Hollywood has made movies about it. Industries have made billions from it. And if the volume of scripture is any indication, the Almighty God must have placed great value on his creation of the head of human hair. After all, He gave Samson—the strongest man of whom the Bible tells—his immense strength through his hair and declared a woman’s hair “a glory unto” her in the 11th chapter of 1 Chorinthians.
Is it any wonder men and women obsess over their hair? And though we may get wiser as we age (a good thing), most of us don’t get hairier — at least not in the places we want to (not a good thing).
But there is a Canadian company who has been working diligently to change that. And if they’re right—and so far the research indicates they are—baldness may become a thing of the past for those who choose not to tolerate hair loss anymore. And they’re not only attacking baldness, Aging skin and tendon degeneration are on the cutting block as well. It’s great news for the tens of millions of older Americans who suffer from these malladies. But the most fascinating part lies in the source of the cure. It’s you. The company focuses on the development of cell therapies using a patient’s own cells.
RepliCel is a regenerative medicine company focused on developing autologous cell therapies (or therapies that involve one individual as both donor and recipient) that address conditions linked to a deficit of healthy cells required for normal healing and function. Located in Vancouver, British Columbia, the company has developed first-of-their-kind cell therapies that will, they hope, treat conditions that now affect 1 in 3 Americans: pattern baldness, aging and sun-damaged skin, and chronic tendon degeneration.
Lee Buckler, CEO and director of RepliCel said cell-based therapies are now being called the “third pillar” of medicine. “First came small-molecule drugs produced by Big Pharma. Next came the genetic engineering revolution and targeted drugs developed by biotech firms. Finally, we have cell-based technologies,” he said.
RepliCel’s technology has proven to grow new hair without transplants, creams or pills because it’s using a patient’s own stem cells to regenerate hair. Buckler said the basis for the company’s science comes from research conducted in the early 2000s in Europe by noted hair biology and dermatology experts Dr. Kevin McElwee, PhD, and Dr. Rolf Hoffmann, MD, who originally discovered the critical cell responsible for hair follicle growth. It is now being tested in human Phase II trials that began in July 2016 in Japan. Two other products of the company are for conditions where there are too few healthy fibroblasts, such as chronic tendinosis and damaged skin.
“Regenerative medicine is a game-changing area of medicine with the potential to fully heal damaged tissues and organs, offering solutions and hope for people who have conditions that today are beyond repair,” Buckler said. “RepliCel is one of the most promising biotech companies to watch in the field of developing medical innovations that are life-changing.”
Buckler said it started in 2003 with the academic research of Hoffmann and McElwee at the University of Marburg in Marburg, Germany. At the time they were trying to understand what was happening in the hair follicles of people suffering from androgenetic alopecia—a common form of hair loss in both men and women—or the underlying cause of hair loss.
A clinical researcher who has spent decades researching the fields of pattern hair loss, alopecia areata, endocrinology of the hair follicle and hair follicle morphogenesis, Hoffmann works in his private practice, as a teaching professor in the Department of Dermatology at the University of Marburg and as a researcher on histopathology on hair diseases. He has participated in dozens of clinical hair studies and is the inventor of TrichoScan®, a computerized technique to measure hair growth.
McElwee is an associate professor in the Department of Dermatology and Skin Health at the University of British Columbia (UBC) in British Columbia, Canada and director of the Hair Research Laboratory in the Vancouver Coastal Health Research Institute (VCHI) at Vancouver General Hospital (VGH). A hair research scientist, McElwee is one of only a small group of research scientists worldwide who studies hair biology and associated diseases.
Hoffmann and McElwee are co-applicants of a landmark patent on the use of hair follicle cup cells and their use in hair diseases.
In their research, the doctors established a correlation between androgen hormones and hair loss. They found that for reasons not completely understood, some people are susceptible to androgens that attack the hair follicles, while others are not. “They found that the androgen hormone decimates the cell population at the base of the hair follicles,” Buckler said. “The hormone attaches to these cells throughout particular receptors and starts to attack.”
If that was true, however, Bucker said the next natural question was why do people who are susceptible to the hormones’ destruction still have hair at the back of their head? He said the answer is that the back of the head doesn’t have these particular receptors.
“We don’t know why, but we have universally established that the cells back there are immune to the attack,” Buckler said. That’s why doctors have worked at relocating follicles from the back of the head to the front to attempt to cure baldness. “That’s proven. If you relocate those cells, they’ll remain immune. “But that is a messy, bloody surgical procedure.”
So Buckler said scientists hypothesized instead: “What if you take a sample of the tissue from the back of the head and then from that tissue isolated the cells?”
Now they were on to something. “We’ve discovered that you can grow tens of millions more of the cells in the lab and then inject them into the affected area of hair loss with the goal of repopulating the hair follicles there with new cells that can kick-start hair growth and are now immune to the condition.”
So in the early 2000s, scientists began taking tissue biopsies and injecting those cells onto the paws and pads of animals where no hair grows. It worked. And in 2010, RepliCel was formed. The doctors had stabilized hair loss in men and women with androgenetic alopecia (pattern baldness).
In 2012, RepliCel announced success in the first human clinical trial assessing the safety of injecting autologous dermal sheath cup cells (DSCC) — in essence the cells from a patient’s own body suspended in a benign, saline-like solution. Millions more of the cells are grown in the lab and added to the solution prior to injection.
Now known as RCH-01, RepliCel’s procedure is a patented cellular replication and implantation technology designed to rejuvenate damaged and miniaturized hair follicles in a balding scalp. According to Buckler, the technology involves the extraction of as few as 20 hair follicles from the back of a patient’s scalp where healthy cycling hair follicles reside. Specific cells are isolated from hair follicles and are cultured using the company’s proprietary cellular replication process. The cultured cells are reintroduced or injected back into balding areas on a patient’s scalp and are expected to rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers.
Signage for Shiseido Co. is displayed outside the company’s headquarters in Tokyo, Japan, on Friday, Feb. 28, 2014. Shiseido, Japan’s largest cosmetics maker, is under reform after posting losses due to weak domestic sales and an impairment loss on goodwill associated with Bare Escentuals, which it bought in 2010.
In 2013, RepliCel began working with the Tokyo-based Shiseido Company, Limited—a Japanese multinational skin care, hair care, cosmetics and fragrance producer—on a collaboration giving Shiseido an exclusive geographic license to use RepliCel’s RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people. “Shiseido and RepliCel will collaborate on the continued improvement of the technology and will conduct human clinical trials in each of their territories with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair,” Buckler said.
This agreement, he said, gives RepliCel’s RCH-01 hair regeneration technology “important third-party validation from one of the most respected — and oldest — cosmetic companies in the world.”
In fact, the Japanese government has recently committed to establish a new approval process for regenerative medicine products focused on accelerating approval timelines. As it turns out, hair loss is a big concern in Asian countries. Buckler said some 21% of adult males and 6% of females in China suffer from hormone-driven hair loss. And the International Society of Hair Restoration Surgery’s (ISHRS) biennial survey of hair restoration physicians found that the number of hair restoration patients in Asia increased 345% from 2004 to 2010.
“This changing regulatory environment enhances the strategic nature of our collaboration with Shiseido,” Buckler said. “In parallel with RepliCel’s planned Phase II trial in Europe, the Shiseido license represents a second clinical pathway for the development of our RCH-01 technology.”
For the U.S.’s part, in terms of value for healthy skin, the global facial rejuvenation market is estimated to expand from a value of $18 billion in 2014 to a value of $26.5 billion by 2021 according to Persistence Market Research.
Buckler said the RepliCel’s technology should be available to the general public by sometime next year in Japan, though it may take several more years to see it on the market in the U.S. as clinical trials will still have to be completed here and the data submitted to the FDA, though the 21st Century Cures Act (Cures Act) may help it along.
Signed into law by President Barrack Obama the act is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. Some $500 million was authorized over nine years to help the FDA with its implementation.
The law enhances the FDA’s ability to modernize clinical trial designs and clinical outcome assessments, which will perhaps speed the development and review of novel medical products, including medical countermeasures. The Cures Act also directs the FDA to create so-called “intercenter institutes” to help coordinate activities in major disease areas between the drug, biologics and device centers and improves the regulation of combination products. An example of one of these centers is the Oncology Center of Excellence.
But Buckler said hair growth isn’t the only perk to his company’s discovery. It turns out that use in skin repair and tendon regeneration are also possibilities of the technology. “While we were delving deep into the hair follicle, we discovered another cell population,” he said. The hair follicle is actually a minor organ. There are two different cell groupings. One grows hair fibers. Another grows the tissue that the hair follicle fiber grows in.” And it is within this latter cell grouping that the magical main structural protein found in skin and other connective tissues—collagen—is found.
“It all comes from the tissue taken from the back of the head. The hair follicle has a lot of Type 1 collagen in it,” he said. “We can isolate the hair-growing or collagen-producing cells and use them to start hair growth or regenerate degenerative tendons or tissues of skin. And it is a more natural way of doing it. There is nothing more natural than using your own cells to make your skin look healthy, to heal damaged tendons or to have a thicker head of hair.”