Hemostatic compositions and therapeutic regimens
Inventors
Finkielsztein, Sergio • Vournakis, John N.
Assignees
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Publication Number
US-10383971-B2
Publication Date
2019-08-20
Expiration Date
Abstract
The present invention relates generally to the field of hemostasis, including methods, compositions, and devices that can be employed to treat wounds. More specifically the present invention relates to hemostatic compositions that reduce the need for, and cost of, nursing care of patients with chronic wounds by reducing the frequency of wound dressing changes.
Core Innovation
The invention relates to hemostatic and wound-treatment compositions comprising shortened poly-β-1→24-N-acetylglucosamine fibers. The shortened fibers comprise at least 70% N-acetylglucosamine monosaccharides and have a length of less than 10 μm, including average lengths from about 2 μm to less than 10 μm in certain embodiments. The compositions are characterized to maintain the microstructure of non-irradiated poly-β-1→24-N-acetylglucosamine fibers, including non-irradiated microalgal poly-β-1→24-N-acetylglucosamine fibers, in at least some embodiments.
In certain compositions, the shortened poly-β-1→24-N-acetylglucosamine fibers have a chemical and physical structure described as microalgal-derived poly-β-1→24-N-acetylglucosamine nanofibers, with an average 20–350 nm×1–2 nm×100 μm in dimension as determined by infrared (IR) spectrum, elemental assay and scanning electron microscopic (SEM) analyses. The disclosed material definitions support compositions in different physical forms for wound-related uses, including dressing, barrier, membrane, film, bandage, gauze, or mat.
The therapeutic context addresses wound healing, including chronic wounds, and describes improved wound healing and angiogenesis associated with pGlcNAc/sNAG in a diabetic mouse model. The described effects include faster wound closure and reepithelialization, reduced wound contraction, enhanced angiogenesis with reported markers, and reduced foreign body reaction when pGlcNAc is applied for shorter durations versus prolonged exposure.
Additional disclosed biological effects in human endothelial cells include rescue from serum-deprivation-induced cell death and enhanced angiogenesis-associated behaviors and gene expression for pGlcNAc, with sNAG described as increasing metabolic rate and migration/angiogenesis markers while not rescuing apoptosis.
Claims Coverage
The partial independent-claim set includes three independent claims, each directed to compositions comprising shortened poly-β-1→24-N-acetylglucosamine fibers with quantitative monosaccharide/length limits and specified structural characterization or microstructure correspondence to non-irradiated fibers.
Shortened poly-β-1→24-N-acetylglucosamine fibers with high N-acetylglucosamine monosaccharide content and length limit while preserving non-irradiated microstructure
Shortened poly-β-1→24-N-acetylglucosamine fibers comprise at least 70% N-acetylglucosamine monosaccharides; the fibers have the microstructure of non-irradiated poly-β-1→24-N-acetylglucosamine fibers that are about 100 μm in length; and the shortened poly-β-1→24-N-acetylglucosamine fibers are less than 10 μm in length.
Shortened poly-β-1→24-N-acetylglucosamine fibers with microalgal nanofiber chemical/physical structure and characterization-defined dimensions
Shortened poly-β-1→24-N-acetylglucosamine fibers comprise at least 70% N-acetylglucosamine monosaccharides; the fibers are less than 10 μm in average length; and the fibers have the chemical and physical structure of microalgal-derived poly-β-1→24-N-acetylglucosamine nanofibers that average 20–350 nm×1–2 nm×100 μm in dimension as determined by infrared (IR) spectrum, elemental assay and scanning electron microscopic (SEM) analyses.
Shortened poly-β-1→24-N-acetylglucosamine fibers with microstructure corresponding to non-irradiated microalgal fibers
Shortened poly-β-1→24-N-acetylglucosamine fibers comprise at least 70% N-acetylglucosamine monosaccharides; the fibers are from about 2 μm to less than 10 μm in average length; and the fibers have the microstructure of non-irradiated microalgal poly-β-1→24-N-acetylglucosamine fibers.
Across the independent claims, the claimed compositions are defined primarily by at least 70% N-acetylglucosamine monosaccharides, shortened fiber length of less than 10 μm or about 2 μm to less than 10 μm, and preservation or specification of microstructure or chemical-physical structure relative to non-irradiated poly-β-1→24-N-acetylglucosamine fibers or non-irradiated microalgal poly-β-1→24-N-acetylglucosamine fibers, including microalgal-derived nanofiber structure characterized by IR spectrum, elemental assay, and SEM.
Stated Advantages
Improved wound healing, including faster wound closure and reepithelialization.
Reduced wound contraction.
Enhanced angiogenesis, including reported increases in angiogenesis markers.
Reduced foreign body reaction when pGlcNAc is applied for shorter durations versus prolonged exposure.
Biological activity in human endothelial cells for pGlcNAc, including rescue from serum-deprivation-induced cell death and enhanced migration/cord formation behaviors.
sNAG described as increasing metabolic rate and migration/angiogenesis markers while not rescuing apoptosis.
Documented Applications
Hemostatic and wound-treatment compositions for wound healing, including chronic wounds.
Wound dressing forms, including dressing, barrier, membrane, film, bandage, gauze, or mat.
Preclinical biocompatibility testing context including intramuscular implantation testing, intracutaneous irritation/sensitization testing, and foreign body reaction evaluation.
Diabetic mouse model wound healing context, including wound closure/reepithelialization, wound contraction, and angiogenesis assessment.
In vitro human endothelial cell context for effects associated with angiogenesis and gene expression.
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