Tissuse And J. Hewitt: Smart Hair Transplant Trial In 2019!

[nameless2]

J Hewitt licensed the technology from TissUse and they are the ones responsible for getting it through the approval process. I don't care how many times you tell me TissUse are a partner because you're mistaken in their role in any previous treatments.

Neither company has yet to deliver on anything through the fast track program so no, they don't necessarily have the expertise or the experience, and we know nothing of the actual competence of Jon Knight besides his development of the PRP treatment 15 years ago.

I already acknowledged I was mistaken when I said it was TussUse who ran a trial through the fast-track Asian process. I already have to repeat lots of stuff to you so stop harping on the one thing you were right about. I conceded that one issue.

Now back to the issue at hand, Hewitt may be the ones responsible for getting the treatment through trial but that doesn't stop TissUse from talking to Hewitt. Partners can and do sometimes talk.

That aside, TissUse wouldn't have gotten involved with J. Hewitt if J. Hewitt is so stupid they don't get it that they need to get approval from appropriate regulatory agencies before they take an experimental treatment from animals to humans for the first time... a treatment that involves injecting cellular biological stuff into people's heads. In order for TissUse to get involved with a company as idiotic as that both J. Hewitt and TissUse would have to be idiotic companies.

 

[nameless2]

I'm sure J. Hewitt are aware they need clearance and have started the process. I never said they hadn't. Whether they have confirmed permission to begin in December though remains to be seen because at this stage all they have revealed is that they have a treatment, they're hoping to start by December and that they haven't recruited patients yet.

No, they did not say they "hope" to start the trial by December. They said they "plan" to start the trial by December 2019.

The words "hope" and "plan" do not mean the same thing. Hope can be based on nothing or next to nothing whereas "plan" indicates one has factored things in.

 

[Throwaway94]

I already acknowledged I was mistaken when I said it was TussUse who ran a trial through the fast-track Asian process. I already have to repeat lots of stuff to you so stop harping on the one thing you were right about. I conceded that one issue.

Now back to the issue at hand, Hewitt may be the ones responsible for getting the treatment through trial but that doesn't stop TissUse from talking to Hewitt. Partners can and do sometimes talk.

That aside, TissUse wouldn't have gotten involved with J. Hewitt if J. Hewitt is so stupid they don't get it that they need to get approval from appropriate regulatory agencies before they take an experimental treatment from animals to humans for the first time... a treatment that involves injecting cellular biological stuff into people's heads. In order for TissUse to get involved with a company as idiotic as that both J. Hewitt and TissUse would have to be idiotic companies.

What is it with you and the straw man arguments? I've said over and over that I'm sure J. Hewitt have started the regulatory processes. A company does not have to be idiotic to underestimate the time it takes external parties to process the information they provide.

I'm all for this treatment too but I don't think it does any good to misrepresent how ready a company actually is to market it.

 

[nameless2]

Any project work involving external regulatory agencies can be dragged out through no fault of the company at hand, but if I were the Japanese regulatory board I'd take my sweet time evaluating a clinical trial plan consisting of injecting "unproven cellular biological stuff" into human patients for a non life threatening condition.

Do you have any proof that the project is being dragged out by external regulatory authorities?

Are you aware that your belief that the Japanese regulatory agency should take their sweet time evaluating a clinical trial plan consisting of injecting "unproven cellular biological stuff" into human patients for a non life threatening condition, is irrelevant to the Japanese regulatory agency involved? But when the Japanese regulatory agency is considering its' decision they will consider meaningful facts such as the suicides, depression, counseling, and substance abuse over hair loss.

 

[nameless2]

What is it with you and the straw man arguments? I've said over and over that I'm sure J. Hewitt have started the regulatory processes. A company does not have to be idiotic to underestimate the time it takes external parties to process the information they provide.

I'm all for this treatment too but I don't think it does any good to misrepresent how ready a company actually is to market it.

So now you are conceding that J. Hewitt has started the regulatory process. Great! That means that you understand that J. Hewitt is more aware of the regulatory agencies thinking and where the regulatory agency is at in the regulatory process than you or I. And since J. Hewitt is more aware on the matter than you or I, I'll go with their opinion. They say they "plan" to begin trials "By December" so that's what I'll believe, at least for now. If facts change I'll adjust my beliefs accordingly but it is late in the game for changes. Since J. Hewitt's plan is to start the human trial in 3 months or less that signals that a lot of the behind the scenes back-and-forth with the Japanese regulatory agency is probably already done and things are likely wrapping up.

 

[thomps1523]

So now you are conceding that J. Hewitt has started the regulatory process. Great! That means that you understand that J. Hewitt is more aware of the regulatory agencies thinking and where the regulatory agency is at in the regulatory process than you or I. Since we agree that J. Hewitt has more knowledge on the matter than you or I I'll go with their opinion. They say they "plan" to begin trials "By December" so that's what I'll believe, at least for now. If facts change I'll adjust my beliefs accordingly but it is late in the game for changes. Since J. Hewitt's plan is to start the human trial in 3 months or less that signals that a lot of the behind the scenes back-and-forth with the Japanese regulatory agency is probably done and things are likely wrapping up.

Welcome back Nameless! It has been too long my friend, but let’s be honest. We all knew it was just a matter of time!

Wasn’t sure if it was you at first, but luckily you confirmed my suspicion with the edits below each comment.

I kept wondering what subject was going to bring you back to us!

 

[Kev123]

If it doesn't lose potency, according to you, why would you then take finasteride?

You want to save and regrow as many native hairs as possible. Transplanted hairs have a fake look to it. Imagine having 100k transplanted hairs on your head and temples. Transplanted temples look the worse. Even with unlimited supply of donor hair for hair transplant’s, i’d still want to preserve as much native hairs as possible. Having that fake *** looking hairline/temples look is worse than being shaved bald headed.

 

[nameless2]

Welcome back Nameless! It has been too long my friend, but let’s be honest. We all knew it was just a matter of time!

Wasn’t sure if it was you at first, but luckily you confirmed my suspicion with the edits below each comment.

I kept wondering what subject was going to bring you back to us!

What do you think about the J. Hewitt/TissUse news?

 

[nameless2]

You want to save and regrow as many native hairs as possible. Transplanted hairs have a fake look to it. Imagine having 100k transplanted hairs on your head and temples. Transplanted temples look the worse. Even with unlimited supply of donor hair for hair transplant’s, i’d still want to preserve as much native hairs as possible. Having that fake *** looking hairline/temples look is worse than being shaved bald headed.

If the treatments uses injected cells to grow hair instead of implanted hairs might that not solve the problem? Couldn't the cells possibly go inside your follicles and use your follicles to grow hairs just like they used to - same angle, direction, everything? After all, isn't hair loss nothing more than insufficient cells for the follicles to use to grow hair? And if that's the case doesn't that mean that if you have a way to get more cells into the follicles then the follicles would use those cells to grow more hair? Possibly? Maybe?

 

[Throwaway94]

So now you are conceding that J. Hewitt has started the regulatory process. Great! That means that you understand that J. Hewitt is more aware of the regulatory agencies thinking and where the regulatory agency is at in the regulatory process than you or I are. So they have more info where things are at than either you or I and they say they "plan" to begin trials "By December". I'll go with their opinion since they have more knowledge on the matter than you or I.

That was never actually in question despite your assertions otherwise, now stop putting words in my mouth because this is getting ridiculous and rather personal. I did not mean to suggest the Japanese regs should take my opinion into account, but regardless of reduced quality of life it is still considered a cosmetic condition and does not compare to heart conditions or paralysis or degenerative diseases.

You can choose to trust that the CEO will deliver on his "plan" of everything going flawlessly and within 8 months of acquiring the license to a new technology, designing and implementing a clinical trial after clearance from the Japanese regulatory agency but it's just not likely given everything we've witnessed from this industry. As nice as it is to hear "my goal is to do things quickly and then see the results and know if it works" from the director of a mid-tier medical device distributor, it also signals irresponsibility and a lack of due diligence.

Announcing a best case scenario like this means that his plans have no room to move but down, and many of his claims so far do not align with what we already know about the approval pathway. He will know more about the approval process than we do and maybe they will be ready to go by then. It's possible. Then what? In December when, all going perfectly according to plan, the first patients will have been injected in his 5 person clinical trial, he claims to be able to say whether or not it's a viable treatment within days / weeks. Unfortunately that alone doesn't make it a viable treatment for any of us, we won't know that until 6-12 months of efficacy and safety follow up by the regulatory agency and subsequent conditional approval or rejection. He's rather out of touch with what constitutes a viable treatment and clearly not very careful with his words so if we take everything he says to heart we're being set up for disappointment everywhere - timings, effectiveness, you name it.

 

[Kagaho]

The idiot of nameless is back...
My god, what a day to be alive

 

[Unspecified]

Guys this is nothing like RCH-01, we all misunderstood neo-papilla as cloned DP cell. These are actually neo-papilla condensates-follicle organoids ( DP+Dermal papilla fibroblasts+Mesenchymal, ectodermal and neuro-ectodermal originated cells+ extracellular matrix coating (protein activation needed for further organoid development-something like follicle placenta)=neo papilla). After 7 days "keratinocyte and melanocyte attachment to the spheroids (these organoids) was forced allowing further follicular development" (these are cells crucial for development of epidermis, which is necessary for follicular development).
"Microfollicles in skin equivalents self-organize in specific distance"(also very important).
This sentence I don't fully understand-"Microfollicles were further integrated into full skin equivalents by dermal surface application or by integration through micromanipulation." Dermal surface application could be some variation of hair transplant, but what is integration through micromanipulation,what's the difference?
So guys if the CEO is not bullshiting us, we'll basically have hair cloning trials starting this December? @HKP
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3284944/

 

[thomps1523]

What do you think about the J. Hewitt/TissUse news?

I think it’s promising, but I’m an optimist with no shame in admitting it. I think it’s super exciting to think something along the lines of hair cloning will start a trial in 4 months.

Good to have you back though man!

 

[OneDay_NW0]

This thing is btw a very good example for the fact that those companies still working and making progress even without making big press releases every day and that there is no need to spam those companies with mails for every sh*t and blaming them for nothing.

 

[RolfLeeBuckler]

Update of Folliclethought! He is asking the CEO again and is anticipating answers at the end of next week!
https://www.folliclethought.com/j-hewitt-to-trial-hair-multiplication-in-2019/#comment-25801
Scroll down

These are his questions:
-Is the SHT expecting grow new hairs in bald areas or thicken existing hairs?
-If new hair is grown, would there be need for a growth guide with SHT?
- Would a 5 person trial be sufficient to get this treatment approved in Japan or are ongoing trial necessary?
- Do you have an estimated cost for this treatment at this time?


If you have other important questions you should write him in the comment section

 

[nameless2]

That was never actually in question despite your assertions otherwise, now stop putting words in my mouth because this is getting ridiculous and rather personal. I did not mean to suggest the Japanese regs should take my opinion into account, but regardless of reduced quality of life it is still considered a cosmetic condition and does not compare to heart conditions or paralysis or degenerative diseases.

You can choose to trust that the CEO will deliver on his "plan" of everything going flawlessly and within 8 months of acquiring the license to a new technology, designing and implementing a clinical trial after clearance from the Japanese regulatory agency but it's just not likely given everything we've witnessed from this industry. As nice as it is to hear "my goal is to do things quickly and then see the results and know if it works" from the director of a mid-tier medical device distributor, it also signals irresponsibility and a lack of due diligence.

Announcing a best case scenario like this means that his plans have no room to move but down, and many of his claims so far do not align with what we already know about the approval pathway. He will know more about the approval process than we do and maybe they will be ready to go by then. It's possible. Then what? In December when, all going perfectly according to plan, the first patients will have been injected in his 5 person clinical trial, he claims to be able to say whether or not it's a viable treatment within days / weeks. Unfortunately that alone doesn't make it a viable treatment for any of us, we won't know that until 6-12 months of efficacy and safety follow up by the regulatory agency and subsequent conditional approval or rejection. He's rather out of touch with what constitutes a viable treatment and clearly not very careful with his words so if we take everything he says to heart we're being set up for disappointment everywhere - timings, effectiveness, you name it.

a) You did not say that you think the Japanese regulators should slow-walk a cell-based treatments for conditions that aren't life threatening. But that's too non-specific. The Japanese regs will look inside that face and get the real underlying facts. Again, the underlying facts are there's a sizable amount of depression, substance abuse, counseling, suicide behind hair loss. (Side bar: since you indicate that hair loss is not a life-threatening condition I should point out that suicide is life-threatening and so is depression.) There is more at stake than reduced quality of life.

b) I will go along with what the CEO is saying unless/until I have reason to believe otherwise. Right now, it appears that the CEO and the Japanese regulatory agencies are likely wrapping things up, the CEO is aware of what's going on behind the scenes, you are unaware of what is going on behind the scenes, so I'm going with the CEO's opinion at this time, over yours.

c) I don't know exactly what constitutes the beginning of a trial so I can't say that the beginning of the trial in December would mean that all 5 patients would be injected by December according to the plan. Since you are not a professional involved in the medical treatment approval process I'm not going to go along with your idea that the beginning date of a clinical trial means all patients involved must be given treatment by that date.

d) Announcing a best case scenario does not mean that his plan has nowhere to go but down. It could also go sidewise.

e) The Japanese take men's concerns about their looks much more seriously than the USA does. A lot of people think the Japanese don't lose hair but they do. But unlike America, in Japan it is totally socially acceptable to wear a hairpiece although Japanese men still do want their own real hair back. In America if a man gets a scar on his face or loses his hair people will tell him to man-up but in Japan if a man gets a scar on his face or loses his hair it's considered a bigger issue.

f) You yourself acknowledged that the Japanese regulators should not care about your opinions regarding the inner-workings of the regulatory process so why would you think I care about your opinions regarding the inner-workings of the regulatory process? I don't. Unless/until new facts emerge I'm going with the CEO's statements.

 

[MeDK]

Update of Folliclethought! He is asking the CEO again and is anticipating answers at the end of next week!
https://www.folliclethought.com/j-hewitt-to-trial-hair-multiplication-in-2019/#comment-25801
Scroll down

These are his questions:
-Is the SHT expecting grow new hairs in bald areas or thicken existing hairs?
-If new hair is grown, would there be need for a growth guide with SHT?
- Would a 5 person trial be sufficient to get this treatment approved in Japan or are ongoing trial necessary?
- Do you have an estimated cost for this treatment at this time?


If you have other important questions you should write him in the comment section

I think its pretty bad questions to be honest.

of course its necessary for ongoing trails, a conditional approval based on ongoing trails !

Would be better to ask for first in human/proof of concept papers & pictures.

when they haven't done phase 1, how can he even answers the two first questions really?

And the estimated cost, how will you answer something about that if you don't know how extensive the treatment needs to be to reach their goals for the treatment.

 

[OneDay_NW0]

Cause they may already know, that the treatment is only thickening exisiting hair for example (which would be amazingly sad). Those questions can be answered over the theoritical approach. In phase 1 they seeing if the theoretical approach works (but there won't be accidently new hairs, if in theory it would be only for thickening).
In my opinion those questions are nice.

 

[nameless2]

Cause they may already know, that the treatment is only thickening exisiting hair for example (which would be amazingly sad). Those questions can be answered over the theoritical approach. In phase 1 they seeing if the theoretical approach works (but there won't be accidently new hairs, if in theory it would be only for thickening).
In my opinion those questions are nice.

If you're not shiny bald then you might not need new hairs.

In androgenetic alopecia hairs shrink until they get down to the size of peach fuzz, and then some time after the peach fuzz stage ends they disappear and then your head becomes shiny bald. If you still have peach fuzz then a treatment that only thickens existing hair may thicken (and lengthen) your peach fuzz back to its' original long thick size.

 

[Joxy]

They should ask one and only simple question. Are they gonna create new full human hair follicle in vitro? That is the only question that I am interested. If this treatment is base again on injections I will not give a sh*t honestly.