Histogen Hair Stimulating Complex to Begin Second Clinical Trial Shortly

Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, announced the one year data findings of its Hair Stimulating Complex (HSC) pilot clinical trial. Statistically significant new hair growth was seen in HSC-treated subjects at this follow-up timepoint, one year after their single treatment with HSC.

In addition to the number of new hairs, a statistically significant (p<0.05) increase in hair density, which is directly related to hair count over the treatment areas, was also seen at the one-year timepoint. Other efficacy factors, such as hair thickness and terminal hair density, showed an upward trend at this timepoint as well. The pilot trial tested two formulations of HSC and, although one formulation was determined to be superior, significant new hair growth was seen in both groups. (p=0.032)


This new data indicates that a single HSC treatment not only results in rapid hair growth (statistically significant increases in the number of terminal hairs, hair thickness density and hair shaft diameter was seen at three months), but that these results persist over time.

“Seeing continued hair growth at this one year follow-up is truly groundbreaking,” said Dr. Craig Ziering, Founder of Ziering Medical and Principal Investigator on the HSC clinical trial. “Not only do currently available non-surgical treatments show limited hair regrowth, but any new hair is lost shortly after discontinued use. We now have preliminary evidence that HSC significantly increases hair counts, and that the effects of a single treatment are lasting.”

The pilot 24 subject clinical trial of HSC was a double-blind, placebo-controlled evaluation of safety in the clinical application of the product as an injectable for hair growth. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy. No adverse events were seen at any timepoint, including the one year follow-up.

HSC is a proprietary formulation of naturally secreted embryonic-like proteins and growth factors. In addition to Wnt 7a, which is recognized to be critical in the induction and maintenance of hair follicle growth, the complex contains a wide variety of factors typically produced by embryonic cells and which are important to the hair cycle, such as follistatin. While these embryonic-like materials are amplified under Histogen’s unique manufacturing conditions, undesirable proteins and growth factors, including Wnt 5a, which has been shown to be associated with cancer, are eliminated.

“The development of hair follicles is the consequence of a complex interplay of factors that is still being unraveled,” said Dr. Jonathan Mansbridge, Histogen’s Chief Scientific Officer. “However, several factors critical to hair growth, such as Wnt 7a, follistatin, VEGF and KGF, are present in HSC, and their secretion by the cells is stimulated by the culture conditions we use. The embryonic conditions under which our cells are manufactured not only upregulates genes associated with hair growth, but induces significantly more production of these critical factors than seen with normal 3D or monolayer cultures.”

HSC is a unique composition resulting from growing newborn cells under embryonic conditions. The hypoxia/microgravity results in large amounts of follistatin (41.6 ng/ml in HSC versus 6.75 ng/ml in normal culture conditioned media), VEGF (9.1 ng/ml versus 2 ng/ml), KGF (5.4 ng/ml versus 2.1 ng/ml), and a lack of the scar-related TGF beta (0 ng/ml versus 1.7 ng/ml in normal cultures). This composition is covered by pending US patent #2010/0047305.

The full results of the HSC clinical trial were presented at the Society for Investigative Dermatology (SID) Annual Meeting, in Atlanta, May 5-8, 2010.

Histogen is currently in planning stages for the next clinical trial of HSC, which is scheduled to begin in late 2010. This next trial will further examine the safety and efficacy of the HSC product as an injectable for hair growth, and will also evaluate optimum treatment dosing and delivery. Histogen is currently seeking a Series B investment round, which will be utilized to finance these next stages of HSC development and trials.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen’s proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families – a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.

This article is reprinted from Histogen’s official website.

New hair loss shampoo Zenagen announced…

Nutraceutical Research Innovations, LLC (NRI) announced increased production of the patent-pending Zenagen hair loss product line, due to increased world-wide demand the hair care products. The Miami based nutraceutical company introduced Zenagen hair loss shampoo at the International Beauty and Barber Show, Miami in August 2009. The company focuses on nutraceutical formulation and extraction process and developed the formulation for the patent-pending Zenagen hair care line of hair loss products.

The Zenagen hair loss line has rapidly expanded its distribution and international presence and has been expanding retail availability through exclusive distribution agreements.


The hair loss industry has experienced rapid development over the last 20 years with the introduction of blockbuster FDA approved products finasteride (Propecia) and Minoxidil (Rogaine). The billion dollar hair loss market has shown rapid growth. Hair loss affects over 80 million people in the US alone, with some studies showing the prevalence of mid-frontal hair loss increases with age and affects 57% of women and 73.5% of men aged 80 and over.

The most common cause of alopecia is known as androgenic alopecia, and is thought to be caused by the hormone dihydrotestosterone (DHT) a derivative of testosterone. DHT initiates a process of follicular miniaturization. Through the process of follicular miniaturization, hair shaft width is progressively decreased until scalp hair resembles fragile vellus hair or “peach fuzz” or else becomes non-existent.

NRI has recently expanded their focus of hair loss solutions including genetic research and gene therapy and expects to conclude a 3rd party phase 1 research study in early 2011.

To read more, click here…

New Stem Cell Hair Loss Player… Biomaster

Histogen reveals results of hair growth clinical trials

The stem cell hair regrowth company Histogen, Inc., revealed for the first time the results of its preliminary clinical trials for its hair regrowth product, HSC, at the International Society of Hair Restoration Surgeons (ISHRS) Annual Scientific Meeting in Amsterdam July 22-26, 2009. The results were encouraging… and caused a significant buzz at the conference. They were presented by Dr. Craig Ziering, founder of Ziering Medical and principal investigator on the clinical trial.

According to Histogen, HSC is a proprietary formulation of “naturally secreted embryonic proteins, growth factors and… the first naturally stabilized, bioactive solution of Wnt proteins and their cofactors.” These constituents, the company adds, have been “implicated” in the induction of new hair follicle formation and growth.

“We are excited that our trial demonstrated safety and efficacy of our HSC product, which contains Wnt proteins and other growth factors important to hair follicle maintenance and growth,” said Dr. Gail K. Naughton, CEO of Histogen. “Wnt signaling has been shown by a number of experts in the field to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and to be important in maintaining the hair inducing activity from existing follicles. Histogen’s trial is the first demonstration that compounds containing bioactive Wnt increase hair growth in humans.”

According to a company press release about the clinical trials…

The five-month double-blind, placebo-controlled clinical trial was focused on evaluation of safety in the clinical application of Histogen’s Hair Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject clinical trial was designed to examine the safety and efficacy of a single injection of HSC alone, as well as in combination with three different perturbation methods. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy.

84.6% of the patients receiving one injection of Histogen’s serum-free HSC showed an increase in terminal hair 12 weeks post-injection, with a statistically significant (p<0.05) increase in the number of terminal hairs, cumulative hair thickness density and hair thickness mean. Perturbation did not enhance the results seen with HSC. There were no adverse reactions seen in any of the treated 24 patients at baseline, 12 weeks, or the 22 week endpoint.

Many patients suffering from hair loss are impatient with the progress being made by the new approaches to treating hair loss, such as hair cloning. The companies developing these therapies have been plagued by poor results, financial setbacks and, most of all, lack of progress. As a result, Histogen’s announcement caused quite a stir.

The company estimates that, of the 87 million people in the United States who suffer from hair loss, only 2% to 7% seek surgical or drug treatment. The same is true internationally due to the general lack of effective medical options for this widespread condition.

“Hair restoration treatments range in effectiveness and invasiveness,” added Dr. Ziering. “All of the current treatment options share the common goal of saving and redistributing existing hairs. For the millions of men and women who grapple every day with their hair loss, the results of our HSC trial indicate the potential for a phenomenal treatment option that stimulates growth of new hairs along with increasing the thickness of existing hairs. Histogen’s HSC represents a potentially major paradigm shift from conventional treatment options to one that can promote the growth of new or dormant hairs using principles of the body’s own regenerative mechanisms.”

Histogen was launched in 2007. According to the company website, it “seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components.” Instead, the company’s “proprietary bioreactors… mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio.”

Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.

HairDX Launches European Branch

HairDX — a pioneer in the development of new genetic tests for accurately predicting male and female hair lossa — announced recently the launch of a European subsidiary, HairDX Europe. HairDX is a subsidiary of PharmaGenoma, Inc., a “pharmacogenomics” research and development company based in Irvine, California, and Hasselt, Belgium.

“HairDX Europe expands the company’s leadership in hair dermatology, and global availability of the genetic tests for Androgenetic Alopecia,” the company said in a statement. “This follows the recent announcement of distribution agreements with Biodue in Italy, and Aderans in Japan. HairDX’s revolutionary genetic tests in Italy, and further expands the company’s leadership in the dermatology of hair.”

HairDX spokesmen announced that Dirk Segers will serve as president of HairDX Europe. He has worked and managed European subsidiaries for U.S. based medical device start-up companies, and brings 18 years of experience in clinical, sales and marketing management. Segers also founded a consulting company called Euramedics bvba and has worked previously at ValleyLab, Colorado, a subsidiary of Pfizer Inc. He holds a Master of Science in Nuclear Physics, a Master in Quantitative Business and a Master of Business Administration.

“The launch of HairDX Europe solidifies PharmaGenoma’s position as a global pioneer in genetic testing and molecular dermatology,” says Segers. “Having a Belgian office will enable HairDX to expand its reach throughout the continent.”

HairDX’s easy to use genetic test provides an accurate and understandable genetic analysis of a man’s or woman’s likelihood of developing Androgenetic Alopecia, the most common type of hair loss.

“We are very excited to introduce the HairDX’s genetic test throughout Europe,” Andy Goren, President & CEO of PharmaGenoma, Inc. “As the first genetic test for baldness, it will be of great help to Dermatologists offer earlier hair loss treatment to their patients.”

About HairDX, LLC

HairDX, LLC (www.hairdx.com and Twitter: HairDX) is a subsidiary of PharmaGenoma, Inc. Based in Irvine, CA, USA. HairDX is a molecular dermatology research and development company. HairDX markets the first genetic test for male and female hair loss. The company is dedicated to the research and development of new prescription based therapies tailored to an individual’s genetic make up. HairDX uses only CLIA certified laboratories (Clinical Laboratory Improvement Amendments) to perform the genetic analysis. The HairDX test collection kit is listed with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the United States Food and Drug Administration (FDA) as a Class I medical device.

Among HairDX leaders is William V. Murray former Division President of the Molecular Biology Division of Applied BioSystems, Inc., who formerly served in various executive leadership positions within Medtronic, Inc., Andy Goren former CEO of MobileWise, Inc. and GeePS, Inc., Professor Doron Lancet, PhD, Head of the Crown Human Genome Center at the Department of Molecular Genetics, Weizmann Institute of Science, Dr. Elon Pras, Director of the Institute of Human Genetics, Sheba Medical Center in Tel-Hashomer, Israel, Sharon Keene, MD and President and Medical Director of Physician’s Hair Institute, in Tucson, Arizona and nationally recognized for her pioneering work in the hair transplant field, and Elliott J. Stein, an intellectual property attorney and co-founder of GeePS, Inc.

Hair Club Launches New Video Blog of Transplant Procedures

A Hair Club client has recently launched a new “video blog,” or “vlog, documenting his hair transplant procedure from start to finish. Julian White, who recently underwent hair transplantation with Dr. Jon Gaffney, a Hair Club managed physician, wants to share his journey with other hair loss sufferers.

The new forum is called “From Bald to Bold: A Patient’s Journal” and is located here. The company wants patients who suffer from hair loss, men and women, to follow Julian through his hair transplant procedure blog, with video, pictures and personal stories that will be captured on Hair Club’s website.

The company says that a wealth of interactive information for those considering a hair transplant procedure, or other hair loss solutions, will be presented. Users will have the opportunity to see, and read about, Julian’s experience leading up to and after his hair transplant. Videos of his consultations with Hair Club’s hair loss solution specialists are available, as well as how he’s been doing since the procedure took place.


Understandably, finding the right solution to dealing with hair loss is a very personal, and life changing decision. Julian hopes to provide hair loss sufferers a forum to learn about, and discuss, not only his experience, but theirs as well. Julian’s “From Bald to Bold - A Patient’s Journal”, will take some of the mystery out of the process, and help alleviate concerns that might exist.

Hair Club is one of the largest companies in the hair restoration and hair replacement industry, with more than 90 locations throughout the United States, Canada, and Puerto Rico. The company was founded in 1976 by Sy Sperling, known by the trademark phrase “I’m not just the president, I’m also a client.”

The company caters to a predominantly male clientele, but in recent years has added services for women to address female hair loss and thinning brought on by chemotherapy, menopause, postpartum stress, trichotillomania, hormonal imbalances, and natural aging. Hair Club provides several different types of services to address hair loss including a non-surgical bio-matrix strand by strand process, in which human hair is added to the balding area in a crisscrossing matrix, and hair therapy programs that use scalp cleansers and conditioners as well as U.S. Food and Drug Administration-approved hair re-growth agents. Hair Club also works with a dedicated physician network that performs microscopic follicular unit hair transplantation procedures.

For more information visit http://www.hairclub.com.

How to choose a hair transplant surgeon

Tips for choosing a hair transplant surgeon - sponsored by:

• Does the physician take a holistic approach to hair restoration? Your physician should help you evaluate all your options, surgical and non surgical.
• Has the clinic made the investment in time and resources to do large sessions of micro follicular unit hair transplantation? Doing outstanding work requires a staff dedicated and trained to use high-powered magnification with the capability of producing at least 2,000 carefully trimmed grafts per surgical session.
• Choose a hair restoration clinic that is patient focused rather than commercially focused. Some clinics emphasize revenue, speed and volume rather than dedicating the time and individual care needed to produce optimal results.
• Is hair restoration the primary focus of their practice? Outstanding results require a physician and a full staff who perform hair restoration surgery on a regular basis. Doing hair restoration as a sideline, along with other cosmetic procedures, may hinder their ability to do large sessions of highly refined follicular unit transplantation.
• How many patients has this physician produced excellent results for? Like any skill, experience over time is critical to acquiring the skill and judgment required to produce excellent results.
• Can the physician provide at least a dozen sets of detailed patient before and after photographs? Do they also have patients who are willing to speak with you and meet with you in person?
• What is the physician’s reputation on hair loss related discussion forums? To learn what patients are saying about hair transplant physicians and hair loss treatments visit the Hair Restoration Forum.

Aderans’s “tissue engineering” approach to hair loss

Aderans Research Institute, Inc. (ARI) is one of a handful of companies racing to develop a realistic treatment for hair loss based on the cultivation of hair follicle cells.  At the recent  BIO International Convention held in late May in Atlanta, the company’s spokesmen described Aderans’s quest to perfect state-of-the-art cell-based hair regeneration technologies for men and women.

“Our research is focused on generating a tissue engineering solution to the regeneration of hair,” said Kurt Stenn, MD, Vice President and Chief Scientific Officer at ARI. “We’re using the hair cells from hair follicles and researching methods to promote their growth in controlled laboratory environments. If successful, we’ll then be able to recombine the cells and restore them to the scalp, where they would ultimately elicit hair growth.”


Co-located in Atlanta and Philadelphia, Aderans is actively engaged in the study of state-of-the-art cell-based hair regeneration for men and women. The company recently launched Phase 2 of its clinical study to assess the impact of its regenerative cell treatment on pattern hair loss, also known as androgenetic alopecia. Phase 2 of the study is being conducted in six U.S. cities: Atlanta, Boston, New York, Raleigh, Houston, and Washington DC. Phase 1 was conducted exclusively in the United Kingdom.

“The second phase of this study is another step in our efforts to truly understand the impact of
regenerative cell therapy on pattern hair loss. It’s a tremendous opportunity,” said Stenn. The company’s research is focused on on taking actual hair cells — technically known as fibroblasts and keratinocytes, the two primary cell types within hair follicles—and promoting their growth in controlled laboratory environments. The research teams then recombine them and these “combined hair cells” are then placed in the patient’s skin, where they are expected to elicit hair growth.

To see a brief video of Aderans’s approach, click here.

Some experts believe that this sort of cell treatment, or “tissue engineering,” represents a major advance on traditional hair transplant procedures, promising to overcome a key limitation of conventional transplantation: a finite hair supply for any one person.

Through cell engineering, Aderans Research is attempting to develop technologies that will allow doctors to multiply existing hair cells capable of eliciting hair growth, providing patients with a comprehensive solution to hair loss regardless of the quantity of their existing hair.

Aderans Research Institute is a subsidiary of Aderans Company, Ltd, the world’s largest wig manufacturer, and an affiliate of Bosley, a global leader in medical hair restoration.

Follica takes radical new approach to treating hair loss

Follica, Inc., a small, privately-held Boston pharmaceutical company, is taking a radically new approach to treating hair loss — one that could revolutionize the new push to develop a cure for baldness.

Unlike recent efforts to reverse hair loss by stimulating or transplanting existing hair follicles, Follica is attempting something far more radical: It is attempting to actually stimulate the development of new hair follicles! The company has an exclusive, worldwide license from the University of Pennsylvania to use and commercialize a breakthrough technology for what they call follicle neogenesis. Dr. George Cotsarelis discovered that the physical disruption of the skin, under the appropriate circumstances, can actually lead to the creation of new follicles — and hence, new hair. According to the company’s literature, the capacity of the adult skin to generate new follicles has been observed since the 1950s and 1960s, but due to lack of understanding of the fundamental biology of the follicle, could never be definitively proven.


While other of the new hair loss companies have been struggling in recent months, Follica appears to be enduring — despite the recession and credit crunch. The company recently announced that William D. Ju, M.D. has been appointed as president and chief executive officer of the company, succeeding founding CEO Daphne Zohar, managing partner of PureTech Ventures. Dr. Ju will join existing Board members including Ms. Zohar, Mr. G. Kirk Raab, former CEO, Genentech, president and COO, Abbott and current chairman, Follica, Protalex, and Transcept, Dr. Kevin Bitterman, principal at Polaris Venture Partners, and Mr. Chris Ehrlich, general partner at InterWest Partners.

“We are thrilled to welcome Bill Ju as the CEO of Follica. He brings the ideal blend of dermatology and drug development experience, creativity and leadership skills to Follica in this next exciting phase of development,” Ms. Zohar stated.

The company explains the development of its new technology this way:

Using tools primarily developed in his lab, Dr. Cotsarelis was able to demonstrate hair follicle neogenesis and show enhanced effect through manipulating the key signaling pathways involved in hair follicle formation. Some of these pathways can be manipulated using known drug compounds. Follica is developing the hair follicle neogenesis platform into clinically effective therapies for treating hair loss and for long term or permanent hair removal. Additional pipeline products may apply in acne, skin rejuvenation, and wound healing.

Intercytex Phase II Trials Prove Hair Cloning Now Possible

One of the more discouraging aspects of Intercytex’s financial struggles is that their results are so promising. We now know that the Phase II clinical study of Intercytex’s pioneering work in hair cloning techologies has been a tremendous success. The study was conducted by Dr Bessam Farjo in Manchester, UK, and involved the removal of dermal papilla cells from a patient, the multiplication of those cells in a lab, and then the re-insertion of those cells on the patient’s scalp. Dermal papilla cells are cells at the base of a hair follicle that help make keratin, the tough, fibrous, insoluble protein out of which hair is made.


In simple language: The scientists are attempting to grow limitless amounts of a patient’s own hair follicles in a lab and then “re-seed” a bald head with them. This overcomes the inherent limitations of even advanced transplantation techniques — which is the limited number of hairs available from a patient’s head to transplant.

On his website, Dr. Farjo summarized the results of this exciting clinical trial. As you can see, the results are very encouraging.

This trial was designed to examine the effect of different DP [dermal papilla] delivery techniques and methods to ensure that the epidermal cells were in the correct state to respond to the signals and produce new hairs.

In this study, subjects were injected 900 times with 1µl aliquots of DP cells in a large area which was photographed at the end of the study. Subjects were also injected in a smaller area, divided into two sections - counts were obtained by shaving and photographing the two small sections of scalp, injecting them multiple times (either 1 injection of 50 µl or 50 injections of 1 µl) with living DP cell suspension and then applying a specialised image analysis system to provide a total hair count. In these small sections, all 19 subjects in the trial were treated using a range of injection and scalp pre-stimulation techniques; the first 6 subjects were injected without stimulation of the scalp. In the remaining 13 subjects the resident hair producing (epithelial) cells were stimulated at the time of delivery of the DP cells in one of the two treatment sites.

13 subjects completed the 48-week trial with 6 subjects lost to follow-up. Of the 13 subjects completing the trial the data showed that:

65% (11/17) of the treated sites in the non-stimulated group responded to the treatment by increasing numbers of hairs of all sizes

71% (12/17) of the treated sites in the non-stimulated group responded to the treatment by increasing numbers of hairs over 30 micron in diameter

78% (7/9) of the treated sites in the stimulated group responded to the treatment by increasing numbers of hairs of all sizes

100% (9/9) of the treated sites in the stimulated group responded to the treatment by increasing numbers of hairs over 30 micron in diameter

The overall take rate (number of hairs produced per 100 injections) in the stimulated areas was

o 40% (n=6) for hairs of all sizes

o 18% (n=6) for hairs over 30 micron in diameter

The larger (900 injection) area photographs have not yet been analysed.

These data are consistent with the interim data reported last September and further confirm the hypothesis that new hair production is improved by pre-stimulation of the scalp, leading to an interaction between the injected cells and the resident hair producing cells.

Hair Growth Pioneer Intercytex Gets Badly Needed Infusion of Cash!

The UK’s Business Weekly is reporting that hair regrowth pioneer Intercytex, which has been losing money hand over fist in recent years, is getting a massive infusion of badly needed cash from pharmaceutical giant Pfizer. Pfizer is pumping an estimated $100 million into its international stem cell development program and increasing its Cambridge staff headcount by around 50%.

The move comes at a desperate time. While Intercytex’s share price profited from the Pfizer announcement with a massive rise percentage-wise, the paper believes “any payment may come too late.” It added that “Intercytex has almost completely run out of cash and is now looking for a buyer, having seen its share price plummet over recent months as poor data has seen key products dropped.”

One of the few companies in the world aggressively pursuing hair cloning technology, therefore, may soon be sold off or shut down.

Aderans, Intercytex and the New Science of Hair Growth and Hair Cloning

The solutions to hair loss are changing rapidly. Plus, some amazing reporting is being done of Aderans Research, Intercytex and the new hair growth technologies. One of the best summaries of the current state of the research — at least that we’ve seen recently — can be found at BestLife.com.

Here are some of the excerpts.

Brandishing a syringe the size of a caulking gun, hair-transplant surgeon James Harris, M.D., injects local anesthetic into the scalp of a male patient, a married financial analyst in his early forties who has asked not to be identified. We’ll call him Scott. For five hours, I’ve been watching Dr. Harris perform a hair transplant called surgically advanced follicular extraction, or SAFE. A follicular unit is a miniature, self-contained hair factory embedded in the skin. Each square centimeter of human scalp contains 80 to 120 follicular units, and each of those has one to four hairs.


Though Scott is sitting upright, his scalp is a gruesome battlefield. Rivulets of blood seep from thousands of BB-size puncture wounds. A trash can is brimming with blood-soaked gauze. But Scott feels nothing. He’s watching CNBC’s financial roundup on a wall-mounted TV while thumbing through e-mails on his BlackBerry, oblivious to the mayhem topside.

Dr. Harris is using a motorized tool he designed himself, in a procedure that, for all its bloodshed, represents the current state-of-the-art in baldness treatment. The instrument has a blunt hollow tube that lets Dr. Harris make incisions less than a millimeter wide, in rapid-fire succession, around clusters of hairs without damaging the underlying follicles. It’s painstaking work. I watched earlier as Dr. Harris donned mantislike headgear (dual loupes with six-fold magnification) and extracted follicular units from a band of hair between Scott’s ears, a region of scalp hair docs call the “horseshoe fringe.” In virtually all men, this fringe is impervious to balding, a vestigial result of genes that dictate how skin forms during fetal development.

By the time he’s through, Dr. Harris will have made 1,045 incisions along the front and top of Scott’s head, enough to accommodate the same number of follicular units removed from his fringe. An assistant counts the extracted follicular units under a microscope, tabulating the number of individual units and the number of hairs protruding from each one. Single-hair units are reserved for the front to create a feathered widow’s peak. “I want to avoid a wall of hair jutting from the forehead,” explains Dr. Harris, citing a common blunder of botched transplants. “SAFE is a lot less traumatic than other transplant procedures, such as a surgery in which a strip of scalp is extracted, because it’s minimally invasive.” Even so, the procedure looks medieval, and it’s hard to believe this gory mélange will have a happy ending.

There is also an interesting point here:

Hair transplants have improved dramatically in the past 10 years, although in the hands of unskilled surgeons, mishaps can occur that leave patients with gruesome doll heads. But transplants remain hamstrung for a more fundamental reason: You can shuffle only so many hairs from fringe to forelock. This is Scott’s fourth surgery, and at this point he’s simply running out of hair. It’s a dwindling game of musical chairs that confounds surgeons and frustrates patients. The average age for undergoing a hair transplant is 40, but hair is doomed long before that. To be precise, its fate is decided in utero, during the tenth week of pregnancy, when the human fetus is the size of a peanut shell. That’s when the fingers and toes take shape and the brain starts to evolve. It’s also when the hair follicles form—roughly 5 million over the entire body. This number is fixed: After exiting the womb, the human body can’t produce a single additional follicle.

That’s why a revolutionary technique known as hair cloning, or hair multiplication, holds so much promise. It changes the game because it gives transplant surgeons an endless supply of follicular units to restore the vanishing manes of their patients. Researchers in a handful of labs around the world have been testing the technique on mice with impressive results. Several start-ups have formed, and these companies are racing to complete successful human clinical trials. It could have a profound effect on the landscape: Male pattern baldness, or androgenetic alopecia, affects 40 million men in America. Although it doesn’t have any known physical downsides, the specter of premature aging and the perception of waning virility and diminished sexual attractiveness can be mentally debilitating and lead to personal, social, and work-related problems, according to Nigel Hunt, Ph.D., an associate professor of applied psychology at the University of Nottingham, in England. In 66 percent of men, hair follicles start to shrink around age 35 (in some men, it starts at age 21), causing hair to thin. By age 50, hair follicles are dying and 85 percent of men have significantly thinning hair. For these men, the cure for balding can’t come soon enough.

The Dawn Of Hair Cloning

The eureka moment for Colin Jahoda, M.D., Ph.D., and Amanda Reynolds, Ph.D.—a husband-and-wife team of biologists at the University of Durham, in England—involved an experiment that also served as a nerdy version of a “Colin Forever” tattoo. Dr. Jahoda removed a hair follicle from his head, put it under a microscope, and snipped off a cluster of dermal papilla cells, which are located in a bulb at the root of the shaft. He then nicked his wife’s forearm with a scalpel and transplanted the cells. A few days later, a thick tuft of dark hair (complete with Dr. Jahoda’s male DNA) emerged. The experiment demonstrated, for the first time, the possibility of growing hair from transplanted dermal papilla cells. It seemed the two had found a new treatment for hair loss. Yet they soon discovered that, once removed from the body, dermal papilla cells quickly lose their ability to make hair if they are not transplanted immediately.

Angela Christiano, Ph.D., a professor of dermatology and genetics and development at the Columbia University College of Physicians and Surgeons, collaborates closely with Dr. Jahoda on hair-related research. “Not long after you remove them, the cells don’t even know they’re dermal papillae anymore,” says Christiano, who is sitting in her office behind a desk piled two feet high with books and papers. “It’s like taking an Etch-a-Sketch and shaking it,” she says. “You erase their identity.”

The Jahoda-Reynolds experiment worked because a clump of hair follicle cells were promptly relocated, which preserved their inductivity, a measure of their capacity to remain uniquely hair cells before devolving into something more generic. While I’m in her office, Christiano calls England and puts Dr. Jahoda on speakerphone. “These cells seem to have an in-built regulatory system,” he explains. “We don’t know how it works. Getting the cells to remain inductive is still the basic challenge.”

Christiano became interested in hair follicle research in 1996, when a common hair disorder called alopecia areata caused patches of her own hair to fall out abruptly (steroid injections have revived it to a formidable whorl of ebony locks). Two years later, she made headlines after announcing she’d pinpointed several specific genes that are responsible for other genetic forms of hair loss—a scientific first. She is now focused almost exclusively on finding new genes for hair loss, as well as using dermal papilla cells to develop new ways of treating it. Scientists are still unclear about precisely what occurs, but they do know that whenever you pluck or shave a hair, molecular compounds in the follicle begin a complex dialogue with surrounding cells. These include dermal papillae, epithelial cells (those lining the wall of the hair shaft), and stem cells in a little-understood region referred to as “the bulge.”

The dermal papillae are encoded with genetic instructions that respond to cues sent from surrounding cells and tissues in the follicle. Once signaled, the dermal papillae begin hatching hair fibers. What Christiano and Dr. Jahoda are trying to figure out is how to trick the cells into growing hair by themselves, without guidance from the rest of the follicle. Doing this would allow scientists to culture, or clone, thousands of dermal papilla cells in the lab that would retain their knack for producing hair. “With current transplant surgery, if you take a thousand follicles from the back of the head and move them to the front, you still only have a thousand,” says Christiano. “With the cloning approach, you could start with a small biopsy of cells and then grow enough of them to repopulate your entire scalp with hair.”

A researcher named Claire Higgins informs us she has just received a fresh dime-size chunk of live scalp donated by a male hair-transplant patient. We join her in a lab, where she is hunched over a steel table, staring into a microscope. With forceps and a long needle, she scrapes dermal papillae from each follicle. I look through the eyepiece. She tells me I’m viewing roughly 3,000 dermal papillae packed into a ball of cells just a fraction of a millimeter wide. They resemble golden tobiko, the flying-fish roe dolloped onto sushi rolls. These cells will end up in an incubator, where they’ll be cultured for at least four weeks and then transplanted into mice to see if they’ll produce hair.

Several factors determine whether this happens. One is the growth medium, the soupy broth fed to the cells to help them thrive. Another is how quickly the cells multiply: As Dr. Jahoda and Reynolds showed, the less time cells spend outside the body, the better they retain their inductivity. A third factor is how the cells are transplanted. Do you inject them? Or position them surgically under the skin? “We’re trying to get into the heads of the dermal papillae and understand why they lose their inductivity,” says Christiano. “Then we’ll do the reverse: Take old cells that have been in culture for many months and bring them back into the fold, coaxing them to grow hair.”

I ask Christiano how she and Dr. Jahoda intend to accomplish this. She smiles, clearly not wanting to tip her hand, and replies, “We have a few ideas. I will say that if we figure it out, a lot of hair-loss sufferers will be very, very happy.” Their research could also inform next-generation baldness cures, genetic fixes that reprogram the cells, much like a software patch, and override the genes responsible for androgenetic alopecia.

According to Beher, the main challenge now lies in hair cloning technologies:

Nude mice are the foot soldiers for the war on balding. These dainty pink-hued rodents have been bred or genetically altered to remain hairless throughout their lives. They can be ordered by the mischief-load from medical suppliers and endure poking and prodding and other unspeakable horrors for the sake of balding men everywhere. In Philadelphia, Ken Washenik, M.D., Ph.D., executive vice president of scientific and medical development for Aderans Research Institute and a clinical assistant professor of dermatology at New York University’s Langone Medical Center, shows me slides of nude mice on his laptop. They have undergone a new type of hair-cloning procedure that Dr. Washenik has been developing for Aderans. The company, which has its headquarters in Tokyo, is the world’s largest manufacturer of wigs. It also owns Bosley, which operates 88 hair-transplant clinics in North America.

When I arrive at Aderans, Dr. Washenik hastily ushers me past several labs, perhaps wary I might glimpse some sort of trade secret, and into an empty conference room. What he does reveal is that his approach to hair cloning (he calls it follicular neogenesis) doesn’t rely solely on dermal papillae. “We are using a two-cell construct, growing not just dermal papillae but also another type of cell from the follicle,” he explains. As the thinking goes, disparate cell types already communicate with one another in the follicle to regenerate hair. Dr. Washenik believes that if he can recreate that environment in the lab, cultured cells won’t get dementia and forget how to make hair. “The different cells in the follicle are smarter than we are,” says Dr. Washenik. “They already know they are supposed to be hairy. In eight days, we grew a ball of hair that never existed before on the back of a mouse.”

Dr. Washenik clicks an image file on his computer: The photo shows what looks like Piglet—but with a sable Mohawk. But there is a caveat: “These were hair cells from a mouse that were injected into a mouse. When researchers injected human cells into a mouse, they didn’t get the same results.” This disappointed Dr. Washenik and other researchers, because unlike other organs, follicles are supposed to be immune privileged: When transplanted across or between species, they’re expected to grow normally, without being rejected or provoking infection. He hopes to have better luck in clinical trials, when he will transplant human cells into humans. Aderans is in the second phase of a human trial, which is expected to be completed by the end of the year.

The company is pouring serious cash (Dr. Washenik won’t say how much) into its hair-cloning effort. Dr. Washenik is also intrigued by other researchers who are pursuing another pathway. They’re cultivating in-vitro microscopic hairs, or “proto-hairs,” as Dr. Washenik dubs them. “These are early follicular structures that you can place in the scalp with the same technology that’s used for a hair transplant,” he says. “The big hurdle so far is getting the cells to multiply to make enough hair. Once we culture them, they sometimes die or de-differentiate.”

But Dr. Washenik remains confident. “The sooner we figure this out, the better,” he says. “So many people are waiting for this technology. I know that with every medical advance, the first one to market becomes the leader, and everyone else plays catch-up.” Like many of the scientists I meet, his passion for a cure is personal. “I started going bald at 25,” he says, tussling his hair to flaunt his 2,200-graft transplant. “While I was working on my Ph.D., I was mixing up homemade minoxidil [the active ingredient in Rogaine] in my lab.”

A few blocks away is a start-up called Follica. One of its cofounders, George Cotsarelis, M.D., is a cutaneous biologist and associate professor of dermatology at the University of Pennsylvania. In 1990, Dr. Cotsarelis was investigating the biological mechanisms of skin regeneration. “I was studying stem cells and found a population of them in the hair follicle, in a strange area called ‘the bulge,’” he tells me when I stop by his office at U. Penn’s School of Medicine. “We didn’t know the function of the area, and we almost blew it off.” From then on, Dr. Cotsarelis started paying more attention to hair follicles. After a series of more recent experiments on mice, he made two important discoveries. First, he found that bulge cells aid in the formation of new hair follicles, suggesting that these cells influence hair growth during embryonic development, when we were bobbing around in the womb. He also learned that, throughout our lives, these same stem cells awaken to mend minor cuts and burns, as well as deeper wounds in the skin. What baffled Dr. Cotsarelis is why, if a healing wound is populated with bulge stem cells, new follicles don’t form. The answer would at least explain why hair doesn’t grow from scars.

Dr. Cotsarelis conducted further studies designed to reveal what kinds of molecular compounds (e.g., hormones and proteins) are present during hair-follicle development in mice embryos and are also present in adult mice. A major one, which he wrote about in a 2007 Nature article, was something called Wnt (pronounced wint), a network of proteins first identified in fruit flies. Curious, Dr. Cotsarelis applied Wnt to small lesions purposely cut into nude mice (such gracious, noble critters). To his shock, follicles formed and sprouted hair. So if a person is bald, the obvious strategy would seem to be to douse his scalp with Wnt and wait for hair to grow. “The problem is that Wnt is involved in a lot of other things, one of which is skin cancer,” says Dr. Cotsarelis. “It’s very tricky business.”

The idea behind Follica is to develop a procedure in which a surgeon would lightly wound the scalp—something akin to microdermabrasion, an antiaging treatment—to disrupt the skin and then apply a compound that would influence hair development in the area. This would trick the cells into reverting to an embryonic state, one in which they are genetically pre-programmed to make hair rather than simply repair skin, as they’re predisposed to do after we’re born. “Just when cells are deciding, ‘Do I make a hair follicle? Or do I make an epidermis?’ we can influence them with a protein to go down a hair-follicle pathway.”

Testing the Science On Humans

My hair started thinning when I was 32. I’m now 40, and my shedding has eased up. Dr. Harris informs me I have plenty left for a follicular unit transplant. But after watching Scott’s procedure, I’m a little freaked out. Yet, all the specialists I speak with urge anyone dealing with hair loss to act fast, because once the hairs are gone, they’re gone for good.

“Absolutely no one concerned about hair loss should wait,” says Dr. Washenik. He started taking Propecia when he was in his thirties (he’s now 50), and he uses Rogaine religiously. He is a big advocate of drug therapies, and readily champions surgical options such as follicular unit grafting. Dr. Washenik examines my scalp and announces, “Rogaine is made for you. You’re not bald; your hairs are just miniaturized.” I’m a chemical-phobe, so I’d rather save my dough and wait for a viable hair-cloning procedure, which many of the experts I talked to claim is less than five years away.

Intercytex, a public company based in London, may be closest to a marketable product, says Jerry Cooley, M.D., a transplant surgeon who has been consulting for the firm since 2001. Nobody directly employed by Intercytex would speak to me for this story. “We do not feel that exposure of our research is helpful,” wrote Jeff Teumer, Intercytex’s director of research, in a curt e-mail. But Dr. Cooley, who works closely with Teumer, tells me that Intercytex scientists have successfully grown large batches of cloned proto-hairs similar to those that other researchers have been struggling to keep alive. What’s more, in animal experiments, the Intercytex team has observed cloned hair follicles growing hair again after the original hairs were plucked. This suggests that their cloned follicles cycle through the entire life span of hair—three phases known as anagen (growth), catagen (transitional), and telogen (resting)—something no other researchers have been able to do.

A key to the team’s success has been growing proto-hairs in a special medium, licensed from a Japanese inventor, which contains cultured skin cells known as keratinocytes. “I’m very excited about this technology,” says Dr. Cooley. “It’s not a matter of if, it’s a matter of when.”

Bessam Farjo, M.D., a hair-restoration surgeon contracted by Intercytex to run its ongoing clinical trials, says, “All I can tell you is that we’ve grown a significant number of hairs on animals through this technique.” It sounds encouraging, and Dr. Farjo expects to complete clinical trials this year.

Hair cloning will be pricey initially, so early adopters may be men who are not only wealthy but also desperate because they don’t have enough hair left to do a follicular unit transplant. Cloning could also be ideal for younger men who aren’t good candidates for follicular grafting. “Younger guys aren’t suitable for current surgical techniques because we don’t know how much hair they are going to lose,” says Dr. Farjo. Imagine if the receded hairline of a 25-year-old male were replaced with a follicular unit transplant. If the rest of his hair were to fall out—and going bald at an early age generally means it will—he wouldn’t have enough hair to complete a second or third follicular unit transplant, so he’d end up with a solitary plume sprouting from his forehead. “It would look like unfinished business, which is why we typically avoid working on young guys,” says Dr. Farjo. “But if I know I’ll never run out of hair, thanks to the new cell therapy, I can treat anyone.”

Nobody is sure how the actual cloning process will be implemented. Most surgeons speculate that they’ll use boring tools similar to the existing ones used for harvesting follicular units. The follicular units will be sent to centralized labs, where industrial incubators will mass-produce millions of follicle cells for a relatively low cost. Another question is how will the cloned cells be transplanted? Instead of transplanting follicular units, your surgeon may inject cloned cells into micro-incisions, or he may implant lab-grown hair follicles. It could be fast, clean, and painless. Or it might entail something closer to Dr. Cotsarelis’s method at Follica. At Intercytex, technicians are tinkering with sundry techniques. “We’re experimenting with varying the number of cells in each injection, and whether we have to inject the cells into the skin as it is, or if we have to pre-stimulate the skin,” says Dr. Farjo.

Whatever the outcome, choices will abound. In the future, hair cloning will coexist alongside follicular unit transplants, drug therapies, and emerging technologies still incubating in the labs. For his part, Dr. Harris is also part of a team designing the world’s first follicular extraction robot: It will fully automate the procedure, making it magnitudes faster and less expensive. While Scott, our balding financial analyst, was being prepped for surgery, Dr. Harris took me into his office to show me a photo of the $25 million speed surgeon (the actual machine was locked in a storage closet a few floors above us). At about six feet tall with a fixed base and a mechanical arm with multiple joints, it resembles one of those space-age automatons you might see on a vehicle assembly line at a Toyota plant. Dr. Harris has already tested it on a couple of willing volunteers (with no alarming mishaps) and is preparing to apply for FDA approval under the name Restoration Robotics.

“We think the robot might be able to extract a thousand grafts an hour,” says Dr. Harris. “That’s more than triple what can be done by hand. This will broaden the market so that more people can afford the procedure. There may be a time soon when hair-transplant surgery will be available to everyone.”

Update on Intercytex’s Hair Cloning Clinical Trials

The folks over at HairLossLearningCenter.org had an interesting post recently about Intercytex’s progress in developing a practical hair cloning technology. As they say, Intercytex is already into Phase 2 testing:

Intercytex has been working on hair cloning and multiplication for some time. The hair regeneration process includes an initial 30 minute procedure extracting a small sample of hair follicles containing cells responsible for generating hair growth called derma papilla (DP) cells. These derma papilla (DP) cells are then sent to a lab, separated from the follicle, cultured and cloned which takes approximately 3 weeks. The balding patient then returns to the clinic where they will receive a series of microinjections containing DP cells under local anesthetic. As DP cells come in close proximity with epithelial cells, new hair follicles are produced. New hair growth should become evident in approximately 3 months.

Phase I and Phase II testing have been completed. During Phase I, 5 out of 7 patients received an increase in hair count after the procedure. Phase II was conducted by Coalition member Dr. Bessam Farjo in Manchester. In this trial, two sub-groups were formed with five subjects in the first and nine in the second. Hair counts were obtained from each patient in each test group and were then injected with DP cells using distinct delivery methods. The scalps of one sub-group were stimulated during the delivery, the other was not. The sub-group without stimulation showed a 60% increase in hair count while the sub-group with stimulation showed an 89% increase in hair count. Phase II proves the earlier hypothesis that new hair growth is improved with pre-stimulation of the scalp. During the first quarter of 2009, photographic data will be analyzed on all subjects at one year.

These tests, though promising, don’t conclude the clinical trials. Intercytex is looking to partner with interested parties in order to continue with development. For more information, go to Intercytex’s website at http://www.intercytex.com/icx/products/aesthetic/icxtrc/.

Aderans Research Launches Second Phase of Hair Cloning Treatment

Update on Stem Cell Cures for Hair Loss

The prospective treatment of hair multiplication/hair cloning, which extracts self-replenishing follicle stem cells, multiplies them many times over in the lab, and microinjects them into the scalp, has been shown to work in mice, and is currently under development, expected by some scientists to be available to the public in 2009-2015.

Aderans Research Institute Inc. (ARI) announced recently it has launched Phase 2 of its clinical study on cell-based hair regeneration for men and women. Structured around the findings of the recently completed Phase 1 of the study, this second phase will continue to evaluate the impact of its novel cell treatment process on pattern hair loss, also known as androgenetic alopecia.
Phase 2 of the study is being conducted in six U.S. cities: Atlanta, Boston, New York, Raleigh, Houston, and Washington DC. Phase 1 was conducted exclusively in the United Kingdom.

“The second phase of this study is another step in our efforts to truly understand the impact of regenerative cell therapy on pattern hair loss. It’s a tremendous opportunity,” says Kurt Stenn, MD, Vice President and Chief Scientific Officer. The company’s research is focused on developing a state-of-the-art tissue engineering solution to the regeneration of hair, taking actual hair cells–fibroblasts and keratinocytes, the two primary cell types within hair follicles–and promoting their growth in controlled laboratory environments. The research teams then recombine them and these “combined hair cells” are then placed in the patient’s skin, where they are expected to elicit hair growth. “This is research the industry has always wanted to do, and ARI has combined the support, the market, and the scientific wherewithal to do it,” says Vern Liebmann, Vice President of Operations.

More information on study outcomes will be released as our studies conclude. To see ARI’s latest clinical updates, please visit http://www.aderansresearch.com/ari_clinicupdates.html
With offices in Atlanta and Philadelphia, the Aderans Research Institute is a subsidiary of Aderans Company, Ltd, the world’s largest wig manufacturer, and an affiliate of Bosley, a global leader in medical hair restoration.

Additional information on ARI can be found at www.aderansresearch.com.

The Pioneering Hair Growth and Hair Treatment Technology of Dr. Gho

Anyone concerned with hair growth, hair cloning, alopecia, hair treatment and so on is probably familiar with the controversial work of Dr. Coen Gho, a Dutch medical doctor and dermatologist who has been a pioneer in efforts to develop practical hair regrowth treatments for male pattern baldness and alopecia.

Dr. Gho’s research has been followed closely by numerous experts in the field of hair transplantation and rejuvenation. He has been criticized, however, for not submitting his research to the rigorous scrutiny of peer-reviewed scientific journals.

Throughout the 1990s, Dr. Gho developed specialized techniques of hair follicle extraction and transplantion. The GHO Clinic was established in 1994 with offices at various places around the world, with head offices in Prague. In 2005, Dr. Gho resigned from the GHO Clinic and launched a new venture, The Hair Science Institute (HSI), located at the World Trade Center in Amsterdam.

According to HSI’s own website, the technology that Dr. Gho has developed — which he terms “HairStemcell Transplantation” (HST) — differs from other types of hair restoration techniques in that it does not redistribute existing hair but “ensures that your own hair generates new hairs in a desired area.”

One of the transplantation techniques Dr. Gho developed - the Follicular Multiplication – was established as a restorative method to treat burn wounds. In the clinical facilities of Hair Science Institute, this method has alleged been improved and is now refined to the advanced and patented technique that is now known as HairStemcell Transplantation. Read more

Stem Cell Technique to Clone Hair May Help Hair Loss Sufferers

New stem cell techniques to clone hair may help hair loss sufferers, a number of scientists claimed this past week.  The combination of breakthroughs in stem cell technology and recent discoveries in the genetics of hair loss could result in a major breakthrough in the treatment of hair loss, they said.

In a recent stem cell study of hair loss led by Viljar Jaks of Sweden’s Karolinska Institute, scientists examined mouse hair follicles for signs of rapid hair growth. They discovered a protein, called Lgr5, on the surface of long-lived, active stem cells in hair cells. Apparently, cells carrying the Lgr5 marker were capable of maintaining hair follicles for as long as 14 months, the researchers said.

While still in the early stages, these recent discoveries could prove crucial in the ongoing push to develop a stem cell technique to clone hair and cure hair loss. The most likely treatment may end up being stopping hair loss before it develops into male pattern baldness. “Early prediction before hair loss starts may lead to some interesting therapies that are more effective than treating late-stage hair loss,” said Tim Spector, a researcher in Kings College London who led a related study of the DNA of hair loss.


The average person has about 100,000 scalp hairs. While most people experience some hair loss as they age, men suffering from pattern hair loss - a genetic condition inherited from parents — can suffer from significant hair loss.

Hair loss or baldness is caused by a gradual shrinking of hair follicles on top of the head. Eventually, they sprout less and less hair. Balding men and some women have follicles that shrink so much they stop producing hair at all.

In the past two years, however, the hope has arisen that it might be possible to stimulate new hair growth when a University of Pennsylvania researcher discovered that mice healing from wounds can produce brand new hair follicles. In 2007, the researcher, Dr. George Cotsarelis, showed that when skin is damaged, the skin cells behave like a stem cell and generate new hair follicles.

Histogen Developing Stem Cell Products for Hair Loss

Hair loss is such a common malady, among both men and women, it’s something of a surprise that so few companies have tried to develop a practical hair loss treatment. The loss of hair is particularly devastating for women. Women hair growth products are found everywhere on the Internet, but, like similar products for men, most are little more than snake oil.

However, the advent of new stem cell research has provided new hope for those suffering from hair loss. The notion that doctors could somehow mass produce hair follicles in a laboratory — taken from a patient — and then “inject” or transplant them on a mass scale on a balding person’s head has caught the interest of literally hundreds of millions of people. Alas, while the fundamental research is proceeding furiously, there remain significant problems in developing practical, real world products for hair loss.

A realistic hair loss treatment based on stem cell technology is probably still years away — yet the research is continuing. Companies such as Intercytex, Alderans and Follica are actively attempting to develop a hair loss treatment based on cloning technologies.

Recently, a new company has appeared on the scene: Histogen. Histogen, a regenerative medicine company founded in 2007 to develop stem cell solutions based on “the products of newborn fibroblasts without the use of embryonic stem cells or animal products.” Using its proprietary “tissue-engineering” platform, Histogen has created products that offer unique commercialization opportunities — including stem cell products for hair loss!

One of Histogen’s new products, dubbed HGEN-001, indicates capabilities for new hair follicle creation. In May, the company presented its findings on HGEN-001 during International Investigative Dermatology 2008 conference taking place in Kyoto, Japan.

Because of the “native soluble WNT proteins and growth factors contained in the formula,” HGEN-001 was evaluated as a stimulus for new hair follicle creation. In laboratory tests with mice, HGEN-001 was shown to significantly increase hair growth and new follicle formation.

“HGEN-001 induced a significant increase in hair follicle growth, as compared to the control, in our preclinical model,” reported Frank Zeigler, General Manager of In Vitro Products for Histogen. “Researchers have reported the importance of wnt proteins and wound healing growth factors in the induction of new hair follicles for over a decade. Our research helps to substantiate the importance of these active agents in follicular neogenesis, all of which are components in HGEN-001.”

Clinical trials for HGEN-001 as an application for hair growth are planned for late 2008.

For more information on Histogen and how its products may aid in the development of a practical, hair loss treatment, visit the company’s website.

Follica Takes in $11 Million for Hair Loss Treatment Approach

Robert Buderi reports that leading stem cell baldness researchers at the new startup Follica have taken in $11 million in new funding — a sure sign that investors believe the new treatments will be viable. Burderi reports:

If only hair could grow as fast as Follica’s pot of money. Just seven months after its $5.5 million Series A financing round, the Boston-based startup today announced it has raised an additional $11 million to bolster its efforts to develop new methods of treating male- and female-pattern baldness and other hair-follicle disorders such as excessive hair growth and acne. Follica, which confirmed a human pilot study of its hair-regeneration technique is underway, also added several new team members, including veteran life sciences and biotech executive G. Kirk Raab, former CEO of Genentech, who joined the company’s board as chairman. Read more

Tags: Follica

Scientists develop gene therapy for baldness

February 19, 2009 by Julian Phillips  
Filed under Follica, Gene therapy, George Cotsarerlis

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Scientists from the University of Pennsylvania say they may have overcome one of hair care’s biggest obstacles, by developing a means of creating new hair cells on the skin of mice. The research team said, in an article published in the journal Nature that in generating the new hair cells, it had defied previous belief that this feat was impossible.

Likewise, the research team also says that the technology could help in formulating skin care products for wound-healing, a secondary research channel to the baldness study.

The study found that, when the skin of mice is wounded, epidermal cells can respond by assuming the same properties as stem cells that generate hair follicles. This eventually led to the growth of new hair.

The team believes that this discovery could mean that older men with established hair loss could eventually be treated to restore their hair successfully.

The research team removed patches of skin from the mice and then studied the wounds as they healed during the course of several weeks.

During this process, cells not previously associated with hair follicles began to express genes found in stem cells that can give way to hair follicles as they develop.

The result was that in the samples, hair growth occurred regardless of the mouse’s age. Although it was also noted that there was no pigment in the hair follicles.

Further to this, the researchers found that the effect was boosted by using mice that had been genetically engineered to produce higher levels of proteins. These activate the genetic pathway underpinning the transformation of follicle stem cells.

The genetically engineered mice then went on to develop twice the density of hair follicles to that found in the untreated mice.

George Cotsarerlis, head of the research team, stated that he now wants to mimic this same process in human skin samples, envisaging a treatment similar to dermabrasion, combined with a topical cream to stimulate the proteins necessary to activate the genetic pathway.

“It’s all preliminary at the moment,” said Costsarelis. “If it all went perfectly then possibly in two to three years we would have a product, but that’s very optimistic.”

However, despite the relatively cautious outlook, the results of the study have given the team the confidence to form a company, Follica, which aims to spearhead bringing the treatment to market.

In parallel to the potential baldness cure, the research team is investigating new insights into skin functions, highlighting the powers of regeneration on the back of the skin wound healing process.

Currently there are a plethora of hair care solution that target baldness, including creams, lotions, shampoos, conditioners, as well as oral treatments like Finasteride and surgical treatments.

Originally posted here.

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Hair Loss Treatment Has Arrived with Follicular Cell Implantation

February 18, 2009 by Julian Phillips  
Filed under Aderans Research Institute, Follicular Cell Implantation, Hair Cloning, Hair Growth, Hair Loss, Hair Rejuvenation, Intercytex, New Hair Growth Technologies

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Stem cells and dermal papilla cells have been discovered in hair follicles and some researchers predict research on these follicular cells may lead to successes in treating baldness through hair multiplication (HM), also called Hair Cloning.

Hair Cloning is being developed by two independent companies: ARI (Aderans Research Institute, a Japanese owned company in the USA) and Intercytex, a company in Manchester (UK). Read more

Tags: Follicular Cell Implantation, Hair Cloning, Hair Growth, Hair Loss, Intercytex

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