It Looks Like Hairclone Found A Way Around Clinical Trials.

MomoGee

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"HairClone aims to begin follicle banking for patients in the UK in 1st half 2017 and transplanting cellular treatments in 2nd half 2017, though this is dependent upon HairClone getting sufficient investments to carry out their development plan."

That can't be right. I don't want to be pessimistic but what are the chances a surgical treatment will just suddenly be available without any trials, in the UK no less.
 
Follisket

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Wouldn't this approach make the treatment exclusive to UK residents? It sounds like the kind of call only a GP, familiar with your medical history etc., could make?
 
G

GotHair?

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Good news! We all know now the end to the hair loss is coming. ITs the waiting until 2021+ that is the problem so if they can do this in next 2 years that would be awesome...
 
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mr_robot

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I'm pretty sure Hairclone is set up by a couple of transplant surgeons and not scientists. They're just riding the wave of other peoples work and hoping to come to agreements with them.
 
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nameless

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Follisket said:
Wouldn't this approach make the treatment exclusive to UK residents? It sounds like the kind of call only a GP, familiar with your medical history etc., could make?
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There are so many people going to foreign countries for medical treatments that there is actually a name for it - it's called medical tourism.
 
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nameless

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mr_robot said:
I'm pretty sure Hairclone is set up by a couple of transplant surgeons and not scientists. They're just riding the wave of other peoples work and hoping to come to agreements with them.
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Isn't Claire Higgins a TOP hair research scientist in the UK? I think she's considered to be a peer of Dr. Jahoda.
 
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nameless

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jo-achim said:
this company looks totally amateurish. in the interview practically they say they still don't know how the cells will be cultured, but through their iterative process they will find out.

it's as if they never heard about the DP culturing problem with retaining the gene expression etc.

looks like a ridiculous attempt from claire higgins and other medical quacks to get a lot of funds to secure another 5 years paycheck for useless lab-tinkering while trying to look like a serious new innovative startup which will cure hairloss forever.

if there wasn't the DP culturing problem which is very well known in the hairloss world, i would be all over it. but looking at the facts the company is doomed to fail.
dr tsuji is the only real deal.

but i have absolutely no doubt that they will achieve getting the funds they need and get rich from it. clever marketing and quackery is all you need these days.
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I think they are fully aware of the loss of hair inductivity in mass pass culture since Claire Higgins is involved and she co-authored a paper on the issue of the loss of hair inductivity during mass pass culture. She co-authored the study with Drs. Jahoda and Christiano. Here's the study:

http://www.pnas.org/content/110/49/19679.full.pdf

And here's some info about Claire Higgins. She is apparently a peer of Dr. Jahoda,

http://www.hairlosscure2020.com/dr-claire-higgins/
 
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nameless

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jo-achim said:
this company looks totally amateurish. in the interview practically they say they still don't know how the cells will be cultured, but through their iterative process they will find out.

it's as if they never heard about the DP culturing problem with retaining the gene expression etc.

looks like a ridiculous attempt from claire higgins and other medical quacks to get a lot of funds to secure another 5 years paycheck for useless lab-tinkering while trying to look like a serious new innovative startup which will cure hairloss forever.
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1. Why do you call Claire Higgins and her associates quacks?

2. Of course Claire Williams has heard of the DP culturing problem - she co-authored a highly respected paper on it with Drs. Jahoda and Christiano.

3. Isn't it possible that they haven't decided how to culture the cells yet because they're analyzing recent and emerging study information to determine the best possible way to culture the cells?
 
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mr_robot

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nameless said:
Isn't Claire Higgins a TOP hair research scientist in the UK? I think she's considered to be a peer of Dr. Jahoda.
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I don't have the link at hand, but she is not a shareholder of this company the two heads who are hair transplant surgeons are. Sure she provides legitimacy to the operation and maybe that is the point why she is on-board.

Secondly, the "specials" legislation that they intend to use applies to doctors importing medicines that are unlicensed because there is no other licensed alternative. I can't see how they could develop their own treatment in the UK and then use this legislation to treat people with it as it would not apply.

As I said previously the only way that this could work is if they use external companies, for example tsuji or replicel. The only issue with this is that it no longer becomes a one-off "special" treatment and as hair loss is not classified as a life threatening condition the regulator may take a dim view of what they are doing and shut it down.

On a positive note, it may be possible for replicel to be offered in the UK under the legislation by sending the biopsy and then receiving the cultured cells.
 
lemoncloak

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Let's move everybody to the Bahamas and have a hair-transplant-fest while sipping on daiquiris
 
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nameless

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mr_robot said:
I don't have the link at hand, but she is not a shareholder of this company the two heads who are hair transplant surgeons are. Sure she provides legitimacy to the operation and maybe that is the point why she is on-board.

Secondly, the "specials" legislation that they intend to use applies to doctors importing medicines that are unlicensed because there is no other licensed alternative. I can't see how they could develop their own treatment in the UK and then use this legislation to treat people with it as it would not apply.

As I said previously the only way that this could work is if they use external companies, for example tsuji or replicel. The only issue with this is that it no longer becomes a one-off "special" treatment and as hair loss is not classified as a life threatening condition the regulator may take a dim view of what they are doing and shut it down.

On a positive note, it may be possible for replicel to be offered in the UK under the legislation by sending the biopsy and then receiving the cultured cells.
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Firstly, I'm not going to assume at this point in time that the fact that a top hair loss researcher, Claire Higgins, is on board means something negative and sinister. I admit that the company could be a for-show-money-grab but it's too early to jump to that conclusion at this point in time. We should keep our eyes for the possibility it might be a scam but it's too early to assume that.

Secondly, Their lawyers know the requirements in regards to the use of UK tech, foreign tech, or both. Like you yourself said, YOU "don't know" how they could use UK tech, but I'm not confident you know all there is to know about that issue. This is tricky stuff even for lawyers who work this stuff. And it sounds implausible to me that the UK would require the tech to come from outside the UK. We in the USA have "The Compassionate Use Program", which allows for use of unapproved medical treatments from within and outside of the USA. I can't imagine why the UK would specifically exclude unapproved treatments from within their own UK. Also, even if you're right there might be ways around that requirement. That's the point to having lawyers.

Thirdly, you don't know that the condition has to be life-threatening in order for use of the Special Program to be approved. If the populace is happy with the treatment I don't think the regulators would shut it down.

My most negative concerns are that they might not raise sufficient capital to stay afloat, they might not be able to get the OK from the owners of the tech, and they might have to charge an exorbitant amount of money for treatments just to pay expenses.
 
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jc3303

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This is very interesting

I definitely don't think this is a scam, but I don't know how likely it will be that they'll be able to offer treatment before trials. There is unmet need for sure but I find it difficult to believe the government will consider what is technically a cosmetic procedure to be offered before trials. But who knows this is uncharted territory and I'll hope for the best.

Hairclone is saying they'll have some news soon so I'll wait patiently for it
 
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mr_robot

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nameless said:
Firstly, I'm not going to assume at this point in time that the fact that a top hair loss researcher, Claire Higgins, is on board means something negative and sinister. I admit that the company could be a for-show-money-grab but it's too early to jump to that conclusion at this point in time. We should keep our eyes for the possibility it might be a scam but it's too early to assume that.

Secondly, Their lawyers know the requirements in regards to the use of UK tech, foreign tech, or both. Like you yourself said, YOU "don't know" how they could use UK tech, but I'm not confident you know all there is to know about that issue. This is tricky stuff even for lawyers who work this stuff. And it sounds implausible to me that the UK would require the tech to come from outside the UK. We in the USA have "The Compassionate Use Program", which allows for use of unapproved medical treatments from within and outside of the USA. I can't imagine why the UK would specifically exclude unapproved treatments from within their own UK. Also, even if you're right there might be ways around that requirement. That's the point to having lawyers.

Thirdly, you don't know that the condition has to be life-threatening in order for use of the Special Program to be approved. If the populace is happy with the treatment I don't think the regulators would shut it down.

My most negative concerns are that they might not raise sufficient capital to stay afloat, they might not be able to get the OK from the owners of the tech, and they might have to charge an exorbitant amount of money for treatments just to pay expenses.
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I never said that Clair Higgins being on-board was a negative, the point was she does not have a stake hold in the company and I seem to recall her full time work is a university lecturer.

Their lawyers may say it's okay, but until it is tested in a court of law it is just an opinion and no investor is going to invest without solid legal ground. As I said previously there is a world of difference between offering someone a one off new drug not currently licensed in the UK that could cure their special form of cancer and offering thousands of people a cell based therapy for "cosmetic" purposes. If this was possible, no company would bother getting their drugs licensed and would just offer new drugs under these programs.

You cant just say "well if the populace is happy, why would they?", you have to ask, why would they allow something untested and potentially dangerous to be used on thousands of otherwise healthy people? The new legislation in Japan allows going from phase II to market via a waiver from the patient that basically says they agree they cant sue if it all goes wrong, that's what would be needed here. In fact if you read guidelines (https://www.gov.uk/government/uploa..._unlicensed_medicinal_products__specials_.pdf) section 1.6 prohibits the use of treatments that are currently going through medical trials.

The whole thing to me looks suspect, but again that is just my opinion.
 
T

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Back in December, 2 months ago, this company's answer to a lot of important questions like "How do you plan to culture the cells? Will you do it in 3D?" was literally "We're not sure". These guys don't even have it all figured out as to exactly how they're going to go about doing this procedure, but want special clearance to begin offering it as soon as this year?

...okay
 
Captain Rex

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Just keep an eye on this
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