Replicel Life Sciences: A Cure for Baldness and Other Essential Remedies
Thirty-five million men – over 10 percent of the population – are thus afflicted in the United States, and globally, that number is well over a quarter of a billion.
RepliCel recently completed a Phase 1 Clinical Trial that has moved the company that much closer to realizing that goal, and from an investor perspective, the news could not be better.
Importantly, RepliCel is not purporting to have a cure – yet. But the completion of this clinical trial is an important step in advancing toward that objective.
While the trial did not specifically seek to address whether or not the technology is effective, it did establish unequivocally the safety of the procedure. According to the company’s press release dated March 14, 2017, “The five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgenetic alopecia.”
In layman’s terms, the dosages required to have an effect on male pattern baldness will not have any dangerous side effects for its users. That might not seem like much, but many future blockbuster drugs have been sunk by a failure to demonstrate safety from undesirable side effects. People would rather remain bald than risk their lives, in most cases.
As stated by RepliCel President and CEO, R. Lee Buckler, “As we march toward commercialization of this product based on this first-in-human data, our aim is to revolutionize the way we prevent, treat, and even reverse hair loss.”
Currently, the only somewhat credibly treatment for male pattern baldness exists in the form of chemical treatments that have limited efficacy.
Male pattern baldness occurs when a man is genetically sensitive and intolerant to androgenic hormone or scientifically known as dihydrotestosterone (DHT).
Clinical Trials are an important step
“The purpose of collecting efficacy data in these early-stage trials,” stated RepliCel’s Clinical Consultant, Darrell Panich, “is for our clinical team and management to obtain data that can be used to inform basic decisions about further development, provide provocative insights into the product’s potential, and – perhaps most importantly – provide useful feedback which we can use to drive decisions about process and product development, ongoing research, and future clinical trial parameters.”
RepliCel is developing what is essentially a stem cell technology referred to as Autologous Cell Therapies. (“Autologous” means cells from the patient’s own body). Cell therapy is the infusion, injection or transplantation of whole cells back into a patient for treatment of the condition. The goal of cell therapy is to repair or restore damaged tissues or organs.
In RepliCel’s case, the company is seeking to reverse hair loss and re-induce hair growth by injecting healthy Dermal Sheath Cup Cells (DSCC) – or the points of origin where healthy hair growth is still normal – into the areas of the scalp where the effects of male pattern baldness are evident.
“This trial involved the injection of a very high dose of DSCC in order to identify any potential toxicity ceiling in accordance with the primary safety objectives of the trial. The efficacy data we saw in this trial, together with recent animal research data, suggests that long-term survival of injected cells improves both with smaller dose size and with several sessions of injections spaced-out over a set time course to cumulatively increase injected cell numbers,” stated RepliCel’s co-founder and Chief Scientific Officer, Dr. Kevin McElwee.
Chronic Tendinitis – Another Medical Trophy
RepliCel’s attractiveness to the investment community rests on the idea that this is no “one trick pony”. Besides male pattern baldness, the company is also advancing a Phase 1/2 trial through Health Canada of its RCT-01 treatment for chronic tendonitis.
Tendonitis is defined as an inflammation or irritation of a tendon, a thick cord that attaches bone to muscle. Tendinitis is most often caused by repetitive, minor impact on the affected area, or from a sudden more serious injury.
In many cases, repetitive stress injuries are compounded by degenerative conditions, where the tissue that anchors tendons to bones is in a state of deterioration caused by either age or some other medical condition or both.
The only avenue available to sufferers of chronic tendinitis today is through the use of analgesic and anti-inflammatory medications, rest, physical therapy, orthotics, ergonomic adjustments, laser therapy, prolotherapy, platelet-rich plasma (PRP) injections and surgery.
RepliCel’s RCT-01 approach is the first that seeks to address the underlying biological deterioration that is the root cause of chronic tendinitis.
Oh and did I mention the medical device angle…?
As if those potentially revolutionary treatments wasn’t enough to drive a company to the fore among its peers in clinical stage companies, RepliCel also boasts a proprietary Dermatology Injector Device developed as a result of its depth of experience in the field of autologous cell therapies.
This next-generation injector is designed to improve the precise delivery and controlled dosage for intradermal, subcutaneous, and/or intramuscular injections.
In February the company announced it had signed agreements with two European firms who will drive production of the company’s RCI-02 dermal injector into commercial reality.
Overall, RepliCel’s achievements during the first quarter of 2017 places it on a steep trajectory toward commercial success, and so investors with an appetite for life sciences companies on the brink of transformational developments should keep a close eye.
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