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S.Biomedics Has Been Approved for Clinical Trials on Periorbital Wrinkle Cell Therapy Using 3D Fibroblast Assembly

  • Monday, March 2, 2020, 5:25 pm
  • ACROFAN=Seunghee Shin
  • seunghee.shin@acrofan.com
 On February 28, S.Biomedics Co., Ltd. (CEO Kang Se-il), a Korean biomedical company specialized in the field of stem cell therapy, has been approved for clinical trials on the product of periorbital wrinkle cell therapy that uses its autologous skin-derived fibroblast aggregates (product name: FECS-DF) by the Ministry of Food and Drug Safety.

The periorbital wrinkle cell therapy was developed using the company's original platform technology, "three-dimensional microstructure formation technology (technical name: FECS – Functionally Enhanced Cell Spheroid)." The clinical trial of cell therapy with cell aggregates is the first case in Korea. The trial is to evaluate safety and efficacy for 24 weeks in subjects with periorbital wrinkles and is scheduled to be conducted in the first half of this year at the Department of Dermatology, Chung-Ang University Hospital.

The product's technology induces the self-organization of cells by coating the surface of the culture plate with bioactive proteins. S. Biomedics and a team led by Dr. Sang-heon Kim at Smart Tissue Engineering & Materials Lab (STEM Lab) of the Korea Institute of Science and Technology (KIST) are conducting joint research and are continuously searching for clinical applications.

Autologous skin-derived fibroblast aggregates are made by culturing fibroblasts isolated from the skin tissue of the patient and then structuring it into three-dimensional microstructure spheroids. As a result, the interaction between cells occurs actively, and the production of extracellular matrix such as collagen and elastin, growth factor related to tissue regeneration, and cytokines has increased compared to conventional cell therapy.

In particular, the extracellular matrix constituting the three-dimensional microstructure formed by the present technology is highly organized similar to the state in vivo. So it is expected that the engraftment rate and cell survival rate in the in vivo injection would be very high. The therapeutic effect is also expected to improve compared to existing cell therapy products.

Meanwhile, as a company specialized in cell therapy products, S.Biomedics Co., Ltd. is intensively researching and developing three-dimensional microstructures and embryonic stem cells with its original technology platforms. The company is developing a treatment for critical limb ischemia using three-dimensional microstructure formation technology and already applied for the clinical trial at the Ministry of Food and Drug Safety. Besides, S.Biomedics is conducting a total of three clinical research programs by developing acne scar treatment and embryonic stem cell-derived spinal cord injury treatment.