RCS-01 – Skin Rejuvenation

NBDS Fibroblast Therapy – Treatment for Aging Skin

RCS-01 Development Status

The company received approval from the German Competent Authority, the Paul-Ehrlich-Institut (PEI) for its Phase 1 clinical trial investigating the use of RCS-01 to treat patients suffering from aged and UV-damaged skin in August 2015. The study, entitled, “Randomized, double-blind, placebo-controlled, single-centre, phase 1 safety study of intra-dermal injections of RCS-01 in male and female subjects (50 to 65 years old)”, addresses the inherent deficit of active fibroblasts required for the production of type 1 collagen, elastin and other critical extracellular dermal matrix components found in youthful skin. The trial is being conducted at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany.

Learn more. To learn more about the trial and to determine if you qualify for participation please visit the clinicaltrials.gov website.

RCS-01 Proposed Trial Design

  • Treatment: Injection of RCS-01 fibroblasts
  • Primary endpoint – local safety and tolerance
  • Secondary endpoints:
    • Efficacy at 6 and 12 months
    • Some patients biopsied for gene expression of skin aging markers
    • Some patients biopsied for histopathology analysis
      • Assess structural characteristics
      • Assess molecular markers associated with skin aging