RepliCel Life Sciences Keeping the Dream of Hair Regeneration Alive

The Vancouver-based biotech company RepliCel Life Sciences is forging ahead with its clinical trials for hair regeneration therapies. The company was established on the research foundations of two scientists, Kevin McElwee and Rolf Hoffmann, who have done pioneering research into what are called dermal sheath cup cells. These cells are located in hair follicles and contain stem cell-like characteristics that, the scientists believe, have the potential to stimulate regrowth of non-producing hair follicles or regeneration of existing ones.

The company is pushing ahead with its research despite increasing public skepticism that cellular regeneration of hair follicles will ever be a reality. Men and women who suffer from hair loss have been following the promise of hair cloning or hair regeneration for years now, with researchers always promising that each breakthrough will lead to a viable treatment soon. After the demise of the British company Intercytex, the hair loss community put its hopes in Follica, Histogen, Aderans and other companies promising a stem cell based approach to treating hair loss… all, so far, to no avail. The cynicism and bitterness among hair loss sufferers is reflected in the many hair loss websites in which every new treatment proposal is routinely derided as a “scam.” To date, the research that appears to be farthest along is that of Aderans, which recently enrolled its 300th subject in Phase 2 of its clinical trial of its Ji Gami™ process. According to the company, the treatment involves removing a small piece of tissue from a subject’s neckline. Hair follicle cells are then cultivated in controlled conditions where they are encouraged to multiply by the addition of proprietary growth media. When enough new cells are formed, they are returned to the scalp, where they are injected and elicit new hair growth and thickness, ultimately producing more hair than the client had before. The goal is to create a virtually limitless supply of new hair follicle cells that can be used for extensive hair transplantation.

It is into this murky research bog that RepliCel has launched itself. The company’s proposed solution sounds remarkably similar to that of Aderans. “A small biopsy is taken from the lower back area of a person’s scalp since these hair follicles are immune to androgen hormones in men, and through that, about 20 to 25 hair follicles are extracted,” explains one website. “The dermal sheath cup cells are then isolated from the hair follicles and replicated in a proprietary blend of culture media for as long as three months. The cells are then re-injected into balding areas on the patient’s scalp, and the procedure is essentially complete.”

In August, the company injected the final participant (9 women and 10 men) in its first Phase I clinical trial being conducted, strangely, in Tsibli, Georgia. If the trial is successful and RepliCel proves “efficacy” and safety by as early as March 2012, the company can then proceed to a Phase II clinical trial. The procedure produced an efficacy rate of 50% in mice and hopes to achieve an efficacy rate of 20% in people.

“The hypothesis for humans, which we’re now testing in Phase I, is that isolating and replicating autologous dermal sheath cup cells and then injecting them back into the patient will lead to not just follicular hair growth, but the rejuvenation of the existing quiescent hair follicles that have been miniaturized and essentially stopped cycling due to the androgens overwhelming the receptors on those cells,” explains CEO David Hall. “That’s what we’re trying to achieve.”

In the meantime, bald men and women who suffer from thinning hair wait… and wait… and wait.

We try to tell people that the research is exciting and new and continuing apace… that there are four or five major research efforts going on and that a major breakthrough in hair loss treatment may be only a few years away… but few people believe us.

Still, there is a very good reason for optimism: greed. Hall estimates that the overall hair loss treatment industry is worth about $2 billion, with micro-transplants accounting for over $1.2 billion and hair loss drugs accounting for about $1 billion. T”here hasn’t been a drug proven to effectively treat female pattern baldness, and Hall says women don’t typically elect to undergo hair transplant surgery,” notes Equities.com in its note on the company. “This translates into a significant opportunity for a safe, minimally invasive treatment to serve this unmet market. Given that RepliCel’s autologous cell-based procedure is designed to be a one-time treatment that requires very little involvement from the actual patient, it could be a much more attractive option than what is currently available.”

On November 30, the company announced that it would convert all 13 million shares of Class C stock into 2.6 million shares of common stock. All told, this will bring the total shares of common stock in RepliCel up to 43,150,006 shares, currently selling for $2.55 per share.