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A clinical trial to treat female diffuse hair loss has been kick started by US regenerative medicine company Histogen.
This month [June 2 2018], the organisation announced the launch of a Phase I Clinical Trial of its lead product, Hair Stimulating Complex, to treat the condition.
The trial launch follows approval of the company’s Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) last month. Recruitment and enrolment 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 company said.
The 27 subject, randomized, blinded, placebo-controlled study will evaluate the safety of the injectable HSC660 treatment in women. It will also look at indicators of treatment efficacy.
The study will be conducted at Dermatology Cosmetic Laser Medical Associates under Dr Butterwick, who is a leading authority 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,”she said.