Autologous Cell Therapy for Aged Human Skin: A Randomized, Placebo-Controlled, Phase I Study

In a study from 2019, researchers investigated the safety and potential efficacy of RCS-01, an autologous cell therapy product for treating aged skin. RCS-01 is made up of approximately 25 million cultured cells derived from the non-bulbar dermal sheath of anagen hair follicles. Participants in the study received intradermal injections of RCS-01, cryomedium, or needle penetration without injection into four areas of buttock skin either once or three times at monthly intervals. The primary endpoint was to assess local adverse event profiles, and the secondary endpoint involved measuring the expression of genes related to extracellular matrix (ECM) homeostasis. The study found that injections were well tolerated with no severe adverse events reported one year after the first injection. A single treatment with RCS-01 significantly upregulated the expression of several genes (TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA) associated with ECM homeostasis when compared to placebo-treated skin. However, the cohort size was not large enough to evaluate dose-ranging or conduct subgroup analyses of efficacy. Overall, RCS-01 therapy was well tolerated and appeared to induce a gene expression response indicative of improved ECM homeostasis.