RepliCel Life Sciences, Inc. is a regenerative medicine company based in Vancouver, British Columbia that is trying to develop a treatment for androgenetic alopecia (common hair loss) using hair cloning techniques. The treatment, RCH-01, uses cloned dermal sheath cup (DSC) cells derived from a biopsy of the patient’s scalp to reverse the miniaturization process and restore the normal hair growth cycle.
Replicel’s Chief Scientific Officer, Dr. Kevin McElwee, PhD, has been studying techniques to induce hair follicle development from cultured dermal sheath cells for over 10 years. ((McElwee KJ, Kissling S, Wenzel E, Huth A, Hoffmann R (2003) Cultured peribulbar dermal sheath cells can induce hair follicle development and contribute to the dermal sheath and dermal papilla. J Invest Dermatol 121: 1267–1275.))
Preliminary findings of phase I testing of their proprietary hair restoration treatment were announced in 2012. While the primary goal of the first phase was to assess the safety of the treatment, this phase showed promising efficacy in hair regeneration. Results at 6 months showed that almost two-thirds of subjects (10 out of 16, or 63%) received a greater than 5% increase in hair density at the injection site. Of that group of 10 subjects, seven of them saw hair density improve by more than 10%. In one patient vellus hair density increased 24.9%, terminal hair density increased 14.5%, overall hair density increased by 19.2%, and cumulative thickness per area increased by 15.4%. ((Lortkipanidze, N. Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia. In Clinicaltrials.gov. Retrieved July 26, 2012.)) There were no significant adverse events.2
The efficacy of the treatment was sufficient to begin preparation for phase II clinical trials. Replicel’s phase II trials are set to take place in Germany and Austria beginning in 2015 with data collection continuing for 39 months.
Partnership with Shiseido
In 2013, based in part on the perceived success of the phase I clinical trials, Japanese cosmetics giant Shiseido formed a partnership with Replicel with the goal of co-developing RCH-01 into a commercial treatment for common baldness. With the partnership, Shiseido acquired exclusive geographic license to market the treatment in Japan, China, South Korea, and other countries in the Association of Southeast Asian Nations (ASEAN) – a region with a population of 2.1 billion.
Since forming the partnership with Replicel, Shiseido has opened the Shiseido Cell-Processing and Expansion Center (SPEC) in Kobe, Japan, which is dedicated to hair regeneration research. In an episode of “Science Zero Japan, which aired on Japanese television in May 2015, Shiseido disclosed that they expect to bring the baldness treatment to the Asian market in 2018. ((RepliCel Life Sciences Inc. “Shiseido Talks RepliCel Technology – Part 1.” YouTube. May 7, 2015. 11:14.))
In addition to RepliCel’s phase II trials, Shiseido has announced their intention to fund clinical trials of RCH-01 in Japan starting in 2015. ((RepliCel Life Sciences in Japan for Key Industry Meetings. (2015). Retrieved from PRNewswire.))
Replicel’s RCH-01 Treatment
The key component of the RCH-01 treatment is a type of cell found in the base of the hair follicle called dermal sheath cup (DSC) cells. It is thought that DSC cells regulate the production of dermal papilla (DP) cells, which are thought to play an important role in modulating the phases of the hair growth cycle.
In the treatment, a small circular graft of skin is taken from the DHT-resistant donor area in the back of the patient’s scalp. DSC cells are isolated from follicular units that are dissected out of the graft and then multiplied in a laboratory culture. Millions of these cloned cells are injected into the balding areas of the scalp where they migrate to the base of hair follicles. There, they work to re-establish the normal hair growth cycle, thereby reversing miniaturization and growing normal terminal hairs.
In the December 2014 issue of the peer-reviewed journal Developmental Cell, researchers found that, “a subset of [dermal sheath (DS)] cells are retained following each hair cycle, exhibit self-renewal, and repopulate the DS and the [dermal papilla (DP)] with new cells.” ((Rahmani W., Abbasi S., Hagner A., Raharjo E., Kumar R., Hotta A., Magness S., Metzger D., Biernaskie J. (2014), Hair follicle dermal stem cells regenerate the dermal sheath, repopulate the dermal papilla, and modulate hair type. Dev Cell, Dec 8;31 (50:543-58).)) Because the DSC cells are able to self-renew and repopulate the follicle with these important cells, the treatment may have a positive effect on hair growth beyond one cycle. The authors also proposed that the DSC cells may help protect against cell death that occurs during catagen phase of the hair cycle when the follicle is transitioning from the growth phase (telogen) to the resting phase (anagen).5
Replicel CEO David Hall said about the RCH-01 treatment, “We are simply delivering a volume of androgen-insensitive DSC cells into an area where androgen-sensitive DSC cells have disappeared … to restore the normal hair follicle cycle.” ((Dutton, G. (2015). Cell Therapy Is “Hair Raising” in a Good Way. Genetic Engineering & Biotechnology News. Retrieved from Genengnews.com.))