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