Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

[Artista]

Im looking into it..a possible intermediate treatment til the long term regenerative treatments arrive.

[534623]

Originally Posted by Dr. Craig Ziering

Histogen's HSC study showed a statistically significant increase in the number of terminal hairs and hair thickness at 12 weeks. At the five month timepoint there was a decrease in hairs in a number of patients, but a significant increase again at 12 months, with the number of new hairs again reaching statistical significance at one year. There were approximately 25 new hairs per 0.1cc injection and the treatment effect was seen within 2mm of the injection site.

The HSC works by stimulating stem cells in the dermal papilla of the hair follicle to grow new hairs. It also seems that stem cells in the scalp can be stimulated to grow into new hair follicles. This has been shown to be possible in the mouse model using the components that are part of HSC and so Histogen's trial really substantiates in patients with male pattern baldness what has been shown to be possible in mice for the past few years.

Doc Z

Tomorrow, Friday, October 19, 2012 (10:18AM-10:30AM),

Dr. Gail Naughton is going to present the following topic at the currently running ISHRS meeting:

Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors

Recently, we had a small discussion (in another context) about her presented and finally published HSC results/data during the SID Annual Meeting:

http://www.histogen.com/downloads/si..._HSC_Final.pdf

Anyway …



I think the presented data during the SID meeting needs CLARIFICATION, because, as you can see (and review) yourself, the presented data simply DON’T reflect the reality!

Hopefully (maybe?) Dr. Ziering can chime in here to answer as well ...

[The Alchemist]

Originally Posted by 534623

Tomorrow, Friday, October 19, 2012 (10:18AM-10:30AM),

Dr. Gail Naughton is going to present the following topic at the currently running ISHRS meeting:

Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors

Recently, we had a small discussion (in another context) about her presented and finally published HSC results/data during the SID Annual Meeting:

http://www.histogen.com/downloads/si..._HSC_Final.pdf

Anyway …



I think the presented data during the SID meeting needs CLARIFICATION, because, as you can see (and review) yourself, the presented data simply DON’T reflect the reality!

Hopefully (maybe?) Dr. Ziering can chime in here to answer as well ...

WTF is this? You throw a bunch of random circles around some of the hairs and then declare the analysis no good? You're a joke. Take your unscientific analysis and go back hairsite, Ironman.

[clarence]

Originally Posted by The Alchemist

WTF is this? You throw a bunch of random circles around some of the hairs and then declare the analysis no good? You're a joke. Take your unscientific analysis and go back hairsite, Ironman.

What do you mean random? The only random about it is that he's being a bit selective about the distinctions, for example, 9, 28, and 56 appear to have improved while 18, 37, and 38 appear to have weakened, even though all of these targets were marked as "unchanged". Also, his analysis doesn't take into account hairs per follicle; we see, for instance, that 55 has progressed from slick bald to 2 hairs, while 41 has still hair growing out of it albeit one less than before. Some hairs have even had considerable change while not even having circles around them (ie. the two hair follicle between 34 and 35 has thinned).

But in the end, that's just hair-splitting; I don't see what the improvement is in s2018, and we are confused as to what Histogen wants to prove by publishing such an image, or how the measurements relate to the image. Oh well, I think I'm getting a hair transplant!

[hellouser]

Originally Posted by clarence

The only random about it is that he's being a bit selective about the distinctions, for example, 9, 28, and 56 appear to have improved while 18, 37, and 38 appear to have weakened, even though all of these targets were marked as "unchanged".

Perhaps it has something to do with growth stages for those hairs that have weakened? As in, maybe those hair recently shed and are in the early stages of growing back?

Just throwing it out there, although it is an interesting observation that some weakened... but if the overall effect is greater thickness, density but especially regrowth, it shouldnt matter TOO much.

[The Alchemist]

Originally Posted by clarence

What do you mean random? The only random about it is that he's being a bit selective about the distinctions, for example, 9, 28, and 56 appear to have improved while 18, 37, and 38 appear to have weakened, even though all of these targets were marked as "unchanged". Also, his analysis doesn't take into account hairs per follicle; we see, for instance, that 55 has progressed from slick bald to 2 hairs, while 41 has still hair growing out of it albeit one less than before. Some hairs have even had considerable change while not even having circles around them (ie. the two hair follicle between 34 and 35 has thinned).

But in the end, that's just hair-splitting; I don't see what the improvement is in s2018, and we are confused as to what Histogen wants to prove by publishing such an image, or how the measurements relate to the image. Oh well, I think I'm getting a hair transplant!

Look at the area surronding circle 13, it looks nothing like the early photo.

There is a follicle between 20 and 21 that he didn't even bother to count
which is substantially thicker than before.

9 is thicker yet buttmunch counted it as unchanged

19 appears entirely different

To the left of 26 there are 3 follicles that have all increased dramatically in size and were completely ignored.

Over circle 25 there are hairs that are substantially larger which he didn't bother to count.

There are hairs to the upper left of circle 76 which are much larger

Etc.. Etc.. Etc..

His analysis is piss poor.

[534623]

Originally Posted by clarence

Some hairs have even had considerable change while not even having circles around them (ie. the two hair follicle between 34 and 35 has thinned).

Correct. I couldn't make circles around ALL follicular units, because ...

Originally Posted by drcole

What’s going on here? It’s certainly not classic androgenic alopecia where the affects are more diffuse. One does not see something like this in an area affected by androgenic alopecia.

That means, the observation area (treated area) has too dense hair in BOTH pics in general - something one indeed does not see like this "in an area affected by androgenetic alopecia". In fact, the pics just show a completely normal circulating (anagen-catagen-telogen-anagen etc) observation area - nothing more nothing less!

And even there is a way to encircle ALL follicular units (you guys can do this anyhow and use the existing circles and numbers as orientation!) - you simply CAN'T see "statistically significant improvement". I mean, idiots can always see improvement if they WANT (or need) to see "improvement".

[maxhair]

Histogen photos always look a bit less impressive than the regrowth percentage stats they're claiming, and when you consider they're only showing the best photos, I think we're in for a disappointing reality check if it does ever come to market. Let's hope two or more of these new treatments are compoundable with each other or with existing treatments.

[2020]

Originally Posted by maxhair

Histogen photos always look as bit less impressive than the regrowth percentage stats they're claiming, and when you consider they're only showing the best photos, I think we're in for a disappointing reality check if it does ever come to market. Let's hope two or more of these new treatments are compoundable with each other or with existing treatments.

That's because their true results are documented here:
http://jddonline.com/articles/dermatology/1650

20% density increase versus 74% that they list on their main page. They always try to show of their BEST result. 20% is still pretty good for just a couple injections.

They need to release the pictures from their independent studies!

[JJacobs152]

Seems like Histogen has had good results. They just released their latest press release article online. However, they're results are best seen between the age groups of 40-59.

Histogen Announces Initial Results from Phase I/II Clinical Trial of HSC
Data shows significant efficacy at all time points and all treated hair loss regions
SAN DIEGO, October 19, 2012 - Histogen, Inc., a regenerative medicine company developing innovative therapies based on the products of cells grown under simulated embryonic conditions, will present preliminary data from the ongoing clinical trial of its Hair Stimulating Complex (HSC) today at the International Society of Hair Restoration Surgery (ISHRS) Annual Meeting. Statistically significant improvement was seen across all targeted hair growth parameters in this Phase I/II clinical trial, with an 86% responder rate.
The double-blind Phase I/II clinical trial was undertaken to further examine the safety and efficacy of intradermal injections of HSC in 56 men with androgenetic alopecia. In addition to other safety outcome measures, clinical evaluation of blood serum chemistry, hematology and urinalysis showed no indication of toxicity over 12 weeks. The treatment was well-tolerated and no study-related adverse events have been reported.

In this second clinical trial of HSC, which was designed with an additional treatment timepoint, the increase in total hair count was 46.5% above that seen in the pilot HSC trial at 12 weeks. Statistical significance was noted in all efficacy endpoints, which include increases in total hair count (p=0.0013), terminal hairs (p=0.0135), and hair thickness (p=0.026). A significant increase in vellus hair count (p=0.033) was seen for the first time, supporting the hypothesis that the HSC treatment rescues dying follicles, in addition to converting vellus to terminal hairs and increasing the number of hairs per follicle. Statistical significance continued to be seen at the 24 week time point.

"We are excited that HSC has not only continued to show unprecedented results, but that the addition of a second treatment time point in the Phase I/II clinical trial has resulted in even greater hair growth than the pilot study," said Gail K. Naughton, Ph.D., Histogen CEO and Chairman of the Board. "Particularly compelling is the growth seen in more difficult types and stages of hair loss. Without limitations to treatment area, age or stage of balding, HSC has the potential to expand the hair restoration market by offering a successful option to those that currently have none."

Available non-surgical treatment options for alopecia focus on younger patients in the earlier stages of hair loss, with a primary purpose of retaining existing hair and supporting limited hair regrowth. This is not the trend seen in the clinical trials of HSC. In both the pilot and Phase I/II clinical trial, HSC treatment has shown efficacy across age groups, with subjects age 40-59 seeing cosmetically significant results beginning at 12 weeks, including a mean increase of 39% in terminal hairs and 19.4% in total hair count in this age group in the current trial.

Importantly, the efficacy of HSC is not limited by hair loss region. The Phase I/II clinical trial has shown noted new hair growth in subjects treated in all regions of the scalp, including temporal recession, mid-scalp and vertex. Subjects receiving HSC in the temporal recession, which is known to be more difficult to treat than other areas of hair loss, saw marked improvement in terminal hair count, with a mean increase of 22.6% at 12 weeks and 25.2% at the 24 week time point.

In addition to the Phase I/II data, Dr. Naughton will present results from a Physician-sponsored IND of HSC conducted by Dr. Craig Ziering, an ISHRS member and leading hair restoration surgeon. Five men and five women received up to four treatments of HSC, with all subjects showing positive hair growth. Increased hair growth was seen as early as 6 weeks, with clinically and cosmetically relevant results seen as early as 18 weeks.

"The clinical data seen to date with HSC is very compelling," said Dr. Craig Ziering, Founder and CEO of Ziering Medical. "Not only is the strong safety profile clinically important, but we have seen cosmetically significant results, with coverage of thinning areas, in a clinical setting. In addition, the response seen in women treated with HSC is unprecedented."

HSC is a complex of proteins and growth factors naturally secreted by multipotent cells under Histogen's proprietary growth conditions. The proteins within HSC, such as KGF, VEGF, and follistatin, are involved in signaling stem cells in the body, and have been shown to be key in hair formation and the stimulation of resting hair follicles.

"Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors" will be presented by Dr. Naughton at the ISHRS Annual Meeting, taking place October 17-20, 2012, in the Bahamas.