Methods and compositions for poly-beta-1-4-N-acetylglucosamine cell therapy system

Abstract

The present invention relates to a purified, easily produced poly-β-1→4-N-acetylglucosamine (p-GlcNAc) polysaccharide species. The p-GlcNAc of the invention is a polymer of high molecular weight whose constituent monosaccharide sugars are attached in a β-1→4 conformation, and which is free of proteins, and substantially free of single amino acids, and other organic and inorganic contaminants. In addition, derivatives and reformulations of p-GlcNAc are described. The present invention further relates to methods for the purification of the p-GlcNAc of the invention from microalgae, preferably diatom, starting sources. Still further, the invention relates to methods for the derivatization and reformulation of the p-GlcNAc. Additionally, the present invention relates to the uses of pure p-GlcNAc, its derivatives, and/or its reformulations.

1 - 2 . (Canceled)  
     
     
         3 . A biocompatible poly-β-1→4-N-acetylglucosamine comprising up to about 150,000 N-acetylglucosamine monosaccharides covalently attached in a β-1→4 conformation and having a molecular weight of up to about 30 million daltons.  
     
     
         4 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 3  having up to about 15,000 N-acetylglucosamine monosaccharides covalently attached in a β-1→4 conformation, and having a molecular weight of up to about 3 million daltons.  
     
     
         5 . (Canceled)  
     
     
         6 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 3  or  4  which has an elution test score of 0.  
     
     
         7 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 3  or  4  which has an elution test score of 1.  
     
     
         8 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 3  or  4  which has an elution test score of 2.  
     
     
         9 - 11 . (Canceled)  
     
     
         12 . A biocompatible poly-β-1→4-N-acetylglucosamine comprising up to about 150,000 N-acetylglucosamine monosaccharides covalently attached in a β-1→4 conformation and having a molecular weight of up to about 30 million daltons in which at least one N-acetylglucosamine monosaccharide has been deacetylated.  
     
     
         13 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 12  having up to about 15,000 N-acetylglucosamine monosaccharides covalenty attached in a β-1→4 conformation, and having a molecular weight of up to about 3 million daltons in which at least one N-acetylglucosamine monosaccharide has been deacetylated.  
     
     
         14 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 12  wherein at least about 25% to about 75% of the N-acetylglucosamine monosaccharides have been deacetylated.  
     
     
         15 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 13  wherein at least about 25% to about 75% of the N-acetylglucosamine monosaccharides have been deacetylated.  
     
     
         16 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 12  wherein at least about 70% of the N-acetylglucosamine monosaccharides have been deacetylated.  
     
     
         17 . The biocompatible poly-β-1→4-N-acetylglucosamine of  claim 13  wherein at least about 70% of the N-acetylglucosamine monosaccharides have been deacetylated.  
     
     
         18 . (Canceled)  
     
     
         19 . The biocompatible poly-β-1→4-N-acetylglucosamine of any one of claims  12 - 17  which has an elution test score of 0.  
     
     
         20 . The biocompatible poly-β-1→4-N-acetylglucosamine of any one of claims  12 - 17  which has an elution test score of 1.  
     
     
         21 . The biocompatible poly-β-1→4-N-acetylglucosamine of any one of claims  12 - 17  which has an elution test score of 2.  
     
     
         22 - 25 . (Canceled)  
     
     
         26 . A biocompatible poly-β-1→4-glucosamine comprising up to about 150,000 glucosamine monosaccharides covalently attached in a β-1→4 conformation, and having a molecular weight of up to about 24 million daltons.  
     
     
         27 . The biocompatible poly-β-1→4-glucosamine of  claim 26  having up to about 15,000 glucosamine monosaccharides covalently attached in a β-1 →4 conformation, and having a molecular weight of up to about 2.4 million daltons.  
     
     
         28 . A biocompatible poly-β-1→4-glucosamine comprising up to about 150,000 glucosamine monosaccharides covalently attached in a β-1→4 conformation, wherein at least one glucosamine monosaccharide has been acetylated.  
     
     
         29 . The biocompatible poly-β-1→4-glucosamine of  claim 28  wherein at least about 25% to about 75% of the glucosamine monosaccharides have been acetylated.  
     
     
         30 . The biocompatible poly-β-1→4-glucosamine of  claim 28  wherein at least about 30% of the glucosamine monosaccharides have been acetylated.  
     
     
         31 . (Canceled)  
     
     
         32 . The biocompatible poly-β-1→4-glucosamine of any one of claims  26 - 30  which has an elution test score of 0.  
     
     
         33 . The biocompatible poly-β-1→4-glucosamine of any one of claims  26 - 30  which has an elution test score of 1.  
     
     
         34 . The biocompatible poly-β-1→4-glucosamine of any one of claims  26 - 30  which has an elution test score of 2.  
     
     
         35 - 59 . (Canceled)