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

Area of Science:

• Dermatology
• Regenerative Medicine
• Cell Therapy

Background:

• Skin aging is characterized by fibroblast senescence, disrupted extracellular matrix (ECM) homeostasis, and reduced collagen synthesis.
• Cellular therapies are being explored to address age-related skin changes.

Purpose of the Study:

• To evaluate the safety and efficacy of RCS-01, an autologous cell therapy derived from hair follicle dermal sheath, for aged skin.
• To assess the impact of RCS-01 on gene expression related to ECM homeostasis.

Main Methods:

• RCS-01 was intradermally injected into buttock skin areas of subjects over monthly intervals.
• Safety was assessed via local adverse event profiles.
• Gene expression of ECM-related markers was analyzed in skin biopsies post-treatment.

Main Results:

• RCS-01 injections were well-tolerated with no severe adverse events reported up to one year.
• A single RCS-01 treatment significantly upregulated key genes involved in ECM homeostasis, including TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA.
• These findings suggest a positive modulation of ECM dynamics.

Conclusions:

• RCS-01 therapy demonstrates a favorable safety profile.
• The observed gene expression changes indicate that RCS-01 therapy may improve ECM homeostasis in aged skin.
• Further studies are needed to confirm efficacy and determine optimal dosing due to cohort size limitations.