Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering
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Phase 2 should end in December 2012
Further study details as provided by Histogen:
Primary Outcome Measures:
Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies) [ Time Frame: Clinically significant change from screening visit to Week 12 ] [ Designated as safety issue: Yes ]
Non-vellus hair counts [ Time Frame: Change from Baseline to week 12 in treatment areas ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Hair Thickness Density [ Time Frame: Change from Baseline to week 48 in treatment areas ] [ Designated as safety issue: No ]
Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events [ Time Frame: Clinically significant change from Screening visit to Week 48 ] [ Designated as safety issue: Yes ]
Enrollment: 56
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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Originally posted by Dr. Craig ZieringHistogen'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
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:
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 ...Comment
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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:
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 ...Comment
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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!Comment
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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.Comment
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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.Comment
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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".Comment
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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.Comment
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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.
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!Comment
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