Due to its excellent biological and mechanical properties, silk fibroin has been intensively explored for tissue engineering and regenerative medicine applications. However, lack of translational evidence has hampered its clinical application for tissue repair. Here a silk fibroin film is developed and its translational potential is investigated for skin repair by performing comprehensive preclinical and clinical studies to fully evaluate its safety and effectiveness. The silk fibroin film fabricated using all green chemistry approaches demonstrates remarkable characteristics, including transmittance, fluid handling capacity, moisture vapor permeability, waterproofness, bacterial barrier properties, and biocompatibility. In vivo rabbit full-thickness skin defect study shows that the silk fibroin film effectively reduces the average wound healing time with better skin regeneration compared with the commercial wound dressings. Subsequent assessment in porcine model confirms its long-term safety and effectiveness for full-thickness skin defects. Finally, a randomized single-blind parallel controlled clinical trial with 71 patients shows that the silk fibroin film significantly reduces the time to wound healing and incidence of adverse events compared to commercial dressing. Therefore, the study provides systematic preclinical and clinical evidence that the silk fibroin film promotes wound healing thereby establishing a foundation towards its application for skin repair and regeneration in the clinic.
Differing from the conventional micelles made of block or graft copolymers, in which the core and corona are connected by covalent bonding, the micelles reported in this paper are composed of a polymer pair and the core and corona are connected by hydrogen bonding. Poly(styrene-co-methacrylic acid) (SMAA) and poly(vinylpyrrolidone) (PVPo) self-assembled into spherical micelles with hydrodynamic radii around 100 nm in aqueous medium. These stable micelles are composed of the core of collapsed SMAA chains and the corona of solvated PVPo chains. The hydrogen bonding between methacrylic acid and PVPo units and the difference in the solubility in water between SMAA and PVPo are the main factors responsible for the micelle formation. Using dynamic light scattering, it was found that the hydrodynamic radius of the micelles significantly increases with increasing initial concentrations of both SMAA and PVPo. The micelle size dose not depend on the MAA content (3.55-13.1 mol %) in SMAA monotonically, which can be rationalized by the coexistence of different stabilization mechanisms. Transmission electronic microscopy (TEM) was used to observe morphologies of the micelles. The core-shell structure of the micelles became visualized only when adequate staining of the TEM specimens was employed.
Increasing evidence has revealed that the surface characteristics of biomaterials, such as chemical composition, stiffness, and topography, especially nanotopography, significantly influence cell growth and differentiation. In this study, we examined the effect of surface biomimetic apatite nanostructure of a new hydroxyapatite-coated genipin-chitosan conjugation scaffold (HGCCS) on cell shape, cytoskeleton organization, and osteogenic differentiation of rat bone marrow-derived mesenchymal stem cells in vitro. Cell shape and cytoskeleton organization showed significant differences between cells cultured on genipin-cross-linked chitosan framework and those cultured on HGCCS with surface apatite network-like nanostructure after 7 days of incubation in the osteogenic medium. The result of specific alkaline phosphatase activity as an indicator of osteogenic differentiation showed that the alkaline phosphatase activity of rat bone marrow-derived mesenchymal stem cells was higher on HGCCS. Based on quantitative real-time polymerase chain reaction, HGCCS induced highest mRNA expression of osteogenic differentiation makers, runt-related transcription factor 2 by 7 days, osteopontin by 7 days, and osteocalcin by 14 days, respectively. The enhanced ability of cells on HGCCS to produce mineralized extracellular matrix and nodules was also assessed on day 14 with Alizarin red staining. The results of this study suggest that the surface biomimetic apatite nanostructure of HGCCS is a critical signal cue to promoting osteogenic differentiation in vitro. These findings open a new research avenue to controlling stem cell lineage commitment and provide a promising scaffold for bone tissue engineering.
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