Hair Stimulating Complex (HSC)
Histogen’s lead product application is Hair Stimulating Complex (HSC), which is a soluble formulation developed as an injectable for hair regrowth. The cell conditioned media that comprises HSC is produced by neonatal cells grown under simulated embryonic conditions of hypoxia (3-5% oxygen) and suspension. Under these conditions, the cells become multipotent and there is a significant upregulation of growth factors which have been shown to be important in hair viability. The proteins within HSC, including KGF, VEGF, and follistatin, are involved in signaling stem cells in the body, and have been shown to be key in hair formation and the stimulation of resting hair follicles. Follistatin in particular has been linked to hair follicle stem cell proliferation.
HSC Clinical Development
Two company-sponsored clinical trials of HSC have been completed, revealing an excellent safety profile and promising efficacy results. In the Pilot trial, 84.6% of patients receiving just one HSC treatment showed a significant increase in terminal hair count and hair thickness at 12 weeks.
In the Phase I/II clinical trial of HSC, which was designed with an additional treatment time point, 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). Such an increase at the one year time point was also seen in the Pilot trial.