Safety profile of human autologous dermal sheath cup cells (DSCC) intended to treat androgenetic alopecia
* Rolf Hoffmann, TrichoScience Innovations Inc., Canada * Kevin McElwee, TrichoScience Innovations Inc.,, Canada
Treatment of hair loss with autologous cells has become a medical research focus in recent years. In 2003 we described dermal sheath cup (DSC) cells at the lowermost part of the hair follicle dermal sheath capable of forming or repopulating hair follicle mesenchymal structures. In mice, DSC cell injections made small hair follicles larger and induced hairs de novo in foot pad skin normally devoid of hair. It was therefore reasonable to develop this observation further in order to allow human trials. In general, autologous cells are considered to be very safe when used to treat diseases, but additional knowledge of safety issues when using DSC cells is a prerequisite before embarking on human trials. Over the course of the last few years we have established the production of DSC cells under GMP (good manufacturing practice) rules. GMP-cultured DSC cells were analysed for safety issues both in vitro and in vivo using GLP (good laboratory practice). Our results showed that DSC cells retain their normal karyogram and are not tumorigenic in vitro. Injection of cultured DSC cells and human fibrosarcoma HT-1080 cells into the skin of Severe Combined Immunodeficient (NOD/SCID) mice showed the expected tumor growth of HT-1080 cells but no tumor formation from injected DSC cells. These studies further confirm the excellent safety profile of DSC cells and results provide regulatory support for continuation of clinical trials.