San-Diego based Histogen, Inc. is one of the fastest-progressing companies in the race to bring a new baldness treatment to market. Already Histogen has performed successful pre-clnical human studies and is moving on to clinical trials in Asia starting Q1 2010. These accomplishments come in spite of several frivolous patent infringement lawsuits and multiple layoffs (due to external economic forces).

Early testing validated the hypothesis that Histogen’s proprietary Regenica complex (which contains various Wnt proteins) has the ability to rejuvenate miniaturized hair shafts and even induce new follicle formation. In 2009 Histogen became the first company to prove confirm these results in a clinical setting.

In a recent presentation to the International Society of Hair Restoration Surgeons, Histogen’s principal clinical trial investigator, Dr. Craig Ziering, revealed that “84.6% of the patients receiving one injection of Histogen’s serum-free Hair Stimulating Complex 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.”

So far Histogen’s Hair Stimulating Complex has not been tested on completely bald skin. It is not known whether Regenica alone can completely restore hair growth on a person with established baldness. It is also unclear whether annual applications of Regenica can prevent hair loss indefinitely. These are some of the endpoints that future trials aim to assess.

Perhaps the most promising research into the field of hair regeneration has been conducted by Follica, Inc.

In 2007 scientists at the University of Pennsylvania School of Medicine unveiled the results of a research study that created new hair follicles in the skin of wounded mice. This process was the first demonstration of de novo hair growth in an animal model, commanding the attention of the international press and hair loss sufferers everywhere.

Since that time Follica has hired many renowned experts in the fields of epithelial stem cell biology and drug delivery. Its medical advisory board consists of Dr. George Cotsarelis (UPenn), Dr. Vera Price (UCSF), Dr. Rox Anderson (Harvard), and Dr. Samir Mitragotri (UCSB).

Although the science is groundbreaking, the process is relatively straightforward:

• A physician would first disrupt the skin of a patient desiring new hair growth.
• This epidermal disruption would result in the creation of an “embryonic window” wherein skin stem cells are receptive to signals released by the body.
• While the body heals in this typical fashion, Wnt proteins can be added.
• Epidermal stem cells within the skin will interpret this signal and begin to create hair follicles as opposed to forming scar tissue.

This original technique was patented in 2007, but subsequent patents have been published in order to protect various protocols and devices designed by company specialists.

While several steps have been taken to build the company there has been almost no substantial communication with the public regarding the process Follica hopes to market.

In 2008 a pilot study was supposed to have taken place, but no information has since been released. As of the present time no clinical trial dates have been announced and no proof of concept has been established.