The TRUTH behind ARI’s clinical study

.

Spanish Dude all i can say is

“I was right all the time about minox and ARI” well well well well should be a tough one for you now :wink:

I won even your picture cant take that away from me ^^

»

Just a memorandum …


Currently Enrolling Trials

  • Do you Suffer from Hair Loss?
    You may be eligible to participate in our study.
    Compensation: up to $1200.
    If Interested please send an email to recruitment@impactla.org
    or call (310) 289-8242.

Source: http://www.impactla.org/trials.htm

Radiant Research-St. Louis, MO Hey there! We are still enrolling for our hair loss study. If you have a patch of shiny bald skin at the crown of your head, you may qualify for this new treatment for new hair growth in areas of baldness. If you qualify, you may be paid up to $900 for your time and travel. If interested, contact Karey Conway, study c…oordinator at 314-362-2100 ext. 4309, or email Karey at: kareyconway@radiantresearch.com
16 June 2010 - 08:14
Source: Redirecting...


But, about I really wonder:

“… providing a potentially unlimited supply of hair growth for up to 80 million Americans suffering from pattern hair loss.”
Source: http://www.aderansresearch.com/index.html

Where are they???

» Just a memorandum …
»
» -----------------------------
» Currently Enrolling Trials
»
» - Do you Suffer from Hair Loss?
» You may be eligible to participate in our study.
» Compensation: up to $1200.
» If Interested please send an email to recruitment@impactla.org
» or call (310) 289-8242.
»
» Source: http://www.impactla.org/trials.htm
» -----------------------------
»
» Radiant Research-St. Louis, MO Hey there! We are still enrolling for our
» hair loss study. If you have a patch of shiny bald skin at the crown of
» your head, you may qualify for this new treatment for new hair growth in
» areas of baldness. If you qualify, you may be paid up to $900 for your
» time and travel
. If interested, contact Karey Conway, study
» c…oordinator at 314-362-2100 ext. 4309, or email Karey at:
» kareyconway@radiantresearch.com
» 16 June 2010 - 08:14
» Source:
» Redirecting...
»
» -----------------------------
»
» But, about I really wonder:
»
» “… providing a potentially unlimited supply of hair growth for up to
» 80 million Americans
suffering from pattern hair loss.”
» Source: http://www.aderansresearch.com/index.html
»
» Where are they???

Guys minox is FDA approved to regrow hair end of story.I don’t know if some didn’t see regrowth or say that it doesn’t work but according to the trials it does.I also saw regrowth when I was using it. Putting minox in the equation will have an effect on the results.

I was speaking to a doctor the other day about the FDA trials and the phases and he told me this. The first two phases is nothing, almost everything tha has a chance can go through trials because the investiment is minimal while the potentiall rewards can be great. Its the phase 3 that makes or breaks the drug or whatever.because there the investors will have to show the real money and access if the money they will invest will be returned and more. So its the phase 3 where everything stops or starts for real. If they are using minox and I was an investor I would be worried because I don’t know which part of the results is minox and what part is the procedure. I would say to myself what are they really making…a minoxidil booster!!!I can add retin a for that.

If they go on with this minox thing and hopefully enter phase 3 I hope at least they will give the placebo group minox as well so we can check what the actual product does more.but if they do that we will have very weird reading,haircounts raising in the placebo group as well as if they were on aminox trial lol.

Another thing the doc told me is that if a product goes dramatically well in phase 3 then they switch all the placebo group to the actual drug and finish the trials and off to the market they are :slight_smile:

» Another thing the doc told me is that if a product goes dramatically well
» in phase 3 then they switch all the placebo group to the actual drug and
» finish the trials and off to the market they are :slight_smile:

Correct. Actually, this is well-known in general:

Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market.

Source: Clinical trial - Wikipedia

This means, FOR INSTANCE (!!), the Bosley clinics COULD sell such procedures during Phase III trails, IF, and this is a huge IF, their “cell-based-therapies” are already damn. good. Sure, such procedures would (partially) compensate the HUGE trail costs etc.

» » Another thing the doc told me is that if a
» product goes dramatically well
» » in phase 3 then they switch all the placebo group to the actual drug
» and
» » finish the trials and off to the market they are :slight_smile:
»
» Correct. Actually, this is well-known in general:
» ----------------------------
» Most drugs undergoing Phase III clinical trials can be
» marketed under FDA norms with proper recommendations and
» guidelines
, but in case of any adverse effects being reported anywhere,
» the drugs need to be recalled immediately from the market. While most
» pharmaceutical companies refrain from this practice, it is
» not abnormal to see many drugs undergoing Phase III clinical trials in the
» market
.
»
» Source: Clinical trial - Wikipedia
» ----------------------------
»
» This means, FOR INSTANCE (!!), the Bosley clinics COULD sell such
» procedures during Phase III trails, IF, and this is a huge IF, their
» “cell-based-therapies” are already damn. good. Sure, such procedures would
» (partially) compensate the HUGE trail costs etc.

I think that IF they go in phase 3 trials and commit themselves to the costs then its for sure that they have something that works damn good. I dont know how it will work compared to propecia & minox but if it works just as good or better then the revolution in hair treatments will be a fact.

I think we will have reasons to be happy as soon as they commit themselves to phase 3. the day that this will happen we will pass from “hoping & waiting” to just “waiting to see how good it really is”. right now making predictions about how well it works is premature

» I think we will have reasons to be happy as soon as they commit themselves
» to phase 3. the day that this will happen we will pass from “hoping &
» waiting” to just “waiting to see how good it really is”. right now making
» predictions about how well it works is premature

Besides that, I really really wonder HOW (if at all) they try to overcome the following problems:

Dr. Washenik (2003):
"One of the challenges with follicle neogenesis is the orientation of hair direction. If you look at the mouse models, some over produced the tissue engineered hair and they grow at all different angles, so we think there might be a need to guide or force the hair to grow in the correct direction or angle. Hair direction is an active area of investigation by ARI.

Also, among some of the other issues that need to be resolved are hair quality, hair direction, and hair cycle. Equally important is whether the new procedure will induce follicular groupings or not. If they are just generating single hairs, we might have to do this technique in conjunction with conventional follicle based hair transplantation to achieve cosmetically acceptable results."

Anyway, the next 24 month, will be an exiting time …

» » I think we will have reasons to be happy as soon as they commit
» themselves
» » to phase 3. the day that this will happen we will pass from “hoping &
» » waiting” to just “waiting to see how good it really is”. right now
» making
» » predictions about how well it works is premature
»
» Besides that, I really really wonder HOW (if at all) they try to overcome
» the following problems:
» ---------------------------------
» Dr. Washenik (2003):
» “One of the challenges with follicle neogenesis is the orientation of
» hair direction
. If you look at the mouse models, some over produced the
» tissue engineered hair and they grow at all different angles, so we think
» there might be a need to guide or force the hair to grow in the correct
» direction or angle. Hair direction is an active area of investigation by
» ARI.
»
» Also, among some of the other issues that need to be resolved are hair
» quality
, hair direction, and hair cycle. Equally
» important is whether the new procedure will induce follicular groupings
» or not
. If they are just generating single hairs, we might have to do
» this technique in conjunction with conventional follicle based hair
» transplantation to achieve cosmetically acceptable results.”
» ---------------------------------
»
» Anyway, the next 24 month, will be an exiting time …

I dont think that they will go ahead with phase 3 if they havent solved these issues before. I am also hoping for exciting times but honestly i dont put all my hopes to the companies we know, i think something else will suprise us there is so much research in this field that maybe a company that focuses on other areas will have a leap and guide all the rest to the right path

Me too iron man, if nothing in 2 years i am going to settle for an FUE, but i hope they or someone will come thorugh

» Me too iron man, if nothing in 2 years i am going to settle for an FUE, but
» i hope they or someone will come thorugh

My bet is on FUE-HST as standard procedure in two years

» My bet is on FUE-HST as standard procedure in two years

I bet we’re all still bald in two years.

But in all seriousness, Histogen is the company to watch, IMO. Their treatment seems relatively minimally invasive, and their published results from safety testing alone already outshine everything we’ve seen from ARI.

Spanish Dude has been spot on during this entire ARI Minox debacle. There is no possible way to spin that into a good thing. I honestly can’t believe it’s use during an FDA hair growth trial for a new treatment is even considered acceptable science.

Total disappointment; though I personally never saw the cellular approach as likely to succeed in the near term.

» I was speaking to a doctor the other day about the FDA trials and the
» phases and he told me this. The first two phases is nothing, almost
» everything tha has a chance can go through trials because the investiment
» is minimal while the potentiall rewards can be great. Its the phase 3 that
» makes or breaks the drug or whatever.because there the investors will have
» to show the real money and access if the money they will invest will be
» returned and more. So its the phase 3 where everything stops or starts for
» real. If they are using minox and I was an investor I would be worried
» because I don’t know which part of the results is minox and what part is
» the procedure. I would say to myself what are they really making…a
» minoxidil booster!!!I can add retin a for that.
»
» If they go on with this minox thing and hopefully enter phase 3 I hope at
» least they will give the placebo group minox as well so we can check what
» the actual product does more.but if they do that we will have very weird
» reading,haircounts raising in the placebo group as well as if they were on
» aminox trial lol.

WRONG! Most Drugs Fail Safety tests in Phase-I or Fail Efficacy tests in Phase-II. If a drug makes it to Phase-III then it is highly likely that it will end up being marketed - because Phase-III is about testing the drug on a huge number of people and also check the full-potential of the drug. In our case Phase-III will be used to regrow most of the lost hair i.e. trying to turn NW5-6 to NW2-3…or adding more density to temples/vertex etc. Whereas in Phase-II ARI is only testing very small patches.

» Total disappointment; though I personally never saw the cellular approach
» as likely to succeed in the near term.

Maybe ARI itself didn’t this either in 2006/2007:

http://www.histogen.com/downloads/hisotgenforinvestor.pdf
(page 8 /37)

• Longer Term Products

– Hair growth: Initial conversations/interest from Aderans(BosleyClinics) P&G and Allergan

But we know NOTHING about the JiGami C and JiGami N approach. The origin “JiGami” seems so far just to represent Intercytex’s approach including their “final results” (proof of concept etc) - nothing more, nothing less.

But besides that, Histogen’s approach seems far more convenient as well as more efficient (at least so far) in general (no biopsy necessary etc) and surely far more cheaper too. So hopefully they’re are able to start their bigger trails in Asia, as soon as possible.

» » My bet is on FUE-HST as standard procedure in two years
»
» I bet we’re all still bald in two years.
»
» But in all seriousness, Histogen is the company to watch, IMO. Their
» treatment seems relatively minimally invasive, and their published results
» from safety testing alone already outshine everything we’ve seen from ARI.
»
» Spanish Dude has been spot on during this entire ARI Minox debacle. There
» is no possible way to spin that into a good thing. I honestly can’t
» believe it’s use during an FDA hair growth trial for a new treatment is
» even considered acceptable science.
»
» Total disappointment; though I personally never saw the cellular approach
» as likely to succeed in the near term.

Guys… i personally dont feel disappointed by the fact that minoxidil is being used in these trails… minoxidil has been proven to promote the synthesis of follicles by widening the capillaries and promoting blood flow and nutrition transport. If minoxidil is useful to gain a greater yield of newly injected stem cells forming into follicles, i’m fine with that. I’m quite certain that ARI will test their procedure with and without the use of minoxidil in order to assess the importance of using minoxidil during the follicle synthesis period.
I actually really don’t understand why everyone is so upset about this.

Dito

I think all the debates about this and that are pretty much worthless because right now nobody knows more then the ARI/ Histogen guys.

So i say lets wait for some NEWS and not assumptions by some narrow minded fellas here.

And BTW you are right Minox is a nice boosting tool. If i would do some clinical tests and see that my procedure works, the next step i would use minox to fasten things up.

» » » My bet is on FUE-HST as standard procedure in two years
» »
» » I bet we’re all still bald in two years.
» »
» » But in all seriousness, Histogen is the company to watch, IMO. Their
» » treatment seems relatively minimally invasive, and their published
» results
» » from safety testing alone already outshine everything we’ve seen from
» ARI.
» »
» » Spanish Dude has been spot on during this entire ARI Minox debacle.
» There
» » is no possible way to spin that into a good thing. I honestly can’t
» » believe it’s use during an FDA hair growth trial for a new treatment is
» » even considered acceptable science.
» »
» » Total disappointment; though I personally never saw the cellular
» approach
» » as likely to succeed in the near term.
»
» Guys… i personally dont feel disappointed by the fact that minoxidil is
» being used in these trails… minoxidil has been proven to promote the
» synthesis of follicles by widening the capillaries and promoting blood flow
» and nutrition transport. If minoxidil is useful to gain a greater yield of
» newly injected stem cells forming into follicles, i’m fine with that. I’m
» quite certain that ARI will test their procedure with and without the use
» of minoxidil in order to assess the importance of using minoxidil during
» the follicle synthesis period.
» I actually really don’t understand why everyone is so upset about this.

Do you think they’ll except candidate who are taking propecia into phase 3 trails? I’m hoping so I’ll have a chance…

» » I was speaking to a doctor the other day about the FDA trials and the
» » phases and he told me this. The first two phases is nothing, almost
» » everything tha has a chance can go through trials because the
» investiment
» » is minimal while the potentiall rewards can be great. Its the phase 3
» that
» » makes or breaks the drug or whatever.because there the investors will
» have
» » to show the real money and access if the money they will invest will be
» » returned and more. So its the phase 3 where everything stops or starts
» for
» » real. If they are using minox and I was an investor I would be worried
» » because I don’t know which part of the results is minox and what part
» is
» » the procedure. I would say to myself what are they really making…a
» » minoxidil booster!!!I can add retin a for that.
» »
» » If they go on with this minox thing and hopefully enter phase 3 I hope
» at
» » least they will give the placebo group minox as well so we can check
» what
» » the actual product does more.but if they do that we will have very
» weird
» » reading,haircounts raising in the placebo group as well as if they were
» on
» » aminox trial lol.
»
» WRONG! Most Drugs Fail Safety tests in Phase-I or Fail Efficacy tests in
» Phase-II. If a drug makes it to Phase-III then it is highly likely that it
» will end up being marketed - because Phase-III is about testing the drug on
» a huge number of people and also check the full-potential of the drug. In
» our case Phase-III will be used to regrow most of the lost hair i.e. trying
» to turn NW5-6 to NW2-3…or adding more density to temples/vertex etc.
» Whereas in Phase-II ARI is only testing very small patches.

what is wrong?i dont say that drugs dont fail but they usually give up on them during phase 2.Phase 1 is for toxicity and in case there are bad reactions to it, most of them pass this stage its easy. If it fails it will fail now during phase 2 where most drugs fail. If it doesnt it will go to phase 3 with a huge chance of making it to the market. we are not saying something different

» » » I was speaking to a doctor the other day about the FDA trials and the
» » » phases and he told me this. The first two phases is nothing, almost
» » » everything tha has a chance can go through trials because the
» » investiment
» » » is minimal while the potentiall rewards can be great. Its the phase 3
» » that
» » » makes or breaks the drug or whatever
.because there the investors will
» » have
» » » to show the real money and access if the money they will invest will
» be
» » » returned and more. So its the phase 3 where everything stops or
» starts
» » for
» » » real. If they are using minox and I was an investor I would be
» worried
» » » because I don’t know which part of the results is minox and what part
» » is
» » » the procedure. I would say to myself what are they really making…a
» » » minoxidil booster!!!I can add retin a for that.
» » »
» » » If they go on with this minox thing and hopefully enter phase 3 I
» hope
» » at
» » » least they will give the placebo group minox as well so we can check
» » what
» » » the actual product does more.but if they do that we will have very
» » weird
» » » reading,haircounts raising in the placebo group as well as if they
» were
» » on
» » » aminox trial lol.
»
»
» what is wrong?i dont say that drugs dont fail but they usually give up on

The doctor apparently told the poster that its phase-3 that makes or breaks the drug…which is wrong. Phase-II is the main drug killer.

Statistics say the following

  1. Almost everything can go into trial phase 1

  2. trial phase 2 is the critical one its the make or break thing

  3. If something survives phase 2 it has a high possibility to get on the market after some fine adjustements in phase 3

Phase 1 is only to test for negative side effects and if the ideas will work in theory. In Phase 2 there are the studies with different approch like in ARis case Minoxil or not and and different types of NW scale patients.
End of phase 2 and beginning of phase 3 the knwoledge about the working components is put together and thats the critical thing. When things work there will be further tests and if you have lets say two different apporches on to equal subjects and one of this treatments works even slightly better, then the other one will be abandones.

You can see this by their different Ji Gami things, cause they have to creat one stop solutions for different kinds of MPB like blank, diffuse, vertex and frontal.

I can only guess that right now they are not try to create something to work on scars, i think their primary objectve is to rejuvenate old follicles and give those follicles the needed informations for a better DHT resistance.

Yes hairs are not easy to understand, but if you have a formula which creates a DHT resistance that follicles adopt, then you will absolutely get your full head of hair back, thats a sure think like death and taxes

» » » » I was speaking to a doctor the other day about the FDA trials and
» the
» » » » phases and he told me this. The first two phases is nothing, almost
» » » » everything tha has a chance can go through trials because the
» » » investiment
» » » » is minimal while the potentiall rewards can be great.
» Its the phase 3
» » » that
» » » » makes or breaks the drug or whatever
.because there the
» investors will
» » » have
» » » » to show the real money and access if the money they will invest
» will
» » be
» » » » returned and more. So its the phase 3 where everything stops or
» » starts
» » » for
» » » » real. If they are using minox and I was an investor I would be
» » worried
» » » » because I don’t know which part of the results is minox and what
» part
» » » is
» » » » the procedure. I would say to myself what are they really
» making…a
» » » » minoxidil booster!!!I can add retin a for that.
» » » »
» » » » If they go on with this minox thing and hopefully enter phase 3 I
» » hope
» » » at
» » » » least they will give the placebo group minox as well so we can
» check
» » » what
» » » » the actual product does more.but if they do that we will have very
» » » weird
» » » » reading,haircounts raising in the placebo group as well as if they
» » were
» » » on
» » » » aminox trial lol.
» »
» »
» » what is wrong?i dont say that drugs dont fail but they usually give up
» on
»
»
» The doctor apparently told the poster that its phase-3 that makes or
» breaks the drug…which is wrong. Phase-II is the main drug killer.

» » » Another thing the doc told me is that if a
» » product goes dramatically well
» » » in phase 3 then they switch all the placebo group to the actual drug
» » and
» » » finish the trials and off to the market they are :slight_smile:
» »
» » Correct. Actually, this is well-known in general:
» » ----------------------------
» » Most drugs undergoing Phase III clinical trials can be
» » marketed under FDA norms with proper recommendations and
» » guidelines
, but in case of any adverse effects being reported
» anywhere,
» » the drugs need to be recalled immediately from the market. While most
» » pharmaceutical companies refrain from this practice, it
» is
» » not abnormal to see many drugs undergoing Phase III clinical trials in
» the
» » market
.
» »
» » Source: Clinical trial - Wikipedia
» » ----------------------------
» »
» » This means, FOR INSTANCE (!!), the Bosley clinics COULD sell such
» » procedures during Phase III trails, IF, and this is a huge IF, their
» » “cell-based-therapies” are already damn. good. Sure, such procedures
» would
» » (partially) compensate the HUGE trail costs etc.
»
» I think that IF they go in phase 3 trials and commit themselves to the
» costs then its for sure that they have something that works damn good. I
» dont know how it will work compared to propecia & minox but if it works
» just as good or better then the revolution in hair treatments will be a
» fact.
»
» I think we will have reasons to be happy as soon as they commit themselves to phase 3. the day that this will happen we will pass from “hoping &
» waiting” to just “waiting to see how good it really is”. right now making
» predictions about how well it works is premature

I could not agree more with the statement in red.