Media

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FINANCIAL POST ARTICLE PUBLISHED ON FEBRUARY 25, 2014

Imagine using healthy cells from your body to heal areas in which other cells are damaged or deficient. That’s what RepliCel Life Sciences Inc. (TSXV: RP) expects to do by developing a new cell-based treatment for chronic tendinosis, in which a patient’s own fibroblast cells from their hair follicles are harvested, replicated, and then reintroduced into the damaged areas within the tendon via ultrasound, which “jump starts” the wound-healing cycle. These cells are replicated but are not altered in any way, so there is no safety issue involved in the re-introduction of a patient’s own cells.

Tendinosis is the result of repetitive injuries and incomplete healing cycles that lead to a degenerative breakdown of the collagen tissue within a tendon, which inevitably leads to pain, dysfunction, and often rupture. The company estimates the potential market for the treatment of tendinosis is in excess of $3 billion per year.

RepliCel’s fibroblast technology uses nonbulbar dermal sheath (NBDS) cells, which are prolific in their expression of type I collagen and are key to creating a complete healing cycle within the damaged and degenerated tendon. These cells are taken from the back of the patient’s scalp with the use of a small punch biopsy. The NBDS cells are unique in that they are capable of dividing and renewing for long periods. In a laboratory, this process can yield millions of cells. These cells, which make up the sheath of a hair follicle, are healthy throughout a person’s life as they are in a continued state of renewal.

“It takes us about five to six weeks to replicate the cells and the cells are returned to the patient via a minimally invasive ultrasound guided injection directly to the area of damage and it takes about six months to return the patient to full functionality,” said RepliCel President and CEO David Hall in a recent interview. Mr. Hall has more than 20 years of biotech experience and is the former Chief Financial Officer at Angiotech Pharmaceuticals Inc.

The Company’s phase 2 tendinosis fibroblast program is being followed into human clinical trials with a treatment for UV damaged and aging skin using the same technology platform. RepliCel has also developed unique injector devices to support the delivery of its treatments. The company expects to complete the development of its injector device, which is programmable to depth and dose and has built-in cooling that replaces the need for an anesthetic. This device could also find a market in the delivery of other cosmetic dermal injectors. The device is expected to be commercialized in the next year, providing additional licensing opportunities for the company and asset value accretion.

RepliCel’s technologies carry issued and filed patent applications. Furthermore, the Company’s cell manufacturing technology is protected by trade secrets and is unique in its ability to quickly replicate fibroblast cells versus other replication technologies. RepliCel is also entering into a Phase 2 clinical trial for the treatment of pattern baldness using another cell isolated from the hair follicle. The technology was the subject of a Q2, 2013 Collaboration and Technology Development Transfer Agreement with Shiseido Company, Limited of Japan, the third-largest cosmetic company in world, in which Shiseido paid RepliCel an upfront fee of $4,120,400 for a geographic license including Japan, China and the ASEAN countries. Shiseido will initiate its own clinical program in Japan, providing two parallel clinical trials. RepliCel plans to initiate a Phase 2 trial for chronic tendinosis and a Phase 1 trial for aging and damaged skin in 2014 with results expected in 2015.

“I expect we can get an approval for treating chronic tendinosis within three years,” Mr. Hall added. RepliCel had $3.2 million in cash and equivalents as of September 30, 2013, and has a cash burn rate of approximately $200,000 per month. The company has 48,118,609 issued and outstanding common shares as of February 1, 2014, and after its listing on the TSX-V in February of this year its stock has surged 50% to its recent price of 90 cents a share.

About RepliCel Life Sciences:
RepliCel Life Sciences Inc. (TSXV: RP) is a clinical stage biopharmaceutical company focused on developing autologous cell therapies that treat functional cellular deficits. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.

Disclosure
RepliCel Life Sciences is a featured sponsored company and has paid SmallCapPower.com a fee for coverage.

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BUSINESS IN VANCOUVER ARTICLE PUBLISHED ON JANUARY 13, 2014

Vancouver-based RepliCel Life Sciences Inc., a clinical stage biopharmaceutical company, has been granted a patent by Japan’s Ministry of International Trade and Industry for the applied use of hair follicle mesenchymal stem cells, the company announced January 13.

These cells are used in RepliCel’s treatment for androgenetic alopecia, also known as pattern hair loss.

RepliCel now has patents issued in Japan, the United States, Australia and the European Union, with other jurisdictions still pending.

RepliCel said the patent approval is an important milestone as its licensing partner, Shiseido Company, prepares to conduct human clinical trials using RCH-01. Shiseido has an exclusive license to use RCH-01 in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people.

According to the International Society of Hair Restoration, almost one million patients sought treatment for hair loss in 2012. Of this number, 41% of the patients were from Asia, representing the largest single region, surpassing the United States by 15%.

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The cure for baldness? It could be closer than you think — i.e. among the baldness-proof follicles that usually reside at the bottom back of the head, stem cell researchers claim.

Erin Ellis, Postmedia News Files

NATIONAL POST ARTICLE PUBLISHED ON OCTOBER 30, 2013

The cure for baldness? It could be closer than you think — i.e. among the baldness-proof follicles that usually reside at the bottom back of the head, stem cell researchers claim.

A cure for baldness doesn’t leap to mind when one ponders the next advance in stem-cell research, but whoever manages to do it could become very rich.

Scientists have already grown liver and brain cells in the laboratory using cell samples from humans. Others are trying to find a way to nurture new hair growth on shiny heads.

A new analysis of existing studies linking hair loss and cardiac health suggests men who experience premature balding before the age of 50 may have an increased risk of developing heart disease.

In the meta-analysis (a critical examination of previous observational studies), conducted at the University of Tokyo, researchers analyzed data from six previous studies that investigated the link between male hair loss, congenital traits and cardiovascular disease. All together, the studies tracked the hair patterns of over 40,000 men ranging from middle age to those over age 60.

“It’s a market where people spend a tonne of money,” says David Hall, CEO of RepliCel Life Sciences Inc., a Vancouver-based biotech firm that has attracted the attention of Japan’s Shiseido Co. The cosmetic giant paid $4.2 million in July to share RepliCel’s research on highly speculative technology for treating hair loss.

Hair transplants are still the “gold standard” for hair restoration, Hall says, but their success relies on the skill of the surgeon and a supply of healthy follicles from elsewhere on the scalp.

The RepliCel technique was pioneered by company co-founders Rolf Hoffmann, a German dermatologist, and Vancouver researcher Kevin McElwee. Hair follicles are harvested from the back of a person’s scalp, where hair is typically resistant to the hormone that causes baldness. That tissue is transferred to the lab, where researchers isolate dermal sheath cup cells from the base of the follicle. Those cells are replicated by the millions over a period of three months, later to be injected into bald areas at the top of the scalp.

“What initially attracted me to this concept is it’s not a drug,” says Hall. “The treatment uses the patient’s own cells to replace hormone-compromised hair-follicle cells in the bald areas. The concept of treating cellular deficits with your own cells is elegant.”

The company hopes to have a clinical trial with 120 men in Germany in the coming months as it works its way through regulatory requirements that could lead to licensing in Europe, the U.S. and Japan. It has already completed an initial trial of 19 subjects that found no serious adverse reactions six months after injections.

But RepliCel’s plan isn’t to bring its cell cloning all the way to market, Hall says. Rather, it wants to prove the effectiveness of the technology in the hopes it will be purchased by another company.

Companies are chasing the estimated $3 billion annually spent on hair-restoration treatments worldwide.The market could be even larger if women — who are turning to hair-replacement surgery in greater numbers — also buy into newer procedures.

‘You feel bad because you’re losing your hair. Then you feel guilty for feeling bad because it’s only hair. So the psychological hit isn’t just once, it’s twice’

Christine Janus, executive director of Ottawa-based Canadian Skin Patient Alliance, says hair loss is a becoming more common for women.

“For women, when you’re starting to lose your hair — no matter what age you are — it really packs an emotional wallop. You can feel less attractive, you can feel less sexy. It turns out a lot of our identity is tied up in our hair,” she said. “It’s how we present ourselves to the outside world.”

Androgenetic alopecia is the medical name for male pattern baldness (thinning hair and eventual baldness starting at the temples, moving to the crown and top of the head) and female-pattern baldness (general thinning.) They’re both caused by a combination of genetic predisposition and hormonal changes that are not particularly well understood in women. Once hair loss starts, says Janus, both women and men are launched on a conflicted emotional journey.

“There’s a real dichotomy. You feel bad because you’re losing your hair, losing who you were. Then you feel guilty for feeling bad because it’s only hair. So the psychological hit isn’t just once, it’s twice. Society tells you you shouldn’t care, but you know you look weird.

Another reason for a jaundiced view of the search for a cure to baldness is that it’s been dominated by snake-oil salesmen for decades. These schemes have played on the emotions of people worried about losing their sex appeal or even their edge in the professional world.

Janus says anyone who can make an effective product will find a world of grateful buyers.

“If they’re selling stuff that really doesn’t work, then I think they’re taking advantage,” she says. “If they actually have a product that works very well, like Rogaine or implants or wigs. … If they’re selling something that is going to give a person — male or female — that sense of self back, then they provide a service. And it’s a good thing.”

‘How do you get the public to understand that this is really backed by science’?

Jeff Donovan, a Toronto dermatologist specializing in hair transplants, agrees the hair-restoration industry has a dismal reputation because it’s short on hard research and long on hard sells.

“It makes it a lot more difficult for people doing good work to get their data seen,” he says. “How do you get the public to understand that this is really backed by science — which is what is so desperately needed — vs. someone who just brings a product to market and licenses it under nutritional supplements, let’s say, and with strong marketing the public can be convinced that both of those are equally promising.”

Donovan advises consumers to wait for clinical evidence before buying into anything.

And like the U.S. Food and Drug Administration-approved treatments already on the market — such as minoxidil cream and finasteride pills — anything new will probably work to some extent on some people, he predicts. Donovan has heard RepliCel’s Hoffman present early findings at a European dermatology conference and says he’s intrigued by the possibility that it could one day be added to the mix.

“These treatments don’t work in everyone and don’t work in advanced hair loss. Minoxidil works differently than Propecia; one’s a topical treatment and one’s a pill, and the two combined work even better. So here we have a third treatment (RepliCel’s) that works even differently. It’s going to be exciting to see if it does anything and, if it does, even a little bit, then it can be combined with minoxidil as a treatment. Because anything you can do to help hair is going to be good.”

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Hisae Nakamura, director of research and development for RepliCel, with a device used to inject cells into the scalp to stimulate hair growth. The company’s process replicates cells from hair follicles on the back of the scalp, which are typically resistant to the hormone that causes baldness, and injects them into bald areas.

Photograph by: Nick Procaylo, PNG

VANCOUVER SUN ARTICLE PUBLISHED ON OCTOBER 26, 2013

A cure for baldness doesn’t leap to mind when one ponders the next advance in stem cell research, but whoever manages to do it stands to become very rich.

Scientists around the world have already grown liver and brain cells in the laboratory using cell samples from humans. Others — including some working for a Vancouver-based company — are hard at work trying to find a way to nurture new hair growth on shiny heads.

“It’s a market where people spend a ton of money,” says David Hall, CEO of RepliCel Life Sciences Inc., a biotech firm with offices in downtown Vancouver that has attracted the attention of Japan’s Shisheido Co. The cosmetic giant paid $4.2 million in July to share RepliCel’s research on a highly speculative technology for treating hair loss.

Hall, who says his own flowing locks have no high-tech enhancement, acknowledges that plenty of people think hair cloning research is frivolous. But those usually aren’t people who are losing their hair, particularly at a young age.

“It’s just not perceived as a medical need, but I think there are a lot of people who would say it’s important to them,” Hall says. “There’s definitely a mental health aspect for young men and for women in their 30s and 40s. It can be very devastating to their self-esteem.”

Hair transplants are still the “gold standard” for hair restoration, he says, but their success relies on the skill of the surgeon and a supply of healthy follicles from elsewhere on the scalp. The RepliCel technique was pioneered by company co-founders Dr. Rolf Hoffmann, a German dermatologist, and Vancouver researcher Kevin McElwee. Hair follicles are harvested from the back of a person’s scalp, where hair is typically resistant to the hormone that causes baldness. That tissue is transferred to the lab, where researchers isolate dermal sheath cup cells from the base of the follicle. Those cells are replicated by the millions over a period of three months, later to be injected into bald areas at the top of the scalp using a specially designed device.

“What initially attracted me to this concept is it’s not a drug,” says Hall. “The treatment uses the patient’s own cells to replace hormone-compromised hair follicle cells in the bald areas. The concept of treating cellular deficits with your own cells is elegant. It’s the same concept we’re using in our other treatment in development for chronic tendinosis.”

The company hopes to have a clinical trial with 120 men test the procedure in Germany in coming months as it works its way through regulatory requirements that could ultimately lead to licensing in Europe, the U.S. and Japan. It has already completed an initial trial of 19 subjects that found no serious adverse reactions six months after injections.

But RepliCel’s game plan isn’t to bring its cell cloning all the way to market, Hall says. Rather it wants to prove the effectiveness of the technology in the hopes it will be purchased by a much larger company.

(Hall was formerly the chief financial officer of Angiotech Pharmaceuticals Inc., a Vancouver biotech darling that rode high during a boom early last decade after it developed a drug-coated cardiac stent. U.S. medtech firm Boston Scientific became a partner on that technology and still sells the stents, but Angiotech faltered in the 2008 financial crisis and filed for bankruptcy protection in 2011.)

Until recently, RepliCel’s main direct competitor in this area was a biotech start-up called Aderans Research Institute based in Atlanta, Ga. It ran clinical trials on a process described as “hair multiplication or hair cloning,” although it targeted different cell from the hair follicle than RepliCel. The work was initially bankrolled by Japan-based Aderans, a multinational company that started as a wig-maker in the ’60s, eventually buying Bosley, a chain of hair transplant clinics. In 2012, Aderans bought Hair Club, formerly known as Hair Club for Men, the U.S. company that spawned a generation of testimonial-style late-night TV commercials.

Vern Liebmann, CEO of Aderans Research Institute, said in a recent telephone interview that his company is now “in hibernation” since Aderans pulled its funding. “It’s perceived as high-risk and in the current climate — going back to 2007-2008 — funds for pioneering-type efforts are hard to come by.”

Liebmann said investors are interested in hair treatments because of the immense market they could potentially tap, but bringing a biological treatment to fruition means following the same strict regulatory process required by pharmaceutical companies before a drug can be sold. That takes deep pockets.

“If RepliCel didn’t have Shisheido, they’d be in a world of hurt,” he said. “They got lucky. We didn’t.”

The companies are all chasing the estimated $3-billion per year spent on hair restoration treatments around the world. The market could be even larger if women — who are turning to hair replacement surgery in greater numbers — also buy into newer procedures.

Christine Janus, executive director of the Ottawa-based Canadian Skin Patient Alliance, says hair loss is a serious condition for women and it’s becoming more common.

“For women, when you’re starting to lose your hair — no matter what age you are — it really packs an emotional wallop. You can feel less attractive, you can feel less sexy. It turns out a lot of our identity is tied up in our hair, ” she said in a telephone interview. “It’s how we present ourselves to the outside world.”

Androgenetic alopecia is the medical name for male pattern baldness (thinning hair and eventual baldness starting at the temples, moving to the crown and top of the head) and female-pattern baldness (general thinning.) They’re both caused by a combination of genetic predisposition and hormonal changes that are not particularly well understood in women. In men, testosterone is converted to dihydrotestosterone (DHT), which causes follicles to slow and eventually stop producing hair.

Once it starts, says Janus, both women and men are launched on a conflicted emotional journey.

Another reason for a jaundiced view of the search for a cure to baldness — the holy grail of hair treatments — is that it’s been dominated by snake-oil salesmen for decades. These schemes have played on the emotions of men and women worried about losing their sex appeal or even their edge in the business and professional world.

But Janus says anyone who can make an effective product will find a world of grateful buyers.

“Are they playing on insecurities and are they making money?” asks Janus. “If they’re selling stuff that really doesn’t work, then I think they’re taking advantage. If they actually have a product that works very well, like Rogaine or implants or wigs … If they’re selling something that is going to give a person — male or female — that sense of self back, then they provide a service. And it’s a good thing.”

Dr. Jeff Donovan, a Toronto dermatologist who specializes in hair transplants, agrees the hair-restoration industry has a dismal reputation because it’s short on hard research and long on hard sells.

“It makes it a lot more difficult for people doing good work to get their data seen … How do you get the public to understand that this is really backed by science — which is what is so desperately needed — versus someone who just brings a product to market and licenses it under nutritional supplements, let’s say, and with strong marketing the public can be convinced that both of those are equally promising.”

Donovan advises consumers to wait for evidence from objective clinical trials before buying into anything.

“These treatments don’t work in everyone and don’t work in advanced hair loss. Minoxidil works differently than Propecia (finasteride), one’s a topical treatment and one’s a pill, and the two combined work even better. So here we have a third treatment (RepliCel’s) that works even differently. It’s going to be exciting to see if it does anything and, if it does, even a little bit, then it can be combined with minoxidil as a treatment. Because anything you can do to help hair is going to be good.”

Not just for Nobel Prizes anymore A team from the Tokyo University of Science made headlines in 2012 by implanting laboratory-made human hair follicle germs on the necks and heads of bald mice which later grew tiny mohawks of straight black hair.

That work builds on the groundbreaking discoveries of 2012 Nobel Prize co-winner Shinya Yamanaka of Kyoto University, who found a way to turn mature cells from mice into immature stem cells that can then be programmed to grow into any type of cell in the body. Until then researchers had concentrated on embryonic stem cells — harvested from animal and human embryos a few days after fertilization — which are known as undifferentiated cells, capable of multiplying into all of the body’s specialized tissues.

Now labs can create induced pluripotent stem cells, meaning they are capable of becoming any type of cell, from mature human cells. That’s the basis upon which other scientists have grown liver tissue and more recently brain tissue in a laboratory setting.

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By Emma Crawford, Thu Apr 18, 2013 10:53am PST

Vancouver biotech RepliCel Life Sciences Inc. (OTCQB:REPCF)(CNSX:RP) has received a United States patent for its technology related to hair regeneration, the company announced this morning.

The company’s hair restoration procedure involves taking a small biopsy from the back of a patient’s scalp and preparing populations of “dermal sheath cup cells” that are then used to treat patients with pattern hair loss.

“The allowance of our first U.S. patent is a major achievement for our business as the United States represents the largest current market for hair restoration procedures, conservatively estimated at over $1.3 billion annually,” said David Hall, CEO of RepliCel. “The market for a permanent, non-invasive procedure like RepliCel’s is clearly significant.

“If you factor in the still-untouched market of hair loss in women, the total patients for RepliCel’s treatment would expand even further.”

The company already has patents in Australia and the European Union.

Link to article: http://www.biv.com/replicel-us-patent-issue-notification

Email: ecrawford@biv.com
Twitter: @EmmaCrawfordBIV

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(English Translation)

Injected hair stem cells are emerging as the most effective therapy against baldness\u2028
EFE News

Barcelona, June 22 (EFE).

Canadian scientists have been able to grow hair in bald individuals through implantation of hair stem cells, a pioneering therapy that experts predict will be most effective against this phenomenon that affects a significant portion of the male population.

After a successful test in mice in 2003, Dr. Kevin McElwee, of the University of British Columbia in Canada, has undertaken, in recent years, the first clinical trial of adult stem cell injections for the treatment of androgenic alopecia (common baldness), the results were presented today in Barcelona.

Canadian researcher have implanted stem cells taken from the back of their heads in 19 balding men, a privileged area which is not affected by hormones that cause other hairs to fall out.

The main characteristic of the stem cells is that they have the ability to regenerate and, therefore, can repair the areas that have lost their hair precisely because such cells have failed to function after reveiving hormonal stimulus.

In order to increase those percentages, Dr. McElwee explained today at a press conference that a second study in Europe will help increase these results and the company has not ruled out participation by any of the centers is in Barcelona.

For the researcher, University of Barcelona (UB) Ramon Grimalt, president of the Spanish Group of Trichologists said the results, although they may seem low, are “very encouraging” to effectively treat common baldness, which affects 50% of men over 50 years.

In this sense, Grimalt stressed that current treatments-topical, oral and surgical, are very effective but their effect lasts only a very short time.

The technique of implantation of stem cells, with hardly any side effects, could be a turning point because, unlike the others, this treatment attacks the root problem.

It has also been observed in mice that underwent implantation of the hair stem cells that the hair continued to grow until they died.

The problem of androgenic alopecia is that the hair is not falling out but becomes so thin that eventually it disappears as a result of hormonal processes in which they operate; a set of genes and environmental factors that science is investigating.

However, when it is observed that the hair grows it is because the stem cells are still working to regenerate tissue, so the hair will appear.

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(English Translation)

HAZTEOIR.ORG \u2028The website of the active citizen

June 22, 2012
The patient’s own stem cells are seen as most effective way to treat alopecia

Introduced in Europe, at a convention in Barcelona, the results of research carried out by the team of Dr. Kevin McElwee, University of British Columbia in Canada.

EDITORIAL HO. – Canadian scientists have been able to grow hair in bald individuals through implantation of stem cells, a pioneering therapy that experts predict will be most effective against this phenomenon that affects a significant portion of the male population.

After a successful test in mice in 2003, Dr. Kevin McElwee, of the University of British Columbia in Canada has undertaken in recent years, the first clinical trial of stem cell injections for the treatment of androgenic alopecia (common baldness), the results were presented today in Barcelona.

Canadian researchers have implanted stem cells in 19 balding men that were taken from the back of their necks, a privileged area in which hormones do not always attack the hair.
The main characteristic of stem cells is that they have the ability to regenerate and, therefore, they can repair the areas that have lost their hair precisely because they have failed to continue to function.

The results, which were presented today for the first time in Europe as part of the meeting of the European Society of Hair Research held in Barcelona, yielded a maximum regeneration in areas of hair loss of 19%, although the overall average from all subjects was 6%. In order to increase these percentages, Dr. McElwee explained to the media that a second study will be conducted in Europe and they have not ruled out any of the participating centers in Barcelona.

For the researcher, University of Barcelona (UB) Ramon Grimalt, president of the Spanish Group of Trichology-the science of hair-the results, although they may seem low, they are “very encouraging” as an effective treat common baldness, which affects 50% of men over 50 years.

In this sense, Grimalt stressed that current treatments, oral and surgical, are very effective, however, their effects wear off once you stop treatment. The technique of implantation of stem cells, with hardly any side effects, could be a turning point because, unlike the others, this treatment attacks the root problem. It has also been observed in mice that underwent implantation of the hair stem cells that their hair continued to grow until they died.

The problem of androgenic alopecia isn’t that the hair is falling out but that it becomes so thin that eventually it disappears. This is a result of a hormonal process in which they operate a set of genes and environmental factors that science is investigating. Sin But when shows that the hair falls is because the stem cells are still working to regenerate tissue, so the hair will appear.

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AskMen.com

Men And Balding By Jeremy Berger, February 6, 2012

The plague that has dogged us for centuries may finally be vanquished.

Balding is the hoverboard of medical research. If someone had told me in 1989 that, more than 20 years later, my Birdhouse deck wouldn’t float, I’d have told the butthead to get lost. But here we are in 2012. Hoverboardless. Dinosaurs.

“There has never been a clinical treatment specifically developed for hair loss that worked.”

Worse: Men have been losing their hair for thousands of years, and the best science has done is smoke and mirrors, ointment and wigs. Perhaps it’s what we deserve for all our vanity, preening and grooming while the promises of liberal democracy smolder. Maybe we should shave our heads and rebuild America. But the truth is even the most stoic guys struggle with hair loss when it sets in, and it’ll happen to about 50% of us by middle age. Only a much smaller percentage — as low as 7% — will ever seek medical treatment.

Understanding why this is boils down to the fact that there hasn’t been a single groundbreaking treatment that permanently stopped or turned back the clock on hair loss. In fact, there has never been a clinical treatment specifically developed for hair loss that worked.

The options from recent history: wearing a wig; using a topical solution or foam with minoxidil, like Rogaine (developed initially to treat high blood pressure); taking finasteride, which is in Propecia and Proscar (first used to treat an enlarged prostate); or getting hair transplants. Each of these works in a piecemeal way, but they’re all problematic. Wigs are a bit silly. Rogaine and Propecia have mixed results and must be used every day, for life. Transplants are limited by the amount of donor hair from the crown and back of the neck. None of them will bring back the flowing locks of your teenage years.

Some scientists and doctors think that could change in the next 10 years. Is it for real this time?

The best defense is a good offense

In recent years the theme of the balding conversation has changed from “maintenance” and “prevention” to actual regrowth. The reason? A better understanding of hair biology, including new knowledge of how cells communicate with the hair follicle. A study led by George Cotsarelis, M.D., chair of the Department of Dermatology at the University of Pennsylvania School of Medicine, that was published last year in the Journal of Clinical Investigation found that a bald scalp and one with hair both have the same number of stem cells, but in the bald scalp, the stems cells are sort of chilling out, just sitting there instead of going to work repairing and replenishing hair follicles and fibers. “However, the fact that there are normal numbers of stem cells in a bald scalp gives us hope for reactivating those stem cells,” Cotsarelis said in a news release issued by Penn Medicine. Get the stem cells working again and the hair comes back.

New Biotech: Follica, Histogen, Replicel

Cotsarelis declined to be interviewed for this story, but he’s been hard at work as co-founder and member of the scientific advisory board of Follica, a privately held biotech company that has an exclusive license from Penn Medicine to develop technology based on the JCI study and another from 2007, which showed that mice with skin wounds regrew hair at the injured site in a process that mimicked embryonic development. This means that activated stem cells can grow new hair follicles. Little else is known of Follica’s forthcoming balding treatment, except that it will likely include a drug compound and some sort of wounding of the skin akin to what went down with the mice.

Follica isn’t the only biotech company trying to find a cure for hair loss and stake a claim in the multibillion dollar market for treatment, one that could conceivably balloon if a better treatment existed. San Diego-based Histogen, a privately held company headed by Gail Naughton, Ph.D., an expert in tissue engineering, also views Dr. Cotsarelis’ work (along with studies at Rockefeller University by Elaine Fuchs and University of Southern California by Cheng-Ming Chuong) as the foundation of current biotech progress in hair restoration.

“Our approach is to take cells that are normally found in the scalp and grow them under embryonic conditions of very low oxygen and suspension culture to trick the cells into thinking they’re back in the embryonic environment,” Naughton said.

“Within a couple of days they start acting like multipotent stems cells and secreting the growth factors that are necessary to stimulate stem cells in the body, including stem cells of the human hair follicle. We’ve basically learned how to manufacture a complex physiological group of growth factors that are normally responsible for stimulating stem cells to create new hairs. We simply mimic nature by figuring out how to make what the body makes to grow a new hair.”

Those growth factors, chemical signals produced by cells that induce more cell growth and maturation or differentiation, are what go into Histogen’s Hair Stimulating Complex (HSC), an injectible liquid formula currently in clinical trials in Manila, Philippines.

Naughton believes she and her team have identified the four growth factors that are most important for the cycling of a hair follicle and for stimulating growth: Follistatin, Noggin (seriously), Vascular endothelial growth factor (VEGF), and Keratinocyte growth factor (KGF). So far, according to Histogen, patients have had statistically significant hair growth (including increases in hair count, hair thickness and hair density) at 12 weeks and at one year. Histogen aims to have a product on the market in Asia in 2015 and in the U.S. a year later. The actual procedure involves a one- or two-time set of injections in the scalp with a very fine 32-gauge needle, taking only several minutes rather than the hours required for a hair transplant.

Vancouver-based RepliCel is also working on an injectible treatment. Scientists there are banking on the dermal sheath cup cell, which they isolate from the root of the patient’s hair follicle. That cell goes into a growth medium where it multiplies into the millions before being injected back into the patient’s scalp and going to work growing new follicles and rejuvenating existing ones. “We believe that the dermal sheath cup cells are the progenitor cells that are necessary to instruct the rest of the cell population to form a follicle and to form a hair fiber,” David Hall, RepliCel CEO, said. “In layman’s terms, we’re doing a cellular transplant as opposed to a follicular transplant.”

RepliCel’s phase one clinical trial is underway in Tbilisi, Georgia, and the company expects to have safety and efficacy data in early 2012. (Phase one of clinical trials primarily establishes the safety of the procedure. Phase 2 focuses on dosing and efficacy in a larger group of patients.) That means that a treatment in the U.S. would probably be available in the next five years.

Meanwhile, in New York…

In the meantime, hair transplant surgery has come a long way from obvious “plugs” — large, clunky grafts — to more precise implants in naturally occurring groups of 1-4 hairs called follicular units. Even RepliCel’s Hall considers microtransplant surgery the gold standard for care in men. “In the hands of a gifted surgeon, it has a really good outcome,” he said. “The problem is that there are only so many gifted surgeons.”

The logic behind hair transplant surgery, aside from the obvious — moving hair from once place to another — is that the donor hair taken from the back of the head isn’t sensitive to the androgen, or hormone, dihydrotestosterone (DHT). DHT is the culprit in male-patterned baldness that stops the follicle from cycling normally. (To the extent that Propecia works, it does so by blocking DHT.) In theory, a successful hair transplant should be relatively permanent. The other problem is that there are only so many hairs.

In the U.S. there are two new developments that could potentially improve the quality and availability of hair transplant surgery, which according to the American Society of Plastic Surgeons was the fifth most common cosmetic surgical procedure among men in 2010, behind nose reshaping, eyelid surgery, liposuction, and breast reduction.

One of these developments is being tested at the offices of Amiya Prasad, M.D., a cosmetic surgeon in New York City. Gary Hitzig, M.D., Medical Director of Prasad Cosmetic Surgery Hair Restoration Division, is banking on the same university studies cited by the biotech companies we interviewed. But instead of coming up with a proprietary injection — like Histogen’s HSC or RepliCel’s dermal sheath cup cells — he has sidestepped the research and FDA approval process by using ACell MatriStem, a product derived from pig bladder that has already been cleared by the FDA and is commonly used in regenerative medicine (including by Prasad in the other areas of his practice).

ACell MatriStem has been in the mainstream press for regenerating a woman’s severed fingertip, healing a toddler’s severed thumb and for its use in healing soldiers with significant battle wounds. It’s made of collagen and other growth factors; when applied to wounds, it provides a sort of scaffolding for healing and simultaneously activates nearby adult stem cells to rebuild tissue.

Hitzig has experimented with several applications of ACell: Using it to accelerate the healing process and prevent scarring where donor hair was extracted, dipping hairs in it before they were transplanted into the top of the scalp, as an injection in non-transplant patients, and as an injection combined with platelet-rich plasma (PRP), blood plasma jacked up with even more growth factors than the ACell alone.

“It’s amazing stuff,” he said. “We’re at the stage now where I can take people who weren’t candidates for transplants and we can go ahead and do them. We have a way of healing the area instead of scarring. And we have a way of getting a better result by multiplication of hairs growing on top.” He’s especially excited about the injection, which he sees and as a way to slow down or stop hair loss.

“I equate it to a flu shot,” Hitzig said. “It may not stop you from getting the flu, but it sure as heck helps. We haven’t had anything else like this.”

It’s not a radically different concept than what the biotech companies are exploring: Create a nutrient- and growth-factor-rich environment to save dying hair follicles and grow new ones. The one problem is that Hitzig hasn’t yet conducted a controlled clinical trial to prove that patients have statistically significant results with the ACell and PRP injection.

Thus, robots

The other development, naturally, is a robot. It turns out that extracting an implanting follicular units successfully is difficult and time-consuming, a procedure too tricky for many transplant surgeons. Restoration Robotics, a privately held medical device company, aims to democratize the procedure. Its first product, ARTAS, uses an image-guided robotic arm to harvest hair from the back of the patient’s head.

Mohan Bodduluri, Ph.D, the founder and CTO of Restoration Robotics, said that he expects to roll out a product that can do even more in five years. “Internally, we call that ‘hair transplantation in a box,” Bodduluri said. “The expectation is that the follicles would be harvested, they would be stored and be implanted — all by the machine. The technicians may never have to handle the graft.”

ARTAS is currently being used at hair transplant facilities in New York, Los Angeles, Dallas, and Denver. It looks a bit like a cross between a massage chair and Optimus Prime. Like most hair transplants, the cost of a procedure with ARTAS costs $10,000 and up, depending on the number of grafts and the reputation of the surgeon.

The future: Hairy

What we know for sure about the future is that there will be more robots. What we sort of know is that there will be a brief period of time when people in Asia and the Caucuses are walking around with pompadours while we’re still in recession (both kinds). And what we can only speculate about is that Chinese President Hu Jintao and Vice-President, Xi Jinping did not get such exceptional hair through genetics alone. Somebody got his hands in the cell transplant injection jar.

Prasad said something interesting when I spoke to him about hair transplants and his work with Hitzig: “Hair transplant surgeons, kind of like chefs who cook chili, talk about how the other guys are not as good as I am because I do this that and the other thing. When you get down to it, no matter what doctor is doing the work, the quality of the transplant has an upper limit. It’s a strategy to frame your face, create the illusion of more hair than you think someone has.”

He’s confident that ACell will be a breakthrough, but his comments have broader implications: chili cooks are a pain in the ass. Also, framing the face is about more than just about the number of follicles in a scalp. It’s about how we see ourselves and whether we really can, and want to, reverse-engineer the building blocks of nature for cosmetic purposes. Whether it’s better to live generally within the bounds of nature or to live with an illusion of youth.

Common procedures are becoming less invasive and less costly. Botox was the most popular minimally invasive cosmetic procedure for men in 2010, up 10% over the previous year. There’s a very good chance that we’re less than 10 years away from a similarly quick and painless injectible treatment to stop or reverse hair loss.

When it happens, when we decide to use it, make no mistake: The treatment may go under the radar, but everything we do frames the face.

-end-

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To watch the September 11th episode of The Bald Truth, click here: http://www.youtube.com/watch?v=N8yO96ANRYc

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