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

nameless2

Established Member
My Regimen
Reaction score
87
Not as such but:

"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."

Unfortunately (yes this is a bit more speculation so please feel free to disagree) I don't see a pilot trial on 5 people producing such groundbreaking results that they convince the governing body. This would mean they will have to move on to a much larger trial, akin to a phase 2, before being granted marketing permission.

I really don't think so. Companies don't set up and start human trials without input from appropriate regulatory authorities. I'm confident that the company had to work with the appropriate Asian regulatory authorities to determine the size and scope of the trial. If the company is doing a 5-person trial then I believe that must be what the regulatory agency has told the company it will require.
 

Throwaway94

Experienced Member
My Regimen
Reaction score
474
Okay interesting. Anyway, J. Hewitt can still extend the trial with more patients if required for approval in Japan.
Easier said than done.
I really don't think so. Companies don't set up and start human trials without input from appropriate regulatory authorities. I'm confident that the company had to work with the appropriate Asian regulatory authorities to determine the size and scope of the trial. If the company is doing a 5-person trial then I believe that must be what the regulatory agency has told the company it will require.

Could be, but since the trial hasn't been started yet in any sense it could just as easily be that the CEO just got ahead of himself. He's probably welcome to set up a trial with as few or as many people as he's willing to fund, but the regulatory agency is unlikely to say "oh yeah you can get away with 5 for your treatment it'll be all good". The fewer they start with, the more dramatic the results have to be, which reduces the chance of commercialising right away after the first trial even if it does work to some extent.
 

BaldAndBalder

Established Member
My Regimen
Reaction score
239
I hope tissuse delivers, of all the cell based treatment i believe they will be the only one able to give natural looking hair unlike transplant.
 
Last edited:

nameless2

Established Member
My Regimen
Reaction score
87
Easier said than done.


Could be, but since the trial hasn't been started yet in any sense it could just as easily be that the CEO just got ahead of himself. He's probably welcome to set up a trial with as few or as many people as he's willing to fund, but the regulatory agency is unlikely to say "oh yeah you can get away with 5 for your treatment it'll be all good". The fewer they start with, the more dramatic the results have to be, which reduces the chance of commercialising right away after the first trial even if it does work to some extent.

Again, I really don't think so. I think that the appropriate Asian regulatory authorities are already weighing in with J. Hewitt and TissUse.

And I don't think a CEO of a company becomes a CEO of a company by overlooking big details by just going out and starting a human study wherein his company is injecting cellular biological stuff into human heads without investigating how this is supposed to be done. I'm just a bald nobody and I wouldn't go injecting cellular biological stuff into people's heads without looking into what is and isn't required in order to do this. I wouldn't want to risk violating criminal laws and going to prison so I would definitely look into the details before I did something like this. Plus, I think it's highly unlikely that the Asian regulatory agency would allow a company to go from animal studies to a human study without getting involved in the new human study. The jump from animal studies to human studies is a big deal. This is going on in Japan and Japan is a civilized country. We aren't talking about the Amazon here.

I think that the idea of a CEO of a medical company waking up one morning and saying to himself, "I think I'll inject some cellular biological stuff into people's heads in a few months" with the intent of actually carrying out that plan, sounds like something out of a comedy skit.
 
Last edited:

Throwaway94

Experienced Member
My Regimen
Reaction score
474
Again, I really don't think so. I'm think that the appropriate Asian regulatory authorities have already weighed in because TissUse has already used the Asian fast-track system successfully for a heart treatment so TissUse knows how to use the fast-track system and TissUse is partnered with Hewitt for this treatment.

And I don't think a CEO of a company becomes a CEO of a company by overlooking big details by just going out and starting a human study wherein his company is injecting biological cellular stuff into human heads without investigating how this is supposed to be done. I'm just a bald nobody and I wouldn't go injecting biological cellular stuff into people's heads without looking into what is and isn't required in order to do this. I wouldn't want to risk violating criminal laws and going to prison so I would definitely look into the details before I did something like this. Plus I think it's highly unlikely that the Asian regulatory agency would allow a company to go from animal studies to a human study without getting involved in the new human study. The jump from animal studies to human studies is a big deal. This is going on in Japan and Japan is a civilized country. We aren't talking about the Amazon here.

I think that the idea of a CEO of a medical company waking up one morning and saying to himself, "I think I'll inject some biological cellular stuff into people's heads in a few months" sounds like something you would see in a comedy skit.

When did I say anything about criminal behaviour? Of course I don't think they'll be commencing treatment on anyone below-board. I'm saying that *if* they do manage to begin in December, legitimate protocol in place etc, the results will have to be spectacular to be allowed to progress to market, or else be forced to go on to phase 2 which may cause them to pack it in.

In his words we'll see if it's a viable treatment based on this first trial - essentially they'll market it based on this trial or they won't.

And I say *if* because this isn't the first time by any means a CEO in this field has announced a best-case-scenario clinical trial situation and then had to let it lapse.
 

nameless2

Established Member
My Regimen
Reaction score
87
When did I say anything about criminal behaviour? Of course I don't think they'll be commencing treatment on anyone below-board. I'm saying that *if* they do manage to begin in December, legitimate protocol in place etc, the results will have to be spectacular to be allowed to progress to market, or else be forced to go on to phase 2 which may cause them to pack it in.

In his words we'll see if it's a viable treatment based on this first trial - essentially they'll market it based on this trial or they won't.

And I say *if* because this isn't the first time by any means a CEO in this field has announced a best-case-scenario clinical trial situation and then had to let it lapse.

The point is that anyone, especially the CEO of a medical company, would understand that you can't just go injecting cellular biological stuff into people's heads without getting proper clearances. What you're suggesting the CEO would be thinking he would do WOULD BE criminal whether you specifically stated that or not. You can't just go injecting cellular biological stuff into people's heads just because you want to.

And you're absolutely right that the trial may not work. I understand that and I think everyone does. But we are allowed to contemplate what the guts of the study will involve among ourselves, and decide whether there's hope or not. Right now it's all speculation and the treatment could totally flop. That having been said, I'm optimistic that *if* the research team can truly preserve inductivity in culture the treatment will probably work.
 
Last edited:

Throwaway94

Experienced Member
My Regimen
Reaction score
474
The point is that anyone, especially the CEO of a medical company, would understand that you can't just go injecting cellular biological stuff into people's heads without getting proper clearances. What you're suggesting the CEO would be thinking he would do WOULD BE criminal whether you specifically stated that or not. You can't just go injecting cellular biological stuff into people's heads just because you want to. And again keep in mind that the company the CEO runs is partnering with TissUse for this project and TissUse just got done using the exact same Asian fast-track system (to get approval for a heart treatment) that the Hewitt CEO referenced. These people know the drill.

And you're absolutely right that the trial may not work. I understand that and I think everyone does. But we are allowed to contemplate what the guts of the study will involve among ourselves, and decide whether there's hope or not. If your point is that the trial might not work I understand that, I agree with you, and everyone else here should also be aware that this experiment might not work. Right now it's all speculation and the treatment could totally flop. That having been said, I'm optimistic that *if* the research team can truly preserve inductivity in culture the treatment will probably work.

No, I never at any point suggested he would perform any treatment without the appropriate clearance, that's ridiculous. I am suggesting he may either not get the clearance as soon as he had hoped as the December timeline does not seem set in stone, or if he already has the clearance and can proceed as planned, that the results may not be enough to proceed due to a record-breakingly low sample size for a non life threatening condition.

I like your optimism but the fact that he's a CEO doesn't make him infallible, their role is to keep shareholders happy and they can make incorrect or premature judgements and predictions from time to time just like anyone else.

I do 100% agree with you on the promising nature of a stem cell treatment with inductivity retained in culture, and I hope for all of our sakes that they've figured out a treatment with them that works well.
 

nameless2

Established Member
My Regimen
Reaction score
87
No, I never at any point suggested he would perform any treatment without the appropriate clearance, that's ridiculous. I am suggesting he may either not get the clearance as soon as he had hoped as the December timeline does not seem set in stone, or if he already has the clearance and can proceed as planned, that the results may not be enough to proceed due to a record-breakingly low sample size for a non life threatening condition.

I like your optimism but the fact that he's a CEO doesn't make him infallible, their role is to keep shareholders happy and they can make incorrect or premature judgements and predictions from time to time just like anyone else.

I do 100% agree with you on the promising nature of a stem cell treatment with inductivity retained in culture, and I hope for all of our sakes that they've figured out a treatment with them that works well.

There's only 3 months between now and "By December" so are you saying he hasn't even talked to the appropriate regulatory authorities yet? How many times have I told you that TissUse is a partner in this project and they know the Asian fast-track drill because they've used that exact process recently. Are you saying that TissUse would wait until perhaps November 15 to start this regulatory process even though they've already gone through this process and they know what this process entails?
 

Throwaway94

Experienced Member
My Regimen
Reaction score
474
Again, I really don't think so. I think that the appropriate Asian regulatory authorities have already weighed in because TissUse has already used the Asian fast-track system successfully for a heart treatment so TissUse knows how to use the fast-track system and TissUse is partnered with Hewitt for this project.

And I don't think a CEO of a company becomes a CEO of a company by overlooking big details by just going out and starting a human study wherein his company is injecting cellular biological stuff into human heads without investigating how this is supposed to be done. I'm just a bald nobody and I wouldn't go injecting cellular biological stuff into people's heads without looking into what is and isn't required in order to do this. I wouldn't want to risk violating criminal laws and going to prison so I would definitely look into the details before I did something like this. Plus, I think it's highly unlikely that the Asian regulatory agency would allow a company to go from animal studies to a human study without getting involved in the new human study. The jump from animal studies to human studies is a big deal. This is going on in Japan and Japan is a civilized country. We aren't talking about the Amazon here.

I think that the idea of a CEO of a medical company waking up one morning and saying to himself, "I think I'll inject some cellular biological stuff into people's heads in a few months" with the intent of actually carrying out that plan, sounds like something out of a comedy skit.

And what's this heart treatment you claim TissUse has driven through the Japanese conditional approvement pathway?

The HeartSheet example from earlier was from Terumo and was a case study on the first treatment ever to receive conditional approval.

TissUse has yet to release anything to market through this system and their specialty is chip-based models of human organs for drug testing purposes.
 

nameless2

Established Member
My Regimen
Reaction score
87
And what's this heart treatment you claim TissUse has driven through the Japanese conditional approvement pathway?

The HeartSheet example from earlier was from Terumo and was a case study on the first treatment ever to receive conditional approval.

TissUse has yet to release anything to market through this system and their specialty is chip-based models of human organs for drug testing purposes.

Oh I thought that HeartSheet treatment was from TissUse. My mistake.

I'm sure these 2 companies are aware that they can't jump from animal studies to a first human study without first getting clearances from appropriate regulatory agencies. It's common sense that they've been quietly working behind the scenes to get things in order for their "By December" human trial.

It's also common sense that these 2 companies would know that it would take more than 3 months to get the necessary clearances so of course they have already been communicating with and working with the appropriate regulatory authorities. How can you think they haven't already checked-in with the appropriate regulatory agencies when there's only 3 months to go until the experiment begins?

Are you thinking that these 2 medical companies don't know they have to get clearances to experimentally inject cellular biological stuff into people's heads for the first time, and since they don't know this they haven't factored getting those necessary clearances into their timeline?
 
Last edited:

Throwaway94

Experienced Member
My Regimen
Reaction score
474
There's only 3 months between now and "By December" so are you saying he hasn't even talked to the appropriate regulatory authorities yet? How many times have I told you that TissUse is a partner in this project and they know the Asian fast-track drill because they've used that exact process recently. Are you saying that TissUse would wait until perhaps November 30 to start this regulatory process even though they've already gone through that process so they know what it entails?

Where are you getting your information from?

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.
 

Throwaway94

Experienced Member
My Regimen
Reaction score
474
Oh I thought that HeartSheet treatment was from TissUse. Anyway, these companies aren't idiots and I'm sure they're aware that they can't jump from animal studies to a first human study without first getting clearances It's common sense that they've been quietly working behind the scenes and they're getting things in order as they prepare for their "By December" human trial. Why you think otherwise is beyond me. There is nothing in the information they released that says they're just now deciding to jump from animal studies to a first human study without first checking-in with any potential regulatory agencies. I don't know why you think they haven't already checked-in with the appropriate regulatory agencies.

Are you saying that these two medical research companies don't know that regulatory clearance is required before you can start injecting unproven cellular biological stuff into people's heads for the first time in an experiment?

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.

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.
 

nameless2

Established Member
My Regimen
Reaction score
87
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

Established Member
My Regimen
Reaction score
87
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

Experienced Member
My Regimen
Reaction score
474
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

Established Member
My Regimen
Reaction score
87
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.
 
Last edited:

nameless2

Established Member
My Regimen
Reaction score
87
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.
 
Last edited:

thomps1523

Established Member
Reaction score
278
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

Experienced Member
My Regimen
Reaction score
350
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

Established Member
My Regimen
Reaction score
87
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?
 
Top