DERMATOLOGY. AGE-RELATED CHANGES IN SKIN

SUBJECT

Topic

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.

purpose

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.

RESEARCH

Preparation

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.

Dose

Up to 100 million cells

principle

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.

expected result

  1. Improvement of facial skin according to the assessment given by the patient and the medical researcher 6 months after the course of treatment compared with the initial state.
  2. Improvement of facial skin according to the Visia photometric complex data by at least 25% (for each indicator) 6 months after the course of treatment compared with the initial state.
  3. Preservation of the achieved positive effect according to the assessment given by the patient and the medical researcher and based on the Visia photometric complex data 12 months after the course of treatment.