Histogen HSC Hair Stimulating Complex
revolutionary cell based wnt protein that reportedly initializes epidermal stem cells for the formation of new hair follicles as a treatment for hair loss and thinning hair.
Ziering Medical & the Development and Testing of Hair Stimulating Complex (HSC)
With Dr. Ziering serving as principal investigator of the study, Histogen’s Hair Stimulating Complex (HSC) is currently under evaluation and development as a progressive new injectable that promotes hair regrowth. HSC is the first bioactive compilation of WNT proteins and their cofactors that have been naturally stabilized and cited for hair follicle growth and development.
HSC represents a potentially momentous new treatment option for Ziering Medical’s patients and for millions suffering from hair loss.
After clinical trials in Singapore in 2011 and plans for pan-Asian approval in 2014, Dr. Ziering looks forward to American approval of the product in 2015.
Hair Stimulating Complex (HSC)
Histogen’s Hair Stimulating Complex (HSC) is a proprietary liquid formula created by the culturing of newborn cells in a simulated embryonic environment of suspension and very low oxygen, and then harvesting the naturally secreted growth factors, proteins and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of Wnt proteins and their cofactors, which have been implicated in hair follicle development and growth.
Histogen’s HSC is currently being developed and evaluated as an injectable for hair growth. The combination proteins and growth factors, including Wnts and follistatin, making up the formulation have been shown to both stimulate resting hair follicles and induce new follicle formation.
HSC Clinical Development
The pilot 24 subject clinical trial of HSC was a double-blind, placebo-controlled evaluation of safety in the clinical application of the product 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 one year follow-up. HSC also achieved statistical significance in its efficacy endpoints, including hair count, hair thickness, and hair density at the 12 week endpoint and patients continued to see statistically significant additional growth at 12 months, even though they received only one treatment at baseline.
The next clinical trial of HSC is currently in planning stages, and is scheduled to begin in Singapore in early 2011, with plans for pan-Asian approval in 2014. Estimated U.S. market introduction of the injectable for hair regrowth in the treatment of male pattern baldness is 2015, with potential for earlier introduction in certain identified countries.
How does Histogen’s HSC work?
Human WNT proteins are shown to encourage activity from the existing hair follicles along with initializing epidermal stem cells to form NEW hair follicles. Histogen’s scientific process imitates an embryonic environment that includes low gravity and low oxygen. The newly generated cells produce stem cell markers that organically produce growth qualities and important proteins that are key factors in accelerated, developing tissue. Histogen extracts two products from this process: a soluble protein complex and an insoluble human extracellular matrix (hECM). Both of these products can be used by the life science industry in a variety of applications.
Within Histogen’s proprietary bioreactors are easily grown newborn fibroblasts that are threaded onto a beadlike strand, and then conditioned with liquid media. Within a few days, cells have secreted WNT proteins and other various growth factors while producing the thick, embryonic-like ExceltrixTM into the test liquid.
Histogen’s Proprietary Technology Process
Through Histogen’s proprietary technology process that mimics the embryonic environment, including very low oxygen and low gravity conditions, newborn cells develop stem cell markers and become embryonic-like and naturally produce vital proteins and growth factors which are characteristic of young, rapidly developing tissue.
From this process, Histogen extracts two products – an insoluble human extracellular matrix (hECM) and a soluble complex of proteins – with a variety of applications in various markets and segments of the life science industry.
Histogen’s one technology, two products, numerous applications model offers a continuum of product introduction opportunities, from lead applications such as hair regrowth and skincare to longer timeline therapeutic applications including oncology and wound care.
Clinical trial - Hair regrowth following a WNT protein treatment