Will HM become a relaity before 2012?
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sphlanx2006
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No, but if the poll was about 2013 or 2014 i would vote yes.
Phase 2 trials of ICX-TRC begun late 2006 and will be completely over late 2008.
Now, i believe there are 2 trials left. A phase2b, and a phase3 (i dont trust the small scale commercial release before phase3, since there have been no tests for a procedure covering the whole head). A phase2b is essential in my opinion since the only tested a small number of patients in phase2a and there are many many issues to be dealt with before trying to inject 30,000-40,000 hairs in one's head.
So, 2 trials x 2 years median time each thats 4 years. 2008 + 4 years = 2012. We also have to count delays between trials and the launching of the procedure which will not be overnight after FDA has aproved ICX-TRC. So... 2013-2014 for an optimistic but (as fas as possible) objective scenario.
Phase 2 trials of ICX-TRC begun late 2006 and will be completely over late 2008.
Now, i believe there are 2 trials left. A phase2b, and a phase3 (i dont trust the small scale commercial release before phase3, since there have been no tests for a procedure covering the whole head). A phase2b is essential in my opinion since the only tested a small number of patients in phase2a and there are many many issues to be dealt with before trying to inject 30,000-40,000 hairs in one's head.
So, 2 trials x 2 years median time each thats 4 years. 2008 + 4 years = 2012. We also have to count delays between trials and the launching of the procedure which will not be overnight after FDA has aproved ICX-TRC. So... 2013-2014 for an optimistic but (as fas as possible) objective scenario.
I basically agree with sphlnax2006. 2012 or 2014 is a pretty safe bet. At least given no more major setbacks between now and then.
We might know a lot more about what it can really do by 2009-2010 though. Could be enough to make aggressive hair transplants into more of a calculated risk.
We might know a lot more about what it can really do by 2009-2010 though. Could be enough to make aggressive hair transplants into more of a calculated risk.
bord3rland
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I spoke to a well respected hair transplant doctor who told me it would not be ready in my lifetime. Considering that I am 38 that means not for another 30 yrs at least. I hope he is wrong. He also told me that the proponents of this technology were saying the same thing 12 yrs ago that they are now. He thinks it's to boost stock price for Bosley Medical.
It wasn't that long ago that plenty of "well respected" hair transplant surgeons said HM wouldn't even see clinical trails for decades to come either. hair transplant surgeons have historically never been a viable source of info about HM efforts, even when we're talking about a doctor that is otherwise pretty honest.
And watch the difference between "cloning" hair versus reviving hair with cell therapy. Intercytex's stuff is cell therapy, and that dodges a lot of the problems that have long plagued efforts to literally clone hair follicles. If you ask about "hair cloning" then you'll probably hear a response about the state of cloned hair efforts. Apples & oranges.
For many years, the claims that "Hair multiplication is only ___ years away!" were being made despite nothing even being in trials yet. THAT never made any sense to me at all.
What helps sway my opinion now is that ICX has a project in phase#2 clinical trials. Nobody blows the kind of money it takes to get there unless they're pretty convinced that it'll produce something commercially viable (and soon). The 3 stages of clinical trials usually take a medium-predictable amount of time to complete, and so far ICX's effort has more or less remained inside the common pattern.
And watch the difference between "cloning" hair versus reviving hair with cell therapy. Intercytex's stuff is cell therapy, and that dodges a lot of the problems that have long plagued efforts to literally clone hair follicles. If you ask about "hair cloning" then you'll probably hear a response about the state of cloned hair efforts. Apples & oranges.
For many years, the claims that "Hair multiplication is only ___ years away!" were being made despite nothing even being in trials yet. THAT never made any sense to me at all.
What helps sway my opinion now is that ICX has a project in phase#2 clinical trials. Nobody blows the kind of money it takes to get there unless they're pretty convinced that it'll produce something commercially viable (and soon). The 3 stages of clinical trials usually take a medium-predictable amount of time to complete, and so far ICX's effort has more or less remained inside the common pattern.
sphlanx2006 said:
Sphlanx, do you think the FDA will take a long time to approve, and special interests might play a role in deterring a speedy approval? My guess is people would go out of the USA to try it immeadiatly. If it's around 2014, hopefully it will be the close of Ron Paul's 2 term presidency and for sure he would have limited the FDA's authority so theres that consideration too. I hope the subjects from the phase 1 trials, and 2a are kept under study throughout all these years to see about anything sprouting up after a while as far as side effects. I'm still a little worried about a cancer risk but hopefully that won't turn out.
DaSand
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I disagree with the majority answer. The reason why is no one including me knows what's really going on at Intercytex. I still aim for 2010 or 2011 for a release. The reason why is from what I've read, they've made progress. The next cohort they will find how to get more hair which will bring phase III around late 2008-early 2009.
The thing is why would a company keep doing trials until 2014? It shouldn't take 7 years to find the right dosage. They need to make profits to pay back investors and those people don't want to be kept waiting.
As with hair transplant doctors, don't ask anyone from the hair transplant business about HM. They want you to get a transplant from them.
But like Durandel, this post will be ignored.
The thing is why would a company keep doing trials until 2014? It shouldn't take 7 years to find the right dosage. They need to make profits to pay back investors and those people don't want to be kept waiting.
As with hair transplant doctors, don't ask anyone from the hair transplant business about HM. They want you to get a transplant from them.
But like Durandel, this post will be ignored.
sphlanx2006
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From my experience and from what i have heard, all products going through trial phases need about 10 years to achieve approval.
Another setback is that ICX-TRC is a procedure which is much different and (imho) much more complicated from trialing a medicine.
Example: If you believe "substance A" can help at "disease A" you test the substance and it may have positive results or it may not. It is preety simple. The only things that you may change is dosage and way of adminstration (pill, topical, injection).
ICX-TRC differs. It is not a final product like a substance is. If phaseII show medium results that does not mean that the procedure can only give medium results. You may change something into the procedure that can make it produce much better results. (the factors involved are almost unlimited: number of shots, injection machine, number of cells in each shot, prestimulation of the scalp and and and....)
In other words, ICX-TRC is STILL under development. It is not just tested for safety and efficacy, it is still being developed. The final product might differ significally from what the original concept was.
Taking that under concer AND the limited enthusiasm in Intercytex mid-year results, i believe there is still some way to go. I still believe though that it is something that WILL happen in the near future (not 30-40 or 50 years away)(well, unless something goes terribly wrong but lets be possitive.)
Another setback is that ICX-TRC is a procedure which is much different and (imho) much more complicated from trialing a medicine.
Example: If you believe "substance A" can help at "disease A" you test the substance and it may have positive results or it may not. It is preety simple. The only things that you may change is dosage and way of adminstration (pill, topical, injection).
ICX-TRC differs. It is not a final product like a substance is. If phaseII show medium results that does not mean that the procedure can only give medium results. You may change something into the procedure that can make it produce much better results. (the factors involved are almost unlimited: number of shots, injection machine, number of cells in each shot, prestimulation of the scalp and and and....)
In other words, ICX-TRC is STILL under development. It is not just tested for safety and efficacy, it is still being developed. The final product might differ significally from what the original concept was.
Taking that under concer AND the limited enthusiasm in Intercytex mid-year results, i believe there is still some way to go. I still believe though that it is something that WILL happen in the near future (not 30-40 or 50 years away)(well, unless something goes terribly wrong but lets be possitive.)
A_DHT_Driveby
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no, b/c of the inevitable amount of red tape associated with having anything mass-marketed, which is what they will want to do, especially re: something that could result in lawsuits if done improperly
30_going_on_60
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I voted no. Part of my ongoing battle to accept my hairloss is to give up on HM. This HM stuff has been talked about since 2000. With every passing year, it was supposed to be out "within 2-3 years" we'll probably be saying that 10 years from now. Now, lets assume that HM DOES come out within the next 4 years (which is a MASSIVE if.) The cost will be astronomical as the companies will milk the market for all its worth. I mean, there would be close to a billion people wanting this...... Demand would far exceed supply. The medical centers performing the operations would be able to charge whatever they wanted to for the first 10 years or so and never run out of customers. There must be hundreds of thousands of people on this planer that would pay over $100, 000 for a full head of hair.... why would these companies do it for $5, 000? Cause they'd be making people happy? 2012? Forget it!
A_DHT_Driveby
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I agree to a certain extent, but remember I believe the overriding greatest asset about the West is the free-market. Assuming the technology becomes available from multiple sources, Intercytex may have a patent on the initial form of the treatment, others will come along shortly thereafter, which will drive the price down. Name the technology, Computers / CD players / DVDs / Ipods / etc all started out astronomically high, but in a short amount of time, the prices plummeted once supply started outpacing demand.
30_going_on_60
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The free market system is based on one thing...individual profit. Hair multiplication cannot be mass produced by companies in factories, thus driving overhead costs down and profit margins up. Any major technology that came out over the past few years, like CD's, MP3's, plasma TVs, Playstation3 and all that were skimmed by the market. Even at a reduced cost, the profit margin is still rather high. This is simply not the case for something in such astronomical demand and such a limited supply. It simply wouldn;t make sense for anyone under any circumstances to charge an affordable rate. Then again, I'm not entirely sure about the procedure itself. If it's something that can be done with a small amount of staff in a short amount of time (unlike hair transplants) then I could be way off on the costs. Although I don;t think so.....even if getting a full head of hair was as simple as swallowing a pill that cost 5 cents to make, they could still charge a hundred thousand for the pill and people would buy it. The biggest concern that I have isn;t the science (although, even if that were the only case, I'd still be pesimistic) It's the cost factors involved.
** Needless to say, such an appetizing market potential ($$$$ !)would certainly motivate companies to get a product out there.
** Needless to say, such an appetizing market potential ($$$$ !)would certainly motivate companies to get a product out there.
A_DHT_Driveby
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there is no question that a lot of thought will go into th exact cost of the procedure, but there is incentive to make it commercially affordable.
sphlanx2006
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The mistake that we -baldies do, is that we sometimes overestime the world's need for a solution in baldness. The truth is that people as a whole dont give a sh*t about miracle cures of hair loss. And in fact there many bald people who also dont give a sh*t. I am not trying to underestimate the psychological effect hair loss can have on one individual but it is not the end of the world.
Do you give a sh*t about acne? (if you dont have of course) Acne effects on ones appearence can be far more devastating than baldness and it does affect quite a lot of people!
Do you slim people spent your nights researching about cures for obesity? There are many available, yet the ones who sell it are not one the top10 with the richest people on the planet.
So dont think that HM at a price of 100,000$ would crowd the facilities of Intercytex. People who can easily spend 100,000$ usually have reasons to care less about their appearence, since they have more self confidence, which -after all- is what hair is about.
Think of it like that: How many nw4s or nw3s could have a full head of hair with a good hair tranplant, and yet they dont do it? How many DONT start propecia or minoxidol when they started losing, not because they were afraid of sides but because they didnt bother finding out about them?
To sum up: Intercytex HAS to launch HM at a reasonable price. And that is cost + paying loans back + reasonable profit. In any case i dont think that would be far more than an expensive hair tranplant!
Do you give a sh*t about acne? (if you dont have of course) Acne effects on ones appearence can be far more devastating than baldness and it does affect quite a lot of people!
Do you slim people spent your nights researching about cures for obesity? There are many available, yet the ones who sell it are not one the top10 with the richest people on the planet.
So dont think that HM at a price of 100,000$ would crowd the facilities of Intercytex. People who can easily spend 100,000$ usually have reasons to care less about their appearence, since they have more self confidence, which -after all- is what hair is about.
Think of it like that: How many nw4s or nw3s could have a full head of hair with a good hair tranplant, and yet they dont do it? How many DONT start propecia or minoxidol when they started losing, not because they were afraid of sides but because they didnt bother finding out about them?
To sum up: Intercytex HAS to launch HM at a reasonable price. And that is cost + paying loans back + reasonable profit. In any case i dont think that would be far more than an expensive hair tranplant!
sphlanx2006 said:
Phase 2 started in Sept 2006 and was supposed to be over within one year so we have yet another delay which i doubt is a good thing.
Phase II - the Design
Phase II has officially started in September 2006. Up to 20 test subjects may be enrolled for phase II. Only local subjects will be recruited. Not all test subjects are scheduled to begin the trial at the same time. There will be fine-tuning and adjustments to the protocol as the trial progresses. Dr. Kemp described phase II as a "rolling or staggering" trial in the sense that the protocol may evolve over the duration of the trial. More than 1 protocol may be tested in phase II depending on the initial results.
In phase II, there will be TWO test sites on each volunteer’s scalp. The first test site is on a completely bald area measuring about 1 sq cm. This site will be subject to100 injections of the cultured suspension. Unlike the first test site that resides on a completely bald area, the second test site is on a much larger area containing thinning hair. The second site will be subject to 900 injections. In other words, each volunteer will receive 1,000 injections divided between two test sites on his scalp. Both test sites will be administered and monitored simultaneously.
Evaluation of the 900-injections test site will be done primarily through photographic assessment of the before and after changes. A more detailed graft-by-graft hair count assessment will be performed on the smaller 100-injections test site.
If all goes as expected, phase II may be concluded in approximately 1 year.
30_going_on_60
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True enough....anyone thats not bald isn't going to spend money on a baldness cure. That's nothign new though. Those people aren;t interested, and never will be. However, its still a MASSIVE market, even if you just account for those willing to do somehting about it. My guess is that a majority of hairloss sufferers believe that it is incurable and hence choose not too. Furthermore, weight gain is curable, by excercising and eating better, and acne goes away in time. This certainly isnt true for EVERY case, but it should be in the majority of them....hairloss will never get better by itself and theres no definite thing that can be done to cure it.....that's why its so frustrating and many people would be willing to pay an arm and a leg for it.
Hell...we're discussing the money part of it...kinda wish we were discussing this as if it were already out. Lets have this discussion in 2020 ok?
Hell...we're discussing the money part of it...kinda wish we were discussing this as if it were already out. Lets have this discussion in 2020 ok?
I agree that it's impossible to judge the demand for a real hair loss cure when we have never previously had one.
Transplants aren't a cure.
95% of them look like sh*t and they're much too severe of a "treatment" to even begin to guage demand.
All the meds so far are total crap.
Patient: "I want my hair back, Doctor."
Doctor: "Then take this pill. It won't bring your old hair back and it hurts your sex drive."
This would seem like an absurd joke if it wasn't real.
We'll find out the true demand for a hair loss treatment when we can turn a Norwood#7 into a Norwood#1, with original density, without horribly disfiguring his scalp in the process, without a lifetime of sexual side effects. That's the bottom line.
Transplants aren't a cure.
95% of them look like sh*t and they're much too severe of a "treatment" to even begin to guage demand.
All the meds so far are total crap.
Patient: "I want my hair back, Doctor."
Doctor: "Then take this pill. It won't bring your old hair back and it hurts your sex drive."
This would seem like an absurd joke if it wasn't real.
We'll find out the true demand for a hair loss treatment when we can turn a Norwood#7 into a Norwood#1, with original density, without horribly disfiguring his scalp in the process, without a lifetime of sexual side effects. That's the bottom line.