Histogen, 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. Principal investigator Kimberly Butterwick, MD, is actively recruiting and enrolling trial participants following U.S. Food and Drug Administration (FDA) approval of the company’s Investigational New Drug (IND) application last month.
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 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.
“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.”