Histogen, Inc., a regenerative medicine company focused on stimulating the body’s stem cells to regenerate tissues and restore youthful function, has launched a Phase I Clinical Trial of its lead product, Hair Stimulating Complex, to treat female diffuse hair loss. This follows approval of the Company’s Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) last month. Active recruitment and enrollment of trial participants is underway under Principal Investigator Dr. Kimberly Butterwick.
Hair Stimulating Complex (HSC660) is a soluble formulation of a subset of naturally-secreted growth factors developed as an injectable treatment for hair growth. Through Histogen’s patented technology process, fibroblast cells are induced to become multipotent stem cells, and there is upregulation of growth factors which have been shown to be important in stimulating the hair follicle, new hair growth and sustained hair viability. HSC660 is manufactured from the purification of cell conditioned media to enrich for these growth factors.
The clinical trial will be a 27 subject, randomized, blinded, placebo-controlled study to evaluate the safety of the injectable HSC660 treatment in women. The study will also look at indicators of treatment efficacy. This trial will be conducted at Dermatology Cosmetic Laser Medical Associates under Kimberly Butterwick, MD, one of the nation’s leading authorities in dermatology injectables.
“Millions of women experience diffuse hair loss due to a range of causes, but the current treatment options are limited in their effectiveness,” said Dr. Butterwick. “The potential of a simple, injected treatment that stimulates stem cells in the scalp to create new hair could be life changing. We are excited to kick off the first trial of this novel HSC660 treatment in women.”
Approximately 30 million women are affected by hair loss in the US alone. Unlike male pattern baldness, female hair loss stems from a range of causes including hormonal imbalance, stress, illness, chemical damage and chemotherapy. HSC660 has the potential to induce new, cosmetically significant hair growth in female hair loss of all causes.
In addition to two completed Company-sponsored trials of an HSC660 predecessor in male pattern baldness outside the US, a physician-sponsored study including five women with varying types of hair loss revealed visible hair growth and a 100% female responder rate with the HSC660 predecessor. More detailed information about results to date can be found at http://www.histogeninc.com/applications/hsc.htm.
Histogen is a regenerative medicine company developing innovative products from cells grown under simulated embryonic conditions, including low oxygen and suspension. Through this unique technology process, newborn cells are directed to naturally produce vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen’s technology focuses on stimulating a patient’s own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.