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We have previously discussed Dr. Angela Christiano‘s work on hair loss genetics with her team at Columbia University in New York. A review of the 16th annual meeting of the European Hair Research Society; held recently in Barcelona, Spain; brings to our attention new research being conducted by a very astute scientist, Dr. Claire Higgins, who works at Dr. Christiano’s laboratory.

With tissue supplied by Bernstein Medical, Dr. Higgins is studying the inductive properties of the dermal papilla (DP), a group of cells that forms the structure directly below each hair follicle. As outlined in our Hair Cloning Methods page, the dermal papilla is of great interest to hair restoration physicians. Ideally, research of this kind will lead to a breakthrough in hair cloning or hair multiplication which will allow physicians to effectively “cure” hair loss by developing a limitless supply of donor hair that can be used in hair restoration procedures.

A description of Dr. Higgins’ work is provided by the Hair Transplant Forum International:

“After isolating [dermal papilla] from human hair follicles, they grow the human DP cells in spheroid cultures in order to retain their inductive potential. Then they place the dermal papilla spheres between the epidermis and dermis of neonatal foreskin and graft it onto the back of mice. Human [hair follicle] neogenesis can be observed after 6 weeks.”

In essence, the scientists were able to capitalize on the potential of dermal papilla cells to induce the growth of a hair follicle by enclosing the DP cells in a small sphere. When implanted, the DP cells maintained their properties of inducing the development of follicles, and, indeed, follicles did grow.

It is another example of how far our understanding of the biology of hair has come in the last 10 years. And it is another example of scientists closing in on the elusive “hair loss cure.”

Read up on the latest Hair Cloning Research

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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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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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Jing Gao, Mindy C. DeRouen, Chih-Hsin Chen, Michael Nguyen, et. al.
Genes & Development 22:2111-2124, 2008

The growth of a hair follicle from its developmental cell stage to a hair bearing follicle is through an interactive process between epidermal cells and those of the dermal papilla. It was found that Laminin-511 is instrumental in facilitating this process.

It has been felt that the extra-cellular protein Laminin is critical to both adhesion and the signaling process in hair development; however, the mechanism is not fully understood.

Through this study, it was shown that the signaling pathways introduced by the administration of noggin and sonic hedgehog alone were insufficient to develop a hair follicle. When Laminin-511 protein was introduced to the tissue culture, the dermal papilla developed. When the protein was inhibited, hair follicle growth again ceased. This information supports prior studies suggesting that Laminin is critical in the early stages of follicle cell development and is required for continued follicle development and growth.

This study reaffirms in vitro and in vivo studies in mice, the importance of Laminin-511 in the formation of dermal papilla to promote the development of more organized dermal papilla cells and the hair follicle development. It also suggests that there is a reciprocal mechanism between the signaling pathways of noggin and sonic hedgehog with Laminin-511.

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by Jeff Teumer, PhD
Hair Transplant International Forum, Volume 18, Number 3, May/June 2008

Follicular cell implantation (FCI) is based on the ability of the dermal papilla (DP) cells, found at the bottom of hair follicles, to stimulate new hairs to form. DP cells can be grown and multiplied in a culture so that a very small number of cells can produce enough follicles to cover an entire bald scalp.

In order to produce new follicles, two types of cells must be present. The first is Keratinocytes, the major cell type in the hair follicle, and the second are dermal papillae cells (DP) which lie in the upper part of the dermis, just below the hair follicle. It appears that the DP cells can induce the overlying keratinocytes to form hair follicles. There are a number of proposed techniques for hair regeneration that use combinations of cells that are implanted in the skin. The two major techniques involve either transplanting dermal papillae cells by themselves into the skin or implanting them with keratinocytes. These techniques can be used with or without an associated matrix used to help orient the newly forming follicles.

Implanting Dermal Papillae Cells Alone

  1. Implanting DP cells by themselves into the dermis, with the hope that they will cause the overlying skin cells (keratinocytes) to be transformed from normal skin cells into hair follicles. This method is called “follicular neo-genesis” since new hair is formed where none previously existed.
  2. Cells of the dermal papillae are placed alongside miniaturized follicles. The transplanted cells would induce the keratinocytes of the miniaturized follicles to grow into a terminal hair. A potential advantage of this technique is that the existing miniaturized follicles already have the proper structure and orientation to produce a natural look growth.

Implanting Dermal Papillae with Keratinocytes

  1. A mixed suspension of cultured keratinocytes and DP cells are implanted into the skin.
  2. Keratinocytes and DP cells are cultured together such that full or partial hair formation takes place in a culture dish. These culture-grown hairs, or “proto-hairs,” are then implanted into the patient. The advantage of using a proto-hair is that there would be better control over the direction of hair growth because of the structural orientation of the proto-hair.

Cell Implantation using a Matrix

  1. A variation of the above techniques is to use a matrix to help orient the implanted cells. This could be either an artificial matrix composed of materials such Dacron or it could be a biological matrix composed of collagen or other tissue components. The matrix would act like a scaffold to help cells organize to form a follicle. If the matrix were filamentous (like a hair) it could help direct the growth of the growing follicle. A matrix could be used with dermal papillae cells alone or in combination with cultured keratinocytes.

With all of the varied approaches for FCI, the aim is to combine keratinocytes and DP cells to efficiently and reproducibly generate thousands of follicles for hair restoration. In some cases, cells are combined in vivo and all of the hair formation must take place in the body after implantation, while in others, some hair formation takes place in culture before implantation.

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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 summarizes an article in the Journal of the National Cancer Institute:

Curis, Inc., a drug development company, has published data showing the effectiveness of a proprietary Hedgehog pathway activator to stimulate hair growth in adult mice. The study shows that a topically applied small molecule agonist of the Hedgehog signaling pathway can stimulate hair follicles to pass from the resting stage to the growth stage of the hair cycle. The Hedgehog agonist produces no other noticeable short or long-term changes in the skin of the mice.

This study also demonstrated that the Hedgehog agonist is active in human scalp in vitro as measured by Hedgehog pathway gene expression. The results suggest that topical application of a Hedgehog agonist could be effective in treating hair loss conditions, including male and female pattern genetic hair loss.

Preliminary results were presented at the American Academy of Dermatology (AAD) in February 2005. This work was based on a study in 2001 by Sato et. Al. who showed that the Sonic hedgehog gene is involved in the initiation of hair growth in mice.

Reference: Sato N., Leopold PL, Crystal, RG. Effect of Adenovirus-Mediated Expression of Sonic Hedgehog Gene on Hair Regrowth in Mice With Chemotherapy-Induced Alopecia. Journal of the National Cancer Institute, 2001, Vol. 93, No. 24.

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