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

[Cymro27]

Probably won't see results until the end of 2020 to mid 2021.
Start trials in 2019, 45 days for the return and injection (so mid January 2020 at earliest), then monitoring for 6-12 months I'd assume. Then putting the results to scrutiny and reporting them.

It's different to 2008 - this time there's far more reputable players in the game and the science has come on so much.

 

[kiwi666]

When did I say they are similar technology? Obviously I never said they are similar scientifically. I’m just predicting they will have similar efficacy if they are just injecting cells into your scalp.

Why would they have similar efficacy? Because they are injected?!?

They couldn’t be more different. So don’t you think it’s weird to predict two totally different things will perform similarly?

 

[Throwaway94]

Can you give us the source of this quote?

Japan to offer fast-track approval path for stem cell therapies - David Cyranoski, 2013

 

[MeDK]

Can you give us the source of this quote?

There is something similar in another case.

"The primary data set for conditional approval of HeartSheet® was from a Japanese clinical trial in which seven patients with severe heart failure due to ischemia were transplanted with the product. In addition, supportive data was provided for four patients with end-stage dilated cardiomyopathy, seven patients with dilated cardiomyopathy and eight patients with ischemic cardiomyopathy. Thus, this conditional approval for heart failure due to ischemia was granted on a very modest size trial (seven patients) plus a modicum of supportive data in related indications (19 patients)." - Japan's Conditional Approval Pathway for Regenerative Medicines

 

[OneDay_NW0]

You're sitting lonely in your room and jugding other people by their look while cyring about your own look. Never saw such a look addicted Person who doesn't even try to improve his own look...
I bet the Prince doesn't even care.

 

[MeDK]

Okay interesting. Anyway, J. Hewitt can still extend the trial with more patients if required for approval in Japan.

It will be impressive if they can overtake everybody else with fast clinical trails. If they have some results in 1st half next year, then the competition is real and pushes the limits faster than we might have thought was possible.

But let us hope it doesn't introduce too fast clinical trails which ends up with unreliable results and consequences.

 

[OneDay_NW0]

You posted a pic of him without any context in a Thread with a complete different topic and called him f*****g ugly. This guy is rich and also a person of interest. He is literally the perfect customer for a hair system if he would care.
I mean I don't care about him, but pls stop posting things like that in the new research section, thanks.

 

[LosingHairLosingPatience]

Pretty safe to say this just launched to the top of the list. No BS from the CEO. My kinda guy.

 

[nameless2]

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]

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]

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.

 

[nameless2]

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.

 

[Throwaway94]

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]

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.

 

[Throwaway94]

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]

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]

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]

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?

 

[Throwaway94]

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]

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.