» » Can somone conact the Compeny and ask,when they want to go on the
» marked?
»
» I remember someone quoted Washnik saying “end of this decade”. If FDA
» allows them to launch their product after phase-II then they could do it by
» the end of 2010 or start of 2011.
If it is just entering phase 2, then approval is about 5-7 years away if everything goes well. Biotech companies in general have to be careful what they say, and the amount of informaiton they release. Too much, and they are at a high risk for lawsuits from investors. Reputable companies don’t pump.
The FDA does not allow approval after phase 2. It is only when people are dying and a treatment shows efficacy very early on that the process has a chance for a quicker review or a limited use.
Even if the process is approved it can be removed from the market at a later date if safety becomes a problem. So you don’t necessarily want to be the first one in the water.
» If it is just entering phase 2, then approval is about 5-7 years away if
» everything goes well. Biotech companies in general have to be careful what
» they say, and the amount of informaiton they release. Too much, and they
» are at a high risk for lawsuits from investors. Reputable companies don’t
» pump.
I just mentioned what washnik’s statement, what’s their latest estimate - I have no idea.
» The FDA does not allow approval after phase 2. It is only when people are
» dying and a treatment shows efficacy very early on that the process
» has a chance for a quicker review or a limited use.
I’m not really sure if FDA is regulating this or not, so I really won’t comment on this matter.
» » If it is just entering phase 2, then approval is about 5-7 years away if
» » everything goes well. Biotech companies in general have to be careful
» what
» » they say, and the amount of informaiton they release. Too much, and
» they
» » are at a high risk for lawsuits from investors. Reputable companies
» don’t
» » pump.
»
» I just mentioned what washnik’s statement, what’s their latest estimate -
» I have no idea.
»
» » The FDA does not allow approval after phase 2. It is only when people
» are
» » dying and a treatment shows efficacy very early on that the
» process
» » has a chance for a quicker review or a limited use.
»
» I’m not really sure if FDA is regulating this or not, so I really won’t
» comment on this matter.
HAHHAHAHAHHAHHHHAHAAHAH…SAME CRAP!!! I will be happy when i see someone walking out of a Bosley Clinic with all his hair back…until then 5yr 10 yrs 1000 yrs dinosaurs come back…whatever…lol
» » » Can somone conact the Compeny and ask,when they want to go on the
» » marked?
» »
» » I remember someone quoted Washnik saying “end of this decade”. If FDA
» » allows them to launch their product after phase-II then they could do it
» by
» » the end of 2010 or start of 2011.
»
» If it is just entering phase 2, then approval is about 5-7 years away if
» everything goes well. Biotech companies in general have to be careful what
» they say, and the amount of informaiton they release. Too much, and they
» are at a high risk for lawsuits from investors. Reputable companies don’t
» pump.
»
» The FDA does not allow approval after phase 2. It is only when people are
» dying and a treatment shows efficacy very early on that the process
» has a chance for a quicker review or a limited use.
»
» Even if the process is approved it can be removed from the market at a
» later date if safety becomes a problem. So you don’t necessarily want to be
» the first one in the water.
The average length of trials (1 through 3) is 8 years, so I don’t think it will take 7 years to get to market. Of course, that’s IF it works, which is a huge “if”. I’d say 5 years to market if it actually works. If they’ve just started recruiting cohorts for Phase II, there is NO way its getting to market before 2012.
» The average length of trials (1 through 3) is 8 years, so I don’t think it
» will take 7 years to get to market. Of course, that’s IF it works, which
» is a huge “if”. I’d say 5 years to market if it actually works. If
» they’ve just started recruiting cohorts for Phase II, there is NO way its
» getting to market before 2012.
Does anyone know how many years it took them to complete phase 1? This will give us an idea how fast they are moving with this.
» Does anyone know how many years it took them to complete phase 1? This
» will give us an idea how fast they are moving with this.
I do know they were in their research phase at the end of 2002. Not sure when Phase 1 officially began. I’m also not sure what hurdles they may have faced during those 6-7 years. The fact they’re moving onto phase 2 though is a good thing. I read somewhere that they would be finished with phase 2 by the end of this year. So if all goes well, phase 3 could start next year I’m assuming.
Didn’t Aderans conduct their phase I trials in the UK? Does that not mean they weren’t going through the FDA at that point? Sure, the procedure (if it works) will require FDA approval to be made available in the US, but it’s a possibility we could see something in another country before then.
» » The average length of trials (1 through 3) is 8 years, so I don’t think
» it
» » will take 7 years to get to market. Of course, that’s IF it works,
» which
» » is a huge “if”. I’d say 5 years to market if it actually works. If
» » they’ve just started recruiting cohorts for Phase II, there is NO way
» its
» » getting to market before 2012.
»
» Does anyone know how many years it took them to complete phase 1? This
» will give us an idea how fast they are moving with this.
I think there were talks about aderans being in phase I two or three years ago.
Well, regardless of when & where & all that, it’s probably the phase#2 that matters most.
Phase#1 just proves it won’t hurt anyone. Phase#3 is mostly the finer-tuning of the effectiveness. It’s phase#2 that most directly proves the whole stupid procedure is capable of working.
If they finish phase#2 and announce it worked well enough to proceed with phase#3, THEN I’ll start getting excited about this really happening soon.
i hve been coming here for about 5 years now, i remember it was about 2004 when aderans first talked about doing their trials, so it took 5 years to finish phase 1 ? is that possible? 5 friggn years for phase 1?
» i hve been coming here for about 5 years now, i remember it was about 2004
» when aderans first talked about doing their trials, so it took 5 years to
» finish phase 1 ? is that possible? 5 friggn years for phase 1?
The probably didn’t have a set protocol to test.
Overall it takes 10 years. You have the actual trials and the time in between to raise funds. Usually after a successful phase 2 most companies will partner with an even larger company with deeper pockets in order to spread the risk. If a company is really greedy they will attempt to fund a phase 3 on their own. If they fail, which is more apt to happen without that bigger partner, they go out of business and the technology is sold off.
You see the system is corrupt. I know it’s hard to believe that big business and government are corrupt. But without that bigger partner that has the FDA connections, approval is extremely difficult. Especially if you are stepping on too many toes.
Due to technical issues with HM consistency, ARI’s technique has a far greater chance of success than Gho’s or ICX’. Gho was the early pioneer and actually used CD34+ stem cells from the patient’s blood to fortify the nutrient mix and enhance the hair follicle stem cells ability to multiply and remain viable. But despite his brilliant pioneering idea, he could never develop a consistent protocol.
Gho had done some early research into ICX’ technique and abandoned it in favor of using hair follicle stem cells mixed with blood stem cell aggregates and kerotinocyte growth factors. Thus, unless ICX could figure out some new way to culture viable DP cells in 2-D suspensions, their research was bound to come up against (and did) similar consistency issues as Gho encountered.
ARI has spent a great deal of time in the lab studying these issues and outcomes, and they’re very familiar with the problems other researchers have encountered. Their emphasis is on 3-D environments using a multi-cell approach. IOW, they specialize in creating a self-contained environment that relies less on the patient’s existing cells interacting with the injected cells. What separates this from previous companies’ trials is this has never been tried before in humans. So it should prove to be quite exciting.
ARI’s approach is not a backyard approach. Kurt Stenn is a world-class hair follicle researcher and has assembled a team of researchers with impeccable credentials. ARI has taken its time in the lab (mostly because the issues are so difficult to solve), but I see this a good thing. The earlier attempts by other companies have been thwarted more than anything by lack of developing a consistent protocol prior to moving into human research. ARI’s approach is different on many different levels and stands a high chance of commercial success. The amount of time and experiments they performed in the lab leading up to human trials is unprecedented. In many ways, this is the real deal this time. However, despite this, I expect the product will be clunky when it’s first released (if it makes it that far).
Phase II trials are typically 20-300 people, so ARI’s effort can be thought of as a legitimate mid-level attempt (quite expensive). If they have success, most likely the phase III trials will be quite a bit bigger than phase II. Phase III trials typically involve 300-3000 people and cost an arm and a leg. So if we see a failure, it will most likely play out in phase II with a reluctance to continue funding.
Technically ARI could finishes phase II in a year, enter and finish phase III in another year, and then submit the product for FDA review and get it on the shelf. However, that is not likely to happen. 2.5 years is possible, but “5 years” is more likely. LOL
» Due to technical issues with HM consistency, ARI’s technique has a far
» greater chance of success than Gho’s or ICX’. Gho was the early pioneer and
» actually used CD34+ stem cells from the patient’s blood to fortify the
» nutrient mix and enhance the hair follicle stem cells ability to multiply
» and remain viable. But despite his brilliant pioneering idea, he could
» never develop a consistent protocol.
»
» Gho had done some early research into ICX’ technique and abandoned it in
» favor of using hair follicle stem cells mixed with blood stem cell
» aggregates and kerotinocyte growth factors. Thus, unless ICX could figure
» out some new way to culture viable DP cells in 2-D suspensions, their
» research was bound to come up against (and did) similar consistency issues
» as Gho encountered.
»
» ARI has spent a great deal of time in the lab studying these issues and
» outcomes, and they’re very familiar with the problems other researchers
» have encountered. Their emphasis is on 3-D environments using a multi-cell
» approach. IOW, they specialize in creating a self-contained environment
» that relies less on the patient’s existing cells interacting with the
» injected cells. What separates this from previous companies’ trials is this
» has never been tried before in humans. So it should prove to be quite
» exciting.
»
» ARI’s approach is not a backyard approach. Kurt Stenn is a world-class
» hair follicle researcher and has assembled a team of researchers with
» impeccable credentials. ARI has taken its time in the lab (mostly because
» the issues are so difficult to solve), but I see this a good thing. The
» earlier attempts by other companies have been thwarted more than anything
» by lack of developing a consistent protocol prior to moving into human
» research. ARI’s approach is different on many different levels and stands a
» high chance of commercial success. The amount of time and experiments they
» performed in the lab leading up to human trials is unprecedented. In many
» ways, this is the real deal this time. However, despite this, I expect the
» product will be clunky when it’s first released (if it makes it that far).
»
» Phase II trials are typically 20-300 people, so ARI’s effort can be
» thought of as a legitimate mid-level attempt (quite expensive). If they
» have success, most likely the phase III trials will be quite a bit bigger
» than phase II. Phase III trials typically involve 300-3000 people and cost
» an arm and a leg. So if we see a failure, it will most likely play out in
» phase II with a reluctance to continue funding.
»
» Technically ARI could finishes phase II in a year, enter and finish phase
» III in another year, and then submit the product for FDA review and get it
» on the shelf. However, that is not likely to happen. 2.5 years is possible,
» but “5 years” is more likely. LOL
Excellent post. Win, lose or draw, ARI’s research should be very useful for future study.
I agree with you James. ARI did state that funding was not an issue. Hopefully things will go well this year and they will move onto phase 3 in a year or so.
» ADERANS RESEARCH Launches Second Phase of Hair Loss Study
» http://www.prweb.com/releases/pattern_hair_loss_study/hair_restoration_research/prweb2358404.htm
» 27 Apr 2009
»
» Aderans Research Institute Inc. (ARI) announced today it has launched
» Phase 2 of its clinical study on cell-based hair regeneration for men and
» women. Structured around the findings of the recently completed Phase 1 of
» the study, this second phase will continue to evaluate the impact of its
» novel cell treatment process on pattern hair loss, also known as
» androgenetic alopecia.
»
» Phase 2 of the study is being conducted in six U.S. cities: Atlanta,
» Boston, New York, Raleigh, Houston, and Washington DC. Phase 1 was
» conducted exclusively in the United Kingdom.
»
» “The second phase of this study is another step in our efforts to truly
» understand the impact of regenerative cell therapy on pattern hair loss.
» It’s a tremendous opportunity,” says Kurt Stenn, MD, Vice President and
» Chief Scientific Officer. The company’s research is focused on developing a
» state-of-the-art tissue engineering solution to the regeneration of hair,
» taking actual hair cells–fibroblasts and keratinocytes, the two primary
» cell types within hair follicles–and promoting their growth in controlled
» laboratory environments. The research teams then recombine them and these
» “combined hair cells” are then placed in the patient’s skin, where they are
» expected to elicit hair growth. “This is research the industry has always
» wanted to do, and ARI has combined the support, the market, and the
» scientific wherewithal to do it,” says Vern Liebmann, Vice President,
» Operations.
»
» More information on study outcomes will be released as our studies
» conclude. To see ARI’s latest clinical updates, please visit
» http://www.aderansresearch.com/ari_clinicupdates.html
»
» With offices in Atlanta and Philadelphia, the Aderans Research Institute
» is a subsidiary of Aderans Company, Ltd, the world’s largest wig
» manufacturer, and an affiliate of Bosley, a global leader in medical hair
» restoration.
»
» Additional information on ARI can be found at
» http://www.aderansresearch.com
big whoopdy do…it only took like 5 yrs to get past the first phase. By the time it comes out, i’ll be to old enough to give a crap anymore. I’m betting the results won’t be what we expect either.
» » ADERANS RESEARCH Launches Second Phase of Hair Loss Study
» »
» http://www.prweb.com/releases/pattern_hair_loss_study/hair_restoration_research/prweb2358404.htm
» » 27 Apr 2009
» »
» » Aderans Research Institute Inc. (ARI) announced today it has launched
» » Phase 2 of its clinical study on cell-based hair regeneration for men
» and
» » women. Structured around the findings of the recently completed Phase 1
» of
» » the study, this second phase will continue to evaluate the impact of
» its
» » novel cell treatment process on pattern hair loss, also known as
» » androgenetic alopecia.
» »
» » Phase 2 of the study is being conducted in six U.S. cities: Atlanta,
» » Boston, New York, Raleigh, Houston, and Washington DC. Phase 1 was
» » conducted exclusively in the United Kingdom.
» »
» » “The second phase of this study is another step in our efforts to truly
» » understand the impact of regenerative cell therapy on pattern hair
» loss.
» » It’s a tremendous opportunity,” says Kurt Stenn, MD, Vice President and
» » Chief Scientific Officer. The company’s research is focused on
» developing a
» » state-of-the-art tissue engineering solution to the regeneration of
» hair,
» » taking actual hair cells–fibroblasts and keratinocytes, the two
» primary
» » cell types within hair follicles–and promoting their growth in
» controlled
» » laboratory environments. The research teams then recombine them and
» these
» » “combined hair cells” are then placed in the patient’s skin, where they
» are
» » expected to elicit hair growth. “This is research the industry has
» always
» » wanted to do, and ARI has combined the support, the market, and the
» » scientific wherewithal to do it,” says Vern Liebmann, Vice President,
» » Operations.
» »
» » More information on study outcomes will be released as our studies
» » conclude. To see ARI’s latest clinical updates, please visit
» » http://www.aderansresearch.com/ari_clinicupdates.html
» »
» » With offices in Atlanta and Philadelphia, the Aderans Research
» Institute
» » is a subsidiary of Aderans Company, Ltd, the world’s largest wig
» » manufacturer, and an affiliate of Bosley, a global leader in medical
» hair
» » restoration.
» »
» » Additional information on ARI can be found at
» » http://www.aderansresearch.com
»
»
» big whoopdy do…it only took like 5 yrs to get past the first phase. By
» the time it comes out, i’ll be to old enough to give a crap anymore. I’m
» betting the results won’t be what we expect either.
If you do not like your hairloss,when your younger,I’m guessing that feeling never goes away whatever age.It might become more acceptable,as you age,as others around are getting balder,as well!
I’m now 44.I hate my hairloss.Luckily I never took much notice until a couple of years ago,or not so lucky which ever way you look at it.
I just hate having to shave my damn head every day - I think the totally shaved look is better than thinning hair.I really wish I could just get over it.
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