Replicel poised to begin Phase II clinical trials of cell-therapy based for hair loss treatment

Reseachers at RepliCel, a Vancouver-based biotech company, have been hard at work developing a remedy for hair loss that could revolutionize the hair loss treatment industry. Rather than relying on traditional pharmaceutical or surgical approaches, RepliCel is attempting to use cell therapy to restore and rejuvenate hair follicles. As RepliCel’s CEO David Hall has explained, the aim is to perform “cellular transplant as opposed to a follicular transplant.”1

The procedure under development makes use of dermal sheath cup (DSC) cells, cells taken from the lower pole of the dermal sheath where they surround the hair bulb much like a cup. This area of the dermal sheath contains cells that play a key role in the maintenance and initiation of hair growth. As stated on RepliCel’s website, “pre-clinical studies have demonstrated that cultured DSC cells are capable of directly reconstituting the dermal papilla (DP) and promoting the development of mature hair follicles.” DSC cells can not only migrate into existing hair follicles, but can also form new ones, resulting in de novo hair growth.2

RepliCel Is Not Alone in Attempts to Use Progenitor Cells to Treat Hair Loss

Earlier this week, scientists at Columbia University working in collaboration with researchers at Durham University in the United Kingdom showed that it was possible to generate new hair follicles from a population of cloned human DP cells.3 As with RepliCel’s approach, the promise of this announcement lies in the implication that a patient’s own cells can be used as to treat their condition.

How do these findings impact RepliCel? Researchers at RepliCel hold that cloned DSC cells have the ability to generate “better quality hair growth than cells of the DP.”2 In a peer-reviewed study published in 2003, RepliCel founding scientists Dr. Kevin McElwee and Dr. Rolf Hoffman reported that DSC cells appear to be the natural source for DP formation.4 According to the company’s website, hair growth resulting from DSC cells tends to be more evenly distributed and to grow at the correct angle.2

Shiseido and RepliCel Complete a Collaboration and Technology Transfer Agreement

Earlier this year, RepliCel and Shiseido completed a collaboration and technology transfer agreement. Shiseido, a cosmetic company based in Japan, paid an estimated $4.2 million in return for Replicel’s “technology, know how, and standard operating procedures.”5

RepliCel Clinical Trials Are Currently Underway

Unlike a follicular transplant or hair transplant, which necessitates the surgical removal of thousands of hair follicles, RepliCel’s technique requires only ten to twenty healthy follicles. A 4mm biopsy is taken from the back of the patient’s head where the androgen resistant (i.e., “healthy”) follicles reside. The DSC cells are extracted and the number of donor cells is expanded in RepliCel’s own proprietary culture medium over a period of three months. The cloned cells are then injected into the affected areas, where they generate new hair follicles in addition to restoring those that are dormant.

RepliCel received approval to begin Phase I clinical trials in 2010. Results from those trials, submitted in 2012, indicated that there were no serious or lasting adverse effects reported twelve months post-injection. Investigators also observed that 63% of participants displayed new hair growth that was greater than 5% above baseline, with the overall average being a 6.1% increase.6 The company has announced that a twenty-four month update of the Phase I trials will be submitted at the end of this year. In the meantime, Phase II clinical trials are scheduled to begin. While the purpose of the Phase I trials was to assess the safety of RepliCel’s procedure, Phase II trials have been designed to determine the optimal number of DSC cells required for treatment. Per RepliCel’s website, results for Phase II may be reported as early as 2014.

References

1. Berger, J. (2012) Ask Men. Web. 29 October 2013
2. RepliCel Life Sciences Inc. (n.d.) Our Techology. Web. 29 October 2013
3. Higgins, C.A., et al. (2013) Proc Natl Acad Sci USA. (epub ahead of print)
4. McElwee, K. J., et al. (2003) J Invest Dermatol 121:1267-75
5. RepliCel Life Sciences Inc. (2013) RepliCel and Shiseido Complete Collaboration and Technology Transfer Agreement on Technology for Treating Pattern Baldness (press release)
6. RepliCel Life Sciences Inc. (n.d.) Phase I. Web. 29 October 2013

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