of dollars in the aesthetic medicine industry. Not everyone has that on their resume.
Knight also told me that early on he had interest from 3 Cell Processing Center companies to do the trial, so, naturally he did not feel he was being too optimistic with a projected December trial date. He actually thought September was possible if not for the back-and-forth legal discussions. Knight also tells me that he feels some companies in Japan have turned him down because they did not want to be seen as helping a competitor to the big local cosmetic companies. Something to think about. I’ve mentioned it previously, but J Hewitt is a private company, is not stock listed, and literally gains no financial value for making announcements regarding the trial.
As for current status, I can say Knight is doing his best to get an SHT trial going. I think for now it’s best to leave it at that and see what comes. Interestingly, he also mentioned that he is paying attention to what Histogen is doing and thinks some good things can come from their recent business development and their new human collagen injectable. I’m hoping to get more commentary from him about that soon.
My take: I still appreciate the fact that J Hewitt has taken an initiative to potentially bring a next-gen hair growth therapy to market. I’ll continue rooting for them as long as they’re in the game. Understanding the situation that Knight was in, it makes sense to me and I think everyone understands that sometimes ‘sure things’ can unexpectedly change. I won’t blame him for that, we’re all human. I don’t believe in ridiculing someone when things aren’t going great and then smiling in their face tomorrow if they have good news for me. I think it’s also worth stating that after many years of the candidate therapy existing J Hewitt was the first company who finally decided to even give TissUse/SHT a chance. Every other pharma company and major investment firm in Europe (and worldwide) passed it up before Hewitt obtained a license. The trial that is being pursued could cost around $50k-$100k per trial subject! That’s pricey even for a 5 man trial and Knight is pursuing this with his own company’s money. I respect it. Here’s to hoping we get some good news on this subject soon.
——
Seems like SHISEIDO has so much faith to stop cell company’s working with J hewitt
March 4, 2020
Update on J Hewitt SHT Trial
So, I’ve heard from J Hewitt CEO Jon Knight today who reached out to me by email after reading some of the comments here.
He too, like everyone else is disappointed by the disruption of the projected trial timeline. But, he’s still pursuing the goal of a SHT trial in Japan and wanted me to reiterate a few things here.
For starters. most people are unaware that Jon Knight/J Hewitt literally invented PRP/Vampire Filler as an aesthetic treatment in Japan in 2005, this was verified in a court case which took place in 2019 involving two other British companies. Knight wanted to emphasize this in response to particular comments which were undermining the caliber of his company. To be fair, that treatment has now created billions of dollars in the aesthetic medicine industry. Not everyone has that on their resume.
Knight also told me that early on he had interest from 3 Cell Processing Center companies to do the trial, so, naturally he did not feel he was being too optimistic with a projected December trial date. He actually thought September was possible if not for the back-and-forth legal discussions. Knight also tells me that he feels some companies in Japan have turned him down because they did not want to be seen as helping a competitor to the big local cosmetic companies. Something to think about. I’ve mentioned it previously, but J Hewitt is a private company, is not stock listed, and literally gains no financial value for making announcements regarding the trial.
As for current status, I can say Knight is doing his best to get an SHT trial going. I think for now it’s best to leave it at that and see what comes. Interestingly, he also mentioned that he is paying attention to what Histogen is doing and thinks some good things can come from their recent business development and their new human collagen injectable. I’m hoping to get more commentary from him about that soon.
My take: I still appreciate the fact that J Hewitt has taken an initiative to potentially bring a next-gen hair growth therapy to market. I’ll continue rooting for them as long as they’re in the game. Understanding the situation that Knight was in, it makes sense to me and I think everyone understands that sometimes ‘sure things’ can unexpectedly change. I won’t blame him for that, we’re all human. I don’t believe in ridiculing someone when things aren’t going great and then smiling in their face tomorrow if they have good news for me. I think it’s also worth stating that after many years of the candidate therapy existing J Hewitt was the first company who finally decided to even give TissUse/SHT a chance. Every other pharma company and major investment firm in Europe (and worldwide) passed it up before Hewitt obtained a license. The trial that is being pursued could cost around $50k-$100k per trial subject! That’s pricey even for a 5 man trial and Knight is pursuing this with his own company’s money. I respect it. Here’s to hoping we get some good news on this subject soon.
——
Seems like SHISEIDO has so much faith to stop cell company’s working with J hewitt
H
Senior Member
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- 775
What do you mean?
- Reaction score
- 984
Follicle Thought
March 5, 2020
Hi Russell, you misinterpreted the quote about companies not working with him, so I went back and reworded it. Companies are not staying away from SHT trials because J Hewitt is too small, that wouldn’t really make sense anyway as long as he had the $ for a trial, he feels they are shying away from the trial because there is a big company in town (you should be able to guess) and these CPCs may not want to be seen as helping a competitor to the big dog. It’s a politics thing. This is why it wasn’t easy to find a replacement CPC after negotiations didn’t work out with the first contact.
I don’t think there’s too much to over-analyze here it’s pretty straightforward. Hopefully J Hewitt can find a company to run the trial and we get to see what SHT is all about. That’s where things are at.
Shhhhhhh shut up insect!.