I am waiting for Histogen\'s final results

Stem cell; cell based hair therapy
41

» I feel they have nothing big to post. otherwise they would have updated
» their website by now. I hope I am wrong.
» anyway, give me Naughton’s email. I think it was posted here previously.
»
» take a breather? it is funny. a forum that is full of idiotic posts, and
» now that there is something worthy to watch, people seem
» unresponsive/apathic.

Eileen Naughton Brandt
enaughton at histogeninc dot com
I dealt with here before. She’s not the CEO, but she always responds to emails… logical ones anyways.

42

» » I feel they have nothing big to post. otherwise they would have updated
» » their website by now. I hope I am wrong.
» » anyway, give me Naughton’s email. I think it was posted here
» previously.
» »
» » take a breather? it is funny. a forum that is full of idiotic posts,
» and
» » now that there is something worthy to watch, people seem
» » unresponsive/apathic.
»

Here’s the first article.
http://www.prweb.com/releases/Histogen/HairRegrowth/prweb2679084.htm

43

» » » I feel they have nothing big to post. otherwise they would have
» updated
» » » their website by now. I hope I am wrong.
» » » anyway, give me Naughton’s email. I think it was posted here
» » previously.
» » »
» » » take a breather? it is funny. a forum that is full of idiotic posts,
» » and
» » » now that there is something worthy to watch, people seem
» » » unresponsive/apathic.
» »
»
» Here’s the first article.
» http://www.prweb.com/releases/Histogen/HairRegrowth/prweb2679084.htm

There’re larger photos and graphics on his website:

http://www.histogeninc.com/aboutus/news_events.htm#23

Anyone knows if they said something about cumulative results? It’s promising the fact that the count, terminal hairs and thickness increases all together.

44

good stuff, I didn’t know that Histogen is testing an all natural substance

"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.

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. "

45

Aren’t these the same pictures that were posted here before?

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%

46

» Aren’t these the same pictures that were posted here before?

Unfortunately, the 12 week (3 month) pictures were posted months ago already.

The only thing that I don’t remember seeing is that graph with the results and some of the stats.

All in all, a pretty weak update, IMO.

Possibly they didn’t include 5 month data in this release because it didn’t show any improvement over the 3 month data. I would prefer to see the 5 month data as well, just to be sure the results don’t disappear quickly. The 3 month results could be sufficient, if the stats are real and

  1. The process is repeatable
    and/or
  2. The dose response curve is not too flat.

After all, the 3 month results were based on a single injection.

47

Yeah I remember seeing these pics already in the forum. I think what’s impressive is that they are after only 1 injection, I didn’t realize that till now.

48

Thanks Rev.
As others have posted, the 12 weeks data is old data. I am going to email Naughton asking for the 22 weeks data.
The article says that none of the 3 perturbation methods made any benefit. I assume these are dermabrasion stuff???

Still, it is wonderful that a single injection in five months brings any benefit to all the scalp. I would like to confirm this. Is it really a single injection in 5 months? If this is the case, this would mean HUGE SAVINGS in terms of time and money. If they can fine-tune the formulation and increase the results, this will be the real holy grail in this field.

» » » I feel they have nothing big to post. otherwise they would have
» updated
» » » their website by now. I hope I am wrong.
» » » anyway, give me Naughton’s email. I think it was posted here
» » previously.
» » »
» » » take a breather? it is funny. a forum that is full of idiotic posts,
» » and
» » » now that there is something worthy to watch, people seem
» » » unresponsive/apathic.
» »
»
» Here’s the first article.
» http://www.prweb.com/releases/Histogen/HairRegrowth/prweb2679084.htm

49

Title of my mail:
“Its SpanishDude from Hairsite. Questions about HSC-Regenica results.”

Body of my mail:
Hello Dr. Naughton:

I am SpanishDude at Hairsite forums.
I have read the information derived from the ISHRS meting last Saturday, about HSC (ie. Regenica).
I have 3 questions for you. if you were so kind to help me clarify these things…:

  1. Is it true that Regenica is just a single injection in the whole scalp? And this injection is not repeated along the 5-month trial? I am so amazed about this,
    that I need to confirm.

2a.Histogen’s website says that “perturbation” did not enhance the results seen with HSC. Does that mean that none of the 3 perturbation methods used in
conjunction with Regenica showed any benefit? In other words, the injection is the only thing that works?
2b. Basically, what are these perturbation methods? Dermabrasion?

  1. We were hoping to see data at the 22-weeks timepoint, but apparently, Dr. Ziering only showed data at 12 weeks at the ISHRS. This data was already available months ago,
    so no new data was revealed. Can you tell us something about the data at 22 weeks?

This is all for now.
I am posting at Hairsite HM forum, so its possible that I post about your reply in this forum. If you don’t want me to post something about your reply, please specify so.

Thank you.
Best regards
Spanish Dude

» Thanks Rev.
» As others have posted, the 12 weeks data is old data. I am going to email
» Naughton asking for the 22 weeks data.
» The article says that none of the 3 perturbation methods made any benefit.
» I assume these are dermabrasion stuff???
»
» Still, it is wonderful that a single injection in five months brings any
» benefit to all the scalp. I would like to confirm this. Is it really a
» single injection in 5 months? If this is the case, this would mean HUGE
» SAVINGS in terms of time and money. If they can fine-tune the formulation
» and increase the results, this will be the real holy grail in this
» field.
»
»
»
» » » » I feel they have nothing big to post. otherwise they would have
» » updated
» » » » their website by now. I hope I am wrong.
» » » » anyway, give me Naughton’s email. I think it was posted here
» » » previously.
» » » »
» » » » take a breather? it is funny. a forum that is full of idiotic
» posts,
» » » and
» » » » now that there is something worthy to watch, people seem
» » » » unresponsive/apathic.
» » »
» »
» » Here’s the first article.
» » http://www.prweb.com/releases/Histogen/HairRegrowth/prweb2679084.htm

50

» » » I feel they have nothing big to post. otherwise they would have
» updated
» » » their website by now. I hope I am wrong.
» » » anyway, give me Naughton’s email. I think it was posted here
» » previously.
» » »
» » » take a breather? it is funny. a forum that is full of idiotic posts,
» » and
» » » now that there is something worthy to watch, people seem
» » » unresponsive/apathic.
» »
»
» Here’s the first article.
» http://www.prweb.com/releases/Histogen/HairRegrowth/prweb2679084.htm

The best thing about this is it proves the increasing WNT in humans increases hair. Which means follica should be sucessful. Plus they are attacking the problem from so many angles.

51

» Title of my mail:
» “Its SpanishDude from Hairsite. Questions about HSC-Regenica results.”
»
» Body of my mail:
» Hello Dr. Naughton:
»
» I am SpanishDude at Hairsite forums.
» I have read the information derived from the ISHRS meting last Saturday,
» about HSC (ie. Regenica).
» I have 3 questions for you. if you were so kind to help me clarify these
» things…:
»
» 1. Is it true that Regenica is just a single injection in the whole scalp?
» And this injection is not repeated along the 5-month trial? I am so amazed
» about this,
» that I need to confirm.
»
» 2a.Histogen’s website says that “perturbation” did not enhance the results
» seen with HSC. Does that mean that none of the 3 perturbation methods used
» in
» conjunction with Regenica showed any benefit? In other words, the
» injection is the only thing that works?
» 2b. Basically, what are these perturbation methods? Dermabrasion?
»
» 3. We were hoping to see data at the 22-weeks timepoint, but apparently,
» Dr. Ziering only showed data at 12 weeks at the ISHRS. This data was
» already available months ago,
» so no new data was revealed. Can you tell us something about the data at
» 22 weeks?
»
» This is all for now.
» I am posting at Hairsite HM forum, so its possible that I post about your
» reply in this forum. If you don’t want me to post something about your
» reply, please specify so.
»
» Thank you.
» Best regards
» Spanish Dude
»
»
»
» » Thanks Rev.
» » As others have posted, the 12 weeks data is old data. I am going to
» email
» » Naughton asking for the 22 weeks data.
» » The article says that none of the 3 perturbation methods made any
» benefit.
» » I assume these are dermabrasion stuff???
» »
» » Still, it is wonderful that a single injection in five months brings
» any
» » benefit to all the scalp. I would like to confirm this. Is it really a
» » single injection in 5 months? If this is the case, this would mean HUGE
» » SAVINGS in terms of time and money. If they can fine-tune the
» formulation
» » and increase the results, this will be the real holy grail in this
» » field.
» »
» »
» »
» » » » » I feel they have nothing big to post. otherwise they would have
» » » updated
» » » » » their website by now. I hope I am wrong.
» » » » » anyway, give me Naughton’s email. I think it was posted here
» » » » previously.
» » » » »
» » » » » take a breather? it is funny. a forum that is full of idiotic
» » posts,
» » » » and
» » » » » now that there is something worthy to watch, people seem
» » » » » unresponsive/apathic.
» » » »
» » »
» » » Here’s the first article.
» » » http://www.prweb.com/releases/Histogen/HairRegrowth/prweb2679084.htm

GOOD JOB, I have other questions too but let’s see if she responds to this one first.

52

» The best thing about this is it proves the increasing WNT in humans
» increases hair. Which means follica should be sucessful. Plus they are
» attacking the problem from so many angles.

True and above all, the icing on the cake is that it only took 1 injection to achieve the results in those pictures, I think many of us didn’t realize that it was done with 1 injection only. I certainly missed that when I read their report a few months ago.

53

» » The best thing about this is it proves the increasing WNT in humans
» » increases hair. Which means follica should be sucessful. Plus they
» are
» » attacking the problem from so many angles.
»
» True and above all, the icing on the cake is that it only took 1 injection
» to achieve the results in those pictures, I think many of us didn’t realize
» that it was done with 1 injection only. I certainly missed that when I read
» their report a few months ago.

Yes it’s great that with only one injection they can reach this efficiency. One “bad” news… if we go to http://www.histogeninc.com/products/hsc.htm we can read… “Estimated market introduction of the injectable for hair regrowth is 2015”. It’s the normal timetable… but we always want to the have the cure now… not five years away.

54

If they’re talking about doing a full 3-stage FDA trial before it gets to market, then it’s more like 10 years off than 5 years. That’s how long the trials really take no matter what anyone says to the contrary. This isn’t pessimism, it’s fact.

55

» If they’re talking about doing a full 3-stage FDA trial before it gets to
» market, then it’s more like 10 years off than 5 years. That’s how long the
» trials really take no matter what anyone says to the contrary. This isn’t
» pessimism, it’s fact.

This was posted by someone else on another message board about trials.

I was doing some research about clinical trials the other day to dispel a lot of the rumors I had been hearing. As it turns out “research studies”, “clinical research”, and “human proof of concept studies” can all be used interchangeably for Phase 1 and Phase 2 clinical trials. Once these are done, Phase 3 takes about another year in most cases. Most of us, because we are so concerned, would be perfect candidates for Phase 3 and can have access to these treatments before they ever hit the market.

I don’t know how this is misconstrued as optimism. I am well aware, and have said repeatedly, that companies in Phase 2 often fail. But companies in Phase 2 also never take 10 years to market. This is just factual, it’s not “hopeful.”

56

Suit yourself.

But, thinking you’ll be in the phase#3 trials? You and every other guy who is wrapped up about his MPB. There are millions of us.

Just look at the trials for ICX-TRC. All I ever heard around here is how fast it should happen, and then how they were always missing deadline after deadline. Right? Except that when you stand back and look at the big picture, they took about 2/3rds of a decade to get through 2 stages of the 3. So were their trials really “falling behind” all the time, or were we just deluding ourselves about the real timeline for the trials process?

57

This might be a stupid question, but are the trials they’ve been doing (the ones they’ve just reported on) Phase 1?

Or were they just “pre-FDA approval process” unofficial trials? I know they were just testing for safety etc but I was wondering if they could use these trials as Phase 1 if they wanted to? I know Phase 1 is normally small-scale and normally to do with safety but there certainly doesn’t seem to be much difference involved between the number of triallists in this trial and say, for example, the number of triallists in ICX’s Phase 1 trial.

58

Dr. Naughton has replied to me, approx. 3 hours after I emailed her!!
The reply was a provisional one, until she gets official answers to all the questions.
I think I can post this first reply, as it doesn’t seem to contain any compromising info, and Eileen didn’t specify any objection.

REPLY:

Hi! On your first question, subject scalps were divided into 4 treatment areas, each area receiving a single injection of HSC at the baseline timepoint.

I will have to get back to you with official responses to your other questions a bit later, but I did want to follow-up to let you know that your inquiry was received.

Thank you, and I look forward to providing further information soon.

Eileen

My comment (SD comment):
Regarding the subject of single injection:
As Dr. Naughton says, the scalp was divided in 4 test areas, and each one received a single injection. I have uploaded a image contained in an Histogen PDF:
contained

I think this image shows clearly that the scope of action of a single injection is limited to a diameter of a few centimeters. And thus, I think, a whole bald scalp would require a dozen or more injections.
Not a big deal, of course. Just compare with cell therapy (ICX, ARI), where you neeed thousands of injections (one per hair).
Also, I assume that the HSC (Regenica) injections are less stringent in regards of precise depth of injection as it is required in cell therapy.

» » Title of my mail:
» » “Its SpanishDude from Hairsite. Questions about HSC-Regenica results.”
» »
» » Body of my mail:
» » Hello Dr. Naughton:
» »
» » I am SpanishDude at Hairsite forums.
» » I have read the information derived from the ISHRS meting last
» Saturday,
» » about HSC (ie. Regenica).
» » I have 3 questions for you. if you were so kind to help me clarify
» these
» » things…:
» »
» » 1. Is it true that Regenica is just a single injection in the whole
» scalp?
» » And this injection is not repeated along the 5-month trial? I am so
» amazed
» » about this,
» » that I need to confirm.
» »
» » 2a.Histogen’s website says that “perturbation” did not enhance the
» results
» » seen with HSC. Does that mean that none of the 3 perturbation methods
» used
» » in
» » conjunction with Regenica showed any benefit? In other words, the
» » injection is the only thing that works?
» » 2b. Basically, what are these perturbation methods? Dermabrasion?
» »
» » 3. We were hoping to see data at the 22-weeks timepoint, but
» apparently,
» » Dr. Ziering only showed data at 12 weeks at the ISHRS. This data was
» » already available months ago,
» » so no new data was revealed. Can you tell us something about the data
» at
» » 22 weeks?
» »
» » This is all for now.
» » I am posting at Hairsite HM forum, so its possible that I post about
» your
» » reply in this forum. If you don’t want me to post something about your
» » reply, please specify so.
» »
» » Thank you.
» » Best regards
» » Spanish Dude
» »
» »
» »
» » » Thanks Rev.
» » » As others have posted, the 12 weeks data is old data. I am going to
» » email
» » » Naughton asking for the 22 weeks data.
» » » The article says that none of the 3 perturbation methods made any
» » benefit.
» » » I assume these are dermabrasion stuff???
» » »
» » » Still, it is wonderful that a single injection in five months brings
» » any
» » » benefit to all the scalp. I would like to confirm this. Is it really
» a
» » » single injection in 5 months? If this is the case, this would mean
» HUGE
» » » SAVINGS in terms of time and money. If they can fine-tune the
» » formulation
» » » and increase the results, this will be the real holy grail in this
» » » field.
» » »
» » »
» » »
» » » » » » I feel they have nothing big to post. otherwise they would have
» » » » updated
» » » » » » their website by now. I hope I am wrong.
» » » » » » anyway, give me Naughton’s email. I think it was posted here
» » » » » previously.
» » » » » »
» » » » » » take a breather? it is funny. a forum that is full of idiotic
» » » posts,
» » » » » and
» » » » » » now that there is something worthy to watch, people seem
» » » » » » unresponsive/apathic.
» » » » »
» » » »
» » » » Here’s the first article.
» » » »
» http://www.prweb.com/releases/Histogen/HairRegrowth/prweb2679084.htm
»
» GOOD JOB, I have other questions too but let’s see if she responds to this
» one first.

59

Lets get real. TRC doesn’t work. That is why the trials were so damn slow.
If TRC had been successful with astonishing results, there would have been plenty of money and trialists put into it, and the trials would have been done fast. Yes, in 5 years, why not. Its all a matter of money. And money goes where success is to be achieved.

» Suit yourself.
»
»
» But, thinking you’ll be in the phase#3 trials? You and every other guy
» who is wrapped up about his MPB. There are millions of us.
»
»
» Just look at the trials for ICX-TRC. All I ever heard around here is how
» fast it should happen, and then how they were always missing deadline after
» deadline. Right? Except that when you stand back and look at the big
» picture, they took about 2/3rds of a decade to get through 2 stages of
» the 3. So were their trials really “falling behind” all the time,
» or were we just deluding ourselves about the real timeline for the trials
» process?

60

I think regenica for skin is the same regenica hair!
What do you think?
Regenica for skin is at the marked!!!
Can we use it?
In europe too?