HSC is currently being developed and evaluated as an injectable for hair growth. The embryonic-like proteins and growth factors within the complex, including follistatin, VEGF and KGF, have been shown to both stimulate resting hair follicles to produce new hair, as well as induce stem cells in the scalp to form new follicles.
HSC Clinical Development
A Phase I/II clinical trial of HSC in 56 patients with male pattern hair loss has passed all timepoints, and final analysis is currently being completed. Dr. Jonathan Mansbridge, Histogen's Chief Scientific Officer, presented safety and efficacy data at the International Investigative Dermatology (IID) Annual Meeting on May 11, 2013. A copy of the presentation can be viewed here.( 718KB).
In this second clinical trial of HSC, which was designed with an additional treatment timepoint, the increase in total hair count was 46.5% above that seen in the pilot HSC trial at 12 weeks. Statistical significance was noted in all efficacy endpoints which include increases in total hair count (p=0.0013), terminal hairs (p=0.0135) and hair thickness (p=0.026). At one year, hair growth parameters remain substantially above baseline, with a statistically significant increase in total hair count (p=0.028).
Previously, a pilot trial of 24 subjects was completed to evaluate safety in the clinical application of HSC as an injectable for hair growth. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy. No adverse events were seen at any timepoint, including the two year follow-up. HSC also achieved statistically significant efficacy at both the 12 week and 1 year timepoints, including increases in hair count, hair thickness, and hair density. Comprehensive results from this first-in-man clinical trial of HSC were published in the peer-reviewed Journal of Drugs in Dermatology in November 2011:
The two completed clinical trials have also revealed efficacy in traditionally difficult-to-treat hair loss populations. HSC treatment has shown efficacy across age groups, with subjects age 40-59 seeing cosmetically significant results, including a mean increase of 39% in terminal hairs and 19.4% in total hair count in the Phase I/II trial. Further, subjects receiving HSC in the temporal recession, which is known to be more difficult to treat than other areas of hair loss, saw marked improvement in terminal hair count, with a mean increase 25.2% at the 24 week time point.
An Investigator-Initiated Trial of HSC in both men and women has been completed by Dr. Craig Ziering, and has shown increased hair growth as early as 6 weeks, with clinically and cosmetically relevant results seen as early as 18 weeks. Initial results from the Phase I/II and Investigator-Initiated Trials were presented by Dr. Naughton during the SID Annual Meeting, which can be found here.( 1.13MB)
Hair Growth Market
The hair loss market is both large and underserved, affecting over 40 million men and 21 million women in the United States alone, but with less than 7% of sufferers currently seek treatment due to the limitations of available options. HSC represents a potentially revolutionary new injectable treatment for the millions suffering from hair loss, offering benefits over daily-use, limited efficacy prescription products as well as invasive surgical treatments.