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

The study evaluated the safety and efficacy of RCS-01, an autologous cell therapy derived from anagen hair follicle cells, for treating aged skin. Conducted as a randomized, placebo-controlled, Phase-I trial, it involved intradermal injections in the buttock skin of participants. The primary endpoint focused on local adverse events, with results showing that the treatment was well tolerated and no severe adverse events were reported a year after the first injection. Secondary endpoints revealed that RCS-01 significantly upregulated genes related to extracellular matrix homeostasis, such as TGFβ1 and COL1A1, compared to placebo. However, the study's cohort size was too small for dose-ranging evaluation and subgroup efficacy analyses. Overall, RCS-01 was associated with gene expression changes indicative of improved ECM homeostasis.