Tag Archives: aderans

Clinical Trials to Grow Hair – Call for Participants 2012

Merck Pharmaceuticals is calling for people living in the New York Area who would like to participate in the Hair Loss Gene Chip Study. The study is under the direction of Dr. Animesh Singha. The project will use micro-arrays or gene chip technology to understand the complex processes need to grow hair. This is a study using RNA rather than DNA genetic models.

Even though researchers are focusing efforts for participants who live in the New York area, they are hoping to find a method where remote sampling can be done for the Phase I project. Merck’s participation in the study to grow hair involves gaining a better understanding of how their product, Propecia, works in different diseases. These trials are for men only between the ages of 18 and 41 in healthy condition.

Aderans is conducting clinical trials and there are still opening in some clinics in the U.S. This is a phase II study as they prepare to get one of their products approved by the FDA and into the pipeline for production. These studies are for males only and involve an in-depth research project to grow hair with men who have androgenetic alopecia.

A collaborative effort between Europe, Asia and U.S. doctors and sponsored by Kerotene, a European product, is doing open trials in 2012 and accepting applicants for several different studies now. The projects involve transplant methods and success rates using their new procedures.

They are seeking identical twins with mild to moderate balding in each of various studies for replacement therapy to grow hair. Both males and female twins are encouraged to participate. The company and sponsors will pay for the transplant procedure but the participants must pay for their own transportation and accommodations during the procedure. The facilities in Zurich, Switzerland will be the location for the clinical trials.

Johnson & Johnson is considering open trials on hair loss restoration by the end of 2012. They have yet to release the precise information on the manner or methods that will be used in these trials.

If you have problems with hair loss or the inability to regrow hair, check out the various clinical trials that may interest you. Several other pharmaceutical teams are preparing to have open trials this year but have yet to find sponsorship. These are usually cutting edge studies that add to the progress of treatments available to grow hair.

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ASHRS Chief: Hair Cloning or Hair Multiplication is Coming

The president of the American Society of Hair Restoration Surgery (ASHRS), Dr. Marco Barusco, declared in January that hair cloning is the most important technological advance on the horizon for hair restoration doctors. While hair cloning is not yet available, Dr. Barusco said he is encouraged that various companies are now in Phase II clinical trials and he expects the technique to be available in the next couple years.

Hair cloning is generally considered to be any technique that attempts to harvest hair follicle cells from a patient, multiply them in growth media in a lab, and then use the new cells to “reseed” bald scalps. Dr. Barusco added that hair cloning will make possible transplants for people who couldn’t have them in the past because they lacked a sufficient amount of donor hair. At least four companies are now actively engaged in hair cloning research – RepliCel Life Sciences, Aderans Research, Follica and Dr. Coen Gho’s Hair Science Institute. They differ slightly on which type of cells they harvest and use in their process.

In 2008, hair cloning was in the news because of pioneering trials being conducted by a British company, Intercytex, that subsequently had financial difficulties and was sold. The hair challenged public became discouraged by the frequent delays so that many today believe that hair cloning is all hype and that the technology will never arrive.

However, Dr. Barusco doesn’t feel that way. He is encouraged by the research done so far and by the fact that companies such as Aderans and RepliCel are moving on to Phase II clinical trials of hair cloning with greater numbers of subjects.

Hair cloning is not the same thing as stem cell treatments. Other companies, such as Histogen in San Diego, are attempting to develop products that restore and reactivate existing hair follicles on balding heads that have been, in a sense, shut off. The hope is that a unique combination of special growth factors and cytokines will be able to “wake up” these dormant hair follicles so that they once again produce hair on a regular basis. Histogen’s Hair Stimulating Complex, which is currently in development, will be an injectable treatment performed in a medical clinic under a doctor’s supervision.

Cygenx currently produces a growth factor hair growth serum, which it calls RegenRXx, that is available now as a topical lotion. It is applied either alone or with the aid of a dermaroller.

ASHRS Chief: Hair Cloning or Hair Multiplication is Coming

The president of the American Society of Hair Restoration Surgery (ASHRS), Dr. Marco Barusco, declared in January that hair cloning is the most important technological advance on the horizon for hair restoration doctors. While hair cloning is not yet available, Dr. Barusco said he is encouraged that various companies are now in Phase II clinical trials and he expects the technique to be available in the next couple years.

Hair cloning is generally considered to be any technique that attempts to harvest hair follicle cells from a patient, multiply them in growth media in a lab, and then use the new cells to “reseed” bald scalps. Dr. Barusco added that hair cloning will make possible transplants for people who couldn’t have them in the past because they lacked a sufficient amount of donor hair. At least four companies are now actively engaged in hair cloning research – RepliCel Life Sciences, Aderans Research, Follica and Dr. Coen Gho’s Hair Science Institute. They differ slightly on which type of cells they harvest and use in their process.

In 2008, hair cloning was in the news because of pioneering trials being conducted by a British company, Intercytex, that subsequently had financial difficulties and was sold. The hair challenged public became discouraged by the frequent delays so that many today believe that hair cloning is all hype and that the technology will never arrive.

However, Dr. Barusco doesn’t feel that way. He is encouraged by the research done so far and by the fact that companies such as Aderans and RepliCel are moving on to Phase II clinical trials of hair cloning with greater numbers of subjects.

Hair cloning is not the same thing as stem cell treatments. Other companies, such as Histogen in San Diego, are attempting to develop products that restore and reactivate existing hair follicles on balding heads that have been, in a sense, shut off. The hope is that a unique combination of special growth factors and cytokines will be able to “wake up” these dormant hair follicles so that they once again produce hair on a regular basis. Histogen’s Hair Stimulating Complex, which is currently in development, will be an injectable treatment performed in a medical clinic under a doctor’s supervision.

Cygenx currently produces a growth factor hair growth serum, which it calls RegenRXx, that is available now as a topical lotion. It is applied either alone or with the aid of a dermaroller.

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Aderans Research and Clinical Trials in Stem Cell Hair Loss Treatments

Aderans Research [ARI] is a subsidiary of two companies interested in developing innovative new stem cell treatments for hair loss resulting from a number of differing causes –  including genetic male and female pattern baldness, medical treatments for cancer, and injuries resulting in damage to hair follicles such as burns or wounds. Aderans Research is located in Atlanta, Ga. The parent company, Aderans Co., Ltd, is located in Beverly Hills working in conjunction with Bosley hair treatment and clinics.

ARI is in the second phase of developing cellular restoration products for hair regrowth applications. In November 2011, Aderans announced that it was opening new facilities for additional clinical trials in association with Radiant Research in four new cities across the nation. Some clinics are still accepting people who wish to participate in the study. To date, over 356 individuals have been joined the study as clinical subjects.

Aderans Research’s signature treatment involves using a subject’s own hair stem cells, thus eliminating concerns about rejection. By cultivating stem cells from the subject himself or herself, other complications – such as infections or disease transmission — are dramatically reduced. ARI studies regeneration of hair cells at the follicular level for both men and women.

A stem cell is any cell from any part of the body – skin, brain, fatty tissue, hair, or organs – which has the ability to replicate itself. This process is much like the stem of a plant which sprouts leaves along its length. These cells are one part of the ingredient in hair regeneration. The second part is the cell that acts an “alarm clock” for waking dormant cells.

It has been known since the University of Pennsylvania’s study in 2004 that hair follicles include multiple cells. Some of these cells are hair replication cells, which control the cyclical growth of hair. Other cells are communicator cells, which are necessary to wake the dormant cells when it is time for them to grow. People with certain types of hair loss are now known to lack the alarm clock cells (also known as progenitor cells). Unless there is a method to inform the dormant cells that it is time to activate, hairs are not generated.

In a Yale University research program in November 2011, it was discovered that the communication cells, which instruct the hair cells to grow, are found in the fatty layer below the epidermis. The full ramifications of this discovery are still not clear but hopes remain strong that this will lead to the ability to replicate other cells in the human body. Until this time, the value of the fatty layer was not understood.

With the latest breakthroughs in molecular endocrinology regarding communicator cells in the fatty layer beneath the skin and with the Yale research demonstrating the importance of fat cells for hair growth, Aderans has developed products that taking advantage of these new breakthorughs. However, this does not address issues with an underlying cause related to the contraction of hair follicles.

One of the major problems that hair restoration doctors face is the patchy effect of surgical transplants. The question of why one area of the scalp would allow hair regrowth while another in close proximity would not could not be explained. The Yale and University of Penn studies shed light on this problem. With that, researchers around the world have been working to develop methods to overcome the problem.

During Phase I of Aderans’s clinical studies, conducted in the U.K., Aderans focused on pattern redistribution issues noted in traditional surgical transplants and medical treatments for regrowth. One of the problems documented was the limitation of distribution of hair regrowth in surgical transplants.

The process used by Aderans involves the reproduction or replication of hair cells taken from a subject. By removing hair samples from the subjects scalp, the stem cells from the follicle are stripped out and placed in a medium that incubates the cells. The medium contains nutrients that are necessary for the cells to replicate on their own. In this way, there are an unlimited number of hair follicles to replant in the subjects scalp. In addition, the fat cells that are a necessary part of the continuation of hair growth develop simultaneously during replication due to the medium used.

Part of the medium used by Aderans is a small amount of tissue removed from the nape of the subject’s neck. By using this method, the fat cells become an integral part of the cloning process and compatible with the subject. This tissue — used with Wnt proteins — stimulates the replication system of the cells in a natural way.

In January 2012, Dr. Ken Washenik participated as a presenter for the 2012 Winter Dermatology Conference in Maui. Speaking on “Emerging Therapies for Hair Loss,” Dr. Washenik discussed the treatments and new breakthroughs of molecular dermatology as well as the latest advances in Aderans’ Ji Gami product line. He stressed the advance in products still in the pipeline that are proving to be consistently stable.

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Update on Aderans on Hair Cloning Technology

Aderans Research Institute (ARI) is currently in the middle of Phase II trials of its much-anticipated, much-delayed new cellular hair regeneration technology. The company hopes to “encourage” follicular cells to reproduce themselves via a method ARI calls the Ji Gami™ process, resulting in a virtually unlimited number of hair-generating cellular units produced. During this process, a small piece of tissue is removed from the neckline. Cells are cultivated in controlled conditions where they are encouraged to multiply by the addition of proprietary growth media. When enough new cells are formed, they are returned to the scalp, where they are injected and elicit new hair growth and thickness, ultimately producing more hair than the client had before. Candidates for hair regeneration may no longer be limited by the number of hairs on their head. ARI envisions a time when crowns (vertex) can be covered with full, natural hair regardless of the degree of hair loss.

The cell multiplication process, which involves a proprietary technology and “cooking” process, takes about 10 to 20 days. The cells are produced in ARI’s 8,000-square-foot laboratory facility in Atlanta, Georgia.

Conventional hair loss treatments, including hair transplants, run into a common problem: The limited amount of hair on a person’s head limits the degree of “redistribution” possible with transplants. For men with severe male pattern baldness especially, there is often an insufficient amount of hair remaining on the back of the head to provide a cosmetically satisfying result.

ARI’s new hair cloning technology could solve this problem… if it works. Several attempts have been made to create a viable hair cloning technology but the results, so far, have been limited. A common problem is that the hair that results tends to be very fine which also does not provide a cosmetically pleasing result.

ARI’s Phase II trial, which began in late 2008 and concludes in 2012, monitors patients for a full year after they have been injected with the regenerated cells. More than half the study participants so far have shown “significant” hair growth one year after administration, the company says.

“Interim data from the early stage of Phase II shows that about 50 to 70 percent of trial subjects are responding at a level that’s at least as good as anything that’s out there for growing hair, and we expect the later stage to get even better,” CEO Ken Washenik, Ph.D., said.

ARI treatments are entirely autologous. That means that ARI only attempts to generate hair growth using the participant’s own hair cells. No foreign growth media, such as plant- or animal-derived growth factors, are involved. When the cultivated follicles are restored to the participant’s scalp, he or she is receiving only his or her hair cells. This serum-free process delivers a degree of safety from complications unique to the field, the company says.

So far, Aderans has invested an estimated $100 million in its follicle cell multiplication technology and expects to spend an additional $50 million. The company is owned by the Japanese conglomerate Aderans Co., Ltd., the world’s largest manufacturers of wigs, which also owns the hair transplant giant Bosley.

To see more on ARI’s hair cloning technology, watch the update on the company’s hair multiplication technology presented by Dr. Ken Washenik during the 4th International Congress Research Against Hair Loss.

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Aderans Research and the Most Innovative Treatment for Baldness Available Now

Aderans Research is pioneering what could end up being the most innovative treatment for baldness to come along in a century. Unlike most other companies researching male hair loss and women thinning hair, Aderans is concentrating on a technology that uses a patient’s own cells (known as autologous cells) to develop a virtually limitless amount of new hair follicles. This will obviously be a very expensive treatment for baldness because it will be, in a sense, customized for each patient.

Aderans calls the technology it is developing the Ji Gami™ process. Here’s how it works. Technicians remove a small piece of hair follicle tissue from a patient’s scalp, generally near the neckline. The hair follicle cells are then cultured in a laboratory so that they multiply. When a sufficient amount of new cells have been grown, the hair follicle cells — each unique to the individual patient — are then injected into the bald or thinning areas of the patient’s scalp.

Aderans executives believe they are on the verge of a true cure for baldness, a treatment for hair that will result in almost unlimited new hair growth. This approach is not the same as those attempting to use growth factor serums to regenerate existing dormant hair follicles. Instead, Aderans is attempting to grow new follicle cells, made from cells taken from the patient’s own scalp, and inject them into balding areas for hair growth.

How is the research proceeding? At the moment, Aderans is completing its Phase II clinical testing of its hair fall remedies. A total of more than 350 hair loss sufferers are now enrolled in the clinical trial from cities across the country. At the 2012 Winter Clinical Dermatology Conference in Maui in January, Aderans CEO Dr. Ken Washenik (M.D. & Ph.D.) presented a paper on “Emerging Therapies for Hair Loss” that received a standing ovation from the assembled dermatologists and hair restoration doctors. That’s because Dr. Washenik reported that the Clinical Trials of the Ji Gami™ process are going very well. While the process is not a magic pill that provides install hair like a Chia Pet, it does appear to grow new hair where none existed before — and, what’s more, can provide a virtually limitless supply of donor hair follicles for hair restoration doctors to use. In earlier tests, released in 2010, Aderans reported that more than half of participants in its clinical study showed “significant hair growth” one year after the cell product treatment was administered.

If you’d like to read more technical information about the early developments of this technology, then click on the link below for a PDF…

Bioengineering the Hair Follicle: Fringe Benefits of Stem Cell Technology

The Aderans “cell engineering” approach appears to be the most promising treatment for baldness on the horizon at the moment, according to the company’s spokesman, Vern Liebmann. That’s because the cell engineering approach offers hope for bald men who do not have enough donor hair for a cosmetically satisfying traditional hair transplant. With a limitless amount of donor hair follicles, the Aderans hair treatment could cover virtually any scalp with thick, natural hair.

If you’d like more information about Aderans and its clinical trials, fill in the form below:

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Predictions for Hair Loss Products in 2013

Well, another year has come and gone and we STILL don’t have a magic cure for hair loss. These companies keep promising and promising… yet nothing seems to come of their promises. Nevertheless, as someone who has been following stem cell technologies for hair loss since 2008, I can say that there have been breakthroughs and a lot is happening behind the scenes. Here are four hair loss product trends to watch for in 2013:

1. Anti-D2 Products. Earlier in 2012, Dr. George Cotsarelis of the University of Pennsylvania announced the discovery of an enzyme, called prostaglandin D2 (PGD2), that tells hair follicles to stop growing hair. His company, Follica, announced that it was working on a new anti-D2 product that could be a major breakthrough in hair loss. (Advantage: There are already drugs on the market for D2 that are used in asthma.)

2. Bimatoprost. Allergan is currently in clinical studies of the drug bimatoprost (Latisse) which appears to stimulate new hair growth. Results should be reported next year. The best guess is that it will turn out to be an effective treatment for hair loss, particularly for women, but probably along the lines of minoxidil — which helps some people but is not really a “cure.”

3. Histogen. A lot of people are anxiously waiting for Histogen’s Hair Stimulating Complex to finally be released… but it’s still a year or two away at best. Histogen’s product is a proprietary blend of growth factors that are surgically injected into the scalp to stimulate new hair growth.

4. Aderans. Aderans is attempting to develop a true hair cloning technology: Its Ji Gami process removes hair follicle cells from a patient’s neck… cultivates and multiplies new follicle cells in a laboratory… and then attempts to “re-seed” a bald head like a new lawn. The company is now in Phase II clinical trials all across North America. Aderans has said it should release its product in 2014 but we should begin to hear a lot more about it next year.

If I had to guess, I would say that hair cloning will turn out to be the treatment of choice going forward. It will not be a silver bullet but will be more like hair transplant surgery than a lotion. The difference is that, with hair cloning, doctors may yield a more cosmetic pleasing result than what is now possible with limited amounts of donor hair.

So, the question remains: What do hair loss sufferers do until hair cloning arrives? We’ve always said you should try a “kitchen sink” approach. You should visit a medical doctor who specializes in treating hair loss. Ask his or her advice on finasteride and minoxidil. Try some of the anti-DHT shampoos and conditioners on the market, like DS Laboratories Revita and Revita.COR. Try cold laser treatments (certified by the FDA as effective for stimulating hair regrowth). If you have extra cash and are willing to try an experimental treatment, you could try growth factor serums such as RegenRXx or Oxford Biolabs TRX2 (both of which we offer in our products section). You could also find a doctor willing to try Bimatoprost as an off-label treatment, although I would rather wait under the Allergan clinical studies are completed. I honestly believe that you should try to slow down the hair loss as much as possible… because some sort of viable hair cloning treatment may be just around the corner.

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