RepliCel Life Sciences Inc (OTCMKTS:REPCF) reported statistically and clinically important promising data from the interim assessment of its Phase 1 trial assessing RCS-01 for the cure of sun-damaged and aging skin. The main goal of this study was to establish a safety profile for RCS-01 at six-months post-injection. Subjects in the Germany-based trial did not report any grave adverse events at the midpoint of the study. Researchers collected compelling promising proof-of-concept report suggesting the product’s prospect for skin rejuvenation.
RepliCel reported that the trial was neither driven for, nor was anticipated to display statistically significant report of efficacy. However, the almost two-fold jump in gene expression of collagen-linked biomarkers in the skin, following a single injection of ‘RCS-01’, was so deep, that the results are noted statistically significant.
The trial observed the injection impact on 10 different biomarkers that, in peer-assessed medical literature, are correlated with chronically sun-damaged skin as well as skin aging. Remarkably, gene expression markers, like TIMP, showed considerable changes anticipated to associate with increased collagen fibers. Reduced collagen degradation and increased collagen production, is related with the repair of sun-damaged skin as well as fewer wrinkles on skin.
Expressing his views on the progress, Prof. Dr. med Jean Krutmann reported that this type of positive impact on TIMP gene expression, is rarely noted. In his experience, after long period of conducting these tests, this is a remarkable finding, especially for a safety study with a small sample size. The promising data showcase the potential of RCS-01 to boost skin rejuvenation. A jump in collagen markers would be projected to translate into aesthetically visible and clinically measurable effects.
Krutmann stated that replication of this data in a larger study would confirm their view of RepliCel product’s potential as a better natural option to Botulinum fillers and toxins that only temporarily stop and reverse aging signs.