Histogen reveals results of hair growth clinical trials

The stem cell hair regrowth company Histogen, Inc., revealed for the first time the results of its preliminary clinical trials for its hair regrowth product, HSC, at the International Society of Hair Restoration Surgeons (ISHRS) Annual Scientific Meeting in Amsterdam July 22-26, 2009. The results were encouraging… and caused a significant buzz at the conference. They were presented by Dr. Craig Ziering, founder of Ziering Medical and principal investigator on the clinical trial.

According to Histogen, HSC is a proprietary formulation of “naturally secreted embryonic proteins, growth factors and… the first naturally stabilized, bioactive solution of Wnt proteins and their cofactors.” These constituents, the company adds, have been “implicated” in the induction of new hair follicle formation and growth.

“We are excited that our trial demonstrated safety and efficacy of our HSC product, which contains Wnt proteins and other growth factors important to hair follicle maintenance and growth,” said Dr. Gail K. Naughton, CEO of Histogen. “Wnt signaling has been shown by a number of experts in the field to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and to be important in maintaining the hair inducing activity from existing follicles. Histogen’s trial is the first demonstration that compounds containing bioactive Wnt increase hair growth in humans.”

According to a company press release about the clinical trials…

The five-month double-blind, placebo-controlled clinical trial was focused on evaluation of safety in the clinical application of Histogen’s Hair Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject clinical trial was designed to examine the safety and efficacy of a single injection of HSC alone, as well as in combination with three different perturbation methods. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy.

84.6% of the patients receiving one injection of Histogen’s serum-free HSC showed an increase in terminal hair 12 weeks post-injection, with a statistically significant (p<0.05) increase in the number of terminal hairs, cumulative hair thickness density and hair thickness mean. Perturbation did not enhance the results seen with HSC. There were no adverse reactions seen in any of the treated 24 patients at baseline, 12 weeks, or the 22 week endpoint.

Many patients suffering from hair loss are impatient with the progress being made by the new approaches to treating hair loss, such as hair cloning. The companies developing these therapies have been plagued by poor results, financial setbacks and, most of all, lack of progress. As a result, Histogen’s announcement caused quite a stir.

The company estimates that, of the 87 million people in the United States who suffer from hair loss, only 2% to 7% seek surgical or drug treatment. The same is true internationally due to the general lack of effective medical options for this widespread condition.

“Hair restoration treatments range in effectiveness and invasiveness,” added Dr. Ziering. “All of the current treatment options share the common goal of saving and redistributing existing hairs. For the millions of men and women who grapple every day with their hair loss, the results of our HSC trial indicate the potential for a phenomenal treatment option that stimulates growth of new hairs along with increasing the thickness of existing hairs. Histogen’s HSC represents a potentially major paradigm shift from conventional treatment options to one that can promote the growth of new or dormant hairs using principles of the body’s own regenerative mechanisms.”

Histogen was launched in 2007. According to the company website, it “seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components.” Instead, the company’s “proprietary bioreactors… mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio.”

Histogen has two product families – a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.