RepliCel Hair-01 (RCH-01), hair follicle-derived mesenchymal stem cells for treatment of androgenetic alopecia

RepliCel Hair-01 (RCH-01) is a product comprised of autologous dermal sheath cup cells (DSCC) intended to treat male pattern baldness (MPB), also known as androgenetic alopecia. DSCCs are mesenchymal stem cells (MSCs) isolated from the lower pole of the hair follicle, expanded under proprietary cell culture conditions, using a nutrient medium, and injected to the patient's scalp. DSCCs in RCH-01 are harvested from androgen-insensitive scalp sites. Phase I placebo-controlled trials assessed the local and systemic safety profiles and efficacy of injections of autologous DSCCs. A 12-month interim analysis revealed no serious treatment-related adverse events. Moreover, 10 of 16 (63%) treated subjects exhibited a more than 5% increase in total hair density within 6 months. Phase II clinical trials will assess the optimal number of cells per injection and the appropriate treatment regimen effective for hair growth renewal.