DSC Cell Therapy – Treatment for Androgenetic Alopecia
RCH-01 Development Status
RCH-01 is an autologous cell therapy utilizing dermal sheath cup (DSC) cells isolated from the hair follicle to treat androgenetic alopecia. RepliCel’s proposed Phase 2 trial will enroll 160 male subjects in good health with mild to moderate androgenetic alopecia. Dermal sheath cup cells will be isolated from a small punch biopsy taken from the back of the subject’s scalp. These cells will be replicated and then reintroduced into balding areas on the subjects scalp. After injections are performed subjects will return to the clinic for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well safety. Participants will remain in the trial for approximately 39 months.
RCH-01 is now under clinical investigation at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama.
The study is being financed by Shiseido Company and each product being injected will be manufactured by Shiseido at their SPEC (Cell-Processing and Expansion Center) facility in Kobe, Japan. RepliCel helped Shiseido design, validate, and prepare the SPEC facility for certification by Japan’s PMDA (Pharmaceuticals and Medical Device Agency). Shiseido’s SPEC team was also trained by RepliCel and Innovacell in the GMP (Good Manufacturing Practice) compliant production protocols for RCH-01.
Watch our video. To learn more about RepliCel’s RCH-01 treatment for pattern baldness please watch our video.