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Q: I read, with considerable interest, your excellent article on the latest in Dr. Angela Christiano’s work on follicular neogenesis. It seems to me that the next questions we should be asking are: when will testing begin on human subjects and when might her research develop into a hair cloning treatment that is available to the general public?

A: It is very difficult to determine when this phase of the research might begin and it is even harder to predict when treatment might become available. First, the technology is not quite there. Dr. Christiano showed in her recent paper that changing the environment of skin (fibroblast) cells so that they could form into 3-D cultures enabled them to induce human hair-follicle growth. Although this was a major step towards cloning hair, additional work needs to be done before we will be able to mass produce fully-functioning human hair follicles to the extent needed for hair transplantation.

In addition, research on human subjects requires that experiments meet rigorous federal regulatory standards and these take time to be approved and carried out. Supposing that further study of follicle neogenesis results in a breakthrough treatment for hair loss, this treatment would still require meeting substantial efficacy and safety requirements of the FDA before it would be made available to the public. We will be communicating important developments as they occur through our Hair Cloning Research section and through periodic updates in the Bernstein Medical Newsletter.

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Hair Restoration in Women, Dr. Bernstein Featured in 'New You' Magazine

Dr. Bernstein and Bernstein Medical – Center for Hair Restoration were featured in New You magazine’s article “My Hair Lady.” The main topic of the article is hair transplantation in women, however it also touches on hair loss in women, Follicular Unit Transplantation (FUT), medication and other products.

On Bernstein Medical – Center for Hair Restoration:

The Manhattan office of Bob Bernstein, just steps from Park Avenue, is the kind of space that makes successful men feel at home — a good thing for one of the country’s foremost specialists in hair restoration (and the co-author of Hair Loss for Dummies). The layout is part design statement, part science lab, slick with granite, slate, and glass and full of microscopes and high tech gizmos. Among the space’s most noteworthy gadgets is one of only twelve robots in the world programmed to help perform hair transplants, which has a home in Dr. Bernstein’s office.

A female patient of ours discussing the “taboo” of hair transplantation in women:

Sara Lyles, 62, whose hair loss was caused by a styling technique, said that when Dr. Bernstein performed her hair transplant 12 years ago, the subject was taboo. “Women never talked about it, and I was so embarrassed that I avoided all social functions,” she recalls. “I’m African American and I slept in large tight rollers to keep frizzing under control. The traction destroyed my frontal hairline.”

At the time, she would have been mortified if someone found out she had undergone a transplant. “Even my hairdresser had no clue,” she says. “Dr. Bernstein not only gave me my hair back, he gave me my life back.”

Dr. Bernstein on the amazing progress of the hair restoration industry:

As Dr. Bernstein emerges from his operating room, sporting green scrubs and green Nikes that match the room’s tiles, he shakes his head and sighs. “When I went into practice back in the eighties, transplantation was almost barbaric and Rogaine was the only alternative,” he remembers. He marvels at the advances and choices he and others now have to over. “I never would have thought I would be working with robots, lasers, and cloning.”

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RepliCel Life Sciences; a company out of Vancouver, Canada; is studying the use of hair cloning techniques to treat male pattern baldness and hair loss in women.

The study is in progress, but analysis of the 6-month interim results of the first phases has been published. The preliminary results at 6 months show that almost two-thirds of subjects (10 out of 16, or 63%) received a greater than 5% increase in hair density at the injection site. Of that group of 10 subjects, seven of them saw hair density improve by more than 10%. In one subject vellus hair density increased 24.9%, terminal hair density increased 14.5%, overall hair density increased by 19.2%, and cumulative thickness per area increased by 15.4%. There were no significant adverse safety events reported in the first 6 months of the trial.

Phase I/IIa of the RepliCel study involved injecting male and female subjects with their own (autologous) dermal sheath cup cells (DSCC), which were replicated or cloned using RepliCel’s laboratory technology. A preliminary analysis of the safety of the injections, as well as a preliminary analysis of the efficacy of the treatment in growing hair, was announced in May 2012 and presented to the European Hair Research Society in June 2012. Subjects in this part of the study will continue to be monitored for any adverse physical reactions and to assess hair growth at 12 months and 24 months after treatment.

Phase IIb of the study is designed to help the RepliCel researchers formulate the optimal treatment for hair growth. Some of the treatment regimens that will be tested include the use of different concentrations of cells and different treatment schedules, plus the effects of single injections versus repeat injections. The final protocols for Phase IIb are currently being worked out, with the clinical trial expected to begin in late 2012.

Reference:

Lortkipanidze, N. Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia. In Clinicaltrials.gov. Retrieved July 26, 2012, from http://clinicaltrials.gov/ct2/show/NCT01286649.

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Q: I haven’t seen much new with ACell. Have you been making progress with your research?

A: Thus far, we have not been able to multiply transplanted hairs with ACell, nor have been able minimize the width of the donor scars following FUT. At present, we are not recommending ACell to our patients, but are continuing to explore different ways of using it.

Visit the Hair Cloning News section to read about the latest research on cloning and multiplication
Read about Hair Cloning Methods

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Dr. Bernstein Touts Benefits Of Robotic FUE On Bloomberg TV
Dr. Bernstein discusses the ARTAS Robot for FUE

Dr. Bernstein spoke with Bloomberg’s Matt Miller about the future of hair transplantation in a segment called, “The Bald Economy: Surgical Solutions to Hair Loss.”

Here is an excerpt from the segment:

Bloomberg’s Matt Miller: Riding the wave into the future happens to be one of the pioneers of FUE, Dr. Robert Bernstein.

Dr. Bernstein: “The robot now allows a mechanized system to do [follicular unit extraction] very, very quickly and very consistently, so that the human error in this part of the procedure is now gone.”

Matt Miller: That’s right, a robot. Dr. Bernstein is piloting a high-tech solution called ARTAS.

Dr. Bernstein: “What it is very precise at doing is getting around the follicular unit to separate it from the tissue.”

Matt Miller: The procedure, which costs twice as much as the standard surgery, has one clear advantage.

Dr. Bernstein: “The difference is, in the back, in the area where we take the hair, there will be little tiny dots that just fade into the scalp.”

Read more about the ARTAS Robot for FUE and Robotic Hair Transplantation

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NYT - New Stratagems in the Quest for HairFred R. Conrad/The New York Times

Dr. Bernstein is featured in Douglas Quenqua’s article in the New York Times — “New Stratagems in the Quest for Hair” — about the latest advances in hair restoration. The article mentions Dr. Bernstein’s pioneering research on hair cloning, including his studies on hair multiplication using the breakthrough biotechnology of ACell’s MatriStem® extracellular matrix.

On hair cloning:

Dr. Robert M. Bernstein, clinical professor of dermatology at Columbia University, is now one of several researchers experimenting with [ACell MatriStem].

“It’s just a question of time now” before hair cloning becomes a reality, Dr. Bernstein said. “We keep on moving back that time, but I think there’s absolutely no doubt that it’s going to be done.”

He believes hair cloning will be commercially available within 10 years. This may sound like a long time to wait, but “it’s important to remember that baldness is unlike other conditions where you can progress past the point of being helped,” Dr. Bernstein said. “Once we have a cure for hair loss, everyone will be able to benefit.”

On male pattern baldness:

“Hair has been an evolutionary sign of health and sexuality and youth, and that doesn’t change,” Dr. Bernstein said. “Shaved heads look cool, but not everyone wants one, and not everyone looks good with one.”

The article also discusses interest among hair restoration physicians in researching the use of the eyelash growth medication Latisse for hair regrowth on the scalp.

Go here to read the article at the NYT.

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Robert M. Bernstein, M.D., F.A.A.D., Renowned Hair Transplant Surgeon and Founder of Bernstein Medical – Center for Hair Restoration in New York, is Studying Four Applications of ACell MatriStem™ Extracellular Matrix in a Type of Hair Cloning, Called Hair Multiplication, as well as in Current Hair Restoration Procedures.

New York, NY (PRWEB) March 15, 2011 – Robert M. Bernstein, M.D., F.A.A.D., Clinical Professor of Dermatology at Columbia University in New York and founder of Bernstein Medical – Center for Hair Restoration, has been granted approval by the Western Institutional Review Board (WIRB) to study four different applications of the ACell MatriStem extracellular matrix (ECM) in hair restoration.

Hair Cloning with ACell MatriStemHair Cloningwith ACell MatriStem

Two of the studies include its use in a type of hair cloning, called hair multiplication, where plucked hairs and transected follicular units are induced to generate new hair-producing follicles. The other two areas of study include evaluating the use of the ECM in current hair transplant procedures to enhance hair growth and facilitate wound healing.

Approval by the WIRB allows the researchers to conduct double-blinded, bilateral controlled studies. Controlled studies are the best way to increase the objectivity of the research and insure the validity of the results.

“The medical research we are performing is important because it may lead to hair multiplication as a way to increase a person’s supply of donor hair. In this way, patients would no longer be limited in the amount of hair which can be used in a hair restoration procedure,” said Dr. Bernstein. “Additionally, in the near-term, the extracellular matrix may be able to improve the cosmetic benefit of current hair transplant procedures. We are simultaneously pushing the boundaries of hair cloning methods and follicular unit transplantation.”

Hair multiplication, a variation of what is popularly known as hair cloning, is a procedure where partial hair follicles are stimulated to form whole follicles. These parts can either be from hairs derived from plucking or from follicles which have been purposely cut into sections. Generally, damaged follicular units will stop growing hairs. However, there is anecdotal evidence that an extracellular matrix applied to partial follicles may stimulate whole follicles to grow and, when applied to wounds, may stimulate the body’s cells to heal the damaged tissue.

This new medical research also attempts to show that ACell can improve the healing of wounds created when follicular units are harvested for hair transplant surgery. Currently, in follicular unit hair transplant procedures, a linear scar results when a surgeon incises the patient’s scalp to harvest follicular units. Occasionally, this scar can be stretched, resulting in a less-than favorable cosmetic result. If ECM can induce the wound to heal more completely, the linear scar may be improved. The extracellular matrix may also benefit general hair growth in hair transplantation in that the sites where hair is transplanted, called recipient sites, can be primed with ECM to encourage healthy growth of the hair follicle.

Dr. Bernstein is known world-wide for pioneering the hair restoration procedures of follicular unit transplantation (FUT) and follicular unit extraction (FUE). Follicular units are the naturally-occurring groups of one to four hair follicles which make up scalp hair. These tiny structures are the components which are transplanted in follicular unit hair transplants.

While hair cloning has been of great interest to hair restoration physicians and sufferers of common genetic hair loss, the method by which this can be achieved has yet to be determined. The use of ACell’s extracellular matrix to generate follicles is a promising development in achieving this elusive goal. In addition to the longer term implications of using ECM in hair multiplication, its impact on hair restoration will be more immediate if it can be proven effective when used in current FUT procedures.

About Dr. Robert M. Bernstein:

Dr. Bernstein is a certified dermatologist and pioneer in the field of hair transplant surgery. His landmark medical publications have revolutionized hair transplantation and provide the foundation for techniques used by hair transplant surgeons across five continents. He is respected for his honest and ethical assessment of a patient’s treatment options, exceptional surgical skills, and keen aesthetic sense in hair transplantation. In addition to his many medical publications, Dr. Bernstein has appeared as a hair loss or hair transplantation expert on The Oprah Winfrey Show, The Dr. Oz Show, Good Morning America, The Today Show, The Discovery Channel, CBS News, Fox News, and National Public Radio; and he has been interviewed for articles in GQ Magazine, Men’s Health, Vogue, the New York Times, and others.

About Bernstein Medical – Center for Hair Restoration:

Bernstein Medical – Center for Hair Restoration is a state-of-the-art hair restoration facility and international referral center, located in midtown Manhattan, New York City. The center is dedicated to the diagnosis and treatment of hair loss in men and women. Hair transplant surgery, hair repair surgery, and eyebrow transplant surgery are performed using the follicular unit transplant (FUT) and follicular unit extraction (FUE) surgical hair restoration techniques.

Contact Bernstein Medical – Center for Hair Restoration:

If you are a journalist and would like to discuss this press release, please email us or call us today (212-826-2400) to schedule an appointment to speak with Dr. Bernstein.

View the press release at PRWeb.

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Q: Like many people who are eagerly awaiting hair cloning, I read about ACell’s new technology, but what is an “extracellular matrix”? — S.B., Chicago, IL

A: An extracellular matrix, or ECM, is the substance between the cells in all animal tissues. It provides support to the cells and a number of other important functions. ECM is made up of fibrous proteins that form a web or mesh filled with a substance called glycosaminoglycans (GAG). One type of GAG, called hyaluronic acid, functions to hold water in the tissues. Another important part of the extracellular matrix is the basement membrane on which the epithelial cells of the skin and other tissues lie. Elastin in the ECM allows blood vessels, skin, and other tissues to stretch.

ECM has many functions including providing support for cells, regulating intercellular communication, and providing growth factors for wound healing and tissue regeneration.

Read more about ACell’s MatriStem ECM on our ACell for Hair Cloning page.

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ACell, Inc. - Regenerative Medicine TechnologyNew developments in regenerative medicine, presented at the 18th Annual Scientific Meeting of the International Society for Hair Restoration (ISHRS) this past week, may have opened the possibility that a patient’s hair can be multiplied in his own scalp.

ACell, Inc., a company based in Columbia, Maryland, has developed and refined an Extracellular Matrix (ECM), a natural biological material that can be implanted at the site of an injury or damaged tissue in order to stimulate a unique healing response. The ECM stimulates the body’s own cells to form new tissue specific to that site (a process referred to as “Auto-cloning”).

The ACell MatriStem devices have had some preliminary success in allowing plucked hairs that were placed into recipient sites on the patient’s scalp to grow. Although this is a major breakthrough, significant work remains in order for hair multiplication to become a practical treatment for hair loss in men and women.

It is also anticipated that the regenerative properties of Extracellular Matrix will facilitate the healing of the incision in the donor area after a hair transplant. We are currently offering ACell to all patients undergoing follicular unit transplant procedures at no additional charge.

We are currently studying the use of ACell for scalp hair multiplication as well as the facilitation of wound healing in follicular unit transplantation procedures. We are also treating select patients outside the studies. If you are interested in participating, please give us a call.

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Q: What are the possible obstacles that you see with hair cloning using the plucking technique? — D.E., Boston, MA

A: Plucked hair does not contain that much epithelial tissue, so we do not yet know what the success of the procedure will be. Plucked hairs will most likely grow into individual hair follicles that are not follicular units and therefore, will not have completely the natural (full) look of two and three hair grafts. This limitation may be circumvented, however, by placing several hairs in one recipient site. It is possible that the sebaceous gland may not fully develop, so the cloned hair may not have the full luster of a transplanted hair.

The most important concern is that, since the follicle is made, in part, by recipient cells that may be androgen sensitive, the plucked hair derived follicles may not be permanent. It is possible, that since all the components of a normal hair may not be present, the cloned hair may only survive for one hair cycle.

Since the ACell extracellular matrix is derived from porcine (pig) tissue, the procedure may not be appropriate if you are Kosher or allergic to pork. Of course, we do not know what other obstacles may arise since this technique is so new –- or even if the ones mentioned above will really be obstacles at all -– only time will tell.

Follow the latest in Hair Cloning Research

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Q: I heard that there have been some new advances in hair cloning and that it may be available sooner than we thought. I was planning on doing a hair transplant soon. Considering that hair cloning may be available at some point in the future, should I do FUE or FUT, or wait for cloning? — K.R., Fort Lee, NJ

A: Although there has been a major development in hair cloning with the use of ACell, an extracellular matrix to simulate hair growth, the model, at this point, is still in its earliest stages of development. It is hard to know when the technology will reach a state where it can be useful in hair restoration.

With respect to which you should do FUE or FUT if, theoretically, cloning is around the corner, the answer would be FUT, since FUT will give you the fuller look.

If the goal is to eliminate any trace of the traditional hair transplant, again FUT will most likely be the best choice, since the single linear scar would be easy to camouflage with cloned hair. With FUE, this would be much more difficult, since there are literally thousands of tiny scars. However, neither FUE nor FUT will preclude a patient from fully benefiting from cloning if, and when, it becomes available.

Read more:

Hair Cloning

Pros & Cons of FUE

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Q: I’ve read about some recent advances in hair cloning techniques with ACell. How does this work? — C.A., Stamford, CT

A: We, and several other groups, are engaged in studies using ACell MatriStem, a porcine extracellular matrix (ECM), to induce hair follicles to multiply in the patient’s own scalp (in vivo). This process differs from what people normally think of when speaking about cloning, namely producing populations of genetically identical cells, organs, or even individuals, in a test tube (in vitro).

In the current studies, a part of a hair follicle is implanted into the scalp in an extracellular matrix (ACell MatriStem), with the goal of inducing a complete follicle to form.

The concept is that if a small enough part of the donor follicle is removed, it will completely regenerate. Then, ACell MatriStem will induce the new hair fragment, implanted into the recipient site on the top of the scalp, to produce a new follicle –- thus we get two hairs from one. In one model being tested, hair is literally plucked from the scalp carrying with it enough genetic tissue to grow a new hair.

For more information, view our ACell page in the Hair Cloning section.

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ACell, Inc. - Regenerative Medicine TechnologyHair cloning is one of the most hotly discussed topics in the field of hair transplantation today. “When will hair cloning become available?” and “How will it work?” are among the most frequently asked questions about treating hair loss that we receive at Bernstein Medical – Center for Hair Restoration.

New developments in regenerative medicine technology, presented at the 18th Annual Scientific Meeting of the International Society for Hair Restoration (ISHRS), may have opened the door to commercialization and medical use of new techniques which could provide an answer to both questions.

ACell, Inc., a company based in Columbia, Maryland, has developed and refined what they consider, “the next generation of regenerative medicine.”

For more information on this exciting development, view our page on ACell technology and hair cloning

Follow news and updates on our Hair Cloning News page.

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Q: If you have already had a hair transplant, once cloning becomes available, will you be able to transplant the cloned hair into the first transplant’s scar on the back of the head? I like to wear my hair short, especially in the summer, and also would feel more comfortable knowing there is no scar in my head. — H.I., Rockville Centre, N.Y.

A: Yes, as long as the scar is not thickened, cloned hair should grow just as normally transplanted hair would and would be a great way to address any residual scarring from the procedure.

Although hair can be transplanted into widened scars, hair does not grow well in thick scars – this would apply to hair restoration procedures performed via traditional means as well as those using cloned hair.

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Q: I just read a press release saying that researchers have developed a successful technique to clone hair by using a wound healing powder. To paraphrase, the press release says:

MatriStem MicroMatrix, a product of regenerative medicine, ACell, Inc., is a wound healing powder that promotes healing and tissue growth and has now proven to help regenerate hair in the donor and recipient regions of hair transplant patients. While intended to heal ulcers and burns, Gary Hitzig, M.D. and Jerry Cooley, M.D., have found that its properties offer a broader scope of treatment, including hair cloning. “We’ve made amazing breakthroughs using MatriStem as a hair cloning tool,” said Dr. Hitzig. “We’ve been able to multiply the number of hair follicles growing in the recipient area, and as an added benefit are seeing faster hair growth. This new hair cloning technique also makes hair transplantation surgery less invasive.”

Is this new technique really a breakthrough in hair cloning? And if so, when can we start cloning hair?

A: It appears from preliminary studies that plucked hairs stimulated by ACell are in some cases able to regenerate new hair. Because the hair is placed into the recipient area and is partially derived from cells in the dermis, it is not yet clear whether the hair will be effected by androgens over time or if it will continue to bald.

The research so far is promising and a number of doctors are doing research in this area, including Dr. Schweiger and myself at Bernstein Medical – Center for Hair Restoration.

For more on the topic, visit our Hair Cloning section, our page on ACell extracellular matrix devices, and answers to questions on Hair Cloning.

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Q: I am 25 year old who just started going bald. My doctor confirmed that I have pattern baldness and put me on Propecia and Rogaine. I don’t want to go bald at any age. So, instead of prolonging the process for 5-10 years and then having a hair transplant, isn’t it easier to just let the hair loss continue and then have a HT, so that I can save the money on drugs for years. — Z.B., Greenwich, C.T.

A: It is far better to keep your own hair using medical therapy. The medications (i.e. finasteride and minoxidil) are relatively inexpensive if use the generic forms and will be far less expensive than surgery – even on the long-term. Keeping your own hair will look fuller than a hair transplant, since a hair transplant just re-distributes a diminishing amount existing hair. When the ability to multiply hair (cloning) is available this, of course will change, but this technology is still years away.

Read about the Candidacy for a Hair Transplant

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Q: What is the major obstacle to hair cloning?

A: Although many problems remain, the main one is to keep cloned cells differentiated (the ability to perform a specialized function, like producing a hair). There are certain cells in the skin, called fibroblasts, which reside around the base of the hair follicle. These cells are readily multiplied in a Petri dish. When these cells are injected into the skin, they have the ability to induce a hair to form (they are differentiated). The problem is that when these cells are multiplied in culture, they tend to lose this ability (they become undifferentiated).

A number of methods are being examined to keep these cells differentiated. Among them is the insertion of new genes into the cell’s nucleus to alter the expression of the existing genes. Another method is to change the spatial relationship of multiplying cells. The idea behind the second technique is that all embryonic cells have the same basic genetic material, but grow to have different functions (i.e., grow to form muscle, bone or nerves). One reason is that that the cells have a different physical relationship to one another and thus send different signals to each other based on this relationship. For example, the cells on the outside of a growing ball of cells may act differently than the cells on the inside, etc. If researchers can influence the way cells orient themselves as they multiply in the lab, this may enable them to become differentiated to produce hair and stay that way as the multiplication process continues.

For more on this intriguing topic, see the Hair Cloning and Hair Cloning Methods pages at the Bernstein Medical – Center for Hair Restoration website.

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Q: If someone were to get a hair transplant now, and then in the future when hair cloning becomes a possibility, would the hair transplant grafts be affected by hairs from the hair cloning procedure?

A: Cloned hair should not be affected by hair that is transplanted the traditional way and visa versa. If you have a hair transplant now, the hair restoration surgeon can add more hair in the future when cloning becomes available.

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Q: I was reading the hair cloning area on your site and came across this passage:

“Donor cells can be transferred from one person to another without being rejected. Since repeat hair implantations did not provoke the typical rejection responses, even though the donor was of the opposite sex and had a significantly different genetic profile, this indicates that the dermal sheath cells have a special immune status and that the lower hair follicle is one of the body’s ‘immune privileged’ sites.”

Does this mean that I could get a hair transplant from someone else’s head of hair one day? Any type of hair?

A: Yes, in theory we will be able to use someone else’s donor tissue to clone hair – but the technology to actually do this is still years away.

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Q: What are the major obstacles for scientists to cloning hair?

A: The main problem is that the cultured cells may lose their phenotype with multiple passages, i.e. lose their ability to differentiate into hair follicles after they have been multiplied.

Another problem of hair cloning is that the orientation of hair direction must be controlled. With mouse experiments, the hairs grow at all different directions. Scientists need to find a way to align the hair so that it grows in the right direction. Hair, of course, must also be of a quality that is cosmetically acceptable and matches the patient existing hair. And the hair should grow in follicular units. Individual hairs will not give the fullness or natural look of follicular units.

Another problem is the issue of safety. Are we sure that cultured cells may not turn into something else – such as malignancy cells with uncontrolled growth?

Finally, FDA approval would be required and this takes time. It is true that you do not need FDA approval for using your own hair, such as a hair transplant; however, when you take cells from the body and manipulate it in the lab, this requires FDA approval.

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Q: I am 22 and losing my hair all across the top of my head. How can I thicken my hair to its level a few years previously? — I.L., Kentfield, CA

A: If medication, such as finasteride, is successful it can thicken hair by increasing the diameter of the existing hair shafts. Although the cosmetic benefits can be dramatic in a person with significant hair loss, a hair transplant can not restore hair to its original density, since it only moves the existing hair around and does create new hair.

When hair cloning technology is available, this will change as a person’s donor supply will be increased.

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The British government has awarded Intercytex a grant to automate the production of their new hair regeneration therapy. Intercytex is a cell therapy company that develops products to restore and regenerate skin and hair. Intercytex has partnered with a private company, The Automation Partnership (TAP), to develop an automated manufacturing process for their novel hair multiplication treatment.

The hair multiplication product, ICX-TRC, has been submitted as a hair regeneration therapy that uses cells cloned from one’s own scalp. It is intended for the treatment of male pattern baldness (androgenetic alopecia) and female pattern hair loss. The key researcher, biochemist Dr. Paul Kemp, founder of Intercytex, is developing the hair multiplication treatment at their Manchester facility. This investment in hair cloning research is spearheaded by UK Science Minister, Lord Sainsbury.

The government grant will be used mainly to develop a robotic system specifically designed to support the commercial-scale production of their hair cloning product ICX-TRC, at a scale that can handle a large number of people. The company is currently in Phase II clinical testing.

How Intercytex’s Hair Cloning Product Works

Intercytex’s method of hair regeneration involves removing a slice of the scalp, complete with hairs and follicles, from the back of the head. Hair follicles from this area are most resistant to typical hereditary baldness. The sample is taken to a laboratory where the hair producing dermal papilla (DP) cells are extracted and multiplied in flasks. After eight weeks, the DP cells should have cloned into millions of hair cells.

To complete the hair cloning process, the new cells are injected back into the patient’s scalp under a local anesthetic. These cultured cells should then develop into brand new hair follicles.

Intercytex

Intercytex is a 6-year-old company with its main office is in Cambridge, UK and has a clinical production facility and research and development laboratories in Manchester, UK. Additional laboratories are located in Boston, Massachusetts. TAP, founded in 1988, is a private company with headquarters near Cambridge, UK. Intercytex is publicly traded on the London Stock exchange (LSE: ICX).

Additional information about this hair cloning product can be found at www.intercytex.com.

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Dr. Bernstein summarizes an article on hair cloning in The Plain Dealer:

An English based company called Intercytex has claimed some success in its research on hair cloning with its first testing in humans. This technique is similar to the one initially proposed by Dr. Colin Jahoda and published in 1999. (Download the article )

The idea is that certain cells (called fibroblasts) found at the bottom of hair follicles can be separated from the follicles after they have been removed from the scalp, and then be used to form new follicles.

The way this works is as follows: a few hair follicles at the permanent area from the back of the scalp (the area that does not bald) are removed. In a lab, the germinative cells at the base of the follicle are dissected off and placed in a Petri dish. They are then incubated in a special medium and allowed to multiply thousands of times.

These cultured cells are then injected into the balding area of the scalp where they induce complete hair follicles to form. In contrast to traditional hair transplants, where the doctor is limited by the patient’s finite donor supply and hair is literally just moved around (from the back to the front), in hair cloning, there will be an actual increase in the total number of hairs on a person’s head.

Initial testing involved seven male volunteers that were suffering from androgenetic alopecia (common baldness). After the process, five of them showed an increased amount of hair. Fortunately, there were no complications, such as skin inflammation or tissue rejection. However, the test area was small and volunteers only grew a little hair.

Towards the middle of next year, additional patients will be tested using a greater number of cloned cells, so that a larger area of the scalp could be covered. The researchers speculate that this new cloning technology may be on the market in as soon as five years.

The researchers speculate that in the distant future, traditional hair transplants may not be needed at all. Instead, as patients start to thin, they could come to the clinic on a regular basis for injections of their own cells to stimulate the growth of new follicles and stop the impending balding – a sort of hair maintenance.

Reference: The Plain Dealer, Tuesday, November 15, 2005. “Hope grows for bald baby boomers,” Malcolm Ritter, Associated Press.

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Dr. Bernstein was featured in an article in GQ Magazine on hair transplantation. The article, written by Peter Rubin is entitled, “Grow Your Own.”

Here is a brief synopsis of the article:

GQ: After fifty years of bad plug jobs, we’ve come to regard “hair restoration” as synonymous with “Astroturf head.” Today’s hair transplant procedures are worlds away from the butcherings of old. So forget what you thought you knew.

Two methods of hair restoration are in wide usage: mini-micrografting and follicular unit transplantation. The methods are similar, to an extent, but FUT; co-developed by New York hair transplant surgeon, Robert M. Bernstein, M.D.; is the more advanced of the two procedures, producing cosmetically superior results.

Dr. Bernstein: Anatomically, follicular unit transplantation is the end of the line. The next step would be hair cloning, which is still quite a way off. The way you get the most amount of hair into the smallest wound — and ensure that it’s going to look natural — is by using a follicular unit transplant. We can create swirls, add sideburns… The beauty of follicular transplantation is that the hair will take on the old wave that the original hair had.

GQ: The best part is that FUT regularly achieves an extraordinarily high success rate, meaning nearly every single transplanted graft takes root and grows properly – unheard of fifteen years ago.

Pierce Mattie, a 28-year-old publicist in New York City, had an FUT procedure in May and couldn’t be happier. “I’ve had dental fillings that were more painful,” he says. “I was back in the office two days later, and my hair looks like it did when I was in high school. Everyone keeps saying, ‘You look so great!’—but they have no idea what I had done.”

About GQ Magazine: For nearly half a century, with 854,000 subscribers and 4 million readers, GQ has been a leading voice in men’s magazines, covering men’s style and culture from fashion and politics to travel, entertainment, sports, technology and relationships. GQ has been nominated for 27 National Magazine Awards.

Reference
“Grow Your Own,” GQ Magazine, November 2003, p173-4.

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Robert M. Bernstein M.D. was asked to provide expert medical commentary in two hair transplant videos produced by Healthology. The topics included “Hair Transplantation Techniques” and “Using Cloning Techniques in Hair Transplantation”.

Healthology, the leading producer of broadcast and webcast programming that provides consumers with direct access to top medical experts, produced an important series of videos on hair loss. As Associate Clinical Professor of Dermatology, Columbia University College of Physicians and Surgeons, Dr. Bernstein was a vital part of the interview series.

Hair Transplantation Techniques

The first video that Dr. Bernstein was invited to take part in, focused on the various techniques used in surgical hair restoration. As a pioneer of Follicular Unit Transplantation, the filmmakers were eager to hear Dr. Bernstein’s thoughts on FUT:

“A major breakthrough in hair restoration came via identification that hair didn’t grow individually, but actually in small groups called follicular units. And these follicular units are naturally occurring groups of hair from one to four” Dr. Bernstein explained, “in modern hair transplantation, a procedure we call Follicular Unit Transplantation is used; we transplant the hair the way it actually grows in nature.”

This Healthology segment explored how the Follicular Unit Transplantation technique is also helping patients who want to improve the appearance of old transplants or scars.

“What we can do now is remove the old grafts, sew the holes closed where they’re transplanted, place those grafts under a microscope, divide them into individual follicular units and then place them back in the scalp the same day.” said Dr. Bernstein.

In addition to covering surgical hair restoration, the segment touched on the issue of medications for hair loss. Though some patients think getting a hair transplant means they can stop taking hair loss medications, Dr Bernstein illustrated why most physicians recommend using medicine along with surgery:

“Hair transplantation and medications do essentially different things. The main benefit of a transplant is to restore hair that’s been lost. The main benefit of medication is to prevent further hair loss.”

Using Cloning Techniques in Hair Transplantation

In this second Healthology video segment, on hair cloning, they invited Dr. Bernstein to take part in the discussion along with other distinguished guests; including Angela Christiano, PhD an Associate Professor of Dermatology and Genetics & Development at Columbia University.

This interesting segment explored how researchers are trying to find ways to make more follicles for hair transplant surgeons to work with. Research into cloning techniques shows it may be possible to create a virtually limitless supply of new follicles in the not too distant future. Dr. Bernstein provided some insights as to how hair restoration doctors might approach hair cloning in the future:

“The actual role of cloning in hair transplantation will depend upon how the cloning technology actually evolves. Initially, cloning may be used to supplement a regular hair transplant. We would use Follicular Unit Transplantation to give definition to a hairline and frame the face. Cloning would then be used to give the hair transplant bulk, by placing the cloned hair (which may not look as natural as normal hair) behind the transplanted hair.”

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Hair transplantation was introduced in the United States by Dr. Norman Orentreich in 1959. He demonstrated that hair taken from one area of the scalp would continue to grow even if it were transplanted to a balding area of the head.

The problem with this scientific breakthrough was that hair was being transplanted in clumps or “plugs” that did not appear natural. And although patients who had hair transplants were indeed growing hair on what was once a balding pate, the appearance was akin to that of a doll’s head and hardly much of a cosmetic improvement for their baldness.

In 1995, Drs. Bernstein and Rassman presented a paper describing a new procedure surgical hair restoration called Follicular Unit Transplantation or FUT. In this new technique, hair would be transplanted using only naturally occurring, individual units of 1, 2, 3 or 4 follicles. These perfectly intact “follicular units” would be obtained by removing a single, thin strip of skin from the back of the scalp and then using a dissecting stereomicroscope to isolate the tiny naturally occurring groups of hair.

Since the publication of “Follicular Transplantation” hair transplantation has undergone an “extreme makeover” itself, in part due to the incredibly natural results that this powerful procedure can produce. FUT is now considered to be the state-of-the-art in hair transplant surgery and is currently the most widely used surgical hair restoration technique.

Robert M. Bernstein M.D., Clinical Professor of Dermatology at Columbia University in New York City, sat with us for a Q&A on hair transplant surgery and its future.

How are Hair Follicles Removed in Follicular Unit Transplantation?

In order to safely remove and preserve the follicular units without causing any damage to them, the donor tissue is removed in one thin piece. This technique is called Single Strip Harvesting and it is an essential component of follicular unit hair transplants.

How Many Grafts Should be Transplanted at Once?

The average session for a moderately bald person, who has lost most of the hair on the top of his scalp is around 2,500 grafts. Although it is best to complete the hair restoration in as few large sessions as possible, there are limits. When too large a strip is removed, it can cause undue tension in the donor area and cause a stretched scar or loss of hair. Excessively long hair transplants, where the grafts are kept outside the body for an extended period of time, may compromise graft survival.

Another issue with very large sessions is that a hair transplant doctor has less flexibility if problems arise during the surgery. Patient variability is an intrinsic part of hair transplants. In some patients, the grafts tend to pop up above the skin surface as they are inserted into the scalp. Popping also occurs when a graft placed in the skin causes an adjacent one to lift. The closer you put the grafts and the more grafts you transplant at one time, the greater the chance that these problems will occur and the more difficult they will be to manage. The goal is to always maximize what you get from the back and what grows in the front and top. It’s not a race where we have to do 3,000 or 4,000 grafts in every patient. When I hear people say, “Oh, I had 5,000 grafts.” I think “How many of those actually grew?”

Is Hair Transplant Surgery Permanent?

Yes, the hair on the back and sides of the scalp is permanent and it retains this characteristic even when moved to the front and top of the scalp.

Will Transplanted Hair Change Over Time?

The genetic tendency of hair to grow is dependent upon the donor area where the hair comes from. We call this “donor dominance.” However, the character of the hair, the wave, the rate of growth, is affected by the area where it is transplanted into. For example, we discovered that when we take scalp hair and transplant it to the eyebrows, over time, the growth rate actually slows down to match the growth of eyebrows. In this case, the recipient area has an influence on the growth of the eyebrow hair.

Can You Take Hair from Someone Else and Transplant it on Your Own Head?

You cannot perform hair transplants with hair taken from someone else. It has to be your own hair or it will be rejected by the body.

What is the Future of Hair Transplantation?

The next big improvement to the field of surgical hair restoration will be hair multiplication – commonly but erroneously referred to as hair cloning. This technique will dramatically increase a person’s limited donor supply, an issue that frustrates many patients wanting hair restoration.

The mechanism for cloning is based on the multiplication of the cells that surround a hair follicle. These cells, called fibroblasts are readily multiplied outside the body. Once multiplied, the “fibroblasts” could be injected into the skin to induce hairs to form. The problem is that when you multiply these fibroblasts, they lose their ability to stimulate hair to grow – a major roadblock that still needs to be overcome.

Another concern with hair cloning is that if you’re inducing hair to grow, what will it look like? Is it going to be wild and uncontrollably wiry? Will it look like the person’s normal hair? Because the recipient area plays a factor in the way a follicle grows, it’s reasonable to assume that even if you inject these fibroblasts to induce a hair to form, that hair will start to take on the characteristics of a person’s original hair.

It is exciting to think of the possibilities that improvements in the science of hair transplants will afford to those suffering from the effects of hair loss. Perhaps someday any baldness in men and women will be a result of choice and not a genetic constraint, but will unlikely be available for at least 5-10 years.

Watch video Q&A with Dr. Bernstein

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Dr. Bernstein was interviewed by New York Newsday in their article, “It’s a Hairy Decision Picking a Treatment for Baldness.” The complete article is below:

HEALTH MATTERS COLUMN

Even IF they don’t talk much about it, just about all the guys he knows are taking medication for their thinning hair, said Steve, a retail manager in his early 30s from Suffolk County, NY. He would be too, but he had side effects right away. He’s had consultations for hair transplants, but that won’t work either because of the pattern of his balding.

So he’s using a protein product that makes his hair look fuller, changed his diet to include leafy green vegetables, gone to two psychics for help. And, he said, he’s biding his time, waiting for new hair restoration medications or for hair cloning to hit the marketplace.

“In the ’90s, everything’s about looks,” said Steve, who asked that his last name be kept confidential. “No one wants to give up their youth.” All the effort to find a hair restoration solution is worth it, he said, “because losing my hair bothers me a lot.”

Sure, hair loss isn’t crippling or life-threatening. But to hear people’s tales, it’s traumatic, depressing and embarrassing.

Yet, you’re more likely to get a snicker than a hug for your pains, said Spencer Kobren, 34, a Manhattan consumer activist and author of “The Bald Truth,” (Pocket Books, 1998, $6.99.) There may be few open arms to comfort you, he said, but there are plenty of extended hands to take your trust and your money.

Kobren should know. He has spent several years testing out hair loss products and talking to the experts about his own hair loss, which began at 22. Now he serves as a sounding board and clearinghouse for the good news and the bad about hair loss and its treatments on a syndicated radio show, aired locally on WEVD /1050 AM on Sunday nights.

“You feel like you’re losing a part of yourself. You see your appearance deteriorate, often rapidly and drastically,” he said. You become vulnerable to promises and pitches, but don’t be swayed by them, said Kobren, who now has a full head of hair. Instead, do a lot of research. The wrong hair restoration products or treatments may not only fail to grow hair, they can make matters a lot worse. For example, he said he gets thousands of letters and e-mails about botched hair transplants that leave men scarred, poorer and balder.

According to Kobren, about $7 billion is spent by consumers annually on finding solutions to hair loss. There are about 50 million men who are balding, with at least 20 percent starting in their 20s. Most have male-pattern baldness, genetically linked and triggered by the action of a hormone called dihydrotestosterone (DHT).

Hair loss is not just a guy thing, though. Plenty of women — about 20 million — have varying degrees of it too. Hair loss is finally getting recognition as a women’s health problem, said Maggie Greenwood- Robinson, whose book, “Hair Savers for Women” (Three Rivers), is due next spring. Kobren’s “The Truth About Women’s Hair Loss,” (Contemporary) will be out in January. “There are more options than ever before for women with hair loss,” said Greenwood-Robinson, and they shouldn’t give up.

But they do have to be cautious. The diagnosis and treatment for men and women is very different, said Dr. Robert M. Bernstein, assistant professor of dermatology at Columbia College of Physicians arid Surgeons and medical director of the New Hair Institute in Manhattan and Fort Lee, N.J.

“Women usually have a diffuse type of hair loss with thinning all over,” he said, “while men generally lose hair on the front and top and keep a permanent zone on the back and sides.” Female baldness can also be due to DHT, but many women lose hair because of anemia, gynecological issues, thyroid disorders or stress, among other reasons. You don’t want to waste your efforts on hair restoration products when what you need is more iron or different birth control pills. “A medical evaluation is extremely important to rule out underlying medical conditions,” said Bernstein.

The treatment of hair loss is an increasingly complicated decision for both men arid women, but at least there is more information than ever to help you ask the right questions. Web sites include www. thebaldtruth.org and www.regrowth.com. Bernstein’s practice has a Web site at www. newhair.com and a detailed book called “The Patient’s Guide to Hair Restoration.”

Your hair restoration options include:

Medication: Finasteride (brand name Propecia), taken orally by prescription. Available for under two years, Propecia is for men only and causes side effects in about 2 percent of them. It has been shown to stop hair loss in about 87 percent of users and new growth in about half. It’s not for women, because it can cause birth defects if a woman is pregnant, and if she’s past child-bearing age, it doesn’t seem to work.

Minoxidil: (brand name Rogaine), used topically. It can be used by both men and women and appears to slow down the rate of hair loss, but not to prevent balding in the long haul. Any effect from either of these hair restoration medications stops when you no longer use them.

Hair transplant surgery: for men and women. Bernstein has pioneered a state-of-the-art technique called follicular unit transplantation, a precise method using hair-follicle groupings that result in a more natural growth of hair and doesn’t leave scars.

Removing grafts of skin from your head and placing them in balding spots is clearly an art as well as a science. Besides being a good candidate for surgical hair restoration, you need to find a dermatologist with a lot of experience performing hair transplant surgery. Expect to ask many questions, learn the risks, see pictures of other patients and meet them in person.

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