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Related Experiment Video

Updated: Jan 19, 2026

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

Susanne Grether-Beck1, Alessandra Marini1, Thomas Jaenicke1

  • 1In vivo Unit, IUF, Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.

Skin Pharmacology and Physiology
|September 12, 2019
PubMed
Summary
This summary is machine-generated.

This study found that RCS-01 cell therapy for aged skin is well tolerated. It significantly improved gene expression related to extracellular matrix homeostasis, suggesting potential benefits for skin aging.

Keywords:
Aged human skinAutologous cell therapyExtracellular matrixPhase-I studyPlacebo-controlled trialRandomized subjects

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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.