Histogen Preliminary Hair Regrowth Clinical Results to be Presented Feb 17

Stem cell; cell based hair therapy
1

http://www.prweb.com/releases/Histogen/Hairtrial/prweb2069524.htm

New York (PRWEB) February 16, 2009 – Dr. Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, will address attendees tomorrow at the 4th Annual Stem Cell Summit in New York. Dr. Naughton will be presenting preliminary mid-trial results from Histogen’s first human clinical evaluation of ReGenicaTM for hair regrowth.

The primary objective of this double-blind, placebo-controlled, randomized study is to evaluate safety in the clinical application of the ReGenica product for hair regrowth. Histogen is also examining product efficacy as a secondary objective, specifically looking at the same end-points the Company has seen in the animal model - new hair growth, and the thickness of new and existing hair. The study is in progress, but the Company has reviewed data from the scheduled 12 week time point and is pleased with the results to date.

“Histogen’s clinical trial was designed to assess the safety of its product over a five month period,” commented Dr. Craig Ziering, principal investigator of the study and founder of Ziering Medical. “In addition to seeing no adverse reactions, we were delighted to see more hair, thicker hair shafts, and what appears to be the growth of completely new hair follicles in the areas that received the ReGenica treatment.”

ReGenica is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment, and then harvesting the naturally secreted embryonic wnt proteins, growth factors, and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors, which are thought to act in the formation of new hair follicles.

“Wnt signaling has been shown to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and is also important in maintaining the hair inducing activity from existing follicles,” said Frank Zeigler, General Manager at Histogen. “We are excited to be the first group to show these effects in a clinical setting using human WNT proteins.”

Histogen began this outside-U.S. study of ReGenica for hair regrowth in November, with the goal of more rapidly obtaining human safety data which will allow the Company to progress with product development. The trial is currently ongoing, and Histogen expects to release full results from this first clinical study in the first half of 2009.

Dr. Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. Dr. Naughton founded Histogen in 2007, and currently serves as Chief Executive Officer and Chairman of the Board for the Company, in addition to her position as Dean of the College of Business at San Diego State University.

BEFORE

AFTER 12 WEEKS

SIDE BY SIDE COMPARISON

2

» “Histogen’s clinical trial was designed to assess the safety of its
» product over a five month period,” commented Dr. Craig Ziering, principal
» investigator of the study and founder of Ziering Medical. “In addition
» to seeing no adverse reactions, we were delighted to see more hair, thicker
» hair shafts, and what appears to be the growth of completely new hair
» follicles in the areas that received the ReGenica treatment.”

IMHO, “appears” doesn’t sound very scientific

BTW, thank’s for the post.

3

» » “Histogen’s clinical trial was designed to assess the safety of its
» » product over a five month period,” commented Dr. Craig Ziering,
» principal
» » investigator of the study and founder of Ziering Medical. “In
» addition
» » to seeing no adverse reactions, we were delighted to see more hair,
» thicker
» » hair shafts, and what appears to be the growth of completely new hair
» » follicles in the areas that received the ReGenica treatment.”
»
»
» IMHO, “appears” doesn’t sound very scientific
»
» BTW, thank’s for the post.

I can totally see why they say “appears” How do you know you didn’t awaken dormant follicles instead of creating a brand new one?

4

Sounds promising. I’m glad to see some real science and proper research protocol, unlike ICX and Acell. Also, there are some photos that accompany that press release. 5 months and they release photos. How many YEARS has it been since ICX started hyping its snake oil? And still no photos from them.
Having looked at their site, Histogen seems to be on the up and up. Its an American company based in San Diego, so that’s a big plus. I guess we’ll know more in a year or so.

5

finally real photos with a real regrowth…

6

» finally real photos with a real regrowth…

Refreshing, isn’t it? Whether this works or not, its nice to see a company actually practicing good science.

I’m happy to see that two of the three front-runners are American companies. That should help cut down on the fraud that seems so prevalent in European biosciences.

7

» » finally real photos with a real regrowth…
»
» Refreshing, isn’t it? Whether this works or not, its nice to see a
» company actually practicing good science.

True. It would be good if other companies took note.

8

» » » finally real photos with a real regrowth…
» »
» » Refreshing, isn’t it? Whether this works or not, its nice to see a
» » company actually practicing good science.
»
» True. It would be good if other companies took note.

The other players (Follica, Adarens) are. They’re doing their trials in America, which means they will be required to follow a transparent methodology that will make them honestly report their results, unlike Europe, where it seems you can perpetrate borderline fraud without any repercussions (except for the total collapse of your stock prices and inevitable bankruptcy of your company).

9

Is it just me or are the hairs only longer in the second picture? I’m not seeing too much of an increase in density.

10

» Is it just me or are the hairs only longer in the second picture? I’m not
» seeing too much of an increase in density.

Length is the same, but they are certainly thicker. As to new hairs, SEEMS like there are more, but someone would have to do a count to confirm that.

11

» The other players (Follica, Adarens) are. They’re doing their trials in
» America, which means they will be required to follow a transparent
» methodology that will make them honestly report their results, unlike
» Europe, where it seems you can perpetrate borderline fraud without any
» repercussions

Americans are such hyprocrites, if there is good regulation and transparency in the US, we wouldn’t have a global depression like we are having now, people around the world are losing their jobs and homes all because of the American greed, lack of transparency and lack of regulation.

12

» » The other players (Follica, Adarens) are. They’re doing their trials in
» » America, which means they will be required to follow a transparent
» » methodology that will make them honestly report their results, unlike
» » Europe, where it seems you can perpetrate borderline fraud without any
» » repercussions
»
» Americans are such hyprocrites, if there is good regulation and
» transparency in the US, we wouldn’t have a global depression like we are
» having now, people around the world are losing their jobs and homes all
» because of the American greed, lack of transparency and lack of regulation.

Right, because drawing parallels between two TOTALLY DIFFERENT INDUSTRIES is a perfectly logical way to construct a cogent argument.

What Europe has contributed to hairloss research:

  1. Gho
  2. ICX
  3. That wackjob from Oxford

What the States has contributed:

  1. Follica
  2. Aderans (Japanese company, US researcher)
  3. Histogen
13

» » » The other players (Follica, Adarens) are. They’re doing their trials
» in
» » » America, which means they will be required to follow a transparent
» » » methodology that will make them honestly report their results, unlike
» » » Europe, where it seems you can perpetrate borderline fraud without
» any
» » » repercussions
» »
» » Americans are such hyprocrites, if there is good regulation and
» » transparency in the US, we wouldn’t have a global depression like we
» are
» » having now, people around the world are losing their jobs and homes all
» » because of the American greed, lack of transparency and lack of
» regulation.
»
» Right, because drawing parallels between two TOTALLY DIFFERENT INDUSTRIES
» is a perfectly logical way to construct a cogent argument.
»
» What Europe has contributed to hairloss research:
»
» 1. Gho
» 2. ICX
» 3. That wackjob from Oxford
»
» What the States has contributed:
»
» 1. Follica
» 2. Aderans (Japanese company, US researcher)
» 3. Histogen

Don’t forget it’s the American greed and irresponsibility that caused global economic crisis, it’s the Americans who fraudaulently packaged the sub prime mortgages and lied about the quality of the investments to the rest of the world, talk about fraud, the same fradaulent and unethical mentality perpetuate in all Americans, the health, medical and research industries are no exception.

14

» » » » The other players (Follica, Adarens) are. They’re doing their
» trials
» » in
» » » » America, which means they will be required to follow a transparent
» » » » methodology that will make them honestly report their results,
» unlike
» » » » Europe, where it seems you can perpetrate borderline fraud without
» » any
» » » » repercussions
» » »
» » » Americans are such hyprocrites, if there is good regulation and
» » » transparency in the US, we wouldn’t have a global depression like we
» » are
» » » having now, people around the world are losing their jobs and homes
» all
» » » because of the American greed, lack of transparency and lack of
» » regulation.
» »
» » Right, because drawing parallels between two TOTALLY DIFFERENT
» INDUSTRIES
» » is a perfectly logical way to construct a cogent argument.
» »
» » What Europe has contributed to hairloss research:
» »
» » 1. Gho
» » 2. ICX
» » 3. That wackjob from Oxford
» »
» » What the States has contributed:
» »
» » 1. Follica
» » 2. Aderans (Japanese company, US researcher)
» » 3. Histogen
»
» Don’t forget it’s the American greed and irresponsibility that caused
» global economic crisis, it’s the Americans who fraudaulently packaged the
» sub prime mortgages and lied about the quality of the investments to the
» rest of the world, talk about fraud, the same fradaulent and unethical
» mentality perpetuate in all Americans, the health, medical and research
» industries are no exception.

Thanks for that totally unsubstantiated and irrational rant bereft of any reference or footnote to fact. Now will you please posit your nonsensical fury in the off-topic forum and stop jacking this thread? We’re trying to discuss Histogen, not ignorant jingoism.

15

» » Is it just me or are the hairs only longer in the second picture? I’m
» not
» » seeing too much of an increase in density.
»
» Length is the same, but they are certainly thicker. As to new hairs,
» SEEMS like there are more, but someone would have to do a count to confirm
» that.

To me it does seem like the hair is longer, it is definitely thicker though.

Your righ that there does ‘seem’ to be more hair, but that could be just be an illusion caused by the hair being thicker/longer.
I Agree a hair count needs to be done (I’m assuming it’s the same spot and the same angle in the pics).
Someone should over lap them in photoshop because the more I look at them they don’t seem to line up. However some patches do seem more dense in the 2nd pic, but that could just be my eyes playing tricks.

This is aimed at everyone.
Can we keep this on topic please people? this appears to be good news, could we just appreciate that and not start arguments and turn this into another thread of pointless spam/drivel and slanging matches please?
If you have a problem with individual posters, the worlds economy or how individual businesses, countries/nations/continents choose to run themselves please take it to off topic, thanks)

16

If those photos are an accurate representation of typical response to the treatment after only 12 weeks, I must say I’m very impressed!

However, a concern is that the photos are of the best responder in the trial and don’t represent the average result. Also, as far as I can tell, the photos are not taken in the same spot. For all we know, the photos might not even be of the same person, but that notion is a bit paranoid. But even if they are of the same person, which I assume they are, hair density and thickness can vary greatly across the scalp.

Very interesting anyway! Refreshing!

17

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At first I thought it was really good growth but now I am not sure if it was just the hair growing long?? Anyway it’s good to see some pictures.

19

» If those photos are an accurate representation of typical response to the
» treatment after only 12 weeks, I must say I’m very impressed!
»
» However, a concern is that the photos are of the best responder in the
» trial and don’t represent the average result. Also, as far as I can tell,
» the photos are not taken in the same spot. For all we know, the photos
» might not even be of the same person, but that notion is a bit paranoid.
» But even if they are of the same person, which I assume they are, hair
» density and thickness can vary greatly across the scalp.
»
» Very interesting anyway! Refreshing!

After reviewing the press release, it is clear that they are indeed of the same subject and in the same region of the scalp albeit perhaps not in the exact same spot.

Photo descriptions:

Subject 007. Right Anterior at Baseline - Active

and

“Subject 007. Right Anterior at 12 week timepoint - Active”

Also, for anyone wanting higher resulotion images, they are attached in the press release above (see link).

Another possible concern is the zoom factor. Are the photos taken at the same distance? Do the strands appear thicker and longer simply because the 12-week photo is closer to the camera?

20

»

ok there clearly is more hair growing, and some of thehair is thickened.

on the other hand though, its obvious that in the before pic, the hair is cut shorter so the result looks a lot better then it actually is.

anyway, its better thn nothing. I like the results, looks good for me to go for it once they start selling it.