Eng
Evaluation of the safety and efficacy of the medical product containing cultured autologous fibroblasts in patients with age-related changes and/or scar tissue defects of facial skin.
Evaluation of the safety and efficacy of transplanting the medical product containing cultured autologous skin fibroblasts in patients with age-related changes scar tissue defects of facial skin.
The medical product containing cultured autologous human skin fibroblasts is intended for use as a cellular graft to correct age-related changes and scar tissue defects of facial skin.
Up to 100 million cells
A skin biopsy (a punch biopsy of skin from behind the ears or between the shoulder-blades) in aseptic surgery conditions is carried out. Further, using biotechnological methods, a suspension of dermal fibroblasts (DFB) is obtained from the skin biopsy. For direct use or short-term transportation, cultured human DFBs are resuspended in an autologous plasma, enriched with platelets, and recruited into one or several injection syringes. The cellular material is introduced according to a special method: intradermally, by tunneling in three sessions.
