Histogen

Histogen

Histogen is a San Diego, CA-based biotechnology company that deals with regenerative medicine technology.

Histogen was formed in 2007 by Gail Naughton, who is currently the CEO and Chairman of the Board. She has spent more than 15 years researching tissue engineering and holds more than 90 U.S. and foreign patents.

Histogen's flagship product is Hair Stimulating Complex, though they have other related targets using similar techniques:

  • BioNuesis - All-human soluble extracellular matrix, developed as a culturing kit for stem cell growth.
  • Exceltrix - Human Extracellular Matrix
  • ReGenica - A diverse mixture of actives including human growth factors such as Keratinocyte Growth Factor, soluble human ECM such as collagen, and embryonic proteins.

All Histogen products are derived from newborn fibroblasts grown in a proprietary bioreactor that mimics the embryonic environment via low gravity and oxygen.

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ABSTRACT BODY: Research has shown the importance of Wnt 7a and wound healing growth factors on the stimulation of bulge cells and inter-follicular stem cells to induce hair growth. We have developed a bioengineered human cell-derived formulation, termed Hair Stimulating Complex (HSC), consisting of growth factors and morphogens recognized to be critical to the induction and maintenance of hair follicle growth. Following preclinical safety and efficacy studies suggesting the increased induction of anagen in the C57Bl model by HSC, a clinical pilot study was undertaken. The double-blind, placebo-controlled, randomized single site trial was primarily designed to evaluate safety of the HSC product, with efficacy as a secondary goal. Data analysis indicated that HSC is safe and showed effectiveness in stimulating hair growth in subjects with MPHL. All subjects tolerated the procedures well, no adverse reactions were reported. Histopathological evaluation of the treatment site biopsies taken at 22 & 52 wk post-treatment revealed no abnormal morphology, hamartomas or other pathological responses. Trichoscan image analysis of placebo sites at 12, 22 & 52 wk showed no significant improvements in any of the measured hair growth indicators over the initial 12wk evaluation period whereas the HSC treated sites demonstrated an increase in all hair growth indicators except vellus hair density. The improvements from HSC treatment were significantly greater than that observed in placebo treated sites: hair shaft thickness (6.3% + 2.5% vs. -0.63% + 2.1%; p = 0.046), thickness density (12.8% + 4.5% vs. -0.2% + 2.9%; p = 0.028), and terminal hair density (20.6 + 4.9% vs. 4.4 + 4.9%; p = 0.029). Similar trends were seen at 22 & 52 wk, with total number of hairs increasing on the HSC-treated site only over one year. These results clearly demonstrate that a single intradermal administration of HSC improved hair growth in subjects with androgenetic alopecia and is a clinical substantiation of previous preclinical research with Wnts and wound healing.

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