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Data shows statistical significance at three key efficacy endpoints
San Diego, CA (PRWEB) July 27, 2009 -- Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, shared the results of the Company's preliminary clinical trial of Histogen's HSC human hair regrowth product for the first time at the International Society of Hair Restoration Surgeons (ISHRS) Annual Scientific Meeting. Dr. Craig Ziering, founder of Ziering Medical and principal investigator on the clinical trial, addressed attendees on July 25th, 2009 during the conference, taking place in Amsterdam July 22-26, 2009.
HSC is a proprietary formulation of naturally secreted embryonic proteins, growth factors and contains the first naturally stabilized, bioactive solution of Wnt proteins and their cofactors, which have been implicated in the induction of new hair follicle formation and growth.
The five-month double-blind, placebo-controlled clinical trial was focused on evaluation of safety in the clinical application of Histogen's Hair Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject clinical trial was designed to examine the safety and efficacy of a single injection of HSC alone, as well as in combination with three different perturbation methods. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy.
84.6% of the patients receiving one injection of Histogen's serum-free HSC showed an increase in terminal hair 12 weeks post-injection, with a statistically significant (p<0.05) increase in the number of terminal hairs, cumulative hair thickness density and hair thickness mean. Perturbation did not enhance the results seen with HSC. There were no adverse reactions seen in any of the treated 24 patients at baseline, 12
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