HairSite
 
All Over,
04.08.2009, 15:37 |
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial (Hair Loss Research & Clinical Trials) |
Dr. Gail Naughton of Histogen has agreed to do a small Q&A with our community. The Q&A will be limited to approximately 10 questions. Forum members are welcome to submit your questions in this thread, in an orderly fashion. Kindly note that Dr. Naughton has NO OBLIGATION to answer each and every question submitted here. Please be respectful with your questions and stay on topic.
For those who are not familiar with Histogen's Hair Stimulating Complex (HSC) clinical trial, please read the following press release.
===========================================================
Histogen Hair Regrowth Clinical Trial Presented at ISHRS Annual Meeting
Data shows statistical significance at three key efficacy endpoints
SAN DIEGO, July 27, 2009 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, shared the results of the Company's preliminary clinical trial of Histogen's HSC human hair regrowth product for the first time at the International Society of Hair Restoration Surgeons (ISHRS) Annual Scientific Meeting. Dr. Craig Ziering, founder of Ziering Medical and principal investigator on the clinical trial, addressed attendees on July 25th, 2009 during the conference, taking place in Amsterdam July 22-26, 2009.
Patients treated with Histogen's Hair Stimulating Complex (HSC)
3 months
Hair count + 22.4%
Terminal hair + 27.8%
Thickness + 23.9%
![[image]](img/uploaded/1_image713.jpg)
==============================
3 months
Hair count + 23.7%
Terminal hair + 24.2%
Thickness + 22.2%
![[image]](img/uploaded/1_image714.jpg)
HSC is a proprietary formulation of naturally secreted embryonic proteins, growth factors and contains the first naturally stabilized, bioactive solution of Wnt proteins and their cofactors, which have been implicated in the induction of new hair follicle formation and growth.
The five-month double-blind, placebo-controlled clinical trial was focused on evaluation of safety in the clinical application of Histogen's Hair Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject clinical trial was designed to examine the safety and efficacy of a single injection of HSC alone, as well as in combination with three different perturbation methods. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy.
Efficacy at 12 weeks with one Application of HSC
cumulative thickness density (mm/cm2) p=0.0249
thickness mean (um) p=0.0402
terminal hair density (n/cm2) p=0.0029
![[image]](img/uploaded/1_image715.jpg)
84.6% of the patients receiving one injection of Histogen's serum-free HSC showed an increase in terminal hair 12 weeks post-injection, with a statistically significant (p<0.05) increase in the number of terminal hairs, cumulative hair thickness density and hair thickness mean. Perturbation did not enhance the results seen with HSC. There were no adverse reactions seen in any of the treated 24 patients at baseline, 12 weeks, or the 22 week endpoint.
"We are excited that our trial demonstrated safety and efficacy of our HSC product, which contains Wnt proteins and other growth factors important to hair follicle maintenance and growth," said Dr. Gail K. Naughton, CEO of Histogen. "Wnt signaling has been shown by a number of experts in the field to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and to be important in maintaining the hair inducing activity from existing follicles. Histogen's trial is the first demonstration that compounds containing bioactive Wnt increase hair growth in humans."
While additional clinical evaluation is needed to further examine product safety, efficacy and treatment specifications, the preliminary clinical trial of HSC represents a potentially significant new treatment option for the millions suffering from hair loss. Of the 87 million people in the United States that suffer from hair loss, it is estimated that only 2-7% seek surgical or pharmacological treatment. The same is true internationally due to the general lack of effective medical options for this widespread condition.
"Hair restoration treatments range in effectiveness and invasiveness. All of the current treatment options share the common goal of saving and redistributing existing hairs," said Dr. Craig Ziering. "For the millions of men and women who grapple every day with their hair loss, the results of our HSC trial indicate the potential for a phenomenal treatment option that stimulates growth of new hairs along with increasing the thickness of existing hairs. Histogen's HSC represents a potentially major paradigm shift from conventional treatment options to one that can promote the growth of new or dormant hairs using principles of the body's own regenerative mechanisms."
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.
HairSite is located in ALL OVER and he is available to meet: YES
email hairsite@aol.com to arrange a meeting. ---
HairSite.com
email: hairsite@aol.com for a free consultation
=====================================
reminder:
1. StandUp2Cancer.org
2. World's #1 Selling Instant Hair Building Fibers
3. Hair Loss & Replacement for Dummies, Dr. Bernstein |
rev
your nightmares,
04.08.2009, 16:40
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» Dr. Gail Naughton of Histogen has agreed to do a small Q&A with our
» community. The Q&A will be limited to approximately 10 questions. Forum
» members are welcome to submit your questions in this thread, in an orderly
» fashion. Kindly note that Dr. Naughton has NO OBLIGATION to answer
» each and every question submitted here. Please be respectful with your
» questions and stay on topic.
I'd like to know:
If they'll release any 5month photos.
What's the deal with their lawsuit, and it's effect on their product release.
Are they still looking for investors/ individual donations?
Are they still on track for a 2015 release, or do their recent findings indicate an earlier or later release?
rev is located in YOUR NIGHTMARES and he is available to meet: NO ---
"Especially important is the warning to avoid conversations with the shill. We may ask what is relevant but anything beyond that is dangerous. He is a liar. The shill is a liar. He will lie to confuse us. But he will also mix lies with the truth to attack us. The attack is psychological, and powerful. So don't listen to him. Remember that - do not listen. " |
nw-9
04.08.2009, 16:51
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
-Is what is shown in the pics the maximum we can expect? Is it possible to get a better result if you make more injections?
-Is the new hair affected by AGA?
nw-9 is located in [NA] and he is available to meet: NO |
therapy
04.08.2009, 16:56
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
Spanish Dude has a list of questions typed up for Histogen, can you find his questions and include them?
therapy is located in [NA] and he is available to meet: NO |
Z79
04.08.2009, 18:14
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
Has it grown hair in any completely bald area during the trials?
Z79 is located in [NA] and he is available to meet: NO |
Van Halen
04.08.2009, 18:28
@ Z79
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
Do you think we'll have a product within 5 yrs ?
Van Halen is located in [NA] and he is available to meet: NO |
p
04.08.2009, 18:37
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
This is an excellent initiative! Thank you!
Also a huge thank you to Dr Naughton for taking the time to answer our questions!
I would like to expand on Rev's earlier question and ask what the 22 week data looks like? Is there an improvement over the 12 week data, was the trial maximum already reached at 12 weeks or was there even a decline in the 22 week data compared to the 12 week data?
Thank you!
We are keeping our fingers crossed for your product!
p is located in [NA] and he is available to meet: NO |
Spanish Dude
04.08.2009, 19:01
@ therapy
|
my questions here |
» Spanish Dude has a list of questions typed up for Histogen, can you find
» his questions and include them?
As I wrote, I already found answers to some of my questions. But if Hairsite desires, he may include them in the list for confirmation purposes.
1. Each one of the injections have a limited scope of action. Just an area of a few centimetres wide.
2. Perturbation seems indeed dermabrasion with a laser. And perturbation didn't produce any benefit.
3. So, the only question that remains unanswered is about the 22-week results. do they have this data available?
4. I will add another question that has been already posted: does it work in totally bald areas? do they target this specific group of totally bald guys, or rather, they are focusing on thinning guys?
5. And another one: do they target to cure women too, or just men?
Spanish Dude is located in [NA] and he is available to meet: NO |
Spanish Dude
04.08.2009, 19:08
@ Van Halen
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» Do you think we'll have a product within 5 yrs ?
I would rather don't ask this question. It is subject to subjective guessing, and, thus, a lot of error. Better ask what do they have done so far.
Spanish Dude is located in [NA] and he is available to meet: NO |
Spanish Dude
04.08.2009, 19:09
@ p
|
22 week data |
» This is an excellent initiative! Thank you!
»
» Also a huge thank you to Dr Naughton for taking the time to answer our
» questions!
»
» I would like to expand on Rev's earlier question and ask what the 22 week
» data looks like? Is there an improvement over the 12 week data, was the
» trial maximum already reached at 12 weeks or was there even a decline in
» the 22 week data compared to the 12 week data?
»
» Thank you!
»
» We are keeping our fingers crossed for your product!
yep, the 22-week data is the main question for Dr. Naughton.
Spanish Dude is located in [NA] and he is available to meet: NO |
HMorHT
04.08.2009, 19:44
@ Spanish Dude
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » Do you think we'll have a product within 5 yrs ?
»
» I would rather don't ask this question. It is subject to subjective
» guessing, and, thus, a lot of error. Better ask what do they have done so
» far.
This is a good question, hairsite please include this one. It makes a big difference whether I am going to get fue now or wait a few more years. Actually I think this is the most important question.
HMorHT is located in [NA] and he is available to meet: NO |
roger_that
04.08.2009, 20:13
@ HMorHT
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » » Do you think we'll have a product within 5 yrs ?
» »
» » I would rather don't ask this question. It is subject to subjective
» » guessing, and, thus, a lot of error. Better ask what do they have done
» so
» » far.
»
» This is a good question, hairsite please include this one. It makes a big
» difference whether I am going to get fue now or wait a few more years.
» Actually I think this is the most important question.
While I appreciate the information given by Dr. Naughton, as it stands right now this product is probably not ready to produce serious thickening of the hair. At most, it could be used in conjunction with a HT, to slightly thicken up the transplanted hair and make it look fuller. But for anyone seriously balding, say Norwood 3 and above, I don't see that this would be any big advantage by itself.
Of course, I may be wrong... but right now, judging by the pictures, it looks like something on the order of Rogaine or Propecia, maybe a little bit more potent and it takes less time to show results. That said, however -- the results aren't that amazing.
But has ANYONE asked if this formula has been tested for side effects? Has it been tested for safety???
roger_that is located in [NA] and he is available to meet: NO |
p
04.08.2009, 20:47
@ roger_that
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» While I appreciate the information given by Dr. Naughton, as it stands
» right now this product is probably not ready to produce serious thickening
» of the hair. At most, it could be used in conjunction with a HT, to
» slightly thicken up the transplanted hair and make it look fuller. But
» for anyone seriously balding, say Norwood 3 and above, I don't see that
» this would be any big advantage by itself.
»
» Of course, I may be wrong... but right now, judging by the pictures, it
» looks like something on the order of Rogaine or Propecia, maybe a little
» bit more potent and it takes less time to show results. That said,
» however -- the results aren't that amazing.
IMHO, I think we should limit the discussion to productive questions to Dr Naughton if possible.
» But has ANYONE asked if this formula has been tested for side effects?
» Has it been tested for safety???
The press release in the original post clearly states that there were no adverse reactions (i.e. side effects) during the 22 week safety and efficacy trial.
p is located in [NA] and he is available to meet: NO |
soitchy
04.08.2009, 20:51
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
When can we expect the next clinical phase to begin or has it already begun, and more importantly, when will it end? Will the data from this trial be made public when it is available?
Many people have suggested this product be released outside the US to avoid FDA regulation prior to the US launch, and in the past, Histogen has not been outright opposed to the idea; has a decision been made, or is management perhaps leaning towards one side or the other?
soitchy is located in [NA] and he is available to meet: NO |
soitchy
04.08.2009, 20:54
@ p
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» IMHO, I think we should limit the discussion to productive questions to Dr
» Naughton if possible.
I agree, and making claims about the products potential effectiveness is clearly premature. We have 2 sets of photos from a trial only meant to prove the safety of the treatment, which it did, and extrapolating from them is a mistake.
soitchy is located in [NA] and he is available to meet: NO |
roger_that
04.08.2009, 20:56
@ p
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» IMHO, I think we should limit the discussion to productive questions to Dr
» Naughton if possible.
Okay, would you think my question below is a legitimate and productive question?
»
» » But has ANYONE asked if this formula has been tested for side effects?
So I will ask this one directly to Dr. Naughton.
Dr. Naughton, has this drug been tested for side effects? Is there any knowledge of it causing side effects? Is it safe?
I'm not asking this because I want to denigrate the product, I am very happy about it. I just think that like any other new medication, we should know something about how it interacts with the body and what kinds of secondary effects it can cause.
For instance, Propecia has some reported side effects, only in a small percentage of people, but important nonetheless. So does Rogaine and others.
Also, my other question for Dr. Naughton is how does this drug work? What does it interact with in the body/cells to cause the hair to grow?
roger_that is located in [NA] and he is available to meet: NO |
abcxyz
04.08.2009, 21:01
@ roger_that
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» Of course, I may be wrong... but right now, judging by the pictures, it
» looks like something on the order of Rogaine or Propecia, maybe a little
» bit more potent and it takes less time to show results. That said,
» however -- the results aren't that amazing.
»
what you see from the pictures are from 1 injection only!!!!! Many of us didn't realize that it was done with only 1 injection. I certainly missed that when I read their report a few months ago.
abcxyz is located in [NA] and he is available to meet: NO ---
Rogaine foam + Propecia + Nizoral 1% + Lysine
No longer use topical Dutas as of Nov 2007. |
rooster
04.08.2009, 21:06
@ abcxyz
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
I would like to know if the skin product that is currently for sale has the same growth factors as the hair product. My guess is yes but obviously in a different base.
rooster is located in [NA] and he is available to meet: NO |
cal
04.08.2009, 22:22
@ rooster
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
I think some of you guys are kind of missing the point with the debate about asking for timelines.
It's not that some of us don't think the question is important. I think everyone would agree that the question of timelines is damn well important.
But even if they do answer these questions, some of us (including me) don't think we could possibly get a real answer based on anything very concrete & reliable. It's just too early in the testing for Histogen itself to know what we wanna know. So we should probably not bother adding more fuel to the speculation fires by asking for more quotes from Histogen about timelines at this stage.
cal is located in [NA] and he is available to meet: NO |
HMorHT
04.08.2009, 22:33
@ cal
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» I think some of you guys are kind of missing the point with the debate
» about asking for timelines.
»
» It's not that some of us don't think the question is important. I think
» everyone would agree that the question of timelines is damn well important.
»
»
» But even if they do answer these questions, some of us (including me)
» don't think we could possibly get a real answer based on anything very
» concrete & reliable. It's just too early in the testing for Histogen
» itself to know what we wanna know. So we should probably not bother adding
» more fuel to the speculation fires by asking for more quotes from Histogen
» about timelines at this stage.
I don't think it hurts to ask. What's the worst that could happen if we throw in that question? We are all speculating anyway, at least we will have something to work with if she does answer that question.
HMorHT is located in [NA] and he is available to meet: NO |
cal
04.08.2009, 22:58
@ HMorHT
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
»
» I don't think it hurts to ask. What's the worst that could happen if we
» throw in that question? We are all speculating anyway, at least we will
» have something to work with if she does answer that question.
That's my point. She can answer the question, and it still doesn't mean we actually have anything to work with yet.
Medical researchers aren't in the business of telling the truth about their timelines to market on things in development. Blatant underestimations of timelines in that industry have become like steriods in baseball - it's so commonplace that you basically get penalized by NOT doing it.
cal is located in [NA] and he is available to meet: NO |
Spanish Dude
04.08.2009, 23:38
@ cal
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
exactly cal, I was thinking along your line when I posted.
After ***ALL*** previous timelines of previous companies in this forum have been proven wrong, I think it is ridiculous to ask Dr. Naughton about timelines.
» »
» » I don't think it hurts to ask. What's the worst that could happen if we
» » throw in that question? We are all speculating anyway, at least we
» will
» » have something to work with if she does answer that question.
»
» That's my point. She can answer the question, and it still doesn't mean
» we actually have anything to work with yet.
»
» Medical researchers aren't in the business of telling the truth about
» their timelines to market on things in development. Blatant
» underestimations of timelines in that industry have become like steriods in
» baseball - it's so commonplace that you basically get penalized by NOT
» doing it.
Spanish Dude is located in [NA] and he is available to meet: NO |
LatinLover
05.08.2009, 04:51
@ soitchy
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» Many people have suggested this product be released outside the US to
» avoid FDA regulation prior to the US launch, and in the past, Histogen has
» not been outright opposed to the idea; has a decision been made, or is
» management perhaps leaning towards one side or the other?
That's a very good question to ask, as well as Rev's about the 22 weeks result.
LatinLover is located in [NA] and he is available to meet: NO |
hairman2
05.08.2009, 05:49
@ Spanish Dude
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» exactly cal, I was thinking along your line when I posted.
» After ***ALL*** previous timelines of previous companies in this forum
» have been proven wrong, I think it is ridiculous to ask Dr. Naughton about
» timelines.
»
» » »
» » » I don't think it hurts to ask. What's the worst that could happen if
» we
» » » throw in that question? We are all speculating anyway, at least we
» » will
» » » have something to work with if she does answer that question.
» »
» » That's my point. She can answer the question, and it still doesn't
» mean
» » we actually have anything to work with yet.
» »
» » Medical researchers aren't in the business of telling the truth about
» » their timelines to market on things in development. Blatant
» » underestimations of timelines in that industry have become like steriods
» in
» » baseball - it's so commonplace that you basically get penalized by NOT
» » doing it.
I agree.. dont waste precious interviewing time and questions asking questions which cannot and will not be answered acurately.
hairman2 is located in [NA] and he is available to meet: NO |
hairman2
05.08.2009, 05:50
@ rev
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » Dr. Gail Naughton of Histogen has agreed to do a small Q&A with our
» » community. The Q&A will be limited to approximately 10 questions. Forum
» » members are welcome to submit your questions in this thread, in an
» orderly
» » fashion. Kindly note that Dr. Naughton has NO OBLIGATION to
» answer
» » each and every question submitted here. Please be respectful with your
» » questions and stay on topic.
»
» I'd like to know:
» If they'll release any 5month photos.
» What's the deal with their lawsuit, and it's effect on their product
» release.
» Are they still looking for investors/ individual donations?
» Are they still on track for a 2015 release, or do their recent findings
» indicate an earlier or later release?
I agree.. the question about the lawsuit which has scared off investors is indeed a big deal and is definatly an issue. However i'm not sure how truthfully this question can be answered.
hairman2 is located in [NA] and he is available to meet: NO |
p
05.08.2009, 08:47
@ roger_that
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» Okay, would you think my question below is a legitimate and productive
» question?
» »
» » » But has ANYONE asked if this formula has been tested for side
» effects?
»
» So I will ask this one directly to Dr. Naughton.
»
» Dr. Naughton, has this drug been tested for side effects? Is there any
» knowledge of it causing side effects? Is it safe?
»
I would have been if it hadn't already been answered in the press release in this very thread! It makes me wonder if you really read the original post, which is a press release about their efficacy and safety trial showing no signs of side effects. Wouldn't it be rather unneccesary to waste one question when we already know the answer, an answer which was communicated directly by Histogen in a press release? Wouldn't it make her wonder why we didn't even have the courtesy to read up before asking questions? Anyway, I'm digressing and won't waste more space by debating this. Suffice it to say I vote for not including this question.
p is located in [NA] and he is available to meet: NO |
rev
your nightmares,
05.08.2009, 09:30
@ p
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » Okay, would you think my question below is a legitimate and productive
» » question?
» » »
» » » » But has ANYONE asked if this formula has been tested for side
» » effects?
» »
» » So I will ask this one directly to Dr. Naughton.
» »
» » Dr. Naughton, has this drug been tested for side effects? Is there any
» » knowledge of it causing side effects? Is it safe?
» »
» I would have been if it hadn't already been answered in the press
» release in this very thread! It makes me wonder if you really read the
» original post, which is a press release about their efficacy and safety
» trial showing no signs of side effects. Wouldn't it be rather
» unneccesary to waste one question when we already know the answer, an
» answer which was communicated directly by Histogen in a press release?
» Wouldn't it make her wonder why we didn't even have the courtesy to read up
» before asking questions? Anyway, I'm digressing and won't waste more space
» by debating this. Suffice it to say I vote for not including this question.
roger_that is a shill. You'll notice a reoccurring theme among his posts - he undermines HM while promoting HTs.
rev is located in YOUR NIGHTMARES and he is available to meet: NO ---
"Especially important is the warning to avoid conversations with the shill. We may ask what is relevant but anything beyond that is dangerous. He is a liar. The shill is a liar. He will lie to confuse us. But he will also mix lies with the truth to attack us. The attack is psychological, and powerful. So don't listen to him. Remember that - do not listen. " |
rooster
05.08.2009, 12:24
@ rev
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » » Okay, would you think my question below is a legitimate and productive
» » » question?
» » » »
» » » » » But has ANYONE asked if this formula has been tested for side
» » » effects?
» » »
» » » So I will ask this one directly to Dr. Naughton.
» » »
» » » Dr. Naughton, has this drug been tested for side effects? Is there
» any
» » » knowledge of it causing side effects? Is it safe?
» » »
» » I would have been if it hadn't already been answered in the press
» » release in this very thread! It makes me wonder if you really read
» the
» » original post, which is a press release about their efficacy and
» safety
» » trial showing no signs of side effects. Wouldn't it be
» rather
» » unneccesary to waste one question when we already know the answer, an
» » answer which was communicated directly by Histogen in a press release?
I hope you people realize this product is more than likely already on the market as a skin wrinkle cream....
» » Wouldn't it make her wonder why we didn't even have the courtesy to read
» up
» » before asking questions? Anyway, I'm digressing and won't waste more
» space
» » by debating this. Suffice it to say I vote for not including this
» question.
»
» roger_that is a shill. You'll notice a reoccurring theme among his posts -
» he undermines HM while promoting HTs.
rooster is located in [NA] and he is available to meet: NO |
Sceptic
05.08.2009, 13:16
@ rooster
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» I hope you people realize this product is more than likely already on the
» market as a skin wrinkle cream....
Do you mean this ? :
http://www.histogenaesthetics.com/products.htm
Sceptic is located in [NA] and he is available to meet: NO |
rooster
05.08.2009, 15:07
@ Sceptic
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » I hope you people realize this product is more than likely already on
» the
» » market as a skin wrinkle cream....
»
» Do you mean this ? :
»
» http://www.histogenaesthetics.com/products.htm
Yes, the product uses the same growth factors. The hair trials however were done by injecting the growth factors. Don't know the dalton size of the growth factors and there ability to penetrate to the follicles via topical non-injection application.
rooster is located in [NA] and he is available to meet: NO |
abcxyz
05.08.2009, 15:12
@ hairman2
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» I agree.. dont waste precious interviewing time and questions asking
» questions which cannot and will not be answered acurately.
Sometimes I don't understand the logic of this board. Does it mean that you guys don't care even if Dr. Naughton thinks that it will take 10 years before it hits the market? I am with Hmorht on this one, if the product is not going to hit the market soon enough, I might get fue now while waiting for one of these companies to come through for us. I think this question is a must-have!
abcxyz is located in [NA] and he is available to meet: NO ---
Rogaine foam + Propecia + Nizoral 1% + Lysine
No longer use topical Dutas as of Nov 2007. |
nixi
05.08.2009, 15:25
@ rooster
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» I would like to know if the skin product that is currently for sale has the
» same growth factors as the hair product. My guess is yes but obviously in
» a different base.
I wouldn't ask for growth factors but for the WNTs. that might be the reason why they are injecting it.
I wonder why nobody is interested in this topic
nixi is located in [NA] and he is available to meet: NO |
chris
05.08.2009, 16:31
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
I want to know if they are accepting trial patients, and where can I sign up.
chris is located in [NA] and he is available to meet: NO |
cal
06.08.2009, 05:25
@ chris
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
Sometimes I don't understand the logic of this board. Does it mean that you guys don't care even if Dr. Naughton thinks that it will take 10 years before it hits the market? I am with Hmorht on this one, if the product is not going to hit the market soon enough, I might get fue now while waiting for one of these companies to come through for us. I think this question is a must-have!
You're saying "why don't you guys care?"
We're trying to tell you that we DO care, but we don't think anything that comes out of their mouth about timelines will be reliable in any way whatsoever. It's not the same thing as not caring.
cal is located in [NA] and he is available to meet: NO |
hairman2
07.08.2009, 04:54
@ abcxyz
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » I agree.. dont waste precious interviewing time and questions asking
» » questions which cannot and will not be answered acurately.
»
» Sometimes I don't understand the logic of this board. Does it mean that
» you guys don't care even if Dr. Naughton thinks that it will take 10 years
» before it hits the market? I am with Hmorht on this one, if the product
» is not going to hit the market soon enough, I might get fue now while
» waiting for one of these companies to come through for us. I think this
» question is a must-have!
cannot and will not be answered acurately. If I knew i wld be getting an honest answer.. ofcourse i would ask. But when have we ever gotten an honest answer when asking about timelines?
hairman2 is located in [NA] and he is available to meet: NO |
p
08.08.2009, 07:27
@ hairman2
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» cannot and will not be answered acurately. If I knew i wld be getting an
» honest answer.. ofcourse i would ask. But when have we ever gotten an
» honest answer when asking about timelines?
Well, the answer will carry some information. Let's put it this way: if she says 5 years, then we KNOW it wont be coming faster than that. The answer we get is likely going to be the theoretical best-case, if-all-goes-incredibly-well scenario, which we all know should be multiplied by 3, give or take, to yield a more likely timeline.  That's just the nature of any complicated project.
Although I personally don't care that much about the timeline, I can see how it is important for others. Getting an optimistic estimate from someone who actually knows what she is talking about beats wild forum speculation.
We could perhaps ask what her opinion is regarding FDA trials and what she thinks they will have to do, should they go down that route. What phases, the number of subjects in the trials, etc. Also, what about the prospect of releasing it outside the US without FDA trials while simultanously doing FDA trials in the US. That way they can get the best of two worlds: the product can start generating some income abroad while they push ahead and get FDA approval in the US. Just her general thoughts on the subject, basically.
Regarding the GFs, I guess WNT is one of the secreted factors they extract from the fibroblasts, along with a number of other growth factors. The fact that their skin product also contains GFs from fibroblasts, neoither means it contains the same GFs nor the same concentrations. And then there's the vehicle. But sure, we could ask about the difference. Do they contain the very same growth factors? In similar concentrations? If not, what is the difference?
Sorry for babbling. 
p is located in [NA] and he is available to meet: NO |
Sceptic
08.08.2009, 08:15
@ p
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» ... their skin product ...
I wonder if anyone is using it, I'm going to google it again but last time I couldn't find anything, but I admit I didn't try it very hard, there are a lot of skin forums out there with people using everything you can imagine... and more
Sceptic is located in [NA] and he is available to meet: NO |
p
08.08.2009, 08:28
@ p
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» neoither
That would be "neither". (That 15 minute editing limit is very annoying. Any chance of extending or removing it, Hairsite?)
p is located in [NA] and he is available to meet: NO |
ymail
08.08.2009, 09:47
@ rooster
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » » I hope you people realize this product is more than likely already on
» » the
» » » market as a skin wrinkle cream....
» »
» » Do you mean this ? :
» »
» » http://www.histogenaesthetics.com/products.htm
»
» Yes, the product uses the same growth factors. The hair trials however
» were done by injecting the growth factors. Don't know the dalton size of
» the growth factors and there ability to penetrate to the follicles via
» topical non-injection application.
How do you know that? If that is true... We can try to use it with a dermaroller and the cream to see what happens.
ymail is located in [NA] and he is available to meet: NO |
Spanish Dude
10.08.2009, 08:41
@ HairSite
|
and the answers will be ready in.... 5 years!! |
if everything goes right, of course.
» Dr. Gail Naughton of Histogen has agreed to do a small Q&A with our
» community. The Q&A will be limited to approximately 10 questions. Forum
» members are welcome to submit your questions in this thread, in an orderly
» fashion. Kindly note that Dr. Naughton has NO OBLIGATION to answer
» each and every question submitted here. Please be respectful with your
» questions and stay on topic.
»
» For those who are not familiar with Histogen's Hair Stimulating Complex
» (HSC) clinical trial, please read the following press release.
»
» ===========================================================
»
» Histogen Hair Regrowth Clinical Trial Presented at ISHRS Annual
» Meeting
» Data shows statistical significance at three key efficacy
» endpoints
»
» SAN DIEGO, July 27, 2009 - Histogen, Inc., a regenerative medicine company
» developing solutions based on the products of newborn fibroblasts grown
» under embryonic conditions, shared the results of the Company's preliminary
» clinical trial of Histogen's HSC human hair regrowth product for the first
» time at the International Society of Hair Restoration Surgeons (ISHRS)
» Annual Scientific Meeting. Dr. Craig Ziering, founder of Ziering Medical
» and principal investigator on the clinical trial, addressed attendees on
» July 25th, 2009 during the conference, taking place in Amsterdam July
» 22-26, 2009.
»
» Patients treated with Histogen's Hair Stimulating Complex (HSC)
»
»
» 3 months
» Hair count + 22.4%
» Terminal hair + 27.8%
» Thickness + 23.9%
»
»
»
» ==============================
»
» 3 months
» Hair count + 23.7%
» Terminal hair + 24.2%
» Thickness + 22.2%
»
»
»
» HSC is a proprietary formulation of naturally secreted embryonic proteins,
» growth factors and contains the first naturally stabilized, bioactive
» solution of Wnt proteins and their cofactors, which have been implicated in
» the induction of new hair follicle formation and growth.
»
» The five-month double-blind, placebo-controlled clinical trial was focused
» on evaluation of safety in the clinical application of Histogen's Hair
» Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject
» clinical trial was designed to examine the safety and efficacy of a single
» injection of HSC alone, as well as in combination with three different
» perturbation methods. Quantitative analysis of clinical macrophotography
» and subject biopsies were utilized to evaluate treatment safety and
» efficacy.
»
» Efficacy at 12 weeks with one Application of HSC
»
» cumulative thickness density (mm/cm2) p=0.0249
» thickness mean (um) p=0.0402
» terminal hair density (n/cm2) p=0.0029
»
»
»
» 84.6% of the patients receiving one injection of Histogen's serum-free HSC
» showed an increase in terminal hair 12 weeks post-injection, with a
» statistically significant (p<0.05) increase in the number of terminal
» hairs, cumulative hair thickness density and hair thickness mean.
» Perturbation did not enhance the results seen with HSC. There were no
» adverse reactions seen in any of the treated 24 patients at baseline, 12
» weeks, or the 22 week endpoint.
»
» "We are excited that our trial demonstrated safety and efficacy of our HSC
» product, which contains Wnt proteins and other growth factors important to
» hair follicle maintenance and growth," said Dr. Gail K. Naughton, CEO of
» Histogen. "Wnt signaling has been shown by a number of experts in the field
» to be responsible for initiating epidermal stem cells to form new hair
» follicles in mice, and to be important in maintaining the hair inducing
» activity from existing follicles. Histogen's trial is the first
» demonstration that compounds containing bioactive Wnt increase hair growth
» in humans."
»
» While additional clinical evaluation is needed to further examine product
» safety, efficacy and treatment specifications, the preliminary clinical
» trial of HSC represents a potentially significant new treatment option for
» the millions suffering from hair loss. Of the 87 million people in the
» United States that suffer from hair loss, it is estimated that only 2-7%
» seek surgical or pharmacological treatment. The same is true
» internationally due to the general lack of effective medical options for
» this widespread condition.
»
» "Hair restoration treatments range in effectiveness and invasiveness. All
» of the current treatment options share the common goal of saving and
» redistributing existing hairs," said Dr. Craig Ziering. "For the millions
» of men and women who grapple every day with their hair loss, the results of
» our HSC trial indicate the potential for a phenomenal treatment option that
» stimulates growth of new hairs along with increasing the thickness of
» existing hairs. Histogen's HSC represents a potentially major paradigm
» shift from conventional treatment options to one that can promote the
» growth of new or dormant hairs using principles of the body's own
» regenerative mechanisms."
»
» About Histogen
»
» Histogen, launched in 2007, seeks to redefine regenerative medicine by
» developing a series of high value products that do not contain embryonic
» stem cells or animal components. Through Histogen's proprietary bioreactors
» that mimic the embryonic environment, newborn fibroblasts are encouraged to
» naturally produce the vital proteins and growth factors from which the
» Company has developed its rich product portfolio. Histogen has two product
» families - a proprietary liquid complex of embryonic-like proteins and
» growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.
Spanish Dude is located in [NA] and he is available to meet: NO |
rev
your nightmares,
10.08.2009, 13:43
@ ymail
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » » » I hope you people realize this product is more than likely already
» on
» » » the
» » » » market as a skin wrinkle cream....
» » »
» » » Do you mean this ? :
» » »
» » » http://www.histogenaesthetics.com/products.htm
» »
» » Yes, the product uses the same growth factors. The hair trials however
» » were done by injecting the growth factors. Don't know the dalton size
» of
» » the growth factors and there ability to penetrate to the follicles via
» » topical non-injection application.
»
» How do you know that? If that is true... We can try to use it with a
» dermaroller and the cream to see what happens.
There's a guy on hlt doing exactly what you suggested.
Go to hlt, and look for posts by 'epictetus'
rev is located in YOUR NIGHTMARES and he is available to meet: NO ---
"Especially important is the warning to avoid conversations with the shill. We may ask what is relevant but anything beyond that is dangerous. He is a liar. The shill is a liar. He will lie to confuse us. But he will also mix lies with the truth to attack us. The attack is psychological, and powerful. So don't listen to him. Remember that - do not listen. " |
p
10.08.2009, 19:56
@ rev
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» There's a guy on hlt doing exactly what you suggested.
» Go to hlt, and look for posts by 'epictetus'
Thanks for the heads-up, Rev!
@Rooster:
How do you know the growth factors are the same? Was that just an assumption on your behalf or is there some verification or other explanation to that claim? (See my post above about fibroblasts and GF extraction.)
p is located in [NA] and he is available to meet: NO |
cal
11.08.2009, 05:34
@ p
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
This is getting interesting fast.
cal is located in [NA] and he is available to meet: NO |
News
13.08.2009, 04:40
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
I would like to know how Dr. Naughton (or any of the other doctors involved in HM research) sees the future of hair growth products. And I don't just want to know whether there's gonna be a product in 5 years. I'd like to know whether doctors Naughton & Co. think the first HM product will be the "silver bullet" we've all been waiting for, or whether it's gonna be a more gradual process, with - for example - the first products being used as "fillers" after a hair transplant. I'd also like to know what they think can be achieved in 10, 20, 30 years.
News is located in [NA] and he is available to meet: NO |
cal
13.08.2009, 09:32
@ News
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
I'm no qualified doctor but I really wanna weigh in on this issue.
IMHO there won't be much of an "early HM" stage. I think it's probably gonna be all or nothing and the first real HM will fix most baldness.
I'm sure Hangin or Sceptic or someone else would say I'm being way too optimistic. That it's only logical to assume it'll be weak for years/decades first because it's a whole new science, look at the development of transplants, etc.
But optimism is not what is driving my feelings here. If anything it's pessimism.
I agree that the idea of a "baby steps" HM progression makes perfect sense in theory. But IMHO we should already be well into this process.
-- We've studied follicles off and on for years. Decades really.
-- We've tried better nutrition.
-- We've tried better environmental factors.
-- We've tried unclogging follicles with harsher shampoos and skin dermabrasions/exfoliations.
-- We've tried Minoxidil and lots of other possible growth stimulants.
-- We've actually tried cutting the supply of the main harmful androgen down way below the levels of any normal male, and what has that gotten us? It doesn't even succeed in halting the worsening of the condition, let alone help it any!
The picture I see developing is that MPB is a terrorist that we cannot negotiate with. It will continue to blow through any and all attempts to fight it or cope with it. We will get no meaningful progress in the direction we want until we completely demolish its ability to function. At which point, we will get TOTAL progress in the direction we want.
With HM in the works right now, I see that "totally demolish MPB's ability to function" stage coming. Researchers aren't trying to fight this thing anymore. They have resorted to just flat-out changing the relevant DNA of the affected follicles (in the form of dermal papillae cell transfers from MPB-resistant donor follicles). The other primary method of HM is to literally wipe the slate clean, forget about fixing the existing MPB at all, and just force the body to re-create all new follicles from scratch.
So either way, they are no longer negotiating with MPB as if it was any mere "problem" to be minimized. The mindset with all forms of HM research these days seems to be that MPB must be completely blown out of the water or we can forget about achieving even one inch of progress against it. The one single upside to this situation is that when something finally does work, then it's gonna REALLY, REALLY work. Because there just isn't any more room in the playbook for actions of a less radical nature.
I know hair transplants came a long way from 1960s 4mm plugs to modern FUE grafting. But I think a better analogy to HM would be if every HT attempt had been failing miserably from the 1960s, punch-grafting, micros, minis, strips, strip megasessions . . . all the way up until single-graft FUE work showed up in the 2000s and suddenly worked beautifully.
cal is located in [NA] and he is available to meet: NO |
nsmnyc
13.08.2009, 15:58
@ HairSite
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
Hi, I read almost all relevant topics, so I have been following all questions and postings. My question is, there seems to be enough relevant questions now, ones that would even answer some of my thoughts, so is there a timeline on when we might submit and get response? I am sure we all would like to know her thoughts. Btw, I have spoken to her previously on the phone and in email, she is a very kind and forthcoming lady, and I can only thank her for going this extra step. Thank you as well.
» Dr. Gail Naughton of Histogen has agreed to do a small Q&A with our
» community. The Q&A will be limited to approximately 10 questions. Forum
» members are welcome to submit your questions in this thread, in an orderly
» fashion. Kindly note that Dr. Naughton has NO OBLIGATION to answer
» each and every question submitted here. Please be respectful with your
» questions and stay on topic.
»
» For those who are not familiar with Histogen's Hair Stimulating Complex
» (HSC) clinical trial, please read the following press release.
»
» ===========================================================
»
» Histogen Hair Regrowth Clinical Trial Presented at ISHRS Annual
» Meeting
» Data shows statistical significance at three key efficacy
» endpoints
»
» SAN DIEGO, July 27, 2009 - Histogen, Inc., a regenerative medicine company
» developing solutions based on the products of newborn fibroblasts grown
» under embryonic conditions, shared the results of the Company's preliminary
» clinical trial of Histogen's HSC human hair regrowth product for the first
» time at the International Society of Hair Restoration Surgeons (ISHRS)
» Annual Scientific Meeting. Dr. Craig Ziering, founder of Ziering Medical
» and principal investigator on the clinical trial, addressed attendees on
» July 25th, 2009 during the conference, taking place in Amsterdam July
» 22-26, 2009.
»
» Patients treated with Histogen's Hair Stimulating Complex (HSC)
»
»
» 3 months
» Hair count + 22.4%
» Terminal hair + 27.8%
» Thickness + 23.9%
»
»
»
» ==============================
»
» 3 months
» Hair count + 23.7%
» Terminal hair + 24.2%
» Thickness + 22.2%
»
»
»
» HSC is a proprietary formulation of naturally secreted embryonic proteins,
» growth factors and contains the first naturally stabilized, bioactive
» solution of Wnt proteins and their cofactors, which have been implicated in
» the induction of new hair follicle formation and growth.
»
» The five-month double-blind, placebo-controlled clinical trial was focused
» on evaluation of safety in the clinical application of Histogen's Hair
» Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject
» clinical trial was designed to examine the safety and efficacy of a single
» injection of HSC alone, as well as in combination with three different
» perturbation methods. Quantitative analysis of clinical macrophotography
» and subject biopsies were utilized to evaluate treatment safety and
» efficacy.
»
» Efficacy at 12 weeks with one Application of HSC
»
» cumulative thickness density (mm/cm2) p=0.0249
» thickness mean (um) p=0.0402
» terminal hair density (n/cm2) p=0.0029
»
»
»
» 84.6% of the patients receiving one injection of Histogen's serum-free HSC
» showed an increase in terminal hair 12 weeks post-injection, with a
» statistically significant (p<0.05) increase in the number of terminal
» hairs, cumulative hair thickness density and hair thickness mean.
» Perturbation did not enhance the results seen with HSC. There were no
» adverse reactions seen in any of the treated 24 patients at baseline, 12
» weeks, or the 22 week endpoint.
»
» "We are excited that our trial demonstrated safety and efficacy of our HSC
» product, which contains Wnt proteins and other growth factors important to
» hair follicle maintenance and growth," said Dr. Gail K. Naughton, CEO of
» Histogen. "Wnt signaling has been shown by a number of experts in the field
» to be responsible for initiating epidermal stem cells to form new hair
» follicles in mice, and to be important in maintaining the hair inducing
» activity from existing follicles. Histogen's trial is the first
» demonstration that compounds containing bioactive Wnt increase hair growth
» in humans."
»
» While additional clinical evaluation is needed to further examine product
» safety, efficacy and treatment specifications, the preliminary clinical
» trial of HSC represents a potentially significant new treatment option for
» the millions suffering from hair loss. Of the 87 million people in the
» United States that suffer from hair loss, it is estimated that only 2-7%
» seek surgical or pharmacological treatment. The same is true
» internationally due to the general lack of effective medical options for
» this widespread condition.
»
» "Hair restoration treatments range in effectiveness and invasiveness. All
» of the current treatment options share the common goal of saving and
» redistributing existing hairs," said Dr. Craig Ziering. "For the millions
» of men and women who grapple every day with their hair loss, the results of
» our HSC trial indicate the potential for a phenomenal treatment option that
» stimulates growth of new hairs along with increasing the thickness of
» existing hairs. Histogen's HSC represents a potentially major paradigm
» shift from conventional treatment options to one that can promote the
» growth of new or dormant hairs using principles of the body's own
» regenerative mechanisms."
»
» About Histogen
»
» Histogen, launched in 2007, seeks to redefine regenerative medicine by
» developing a series of high value products that do not contain embryonic
» stem cells or animal components. Through Histogen's proprietary bioreactors
» that mimic the embryonic environment, newborn fibroblasts are encouraged to
» naturally produce the vital proteins and growth factors from which the
» Company has developed its rich product portfolio. Histogen has two product
» families - a proprietary liquid complex of embryonic-like proteins and
» growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.
nsmnyc is located in [NA] and he is available to meet: NO |
ymail
13.08.2009, 17:34
@ rev
|
Q&A with Dr. Gail Naughton on Histogen's Hair Regrowth Trial |
» » » » » I hope you people realize this product is more than likely already
» » on
» » » » the
» » » » » market as a skin wrinkle cream....
» » » »
» » » » Do you mean this ? :
» » » »
» » » » http://www.histogenaesthetics.com/products.htm
» » »
» » » Yes, the product uses the same growth factors. The hair trials
» however
» » » were done by injecting the growth factors. Don't know the dalton
» size
» » of
» » » the growth factors and there ability to penetrate to the follicles
» via
» » » topical non-injection application.
» »
» » How do you know that? If that is true... We can try to use it with a
» » dermaroller and the cream to see what happens.
»
» There's a guy on hlt doing exactly what you suggested.
» Go to hlt, and look for posts by 'epictetus'
Thank you! I will try to search his posts and follow his treatment.
ymail is located in [NA] and he is available to meet: NO |
Spanish Dude
15.08.2009, 05:33
@ HairSite
|
Important Q: How many injections needed for a very bald person? |
I am going to insist a little on the subject of number of injections.
We have been told about "single injections", but this could be misleading.
The "single injection" was just to treat a small area of the scalp.
IMO, If you want to try the whole scalp, you will need multiple injections.
For example, I guess, a dozen injections.
Q: would you please tell us how many injections will be required for treating a 10cmx10cm area of bald scalp?
And another question (repeated):
Q: is HSC capable of treating totally bald areas? have you tested it on totally bald areas, that have been depleted of hair for many years?
Spanish Dude is located in [NA] and he is available to meet: NO |
baldlatino34
15.08.2009, 07:08
@ Spanish Dude
|
Important Q: How many injections needed for a very bald person? |
» Q: is HSC capable of treating totally bald areas? have you tested it on
» totally bald areas, that have been depleted of hair for many years? ..........................[color=blue][/color](THIS IS THE BEST QUESTION)...
baldlatino34 is located in [NA] and he is available to meet: NO |
alopecia
13.09.2009, 19:56
@ HairSite
|
releasing outside US |
One more question:
When can we expect the release of their product outside US? When it could be possible?, after second phase? What is the realistic timeline of releasing outside US?
Can they tell us more about this process
alopecia is located in [NA] and he is available to meet: NO |
alopecia
13.09.2009, 19:57
@ alopecia
|
releasing outside US |
ok
alopecia is located in [NA] and he is available to meet: NO |
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