RepliCel initiates skin aging treatment study

RepliCel Life Sciences announced it has initiated a phase 1 study of its RCS-01 cell therapy injected interdermally to treat aged skin in Germany.

“We look forward to analyzing the safety of triple injections our autologous cellular product, RCS-01, as a potential treatment for intrinsic aging, wrinkling and solar degeneration of the skin,” Rolf Hoffmann, MD, chief medical officer and director of RepliCel, said in a press release.

“We also will be measuring 10 different biomarkers related to skin aging that will give us a good indication of the changes in the skin,” Hoffman stated in the release. “The repair of damaged skin at the cellular level, via the natural cell-based production of type 1 collagen and other important matrix molecules, would fundamentally change the aesthetics market currently flooded with dermal products that temporarily reverse the signs of aging using fillers and hyaluronic acids.”

The study is expected to include 30 participants, who will have a biopsy taken from the scalp, from which RCS-01 will be prepared. The treatment evaluation sites will be on the buttocks, with two on each buttock. Patients will be randomized into two treatment cohorts to either receive injections of RCS-10 or placebo or a ‘sham’ injection of a needle penetration without injection of liquid, or only placebo or a ‘sham’ injection, according to the release.

The safety profile of RCS-01 compared to placebo injections will be studied. The impact on RCS-01 injections on skin markers related to aging through evaluation of gene expression profiles also will be studied, according to the release.

“This trial design is intended to deliver data related to how, and the degree in which the product injection improves the fullness of the extracellular matrix supporting the skin,” the release reported.

Study results are expected in the second half of 2016, according to RepliCell.

Reference: www.replicel.com