Clinical Translational Research on Silk Fibroin-Derived Artificial Skin

Clinically treating skin injuries requires functional wound repair materials. Silk fibroin, derived from mulberry silkworm cocoons, has been proven to be an excellent natural biomedical material with promising prospects in tissue repair applications. Although many wound care products based on silk fibroin have been developed in the laboratory, the lack of translational research such as relevant large animal experimental verification and clinical trial evaluation has greatly limited the clinical promotion and application of silk fibroin materials. Recently, the company's technical team, in collaboration with the Zou Xiaohui research group from the First Affiliated Hospital of Zhejiang University School of Medicine, has jointly developed a silk fibroin skin regeneration and repair membrane that is antibacterial, transparent, breathable, and possesses semipermeable membrane functionality,A series of studies were conducted, including material preparation methods, material analysis and characterization, biological performance and biocompatibility evaluation, and in vivo experiments on small and large animals. After completing the safety and effectiveness evaluation of preclinical research, a randomized controlled clinical trial was conducted in collaboration with Qian Li, Deputy Chief Physician of Xiangya Second Hospital affiliated to Central South University, and Zhou Jian, Chief Physician of Xiangya Third Hospital. The clinical application safety and effectiveness of the silk fibroin film were systematically evaluated. The silk fibroin film exhibits excellent transparency, breathability, bacteriostasis, and biocompatibility. Experiments on full-thickness skin defects in New Zealand rabbits showed that the silk fibroin film significantly reduces wound healing time and improves wound healing quality, outperforming commercially available control products. Experiments on full-thickness skin defects in Bama miniature pigs further confirmed the long-term safety and effectiveness of the product. Finally, in a randomized controlled clinical trial involving 71 patients, compared to commercially available control products, the silk fibroin wound-protective film significantly accelerated wound healing and reduced the incidence of adverse reactions. The clinical trial protocol has been pre-registered with the International Clinical Trials Registry (ClinicalTrials.gov Identifier: NCT01993030). This research contributes to the development and promotion of clinical applications of silk fibroin materials, and the complete research and development process of the silk fibroin film holds significant reference value for researchers dedicated to the translational application of novel biomedical materials.

Silk fibroin is a natural protein derived from Bombyxmori cocoons, and shows potential in tissue repair applications due to itsexcellent biomedical properties. The silk fibroin film, developed by XiaohuiZou, Hongwei Ouyang, and co-workers from Zhejiang University in article number1700121, is a highly transparent, biocompatible, air-permeable, waterproof andbacteria barrier scaffold. It significantly reduces the time to wound healingand incidence of adverse events compared to commercial dressing.

Thesis title：

Silk Fibroin Biomaterial Shows Safe and Effective WoundHealing in Animal Models and a Randomized Controlled Clinical Trial.

Paper link：

http://onlinelibrary.wiley.com/doi/10.1002/adhm.201700121/full