Histogen Hair Stimulating Complex to Begin Second Clinical Trial Shortly

Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, announced the one year data findings of its Hair Stimulating Complex (HSC) pilot clinical trial. Statistically significant new hair growth was seen in HSC-treated subjects at this follow-up timepoint, one year after their single treatment with HSC.

In addition to the number of new hairs, a statistically significant (p<0.05) increase in hair density, which is directly related to hair count over the treatment areas, was also seen at the one-year timepoint. Other efficacy factors, such as hair thickness and terminal hair density, showed an upward trend at this timepoint as well. The pilot trial tested two formulations of HSC and, although one formulation was determined to be superior, significant new hair growth was seen in both groups. (p=0.032)


This new data indicates that a single HSC treatment not only results in rapid hair growth (statistically significant increases in the number of terminal hairs, hair thickness density and hair shaft diameter was seen at three months), but that these results persist over time.

“Seeing continued hair growth at this one year follow-up is truly groundbreaking,” said Dr. Craig Ziering, Founder of Ziering Medical and Principal Investigator on the HSC clinical trial. “Not only do currently available non-surgical treatments show limited hair regrowth, but any new hair is lost shortly after discontinued use. We now have preliminary evidence that HSC significantly increases hair counts, and that the effects of a single treatment are lasting.”

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 is a proprietary formulation of naturally secreted embryonic-like proteins and growth factors. In addition to Wnt 7a, which is recognized to be critical in the induction and maintenance of hair follicle growth, the complex contains a wide variety of factors typically produced by embryonic cells and which are important to the hair cycle, such as follistatin. While these embryonic-like materials are amplified under Histogen’s unique manufacturing conditions, undesirable proteins and growth factors, including Wnt 5a, which has been shown to be associated with cancer, are eliminated.

“The development of hair follicles is the consequence of a complex interplay of factors that is still being unraveled,” said Dr. Jonathan Mansbridge, Histogen’s Chief Scientific Officer. “However, several factors critical to hair growth, such as Wnt 7a, follistatin, VEGF and KGF, are present in HSC, and their secretion by the cells is stimulated by the culture conditions we use. The embryonic conditions under which our cells are manufactured not only upregulates genes associated with hair growth, but induces significantly more production of these critical factors than seen with normal 3D or monolayer cultures.”

HSC is a unique composition resulting from growing newborn cells under embryonic conditions. The hypoxia/microgravity results in large amounts of follistatin (41.6 ng/ml in HSC versus 6.75 ng/ml in normal culture conditioned media), VEGF (9.1 ng/ml versus 2 ng/ml), KGF (5.4 ng/ml versus 2.1 ng/ml), and a lack of the scar-related TGF beta (0 ng/ml versus 1.7 ng/ml in normal cultures). This composition is covered by pending US patent #2010/0047305.

The full results of the HSC clinical trial were presented at the Society for Investigative Dermatology (SID) Annual Meeting, in Atlanta, May 5-8, 2010.

Histogen is currently in planning stages for the next clinical trial of HSC, which is scheduled to begin in late 2010. This next trial will further examine the safety and efficacy of the HSC product as an injectable for hair growth, and will also evaluate optimum treatment dosing and delivery. Histogen is currently seeking a Series B investment round, which will be utilized to finance these next stages of HSC development and trials.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen’s proprietary bioreactors that 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.

This article is reprinted from Histogen’s official website.

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.

Histogen Developing Stem Cell Products for Hair Loss

Hair loss is such a common malady, among both men and women, it’s something of a surprise that so few companies have tried to develop a practical hair loss treatment. The loss of hair is particularly devastating for women. Women hair growth products are found everywhere on the Internet, but, like similar products for men, most are little more than snake oil.

However, the advent of new stem cell research has provided new hope for those suffering from hair loss. The notion that doctors could somehow mass produce hair follicles in a laboratory — taken from a patient — and then “inject” or transplant them on a mass scale on a balding person’s head has caught the interest of literally hundreds of millions of people. Alas, while the fundamental research is proceeding furiously, there remain significant problems in developing practical, real world products for hair loss.

A realistic hair loss treatment based on stem cell technology is probably still years away — yet the research is continuing. Companies such as Intercytex, Alderans and Follica are actively attempting to develop a hair loss treatment based on cloning technologies.

Recently, a new company has appeared on the scene: Histogen. Histogen, a regenerative medicine company founded in 2007 to develop stem cell solutions based on “the products of newborn fibroblasts without the use of embryonic stem cells or animal products.” Using its proprietary “tissue-engineering” platform, Histogen has created products that offer unique commercialization opportunities — including stem cell products for hair loss!

One of Histogen’s new products, dubbed HGEN-001, indicates capabilities for new hair follicle creation. In May, the company presented its findings on HGEN-001 during International Investigative Dermatology 2008 conference taking place in Kyoto, Japan.

Because of the “native soluble WNT proteins and growth factors contained in the formula,” HGEN-001 was evaluated as a stimulus for new hair follicle creation. In laboratory tests with mice, HGEN-001 was shown to significantly increase hair growth and new follicle formation.

“HGEN-001 induced a significant increase in hair follicle growth, as compared to the control, in our preclinical model,” reported Frank Zeigler, General Manager of In Vitro Products for Histogen. “Researchers have reported the importance of wnt proteins and wound healing growth factors in the induction of new hair follicles for over a decade. Our research helps to substantiate the importance of these active agents in follicular neogenesis, all of which are components in HGEN-001.”

Clinical trials for HGEN-001 as an application for hair growth are planned for late 2008.

For more information on Histogen and how its products may aid in the development of a practical, hair loss treatment, visit the company’s website.

New Hair Loss Treatments: 9 Best Websites for Info on Hair Follicle Cloning

The science of hair follicle cloning — or stem cell treatments for hair loss — is evolving rapidly. Alas, we remain years away from a practical, real-world alternative to current hair transplant techniques, even sophisticated ones that replace hair follicle by follicle. The real goal for most people suffering from hair loss is some sort of hair cloning process… in which a person’s own hair is extracted, then multiplied in a laboratory, and replaced en mass in the area of loss. This is the dream… and it remains elusive.

But for all those researching this potentially revolutionary field, as a treatment or an investment, there are a few good places to start. Here is our Top 10 (Actually, Top 9) List of the best websites about hair follicle cloning or which follow it closely. In no order of rank, they are…

1. Aderans Research Institute: “dedicated to developing state-of-the-art cell engineering solutions for hair loss.”

2. Intercytex: It promotes “an autologous hair regeneration therapy, a suspension of human dermal papilla (DP) cells, for the treatment of male pattern baldness and female diffuse alopecia.”

3.  Follica:  “Developing novel therapies for conditions and disorders of the hair follicle, the epicenter for the development and replenishment of human hair and skin.”

4.  Histogen:  It is marketing “a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment and then harvesting the naturally secreted growth factors, anitoxidants and other synergistic bioproducts that are produced” that, it claims, may have “significant applications” as “an injectable for hair growth.”

5.  Luna Innovations:  It is use “nanomedicine” to stimulate new hair growth.

6.  Hair Science Institute:  Dr. Coen Gho’s clinic that claims a superior method for individual follicle transplantation.

7.  Phoenix Bio:  A Japanese biotech company that “propagates hair papillar cells which are the key element in hair growth and develops therapies that enable the implantation of these cells on patients thus regenerating the ability of the patient’s scalp to produce hair naturally.”

8.  Shisheido Research:  Another Japanese company that is doing research into hair multiplication technologies.

9.  Bernstein Medical Center for Hair Restoration:  An advanced hair transplantation clinic, the Bernstein Center also follows closely developments in hair cloning technologies and is a good source for a
“hands on” reality check on what is realistic at the moment.

Pioneering Hair Growth Company Histogen to Open Arizona Offices

The Arizona Republic newspaper is reporting that Histogen, a San Diego-based bioengineering company working on new stem cell-like hair growth technologies, is expanding into Arizona. The paper reported that Histogen has already opened an office in Temple and will soon offer a line of anti-aging skin products.

The company said it uses a stem-cell-like technology to foster a skin product derived from skin discarded from infants after circumcisions.

The company wants to parlay revenue collected from the sale of aesthetic products to fund research in areas such as cardiovascular and wound healing.

It’s the same playbook sketched out by other Arizona biotechnology companies such as Tucson-based Niadyne Development: develop anti-aging skin products backed by science to raise cash while focusing on a bigger prize of health research.

The Tempe division is called Histogen Aesthetics.

President Lawrence Rheins said the company chose Arizona to launch its aesthetics business due to the Phoenix-area’s large network of dermatologists and plastic surgeons focused on cosmetic and anti-aging procedures as well as the state’s growing biotechnology hub.

“Everybody who lives here gets photo (sun) damage,” said Rheins, who previously served as a director at Hill Top Research in Scottsdale and an assistant dermatology professor at the University of Cincinnati. “There is a real need for these types of products because of the desert climate and the intense sun.”

The newspaper also reports on the history of Histogen. According to the report, Histogen CEO Gail Naughton was the co-founder of another San Diego biotech company, Advanced Tissue Sciences, that eventually filed bankruptcy when it had difficulty getting approval from the Food and Drug Administration for one of its key products.

Naughton apparently has regrouped and, with 18 of her former colleagues at Advanced Tissue Sciences, founded Histogen. That is one reason, she told the paper, that Histogen was able to get such a fast start right out of the gate.

The company claims that its technology mimics the embryo, “allowing the growth of protein-rich material that is similar to what is found in young skin.” It allegedly has therapeutic value in treating burns and, of immense interest to many, hair loss. Histogen is one of a number of new biotech companies struggling to develop a realistic hair regrowth technology based on non-embryonic stem cell research. One of its first products, released earlier this year, was a a kit to grow stem cells called BioNuesis.