Translating Our Findings Into Autologous Cell Therapies
RepliCel’s current research activity is focused on the company’s core understanding of the unique biological function of hair follicle cells. Two distinct autologous cell therapies are currently in development. The first is a cellular treatment for androgenetic alopecia (pattern baldness) named RepliCel Hair-01 (RCH-01). The second is a cell therapy for the treatment of chronic tendon injuries named RepliCel Tendon-01 (RCT-01).
RCH-01 – Treatment for Pattern Baldness
The product development path of RCH-01 effectively began in 2000/03 when Drs. McElwee and Hoffmann began focusing on dermal sheath cup (DSC) cells. Together they hypothesized that these DSC cells were a reservoir of cells that were responsible for the continued health of the hair follicle and the normal cycling of the hair fiber. They believed that if these DSC cells were in deficit due to sensitivity to androgen hormones (the cause of pattern baldness), then isolating these same cells from a patient’s own scalp in an area where the cells are unaffected by androgen and moving them to the affected area would resolve the cellular deficit and rejuvenate the hair fibre producing cycle. Multiple experiments on mice demonstrated that hair follicle DSC cells could induce new follicular growth as well as cause resident hair follicles to grow thicker and longer. The scientists’ landmark study was published in the peer-reviewed Journal of Investigative Dermatology© in 2003. Together, the scientists filed patent applications. To date, patents have been issued in Europe, Australia, and the US, with additional patents pending in the European Union, Canada, Japan and the United States.
These results have led the company to believe in the effectiveness of the procedure and its potential to become a solution to hair loss for the hair restoration market.
The product development path of RCT-01 effectively began in 2008 when RepliCel’s collaborator, Dr. David Connell, began focusing on skin-derived fibroblast. Dr. Connell hypothesized that the main underlying reason of chronic tendinosis was a deficit of tenocytes (fibroblasts) in the tendon. As these fibroblasts are responsible for producing type 1 collagen, the primary collagen in human tendon, it was theorized that isolation and replication of a source of fibroblasts for injection into the injury site could initiate normalized healing. Dr. Connell conducted three Phase I clinical trials using this approach producing evidence that treatment of tendinosis with autologous expanded skin-derived fibroblasts was both safe and effective and should be explored in larger human trials. Dr. Connell filed patents covering the use of skin-derived fibroblasts for the treatment of tendinosis. In 2011, RepliCel began collaborating with Dr. Connell on the development of this technology. RepliCel expanded on Dr. Connell’s approach by isolating fibroblasts from the hair follicle. This was based on the knowledge that fibroblasts from the dermal sheath of a hair follicle can produce upwards of five times the amount of type 1 collagen than skin-derived fibroblasts as pursued by Dr. Connell. In 2013, Dr. Connell’s patents were licensed by RepliCel.
Dr. David Connell has conducted three Phase I human pilot clinical trials focusing on each of Achilles, patellar and lateral elbow tendinosis (tennis elbow) using skin-derived fibroblasts. A total of 104 tendons were treated using these fibroblast cells. There were no adverse events related to the cell therapy. RepliCel intends to initiate Phase II trials in all three indications beginning with Achilles tendinosis using its autologous cell product, RCT-01.