Tag Archives: RepliCel Life Sciences

Hair Cloning: RepliCel and the World of Cellular Hair Restoration

RepliCel, also known as RepliCel Life Sciences, is a research and development company for treatment and cure of hair loss – genetic based pattern baldness in men and women. The company is in the process of documenting the safety and procedures for its hair regrowth technologies in human subjects. The long-term goal is to produce a procedure that is minimally invasive and will be able to cure multiple forms of hair loss disorders.

In 2003, Dr. McElwee and Hoffman at Phillips University in Marburg, Germany discovered dermal sheath cup cells had the ability to initiate mature hair follicles cell growth. Dermal sheath cup cells or DSC cells are the portion of the hair bulb located at the lower pole that appears to surround the bulb in a distinct cup like shape. These particular cells are capable of formation of new hair when grown in a proper medium. In their experiments, the researchers used Green fluorescent protein as the growth medium.

Part of their research discovered a method of identifying mesenchyme cells by use of these DSC cells. Mesenchyme is the embryonic tissue derived from the derma level and differentiates connective tissues. These MSCs are multipotent cells from tissues such as adipose tissue, adult muscle or dental pulp from baby teeth. These cells display a direct correlation to the cyclical process of hair cell growth. This was a tremendous breakthrough that coupled with other researchers findings became one of the baselines for medical research into hair regeneration.

This discovery led to applications worldwide for patents to produce a variety of products and to continue research in hair growth procedures. RepliCel has patented the process for claiming the DSCs and preparing them for replication. Once these cells have replicated in the thousands, they are injected into the necessary areas of the patient’s scalp.

There are several types of alopecia related causes of balding in men and women. This method of treatment is believed to be on track to treat many of these. The most common alopecia is androgenetic alopecia or pattern baldness. This is seen in men and women and is a genetic predisposition disorder. In some cases, it is believed that the follicle shrinks, which disallows the natural replication of hair in adjacent cells.

Yet, with the wars in Iraq and Afghanistan and the civil outbreaks across the Middle East, the research for trauma induced alopecia. This is caused by burns, chemical trauma, scarring from skin cancer surgery and other surgical procedures. While RepliCel is thought of more in the field of hair regeneration, the research and product development applies to far more.

Traction alopecia is another common form of hair loss. Seen in men, women and children, this is caused by pulling on the hair. Some people do this when under stress and others when sleeping. The RepliCel procedures are working to regenerate hair in severe cases of this disorder.

Once the replicated cells are injected into the subject’s scalp area, researchers anticipate that they will produce follicles that match the patients’ cells. At that point, these follicles will initiate natural hair growth that is identical to the hair of the subject. There is early evidence that this particular process results in the hair-producing cells migrating into follicles that are adjacent to the new ones. What has also been revealed is that this migration only seeks out follicles that are in need of some kind of repair.

There is evidence that one of the causes for shrinking follicles is related to lack of or an overabundance of testosterone hormone indicators called androgens. Research has already shown that the injected replicated cells are not affected by the androgen process. This means that the new hair will not undergo shrinkage again. There is every hope that this methodology will become a permanent solution for this disease.

One of RepliCel’s proudest achievements is the current testing on human volunteers at the Scientific Research Institute for Skin and Venereal Disease in Tblisi, Ga. These clinical trials are focusing on the specific regenerative effects of DSC cell treatments in humans. In these trials the effort is for the purpose of replacing skin tissue by growing new skin from a patients own cellular structure. Additionally, the replication of hair growth in those with androgenetic alopecia is underway in the same study.

The primary purpose of these studies is to ascertain the safety of these injections in human bodies and if there are unexpected consequences or rejection issues as yet undiscovered. All of the volunteers at the Tblisi clinic undergo biopsies in order to properly document any issues before, after or during the process. RepliCel is not a drug treatment therapy. Yet, for the purpose of documentation RepliCel is following procedures outlined for pharmaceutical research studies. It is estimated that this formula for its research will allow the necessary FDA approval to be expedited when the research is completed.

 

Replicel Says Its Potentially Revolutionary Hair Cloning Technology Passed Its First Safety Test, Market Unimpressed

Replicel Life Sciences, the Vancouver-based biotech start-up, announced May 2 that the first clinical trials of its potentially revolutionary hair cloning technology have been completed and that the results were positive.

Replicel’s hair loss product involves the harvesting of hair cells from a patient’s hair follicles — technically known as autologous dermal sheath cup cells (DSCC) — multiplying them in a laboratory, and then re-injecting the new hair cells in bald areas of the patient’s scalp, like re-seeding a lawn.

The six-month assessment of the technology, the first ever involved human test subjects, was to determine whether the technology was safe so that testing could move on to even larger clinical trials.

There are 19 total test subjects in this trial, nine women and ten men. The researchers found that the injection sites of the participants showed very few signs of bleeding, infections, burning or itching, or the growth of cysts. Instead, the researchers found that the injections of DSCC cells directly into the scalp were well tolerated.

According David Hall, Replicel’s president, the safety findings were essential so the company can proceed with its far more ambitious Phase IIb clinical trials with a larger number of volunteers. Relpicel is currently taking names of people worldwide who might be interested in participating in its next found of clinical testing. (To get more information on these clinical trials, see below.)

The data from this latest assessment also supported the claim that Replicel’s technology is effective as a hair loss product. However, the initial results will no doubt disappoint hair loss sufferers because, while statistically significant, they show only mild hair regrowth. According to the company, total hair density in the areas injected with DSCC cells increased a total of 6.1% from baseline.

More precisely, vellus hair (light whispy hair) density increased approximately 12% and terminal (regular) hair density increased only 3.2%. Company officials, however, were encouraged. Calling the hair growth at DSCC injected areas of the test subjects’ scalps a “significant response,” Darrell Panich, the company vice president, said that RepliCel’s technology fully justified a much larger Phase IIb clinical trial. He added that the new testing will concentrate on “optimum dosing and treatment regimens.”

The announcement of the study’s results does not appear to have helped the company’s stock, however. Relicel Life Sciences (REPCF) was trading around $2.05 a share on May 1 but fell to $1.27 a share at close of trading on May 4 — a loss of 40% in just days.

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Replicel Says Hair Cloning Tests Better Than Originally Thought

RepliCel Life Sciences, the Vancouver, BC biotech company pioneering a new hair cloning technology, issued a press release on May 17th and clarified the results of its recent clinical trials.  According to the press release, “further analysis” of the Phase I/IIa clinical trials of its hair cloning process revealed “substantial hair growth” among some study participants, with some participants seeing growth of between 17 and 20%.

Earlier, the company had reported that participants had seen on average growth above 5%.  However, Replicel’s spokesman explained that the averages, especially in such small studies, are often deceptive.  For example, a number of participants actually saw a decrease in the number of hairs as hairs fell out from the trauma of the process itself… only to grow back after the study concluded.  When the scientists looked at the data more closely in recent days, the spokesman said, they noted substantially more growth than they had before.

According to the company, RepliCel’s technology involves the harvesting and implantation of autologous (the patient’s own) hair cells from their own healthy hair follicles. The hair cells are then multiplied in a lab and re-injected into balding parts of the scalp.

RepliCel is one of a number of companies attempting to develop viable hair cloning or follicle multiplication technologies for hair regeneration. The hope is that in the near future hair restoration doctors will be able to “re-seed” a person’s scalp the way gardeners reseed a lawn — and using cells taken from the patient’s own healthy hair follicles. RepliCel says it has won patents for its technology from the European Union and Australia and that other patents are pending in other international jurisdictions.

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