Hair

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VANCOUVER, BC – September, 26, 2012 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB:REPCF) today announces that Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer, will be presenting at the 21st European Academy of Dermatology and Venereology Congress in Prague, Czech Republic on Thursday, September 27th from 3:00 PM to 6:00 PM local time. During this focused session on hair and scalp diseases, Dr. Hoffmann will explain the background of the invention and will be discussing results from the Company’s first- in-man Phase I clinical trials using the RepliCel® treatment as a potential solution for androgenetic alopecia. For more information please visit www.eadvprague2012.org.

About RepliCel Life Sciences Inc.
The Company has developed RepliCel™, a patented natural hair cell replication technology that has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. RepliCel™ is based on autologous cell implantation technology that replicates a patient’s hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, initiates natural hair regeneration. The Company is currently conducting first-in-man clinical trials. Additional information on RepliCel is available at www.replicel.com.

For more information please contact:

Tammey George
Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

Notice Regarding Forward Looking Statements
This press release contains forward-looking statements, including but not limited to: states that the Company will complete a Phase II clinical trial and that RepliCelTM has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements. These risks and uncertainties include: whether the Company can obtain regulatory approval for its planned Phase II clinical trial; that negative results may result from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital to carry out its planned activities; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2011, and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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VANCOUVER, BC – September 10, 2012 – RepliCel Life Sciences Inc.’s (the “Company” or “RepliCel”) (OTCBB:REPCF) today announces that David Hall, CEO and President, will be presenting at the Rodman & Renshaw Global Investment Conference. Mr. Hall is scheduled to present on September 11th at 2:25 PM ET in the Starlight South suite at the Waldorf Astoria hotel in New York.

The 20 minute presentation will include an update on corporate events and plans for a Phase II dose-ranging trial using RepliCel™ as a potential treatment for hair loss in men and women.

The presentation will be webcast and posted on Rodman and Renshaw’s website at www.wsw.com/webcast/rrshq22/repcf and on RepliCel’s website at www.replicel.com in the media section.

For more information please contact:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

Notice Regarding Forward Looking Statements
This press release contains forward-looking statements, including but not limited to: states that the Company will complete a Phase II clinical trial and that RepliCel™ has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements. These risks and uncertainties include: whether the Company can obtain regulatory approval for its planned Phase II clinical trial; that negative results may result from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital to carry out its planned activities; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2011, and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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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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VANCOUVER, BC – June 26, 2012 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB:REPCF) Chief Scientific Officer, Dr. Kevin McElwee, presented results from the Company’s TS001-2009 first-in-man clinical study at the 16th meeting of the European Hair Research Society in Barcelona, Spain this past week.

Dr. McElwee’s presentation included a brief review of preclinical research data, an examination of the production development process, and an interim analysis of six-month post-injection data. All findings from this interim analysis will be incorporated into the regulatory filings presently being developed for European regulators for the initiation of a Phase II dose-ranging trial. The preliminary plans for the Phase II trial were also presented in Barcelona.

The European Hair Research Society (EHRS) is an independent, non-profit organization dedicated topromoting the research of hair biology and hair disease in Europe. Their international membership includes scientists, dermatologists and professionals working in academia, industry and government. The EHRS supports and organizes meetings throughout Europe, dedicated to the presentation of new research findings, exchange of information, education of its members and the advancement of science.

For more information please contact:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements, including that the Company will complete a Phase IIb clinical trial and that RepliCel™ has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements. These risks and uncertainties include: whether the Company can obtain regulatory approval for its planned Phase IIb clinical trial; that negative results may result from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital to carry out its planned activities; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2011, and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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Company Takes Next Steps for Phase IIb Dosing Trial

VANCOUVER, BC – May 17, 2012 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) is pleased to report that further analysis of results from its successful first-in-man clinical trial revealed substantial hair growth including seven participants with growth in excess of 10%, including 17.2%, 19.2% and 19.6%. Furthermore, there were no negative health effects.

“The RepliCel TS001-2009 trial was a first-in-man trial with a primary endpoint of safety and this was confirmed emphatically,” stated Dr. Rolf Hoffmann, Chief Medical Officer at RepliCel. “Even though the size of the trial was only powered for safety measures, secondary endpoints were included in interim analysis to give us an early look at efficacy to allow us to better drive the design of the next steps of the clinical development of the RepliCel™ procedure,” Dr. Hoffmann concluded.

Darrell Panich, Vice-President of Clinical Affairs at RepliCel said, “While the interim analysis results show us that significantly more subjects (63%) had an increase in hair density of greater than 5% (vs. control) at six months post injection, some subjects had not yet shown an increase at this time point. Participants demonstrated changes from baseline, as much as 19.6%, while others showed decreases of as much as 6.2%. The overall average, as previously reported, was 6.2%.” Mr. Panich went on to say, “A negative measurement from baseline at six months is not unexpected as many hair fibres in the area of injection typically fall out from trauma; not unlike hair transplant surgery. Further analysis of the data we collected from our small, first-in-man trial will help us characterize the many factors that determine an individual’s response to treatment with injected autologous Dermal Sheath Cup Cells (DSCC) which will lead to an improved treatment regimen.”

RepliCel is currently performing an in-depth analysis of the interim data collected during the TS001-2009 clinical trial to identify factors that may impact the efficacy DSCC. The extent of subject response will be reviewed in relation to subject-factors (age, gender, health status, etc.), cell culture factors (duration of cell culture, cell morphology, cell protein markers, gene expression, etc.), and environmental factors (duration between biopsy and culture preparation, shipment durations/temperatures, etc.). “By cross-referencing the subject-response data collected by the primary investigator against other measured variables and against results from histopathological analysis of biopsies collected from treatment zones, we will develop an improved understanding of the factors that impact the efficacy of our technology in humans and therefore the protocol for treatment going forward,” said Kevin McElwee, PhD, Chief Scientific Officer of RepliCel. “The development of this technology is an iterative process beginning with our first-in-man trial. The next research steps are driven off the back of the data points that have been collected and will enable development of the next treatment protocol,” Dr. McElwee commented further.

RepliCel’s next (Phase IIb) trial is designed to be a dose-finding study which will assess the number of characterized cells and the appropriate treatment pattern necessary to promote optimal hair growth. Subject to regulatory approval, the Company is planning a 12-24 month clinical trial that will include multiple subject cohorts studying different doses of DSCC. Each subject will be given several different injections, while some cohorts will receive additional injections at subsequent time points. The Company will also review its standard operating procedures (SOPs) of cell biopsy, cell isolation, cell culture media, cell carrier, and injection media to fine-tune those processes in advance of a regulatory submission for a Phase IIb dosing trial.

Subjects in RepliCel’s Phase I/IIa clinical trial will continue to participate in the post injection follow-up period of the study until August 2013 and a review of final safety and efficacy results will commence before the end of 2013. The continued follow-up period is a key component of the study to confirm treatment safety profile and response trends at 6, 12 and 24 months.

“The Company’s first-in-man trial has accomplished the regulatory and corporate goal of providing the required safety data, as well as an early proof of principle in humans of response to treatment,” stated David Hall, CEO of RepliCel. “Further analysis of our data and iteration of SOPs will together define the protocols for our next stage of development designed to increase both response and efficacy. We now have the basis for the development of our Investigational Medical Product Dossier and to initiate direct meetings with the appropriate regulatory bodies. We are excited by the results and the opportunity they provide to advance our autologous DSCC therapy towards a successful treatment for pattern baldness in men and women,” concluded Mr. Hall.

About RepliCel Life Sciences
The Company has developed RepliCel™, a natural hair cell replication technology that has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. RepliCel™ is based on autologous cell implantation technology that replicates a patient’s hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, the Company hopes to initiate natural hair regeneration. Patents for the technology have been issued by the European Union and Australia and are pending in other major international jurisdictions. The RepliCel™ procedure has been developed over the past ten years by the Company’s recognized research scientists and medical experts – specialists in the fields of hair growth, hair biology and dermatology. Additional information on RepliCel is available at www.replicel.com.

For more information please contact:

Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements include that the Company will complete a Phase IIb clinical trial and that RepliCel™ has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: that regulatory approval will be received for its planned Phase IIb clinical trial; negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital to carry out its planned activities; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2011 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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VANCOUVER, BC – May 2, 2012 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) is pleased to report positive results from its interim analysis of six-month post-injection data collected from its first-in-man clinical trial (TS001-2009) designed to test the safety and efficacy of the RepliCel™ technology in men and women with androgenetic alopecia (pattern baldness). The primary protocol objective of the study is to assess the local (at treatment sites) safety profile of injections of autologous dermal sheath cup cells (DSCC) at six months post-injection compared to placebo. Secondary protocol objectives are to assess systemic (overall) safety and efficacy (hair growth at treatment sites) at 6 and 24 months post-injection and local safety at 24 months post-injection. The six-month interim analysis was designed to provide the Company with safety information to support the regulatory filing for a Phase IIb clinical trial.

The Company is delighted to report that the six-month interim analysis results support the continued development of DSCC for the treatment of androgenetic alopecia. “The assessment of the primary endpoint of the TS001-2009 clinical trial shows a favourable local safety profile for injections of autologous hair follicle cells,” said Darrell Panich, RepliCel’s Vice-President of Clinical Affairs. “We are also encouraged that the early analysis of efficacy endpoints has shown a trend for improvement in hair growth parameters and a statistically significant number of participants showing a treatment response. The results of this first-in-man trial tell us that we are on the right track in developing an effective treatment for people suffering from pattern baldness.”

All 19 subjects (10 male and 9 female) completed six-month post injection follow-up visits and the data collected from these visits was used for the interim analysis of the primary and secondary safety and efficacy endpoints for the TS001-2009 study.

In regards to the primary objective of assessing the local safety, the primary investigator monitored the injection sites for signs of bleeding (hematoma), bacterial infection (pyoderma), foreign body reaction or cysts (papules) or other skin reactions like eczema (inflammation), atrophy (shrinking of tissue) and any reports of local sensations such as burning and itching at the injection sites from the treatment-blinded patients. The results show that injections of autologous DSCC were very well-tolerated with only a few mild scalp irritations reported. There were no statistically significant differences in the number of local adverse events (AEs) reported at DSCC injection sites as compared to placebo sites.

“Beyond the initial primary endpoint of safety, the interim analysis of our first-in-man trial also provided the Company an early indication of the efficacy of injections of hair follicle cells prepared using the RepliCel™ procedure,” said David Hall, President and CEO of RepliCel. “The early safety data is essential for the continued development of the Investigational Medicinal Product Dossier that will support RepliCel’s application to conduct a Phase IIb dosing trial of our technology. This initial look at efficacy at six months shows us that these DSCC injections are having a positive effect on hair growth and support a decision to invest in our next clinical program.”

The efficacy of injections of autologous DSCC in the treatment of androgenetic alopecia was assessed through measurements of hair growth for those patients treated according to the protocol (16 patients). (Note that 3 patients were removed from this analysis because their injection products were shipped outside of the temperature range stated in the protocol.) Relative to measurements taken prior to injection (baseline), the total hair density (the total number of hairs in a given area per cm²) at sites injected with autologous DSCC increased 6.1%. Vellus hair (small/intermediate sized-hair: approximately 10-40µm thick) density and terminal hair (thick hair) density increased by 12.5% and 3.2%, respectively. Cumulative hair thickness per area (an estimate of scalp hair coverage; the sum of thickness of all hair diameters in a given area per cm²) also improved (by 4.3%) at DSCC-injected treatment sites relative to baseline measurements.

The response to treatment was assessed for the entire study population by calculating the number of patients demonstrating a greater than or equal to (>=) 5% change from baseline hair measurements. The interim analysis results showed a statistically significant difference (P=0.020) between the number of patients demonstrating a >=5% increase in total hair density at sites injected with DSCC relative to sites injected with placebo 6 months post-injection. Where 63% of patients demonstrated a >=+5% change from baseline at DSCC-treated sites, only 37% showed such an increase at placebo-treated sites. “The significant response shown at DSCC-treated sites and improved hair growth measures, even at this early 6-month time point, fully support further development of the RepliCel™ technology in a larger Phase IIb clinical trial,” said Mr. Panich. “Our upcoming study will explore optimum dosing and treatment regimens to improve treatment with injections of autologous DSCC while adding to our data on the safety of these injections.”

Secondary safety endpoints at the six-month post-injection time point included assessment of systemic AEs (those being AEs not at treatment sites) and results from independent raters’ assessments of injection sites during the first six months post-injection. A total of 25 systemic adverse events were reported by 12 patients during the first six months after study injections were completed. None of the reported events were considered serious or related to the study treatment. Overall, the results from the independent assessment showed no statistically significant differences between assessments of reactions at DSCC and placebo injection sites.

Further analysis of these findings in relation to other study factors will be taking place over the upcoming weeks. Detailed results from this interim analysis will be presented along with results from histopathological analysis of six-month post-injection site biopsies from four patients at the 16th meeting of the European Hair Research Society in Barcelona, Spain, June 21st-23rd, 2012. All results from this interim analysis will be incorporated into the regulatory filings presently being developed for the initiation of a Phase IIb clinical trial.

For more information please contact:

Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements include that RepliCel™ has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2011 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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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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The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.

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Please note that any opinion, estimates or forecasts made by the authors of these statements are theirs alone and do not represent opinions, forecasts or predictions of RepliCel Life Sciences Inc. or its management. RepliCel Life Sciences Inc. does not, by its reference or distribution of these links imply its endorsement of, or concurrence with, such information, conclusions or recommendations.