RepliCel announced the completion of its Phase I trial for RCH-01 on March 14, reporting that the trial had met its endpoints, and a five-year data report has established the product’s safety.
The treatment - RCH-01 - is a regeneration procedure which uses patient derived stem cells to rejuvenate and stimulate hair growth.
To begin treatment, healthy hair follicles are extracted from the patient’s scalp. These follicles are then dissected to isolate the dermal sheath cup cells (DSCC) from the hair’s root.
The DSCC are then multiplied in a growth medium, and injected below the patient’s epidermal layer, in the upper dermus of the scalp.
RepliCel said injected cells then detect damaged and dormant hair follicles in order to rejuvenate and further stimulate hair growth.
According to the firm, DSCC can also encourage epidermal cells to assemble, expand and multiply in order to create new hair follicles.
Spokesperson Dwain Schenk told Biopharma-Reporter this technology can be used for a variety of conditions.
“RepliCel is leveraging a patient’s own stem cells to give them more hair, look younger, and fix damaged tendons,” he told us.
“The company’s treatments use autologous cell therapy, which is one of the most rapidly developing areas of regenerative medicine in the development of novel treatments for a myriad of human disorders,” he said.
Next up
RepliCel CEO Lee Buckler said the data from the Phase I trial will inform development of the treatment.
“We have a much greater understanding and opportunity for further insights from the hair density responses recorded in this first-in-human trial.”
“This data will feedback into our R&D programmes and help us develop the best possible product and treatment protocol for men and women suffering from androgenetic alopecia,” he said.
RepliCel’s chief scientific officer Kevin McElwee said future clinical trials will experiment with cell dosage.
“We expect cell number and long-term cell survival to be correlative with hair density efficacy. Next-phase trials will be designed to test repeated injection sessions with smaller cell doses than were used in this study,” he said.
Follicle ‘map’
On June 13 RepliCel announced a collaborative research project agreement with the University of British Colombia in order to study a gene and protein expression ‘map’ of healthy hair follicle cells.
RepliCel said the research will enable the firm to better identify genes which best correspond to hair growth in cultured cells, and ultimately inform manufacturing and regulatory procedures of its cell therapy products.
RCI-01 is under exclusive license by Shiseido Company for certain Asian countries.