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Biostem Seeks to Expand Its Stem Cell Hair Loss Products Worldwide

Biostem Seeks to Expand Its Stem Cell Hair Loss Products Worldwide

Biostem U.S., which describes itself as a “technology licensing company” with hair regrowth treatment using using human stem cells, is seeking to expand its operations worldwide. The company, a NEvada corporation based in Clearwater, FLorida, recently announced the change of its stock symbol to HAIR. The company offers hair growth treatments that feature a combination of Platelet Rich Plasma (PRP) injections, the user of low level lasers, nutritional supplements and other hair products to stimulate new hair growth. The company is hoping to license its technology to private clinics around the world. Its first clinic outside of the Clearwater area is in Ohio.

Biostem was founded by two hair restoration doctors, Dr. John Satino and board-certified Medical Director Dr. Michael Markou, who work out of the Hair and Scalp Clinics in Clearwater, Florida.

It appears that the technique used by Dr. Satino and Dr. Markou is a variation on a technique used by some other hair restoration doctors around the world, which is to gently “wound” or irritate the scalp and then use injections of concentrated growth factors, taken from Platelet Rich Plasma, to stimulate hair follicle regeneration. Recent research has show that the “healing” process in skin seems to have this stimulating effect. Dr. Satino and Dr. Markou use special CO2 lasers to assist them in the gentle wounding of the scalp. They follow up the PRP process with other proven hair growth treatments, including low level lasers and nutritional supplements.

In addition to patients suffering from male pattern baldness, Dr. Satino and Markou have also used their techniques for patients suffering from alopecia areata and female hair loss.

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Wound healing and hair cloning

Hair loss or Androgenetic alopecia (AGA) is characterized by the miniaturization of the hair follicles in susceptible individuals and occurs in a defined pattern on the scalp.

Hair loss in aging men and women is characterized by these “damaged hair follicles.” Normal hair growth depends on a cycle in which periodic regeneration of the underlying hair follicle occurs through a process directed by stem cells.

Within the follicle, normal stem cell function is essential for hair follicle regrowth. What has been discovered in just the past few years, through studies of wound healing in burn victims and other patients, is that it is possible to actually grow new hair follicles and, as a result, new hair. The formation of new follicles and hair growth was shown to be associated with a cascade of cellular and biochemical events during the wound healing process.

By studying wound healing at the cellular and molecular levels, the skin was observed to have the ability to revert to a more primitive or “embryonic” state as progenitor cells “migrate” to the wounded area, restoring the regenerative capacity of the skin not previously thought to occur in adults.

The regenerative response includes new hair follicle formation, allowing new hair to grow at the restored site.

A major part of the wound healing cascade is the release of growth factors and cytokines from stem cells into the layers of the scalp at the site of the wound. These growth factors and cytokines function like a light switch, turning on lost or decreased function of the hair follicle.

Although dihydrotestosterone (DHT) is only one factor, and a minor one, in causing the unhealthy minaturization of the follicle in male pattern baldness process, it has received much attention. Several products are now on the market that attempt to restore hair growth based on interacting with the DHT pathway. These DHT specific products have demonstrated limited efficacy in growing new hair yet can show debilitating side-effects, including sexual dysfunction.

Based on the similar etiologies of male pattern baldness through DHT, it was thought that naturally occurring growth factors may also benefit the treatment of hair loss through the DHT pathway, but without the side-effects seen with other products. More importantly, the direct effects of topically applied cytokines and growth factors to the hair follicle restores the normal physiology and anatomy of the hair follicle and is the critical factor in restoring hair growth.

Below is the first example of a placebo-controlled, double-blind study undertaken to examine the benefit of these naturally occurring growth factors in the treatment of hair loss.

Objectives: The goal of this study was to test naturally occurring growth factors in the treatment of AGA.

Subjects included in this study were males between the ages of 25 and 65 years of age, in good health, with mild to moderate AGA.

Results: The results of this study showed a highly positive response to treatment. The blinded investigative staff assessment report showed that over 90% of study subjects dosed with the active study formulation were rated as improved at the final visit. Patient self-assessment demonstrated that 94% of the patients saw significant improvement in hair growth and prevention of hair loss.

Conclusions: This study establishes the effectiveness of naturally occurring growth factors for the first time in the treatment of hair loss. Growth factor technology has been used to generate completely new hair follicles for the first time in normal adult males. The researchers were able to induce the regenerative response, including new hair follicle formation, by applying a combination of factors to the scalp. This work showed that the application of these growth factors resulted in skin triggered molecular pathways, allowing a new topical treatment option for re-growing hair.

Caution: the application of any artificially created or synthesized signaling molecule is discouraged for two reasons; they lack potency and they may cause unnecessary secondary side effects. A good rule of thumb is to stay as natural as possible.

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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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