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The following has been published in the Financial Post:

There is enormous interest in the worlds of medicine and esthetics in the promise of regenerative medicine. From cellular replacement techniques for treating Parkinson’s disease to collagen-producing cell injections for wound healing and rejuvenating aging skin, significant steps are being made towards the commercialization of cell therapies. These changes are going to attract major industry players who are constantly on the watch for the latest technologies in development.

Vancouver-based RepliCel Life Sciences Inc. (TSX.V: RP) is a company that is already capturing industry attention. Its unique research into cells from hair follicles could play an integral part in accelerating the repair of tendons, damaged skin and pattern baldness.

David Hall, chief executive officer of RepliCel, describes the premise behind its research as being “elegant in its simplicity.” For example, to treat chronically injured tendons, a patient’s collagen-producing cells (fibroblasts) are isolated from a small biopsy taken from the nape of the patient’s neck, replicated and then injected directly into a damaged tendon to stimulate the stalled healing process leading to structural rehabilitation.

“These isolated fibroblast cells are prolific in their ability to produce Type 1 collagen, the key and missing cell in the stalled healing cycle of a tendon. This same principle holds for aged and sun-damaged skin where the collagen-producing fibroblasts have been damaged by ultraviolet light over time. Our focus is to address indications where there is a deficit of active fibroblasts,” Hall explains. “As injuries occur and people age, their ability to produce collagen and other critical proteins is depleted through repeated injury, sun damage, aging and other factors. Our technology, as it’s proposed, will jump-start the healing process.”

One focus for RepliCel is on clinical trials for chronic tendon injuries, an area of major concern for employers, compensation boards, athletes, active aging populations and the military. Early clinical work using cells isolated from the skin returned excellent results, and RepliCel believes that it has improved the technology even further by using healthier cells isolated from hair follicles. Trials planned for the fall of 2014 will return results in 2015.

The power of the RepliCel approach lies in the fact that treatment utilizes a person’s own cells, thereby reducing risk of complications, notes Lee Buckler, managing director for Cell Therapy Group, a Vancouver-based regenerative industry consulting company. “Taking a patient’s own cells, replicating them in a regulated facility and then returning them to the body minimizes safety risks.”

The markets RepliCel is addressing with their products are significant, he adds. “Their platform, built around two different hair follicle cell populations, could be instrumental in skin applications for burns, acne scarring or aging, in addition to the market for musculoskeletal injuries. It could also play a key role in disrupting the micro-transplant and hair rejuvenation business for pattern baldness.”

Regenerative medicine technologies are now solidly on the radar of big pharmaceutical, biotech and health care companies, Buckler says. “Most life science company executives now believe that cell-based products will represent a new way of delivering therapies to patients. As such, they’re now starting to invest in technologies to make sure they have a horse in the race.”

“Most of the top companies like Pfizer, Janssen, GSK, Novartis, Celgene now have internal and/or external cell therapy programs,” Buckler adds. “Other companies are investing in bringing manufacturing technologies to the sector and even companies not traditionally in health care, like Nestlé and L’Oreal, have established their own research institutes for these cell-based programs. If you look at the industry’s development pipeline, most every condition is being pursued as a target for a cell therapy.”

RepliCel’s current pipeline includes trials for tendinosis, pattern baldness and treatments for aging and sun-damaged skin in various stages of development. Hall estimates that data from the tendon and dermal programs will be available to support licensing discussions by 2015, and pattern baldness in 2016.

“Having this many trials is pretty impressive for a small company,” Hall says. “Our model has always been to develop products, demonstrate efficacy and then license to large pharma or cosmetics firms who can do the final commercialization. We want to be the research and development engine that creates revenues from licences and royalties. In fact, Shiseido Company of Japan has already partnered with us on our pattern baldness product. They acquired an exclusive geographic license for Asia.”

Having spent much of his career researching treatments for tendinosis, Dr. Jack Taunton, professor at the University of British Columbia faculty of medicine’s sports medicine division, says regenerative therapy holds great promise when dealing with chronic, long-term injuries. “We’ve dealt with a number of these types of injuries caused by overuse or repetitive strain in thousands of patients. Typically treatments have included physiotherapy, ice, anti-inflammatory’s, dextrose and PRP [platelet-rich plasma] injections. Yet, we still have a significant population of patients that do not get better.” He is hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”

Dr. Ross Davidson, an orthopedic surgeon and director of post-graduate sports medicine at the University of Auckland in New Zealand has treated countless athletes with chronic overuse injuries throughout his career. “I do see a huge potential for this. It has been a pleasant surprise to see the amount of collagen these fibroblasts produce for repairing tendons. It’s a big change from other treatments being released. If it works — and I believe it will — it will reduce the number of surgeries significantly.”

Beyond its clinical trials, the success of RepliCel’s products will be put in the hands of licensing partners which have the infrastructure to support commercialization, says Mark Landy, director of research for senior medical technology and regenerative medicine analyst for Summer Street Research in Boston. The good news is that the industry is not having to wait too long for the clinical trials to get proof of concept. “Having data coming in 2015 and 2016 enables the company to accelerate licensing.”

He believes RepliCel has a significant opportunity ahead given that its regenerative therapy approach addresses extremely large markets that are ready for solutions not provided by today`s treatments. “The industry as a whole has gone beyond the fears around regenerative and genetic engineering and is seeing its value. We now know we can take certain cells from the body and safely put them in certain areas. It’s a notion that goes back to bone marrow transplants and implants. The opportunities — and the markets — for regenerative medicine are very, very large.”

With results from clinical trials on the horizon, Hall is confident things are moving forward as they should. “We’ve been quietly building the fundamentals of this business – forging deals with major players, building up a diversified portfolio and strengthening our management team. Every step we take is incrementally adding value to the shareholders and furthering therapies for patients.”

hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”

Dr. Ross Davidson, an orthopedic surgeon and director of post-graduate sports medicine at the University of Auckland in New Zealand has treated countless athletes with chronic overuse injuries throughout his career. “I do see a huge potential for this. It has been a pleasant surprise to see the amount of collagen these fibroblasts produce for repairing tendons. It’s a big change from other treatments being released. If it works — and I believe it will — it will reduce the number of surgeries significantly.”

Beyond its clinical trials, the success of RepliCel’s products will be put in the hands of licensing partners which have the infrastructure to support commercialization, says Mark Landy, director of research for senior medical technology and regenerative medicine analyst for Summer Street Research in Boston. The good news is that the industry is not having to wait too long for the clinical trials to get proof of concept. “Having data coming in 2015 and 2016 enables the company to accelerate licensing.”

He believes RepliCel has a significant opportunity ahead given that its regenerative therapy approach addresses extremely large markets that are ready for solutions not provided by today`s treatments. “The industry as a whole has gone beyond the fears around regenerative and genetic engineering and is seeing its value. We now know we can take certain cells from the body and safely put them in certain areas. It’s a notion that goes back to bone marrow transplants and implants. The opportunities — and the markets — for regenerative medicine are very, very large.”

With results from clinical trials on the horizon, Hall is confident things are moving forward as they should. “We’ve been quietly building the fundamentals of this business – forging deals with major players, building up a diversified portfolio and strengthening our management team. Every step we take is incrementally adding value to the shareholders and furthering therapies for patients.”

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