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  1. #1
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    Great news - Histogen is starting to work with women

    see below


    ABSTRACT FINAL ID: 519
    TITLE: Stimulation of hair growth in humans by cell-secreted proteins
    AUTHORS (FIRST NAME INITIAL LAST NAME): G. K. Naughton1, C. Ziering2, N. Sadick3, D. Perez-Meza4, M. Hubka1, D. Ehrlich1, J. Mansbridge1
    INSTITUTIONS (ALL): 1. Histogen, San Diego, CA, United States.
    2. Ziering Medical, Los Angeles, CA, United States.
    3. Sadick Dermatology, New York, NY, United States.
    4. Permanent Hair Solutions, Maitland, FL, United States.
    ABSTRACT BODY: We have evaluated a bioengineered human cell-derived formulation, termed Hair Stimulating Complex (HSC), on the effects of hair growth activity in male pattern baldness and female diffuse hair loss. HSC is produced by cells grown on beads in hypoxic bioreactors and contains cytokines including KGF,VEGF,follistatin and noggin. Follistatin and noggin antagonize activin and BMPs which maintain the quiescent state of hair follicle stem cell proliferation. We hypothesized that injection of this medium may increase the supply of progenitor and transit amplifying keratinocytes to the hair shaft, leading to an increase in the thickness of the hairs and a reversal of the miniaturization process. Three clinical studies have been performed. The pilot study was a double-blind, randomized, placebo-controlled trial involving 26 men with androgenetic alopecia. At baseline one area of the scalp received (4) 0.1cc intradermal injections (injs) of HSC and the parallel site received identical injs of placebo. HSC showed an excellent safety profile and a statistically significant increase in hair shaft thickness (p<0.05) at 3 months and hair density at 3 months (p <0.03) and 1 year (p<0.03) as assessed by Trichoscan image analysis. Analysis of the distribution of hair density at 1 year showed that the effect was no longer localized to 2-3mm around the injection site, as was the case at 12 weeks. Increased terminal hairs were seen in the entire region within the 4 injection sites supporting the hypothesis that HSC stimulated resting and miniaturizing follicles to increase terminal hair growth. A Phase I/II 55 patient trial with an identical protocol but with 8 injs of HSC and control at baseline and a repeat dose at week 6 has completed enrollment. A 10 patient non-controlled study for men and women with hair loss is being conducted, with patients receiving 20 injs of HSC at baseline and week 6. The efficacy results seen with HSC represent a novel regenerative medicine approach in hair growth treatment.

    KEYWORDS: Hair, Clinical trials, Biologic therapy.
    CURRENT 1ST PREFERRED CATEGORY: Human Clinical Research and Therapeutics
    CONTACT (E-MAIL ONLY): ebrandt@histogeninc.com
    SESSION LOCATION: Ballroom B/C
    SESSION DAY & DATE: Thursday, May 10, 2012
    SESSION START TIME: 10:00 AM
    Okay, even if they haven't started an official trial, they are at least thinking of us which is more than what I thought. They are looking at this as a treatment for both male pattern baldness and female diffuse hair loss, and it does say at the very end that their 10 person trial includes women. I was worried that they weren't going to be considering women for years, that they would be solely focused on balding men for at least another couple of years. But it looks like that may not be the case. Maybe they really see putting plans into place for female trials, and their responses to us about female trials weren't just BS.

    And they are going to be presenting results this Thursday. I am very excited about this, since maybe they'll be presenting the results of this recent informal trial that includes women. And I'm optimistic that they have something good to present, since they probably would not be presenting bad results at a conference.

  2. #2
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    Re: Great news - Histogen is starting to work with women

    their 10 person trial includes women.
    A ten person trial? WTF. Are they having trouble finding more than 10 people with hair loss issues willing to act as guinea pigs or what? And within those 10 how many are women?

    I'll be interested to read the paper when it comes out but it's not going to have much statistical significance with such a small number of subjects... and it's a non controlled trial too.

  3. #3
    Experienced Member nocturne's Avatar
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    Re: Great news - Histogen is starting to work with women

    Nilli - THanks, that is some positive news. Let us know what happens on Thurs!

  4. #4
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    Re: Great news - Histogen is starting to work with women

    Quote Originally Posted by waterbaby
    A ten person trial? WTF. Are they having trouble finding more than 10 people with hair loss issues willing to act as guinea pigs or what? And within those 10 how many are women?

    I'll be interested to read the paper when it comes out but it's not going to have much statistical significance with such a small number of subjects... and it's a non controlled trial too.
    It may not be a full-on, statistically powered trial, but it's definitely a step in the right direction. I was worried that they weren't even thinking about women's hair loss at all, that they were just making up BS about female trials to keep us with our emails at bay. After all, I emailed them in 2010 about it and got a response that they are planning a female study, and almost two years later still nothing. But now this...shows that they actually are at least doing SOMETHING to work on this as a solution for us too, not just men.

    I guess I should give them the benefit of the doubt - they just barely kept their company intact because of the lawsuit they were dealing with last year, so it makes sense that any trials or plans for trials would have been delayed.

  5. #5
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    Re: Great news - Histogen is starting to work with women

    Are the results out today?

  6. #6
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    Re: Great news - Histogen is starting to work with women


  7. #7
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    Re: Great news - Histogen is starting to work with women

    So I see.

    I read the report (well skimmed it) and see they only had 9 subjects, not 10, (did one drop out?) but at least 4 of them were women so it's a start. I like the "no side effects" bit... I trust that means no horrible shedding or irritation like you get with Rogaine?

    Do you know if they planning to follow those patients over a longer period of time to see what happens and are they going to do bigger trials with more women?

    And how much do you reckon it would cost to get this treatment? Would it be affordable for the majority of women?

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