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): email@example.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.