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’

» 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.)

This is getting interesting fast.

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.

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.

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.

» » » » » 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.

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?

» 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? …(THIS IS THE BEST QUESTION)…

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

ok

Please ask if histrogens technologie (regenica) will work for eyebrows. If regenica will be able to grow them back aswell to the length that eyebrow hair naturally grows too. Rather than the way it’s done now with eyebrow transplamts were they take scalp hair and transplant it to eyebrows and it continues to grow like head hair.

Thank you so much!

I haven’t been on here for a while. I can’t find the interview anywhere. Has it taken place yet?

» Please ask if histrogens technologie (regenica) will work for eyebrows. If
» regenica will be able to grow them back aswell to the length that eyebrow
» hair naturally grows too. Rather than the way it’s done now with eyebrow
» transplamts were they take scalp hair and transplant it to eyebrows and it
» continues to grow like head hair.
»
» Thank you so much!

virgo, if I remember correctly you once shaved your eyebrows and they haven’t grown back since right?

That’s probably because eyebrows grow slowly to a certain length and stay that for a few months. They are not like scalp hairs they don’t grow for 2-3 years continously. The problem is you’ve shaved your eyebrows, so most of your hair (below the skin) are still waiting for the cycle to finish before they’ll shove the current hair out and start with new ones. So they will grow back but may take a few more months. The other option is to someone pluck or wax them - basically take them out with roots. This will cause the follicles to go back into anagen phase immediately and start producing new hair - which you would see in a few weeks.

» » Please ask if histrogens technologie (regenica) will work for eyebrows.
» If
» » regenica will be able to grow them back aswell to the length that
» eyebrow
» » hair naturally grows too. Rather than the way it’s done now with
» eyebrow
» » transplamts were they take scalp hair and transplant it to eyebrows and
» it
» » continues to grow like head hair.
» »
» » Thank you so much!
»
» virgo, if I remember correctly you once shaved your eyebrows and they
» haven’t grown back since right?
»
» That’s probably because eyebrows grow slowly to a certain length and stay
» that for a few months. They are not like scalp hairs they don’t grow for
» 2-3 years continously. The problem is you’ve shaved your eyebrows, so most
» of your hair (below the skin) are still waiting for the cycle to finish
» before they’ll shove the current hair out and start with new ones. So they
» will grow back but may take a few more months. The other option is to
» someone pluck or wax them - basically take them out with roots. This will
» cause the follicles to go back into anagen phase immediately and start
» producing new hair - which you would see in a few weeks.

thank you goata! :lol3:

i hope your right

(bumping roger_that’s threads off the bottom of the page)

Hairsite - any idea when this interview is going to happen?

ide still like my question asked…

» (bumping roger_that’s threads off the bottom of the page)

lol thats cool ill help contribute

»
» 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?

Even if it can’t you can still increase your density where you DO have hair. Then, simply get a transplant into bare regions. If the results are compoundable for additional injections, then you essentially have an endless supply of donor hair.