Histogen's Hair Stimulating Complex for Hair Loss, Hair Growth

Histogen is a San Diego company that is seeking to develop a revolutionary new stem cell treatment for hair loss based on its own proprietary formula made up of follistatin, Wnt 7a and wound healing growth factors. The company’s hair loss product, known as Hair Stimulating Complex (HSC), recently completed Phase 1 clinical trials. The results were reported in the November 2011 issue of the Journal of Drugs in Dermatology.

Technically, HSC is a liquid that is made up of stem cell products, Inhibin, Activin and Follistatin, that are then injected into the scalp of balding men and women to stimulate new hair growth. Recent research has revealed that people who suffer from genetic pattern hair loss do not have fewer stem cells or hair follicles than normal people. What is appears to be different in bald people is that, in a sense, the growth of existing stem cells is stunted in some way. The stem cells are not able to develop into what are called “progenitor” cells which are the cells that actually produce hair on an ongoing basis. In the past few years, therefore, the question that has nagged scientists is this: What will stimulate these stem cells into further growth?

Histogen’s Hair Stimulating Complex is one answer to this question. Researchers at Histogen and other companies have focused on a special class of proteins known as growth factors that appear to “jump start” stem cell development in hair follicles. There are hundreds of growth factors, however, and the question is now: which growth factors and in what combination?

The development of Histogen’s Hair Stimulating Complex was delayed for years by a patent infringement lawsuit; however, in late 2011 a federal judge dismissed the lawsuit and concluded that Histogen’s product does not infringe on existing patents.

Cygenx’s RegenRXx product is also made up of growth factors and cytokines derived from Human Fibroblast Conditioned Media, and it is meant to be applied topically, on the scalp. To aid penetration of the product into the hair follicles, Cygenx also sells and recommends use of a dermaroller.

Histogen, however, plans on marketing its Hair Stimulating Complex as an injectible — which means that it will only be available in a clinical setting, such as a doctor’s office or medical hair treatment facility. It is not clear when this product will be available but it will no doubt be a few years at least. Histogen has enrolled patents in its Phase I/II clinical trial in the Philippines.

For the purpose of clarity, stem cells are found in every part of the body. They are not limited to human or animal fetuses. Hair and skin cells have stem cells all their own. The scientific definition of “stem cell” describes an undifferentiated cell [any cell] of a multicellular organism [any life form over the single cell amoebic stage] capable of replicating itself.

Hair follicle stem cells are able to replicate themselves when placed in a conducive environment. The process of generating hair follicle stem cells involves the creation of niches. You could think of niches as incubators where the appropriate growth material allows the cell to duplicate as if in an embryonic condition.

It was in the late 1990s that researchers discovered that Wnt [also known as Follistatin] was the binding protein agent between all three. This discovery opened up new methods and techniques for a multitude of possibilities. In 2002, one of those studies resulted in a study of skin cell regeneration in mice with scarring. Not only did the severely damaged skin regenerate, so did the hair in the damaged skin area.

It was not until 2011 that molecular science understood the nature of dormant cells or the reason that these cells were not responding to natural growth. They discovered that in the fatty layer of skin, there are cells whose sole job is to communicate with hair follicles and tell the dormant growth cells within them to get going and grow. In a sense, baldness is all a failure to communicate — or rather, a failure of special communicator cells to tell stem cells to grow up. From this the knowledge that stem cells need an outside source to wake them up, researchers began working toward stimulation techniques meant to wake the sleepers.

In the simplest of terms, Inhibin and Activin are protein compounds that need a third party protein attached to them in order to become activated. Both inhibin and activin have been studied since the 1930s and were known to be important proteins in the growth process. Unfortunately, scientists did not know what type of growth or what active their ability.

The most necessary stimulant agent became known as Follistatin. Three elements are required to shake up these dormant cells: Inhibin, Activin and Follistatin. This combination is the basis of HSC. Follistatin was the one element that was necessary to bind the other two together to create the communication between cells.

Since then, scientists have been testing and developing products utilizing this basic premise. By substituting simulated cell development, the company focused on the ability to provide a product that is able to be used by more than one person. In traditional stem cell hair regeneration, the treatment involves implanting the cells taken from the patient’s own scalp (autologus). This is both time consuming, somewhat technical… and expensive.

Histogen is attempting to develop products designed for use by a large group of people without the need for transplanting cells or hair follicles. The advantage is two-fold. Because it does not use actual human or animal cells, cross contamination and rejection issues are eliminated. Since the product can be distributed on a wide scale, it reduces the cost of services and time constraints of those people at the clinics trained to use it.