Randomized, Double-Blind, Placebo-Controlled, Single-Center, Phase I Safety Study of Intradermal Injections of Autologous Fibroblasts Isolated from the Non-Bulbar Dermal Sheath of the Hair Follicle to Treat Skin Aging
September 2017
in “
Journal of Investigative Dermatology
”
TLDR RCS-01 is safe and may help rejuvenate aging skin.
The study evaluated the safety and efficacy of RCS-01, a cell therapy product made from autologous fibroblasts isolated from the dermal sheath of hair follicles, in treating skin aging. It involved 21 healthy Caucasian participants aged 50-65, with 13 receiving RCS-01 and 4 receiving a placebo. Injections were administered intradermally into the buttock skin, either once or three times at monthly intervals. The treatment was well tolerated with no severe adverse events reported. Gene expression analysis showed significant upregulation of genes related to extracellular matrix homeostasis, suggesting potential skin rejuvenating properties. However, triple treatments did not show superiority over single treatments. Overall, RCS-01 appeared to be a safe approach with beneficial molecular effects on skin aging.