I'm referring to Aderans and more specifically Histogen. I beleive the lastest data suggest Aderans is shooting for 2013 and Histogen saying 2013 Asia and 2015 US. My question is why? Is it a matter of funding or simply being extra careful to make sure everything is perfect. I would think if photos of what Histogen has produced are typical that they would be running to the finish line wide open instead of saying we hope to have a product in 5 years? If they have a product that was able to produce the results shown in thier photo why not give it to consumers let them sign away the rights regarding risk and let that serve as your trials. I realize that the FDA approval process will be slow but if the product is ready then why 5 years. I could understand one year maybe two but five. It makes me think that these copmanies are not as close as they claim. Also, if Histogen does prove succesful in Asia in 2013 will the treatment somehow sneak its way into the USA but simply be a non FDA approved treatment.
Can someone explain why clinical trials take so long?
- Thread starter rtpatter
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andrei_eremenko
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first of all...i've never heard histogen or aderans saying that their products are ready to use and they will give a full head of hair...it is a clinical trials because they still need to fix the formula and to improve it...nobody said that this is ready for use now...and 2014 looks like a realistic date to release the product....
stop saying the same thing...that in the past...they have said the same that they are 5 years away till the final release...in the past where no aderans and hsitogen and acell and trichoscience and follica...companies that are struglling to fix the problem...what companies were there? what trials were conducted at that time? you can not compare that period with this...as you can compare this with the period over 10 years...when by the way...HM will be available...
stop saying the same thing...that in the past...they have said the same that they are 5 years away till the final release...in the past where no aderans and hsitogen and acell and trichoscience and follica...companies that are struglling to fix the problem...what companies were there? what trials were conducted at that time? you can not compare that period with this...as you can compare this with the period over 10 years...when by the way...HM will be available...
I'm not saying the same thing I do believe these companies are closer than in the past. It just seems like 5 years is a long time to go from "we have a product that showed significant results based on this photo however you can't have it for 5 more years". iF they were really that close it seems like they would be hyping it a little more and showing more results. Who knows in 5 years there could be a completly new treatment for hair loss that has nothing to do with the test going on now.
Also if Histogen works would it be available in the US before FDA approval?
Also if Histogen works would it be available in the US before FDA approval?
somone uk
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it's because hair takes a long time to grow
you start off with a product first thing you have to do is recruit which takes a while
lets say recruitment will take about 8 weeks, that's 2 months
then the trial they usually test phase 1 under is about a year
so 14 months
after they get the data they'll have to cross analyse the data and try and draw scientific conclusions, they will also have to publish the conclusions and then the trail will require peer reviews etc
it sucks it takes so long but the fact of the matter is to get a scientific conclusion takes a long time
histogen started trials in 2009, getting a product in 5 years is actually fast for a clinical trial
you start off with a product first thing you have to do is recruit which takes a while
lets say recruitment will take about 8 weeks, that's 2 months
then the trial they usually test phase 1 under is about a year
so 14 months
after they get the data they'll have to cross analyse the data and try and draw scientific conclusions, they will also have to publish the conclusions and then the trail will require peer reviews etc
it sucks it takes so long but the fact of the matter is to get a scientific conclusion takes a long time
histogen started trials in 2009, getting a product in 5 years is actually fast for a clinical trial
andrei_eremenko
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yea indeed...and regarding us release they do need the fda approval...that's why they are researching in asia where is not so much approval...
any way...we would discuss about HM when it will be capable to multiply 10 hairs in 150 000 hairs...and i think histogen is more like a treatment and it shouldn't be included in hm industry...
any way...we would discuss about HM when it will be capable to multiply 10 hairs in 150 000 hairs...and i think histogen is more like a treatment and it shouldn't be included in hm industry...
andrei_eremenko
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) lol...
Boondock
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FDA approval always takes a lot of time. Trials take a lot of time. Bureaucracy takes a lot of time. It's always a lengthy process.
But all indications are that these guys are nowhere near getting anything on the market. You may as well put it out of your mind for ten years at least. It's just painful otherwise.
But all indications are that these guys are nowhere near getting anything on the market. You may as well put it out of your mind for ten years at least. It's just painful otherwise.
andrei_eremenko
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I am a pesimistic person....but...you guys...some of you are waaayyy to pesimistic...I mean Boondock...c'mon hsitogen will not be a HM method...I think it will be a treatment...so for a treatment it is a reasonable time to release it in 2013...and regarding aderans...they are conducting now large trials on different cities...they wouldn't do that if they weren't so close...
Boondock
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andrei_eremenko said:
They are close - in medical terms. The problem is, normally medical technologies take decades to evolve and come to market. It's not like bringing out a new kids toy. I challenge you to find one actual doctor or biomedical worker who disagrees with me. So far as I can tell the only people who think this stuff will be here in 2013 are the HM firms themselves and people on hair loss forums. Go figure.
andrei_eremenko
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if HM will take a decade...it will be all right still young at 33...till then I am sure that I will wear a wig...or something...because baldness it is the worst thing that can happen to a guy...it is like missing your ears...or your nose or...something like this...
but I don think that this will not take a decade maybe 5 years from now on...and it will be on the bureau of FDA for approval...
I was thinking one day...that baldy man will go crazy...I mean instead of 100 000-150 000 of multiplied hair they will desire to have 250 000 or so...)
this is the problem too when a guy is order a wig...he take too much density...and the results are not natural...
but I don think that this will not take a decade maybe 5 years from now on...and it will be on the bureau of FDA for approval...
I was thinking one day...that baldy man will go crazy...I mean instead of 100 000-150 000 of multiplied hair they will desire to have 250 000 or so...
)this is the problem too when a guy is order a wig...he take too much density...and the results are not natural...
You exaggerate I think. Incurable form or state of cancer, yes, I can understand. But baldness is nowhere near.andrei_eremenko said:
Actually I am Norwood 7 and I feel rather comfortable when I have my hair really short (3-6 mm). Of course I am not interested anymore in getting intimate with people (women for me) and perhaps this plays some role, I don't know. Nevertheless, if some company comes out with a working and safe solution in the next 5-10 years I will go for it for the single reason that baldness is perceived as a handicap and major aesthetic issue by many.
Ekusute :shock:andrei_eremenko said:...
I was thinking one day...that baldy man will go crazy...I mean instead of 100 000-150 000 of multiplied hair they will desire to have 250 000 or so...
this is the problem too when a guy is order a wig...he take too much density...and the results are not natural...
andrei_eremenko
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in my opinion it is a big difference between HM and a treatment...I understand that HM suppose to be something that cure the baldness...I mean form 10 hairs you can multiply till 1 million theorethicaly ...and histogen has showed that it can not do this...just to improve the situation i mean no future hair loss and thickening the existing and velus hair...no one has said that this is a HM procedure...just more like a treatment...
maybe they will be able to revive the roots of hair...but they didn't said that either...
maybe they will be able to revive the roots of hair...but they didn't said that either...
somone uk
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what annoys me a little is every other science uses maths instead of trial and error but medicine seems to be very concerned with trial and error
attempts at mathematical models seem to be unsuccessful not in practice but in prevalence and recognition i think we would of had HM by now if the FDA would recognise a computer model (like This) as medical evidence for safety and effectiveness the progression of medicine could speed up many times
i have a slight suspicion that histogen has already carried out a mathematical model on HSC, if that's so their prediction for hm by 2014 wouldn't' be far out since they could essentially predict the outcome of phase 2 and 3 however if they haven't carried out a maths model then they are just being too optimistic
attempts at mathematical models seem to be unsuccessful not in practice but in prevalence and recognition i think we would of had HM by now if the FDA would recognise a computer model (like This) as medical evidence for safety and effectiveness the progression of medicine could speed up many times
i have a slight suspicion that histogen has already carried out a mathematical model on HSC, if that's so their prediction for hm by 2014 wouldn't' be far out since they could essentially predict the outcome of phase 2 and 3 however if they haven't carried out a maths model then they are just being too optimistic
Matt Skiba
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I know this is going off topic a little bit..
But hey you can still get chicks if you're bald, as long as you have a slim body and good wit and charisma.
Maybe certain (immature) personality type of girls may not like you as much, but women who actually do know what they want will not care as long as you're not a total shmuck. Just cause these girls are more mature and think this way definitely doesn't mean that they're any less attractice physically.
HM might take a while, but you would do good to make the best of your life however it is, and not live as a shut-in.
Stay physically active, healthy, fit, emotionally and psychologically balanced and you'll do just fine, hair or no hair.
But hey you can still get chicks if you're bald, as long as you have a slim body and good wit and charisma.
Maybe certain (immature) personality type of girls may not like you as much, but women who actually do know what they want will not care as long as you're not a total shmuck. Just cause these girls are more mature and think this way definitely doesn't mean that they're any less attractice physically.
HM might take a while, but you would do good to make the best of your life however it is, and not live as a shut-in.
Stay physically active, healthy, fit, emotionally and psychologically balanced and you'll do just fine, hair or no hair.