The RepliCel™ Solution
One company on the verge of introducing a potential game-changer, however, is RepliCel Life Sciences, Inc. (REPCF), a Vancouver-based company focused on developing a safe and effective cell-based hair regeneration treatment for humans.
The company was established on the foundations of breakthrough findings by Dr. Kevin McElwee and Dr. Rolf Hoffmann, two highly regarded research scientists in the fields of immunology, hair biology, hair growth, and dermatology. For McElwee and Hoffmann, the key to hair regeneration lies in what is known as dermal sheath cup cells. This specific group of cells are located in hair follicles and contain stem cell-like characteristics that have the potential to stimulate neogenesis of non-producing hair follicles or regeneration of existing ones.
"The hypothesis for humans, which we're now testing in Phase I," says CEO David Hall, "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. That's what we're trying to achieve."
Effective Hair Regeneration
The actual procedure and treatment that RepliCel is currently testing is simple enough to understand. 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. 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.
"The present clinical trial process of injection takes approximately 15 minutes," Hall says. "In a commercial setting where you are doing a full head, it would take upwards of half an hour to 45 minutes, but it's not really an involved procedure. The real involvement of the technology itself is in the culture of the cells. So from the clinical point of view, the clinician can do many more procedures in a day with far less staff and far less sophisticated facilities than micro transplant."
In August, the company injected the final participant in its first-in-man clinical trial. If this trial proves successful, and RepliCel can prove systemic efficacy and safety by as early as March 2012, after the initial six-month patient follow-up, the company can then proceed to file an Investigational Medicinal Product Dossier (IMPD) for a Phase II trial. The procedure has already been proven successful in earlier trials conducted on SCID mice and produced an efficacy rate of about 50 percent. Hall says that if RepliCel can show safety and an efficacy rate of 20 percent for humans, it would become the new standard.
"The quantum of costs for the preclinical work and the clinical work is dramatically lower than for a drug or a biologic," Hall says. "All we have to do is establish what it is we do with those cells for the regulatory body. You have to establish the source and all the materials that you introduced in the replication procedure. The good news about that is the material that we use is all approved. So there's nothing that's new that we have to spend a lot of money to prove that it doesn't cause adverse effects."
Hair Loss Treatment Market
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.
"Micro-transplants are actually considered the gold standard; not drugs," he said. "The problem is that that gold standard micro-transplant is basically in the hands of a few surgeons. There are devices that have been developed for precision follicular extraction. However, there are no devices that achieve the sophisticated insertion of hair follicles. The re-injection of those follicles is still subject to the skills of the surgeon. So there's a limit to the amount of ‘gold standard’ that is out there."
In regards to drug treatments, Rogaine and Propecia are two of the more recognized names, but the majority of these treatments have shown to have considerable limitations. One such limitation that both drugs and micro-transplants have been unable to address is broadly treating hair loss for women. There 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.
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.
But before that can happen, the company needs to successfully complete its clinical trials and prove to international regulatory bodies, such as the Food and Drug Administration, Health Canada, and the European Medicines Agency that its procedure is both effective and safe for human use. The significance of this isn't lost on Hall, or the RepliCel team for that matter.
"I understand how important the development of this technology is to people," Hall said. "But what people have to understand is how important the proper development of this technology is because if we don't do it the right way, the regulators will stop us, and cause us to restart the process. You can't cut corners!”
"So the Phase I milestone in March is critical and we're confident that we're going to have hair growth. We're not going to go forward unless we have growth. If we achieve 20 percent growth that would be a home run in terms of the comparative technologies out there."
