General Questions
What causes hair loss?
No one is 100% certain of what causes hair loss; however, it is believed that there is a link between male pattern baldness (MPB), also known as androgenetic alopecia, and androgenic hormones. In males, a hormone known as dihydrotestosterone (DHT) triggers androgen receptors in hair follicles on the top of the scalp. This activation of the hormone receptors changes the cells and reduces their cell growth activity. Over time, the hair follicle miniaturizes causing each successive growth cycle to get shorter and the hair follicles get thinner and smaller. The large terminal hair follicles turn into tiny unpigmented vellus hair follicles. Eventually, the follicles are no longer able to function properly and they completely disappear in men, though in women the follicles usually survive in their miniaturized state.
In men, balding typically starts on the top of the head. In some men the hair loss can progress until there is nothing left but a fringe of hair around the bottom half of the head. Women’s hair loss is quite different from male pattern baldness as the hair loss pattern is usually a diffuse thinning over the top of the scalp, but it too is primarily hormonally driven. It has been noted that both the number of androgen receptors and the level of 5-alpha reductase, which converts testosterone to DHT, are higher in hair follicles on top of the scalp than in the rest of the scalp. This may partly explain why hair loss occurs in hair follicles on top of the scalp while hair follicles at the back and sides of the scalp seem more resistant to the androgen hormones.
In addition to androgens causing pattern baldness, it is believed that there are other factors that contribute to the condition along the way. Some suggest that inflammation may also contribute to hair loss. Sometimes, but not always, hair follicles that are in the process of miniaturizing have inflammatory cells around them. A possible explanation for this inflammatory cells activity is that elevated androgens also trigger increased sebum (oil) production, which can favor an excessive microbial and parasitic population which can also lead to inflammation of the hair follicle.
Doctors have found a strong correlation between early onset and extensive baldness and heart disease and even diabetes, so there appears to be some common etiology outside of the strictly androgen paradigm for pattern loss.
What is DHT?
Dihydrotestosterone (DHT) is produced from the male hormone testosterone by the enzyme 5-alpha reductase. DHT is the androgen thought to be most responsible for the type of hair loss known as male pattern baldness (androgenetic alopecia). DHT has a very high affinity for the androgen receptor and is estimated to be five to ten times more potent than testosterone. Other androgens that may be significant in pattern loss include androstenedione, androstanedione and DHEA (especially in women). All of these fall into hormonal pathways that can potentially result in elevation of DHT downstream via various enzymes. It is possible that certain DHT metabolites may play a role in male pattern hair loss as well.
Is stress a factor in hair loss?
It is believed that stress can play a role in diffuse hair loss called telogen effluvium. Stress-induced hair loss usually regrows within a year of eliminating the cause. In the absence of any prolonged emotional or physical trauma that has affected overall health, stress is not likely the cause. Crash dieting, medical conditions, certain medications, pregnancy, and other major life changes can also initiate telogen effluvium shedding. However, if you are male and you are seeing thinning hair or hair loss in a pattern, you are most likely experiencing male pattern baldness.
Thinning hair in women can be more difficult to diagnose. The diffuse hair loss due to stress can look similar to female pattern hair loss. However, stress induced hair loss tends to be a more all over thinning while female pattern hair loss is usually more apparent on the top of the scalp with the side and back much less affected. Stress induced hair loss often reverses itself with time and a reduction in stress levels.
Can hair loss be avoided?
There is no way to avoid hair loss caused by androgens, as it is primarily hereditary; caused by genes. If one or both of your parents have genes that cause hair loss, you will inherit some of those genes and so it is most likely that you will lose your hair as well. It is possible that the environment also contributes to the development of pattern hair loss, but genes are certainly the dominant factor. Medical treatments that are offered by doctors can help reduce pattern hair loss. Recently, some genetic tests have been developed that can be used to predict whether a person will develop hair loss and also whether they might respond to certain drug treatments.
What is the best treatment for pattern hair loss?
There are many different products on the market including finasteride which reduces the conversion of testosterone to dihydrotestosterone (DHT). There are also hair follicle growth stimulants such as minoxidil and therapeutic antimicrobial shampoos containing ketoconazole. Women also have several anti-androgen drug options that cannot be used in men such as spironolactone. Some regimes show some effect but have to be used for life and may be associated with side-effects.
The only permanent cure currently available is hair transplant surgery which requires a large patch of hair to be surgically removed from the back of your scalp and replanted in bald areas. The problem with transplant surgery is that it is a major surgery and it only works if you have enough hair to take from one area to move to another. With RepliCel’s treatment a very small punch biopsy is taken and new hair cells are replicated eliminating the need for a large hair donor site to be moved to the bald area.
Clinical Trials:
Can I volunteer now to be in your trials?
Subject recruitment for our first RepliCel™ clinical trial is now complete.
Our clinical team has initiated discussions with regulators in Europe and Canada. Once approval to conduct those trials has been obtained and clinical sites have been selected, there will be an opportunity for subjects to qualify to be study participants. Note that subjects that do qualify for study participation will be required to make frequent clinical site visits to ensure their safety and to monitor the effects of the RepliCel™ procedure as such, subject proximity to a trial site is an important consideration.
If you are interested in participating in our next clinical trial, please fill out the clinical trial sign-up form.
When will you announce results from your clinical trials?
RepliCel’s first-in-man TS001-2009 clinical trial is available at http://www.replicel.com/replicel-releases-positive-results-from-the-interim-analysis-of-data-from-its-first-in-man-ts001-2009-clinical-trial/.
Information on the first RepliCelTM trial can be found at www.clinicaltrials.gov; a website provided by the United States National Institute of Health. http://clinicaltrials.gov/ct2/show/NCT01286649?term=TrichoScience&rank=1
Company Basics:
What is RepliCel?
Do you have a rough estimate of how long it will take for the treatment to be available to the public?
RepliCel is following a clear regulatory clinical pathway. Upon completing the first-in-man Phase I clinical trial, which is designed to test safety as well as efficacy, the company will initiate a Phase II dosing trial followed by a Phase III approval trial. The timeline to a commercial product depends on the execution of these trials and regulatory approvals. Nevertheless, if the technology proves safe and effective, RepliCel anticipates that a commercial product may be available in 2015 in Western jurisdictions.
How much will the treatment cost?
The cost of the treatment has not yet been established. However, we expect that it will be more than competitive on a price/performance basis with micro-transplant in developed nations.
Stock Information:
What is the company’s ticker symbol?
Our common stock ticker symbol is REPCF and our stock trades on the OTCBB.
How do I get the current stock price?
How do I purchase RepliCel shares?
You will need to contact a brokerage firm to purchase shares.
When is RepliCel’s year-end?
When are the company’s quarterly financials released?
How do I get a copy of the investor package?
What is a transfer agent?
Who is your transfer agent?
How do I replace lost stock certificates or make name and address changes?
Computershare
510 Burrard Street, Suite 200
Vancouver, British Columbia V6C 3B9
Tel: 1.800.564.6253
How do I obtain copies of your annual reports, quarterly reports and SEC filings?
When is the next Annual General Meeting?
All registered shareholders will receive written notice.
