Compositions and Methods for Soft Tissue Augmentation

Abstract

The present invention provides compositions comprising isolated human collagen, isolated human elastin and a pharmaceutically acceptable carrier wherein the human elastin is substantially insoluble in water with a molecular weight greater than 100 kDa. The present invention further provides methods and kits for soft tissue augmentation.

We claim: 
     
         1 . A composition comprising isolated human collagen, isolated human elastin and a pharmaceutically acceptable carrier wherein the human elastin is substantially insoluble in water with a molecular weight greater than 100 kDa. 
     
     
         2 . The composition of  claim 1 , wherein the isolated human collagen is derived from engineered vascular tissue. 
     
     
         3 . The composition of  claim 1 , wherein the isolated human collagen is derived from micro-bead culture. 
     
     
         4 . The composition of  claim 1 , wherein the isolated human elastin is derived from engineered vascular tissue or native vascular tissue. 
     
     
         5 . The composition of  claim 1 , wherein the isolated human collagen has a molecular weight of about 100 to about 500 kDa. 
     
     
         6 . The composition of  claim 1 , wherein the isolated human elastin is cross-linked. 
     
     
         7 . The composition of  claim 1 , wherein the composition comprises about 10-100 mg/ml of isolated human collagen. 
     
     
         8 . The composition of  claim 1 , wherein the composition comprises about 30 mg/ml of isolated human collagen. 
     
     
         9 . The composition of  claim 1 , wherein the composition comprises about 2 to about 60 mg/ml of isolated human elastin. 
     
     
         10 . The composition of  claim 1 , wherein the composition comprises about 3 to 30 mg/ml of isolated human elastin. 
     
     
         11 . The composition of  claim 1 , wherein the composition further comprises isolated human glycosaminoglycans. 
     
     
         12 . The composition of  claim 1 , wherein the composition further comprises adipose tissue. 
     
     
         13 . The composition of  claim 1  wherein the composition further comprises dermal fibroblasts. 
     
     
         14 . The composition of  claim 1 , wherein the composition further comprises one or more active agents selected from the group consisting of one or more anti-inflammatory agents, tissue formation agents, adipose tissue formation agents, anesthetics, antioxidants, heparin, epidermal growth factor, transforming growth factor, transforming growth factor-β, platelet-derived growth factor, fibroblast growth factor, connective tissue activating peptides, β-thromboglobulin, insulin-like growth factors, tumor necrosis factors, interleukins, colony stimulating factors, erythropoietin, nerve growth factors, interferons or combinations thereof. 
     
     
         15 . A dermal or subdermal filler comprising composition of  claim 1 . 
     
     
         16 . The composition of  claim 1 , wherein said elastin is isolated from human non-frozen vascular tissue and wherein the composition does not induce calcification in vivo. 
     
     
         17 . A method for soft tissue augmentation in a subject comprising, administering a composition comprising isolated human collagen, isolated human elastin and a pharmaceutically acceptable carrier wherein the human elastin is substantially insoluble in water with a molecular weight of above 100 kDa. 
     
     
         18 . The method of  claim 17 , wherein the soft tissue augmentation improves condition selected from the group consisting of lines, folds, wrinkles, minor facial depressions, cleft lips, correction of minor deformities due to aging or disease, deformities of the vocal cords or glottis, deformities of the lip, crow's feet and the orbital groove around the eye, breast deformities, chin deformities, augmentation; cheek and/or nose deformities, acne, surgical scars, scars due to radiation damage or trauma scars, and rhytids. 
     
     
         19 . The method of  claim 17 , wherein the soft tissue is located in the pelvic floor, in the peri-urethral area, near the neck of the urinary bladder, or at the junction of the urinary bladder and the ureter. 
     
     
         20 . The method of  claim 17 , wherein the soft tissue augmentation increases tissue volume. 
     
     
         21 . The method of  claim 17 , wherein the composition is injected into the skin. 
     
     
         22 . The method of  claim 17 , wherein the composition is injected underneath the skin. 
     
     
         23 . The method of  claim 17 , wherein the composition comprising insoluble elastin derived from human vascular tissue does not induce an inflammatory or immune response and does not induce calcification. 
     
     
         24 . A kit for augmentation of a soft tissue comprising composition of  claim 1 , a syringe, a sterile wrapper surrounding said syringe and providing a sterile environment for said syringe and any other material/ and or reagents necessary. 
     
     
         25 . The kit of  claim 24  wherein said reagents include agents selected from the group consisting of heparin, epidermal growth factor, transforming growth factor-alpha, transforming growth factor-beta, platelet-derived growth factor, fibroblast growth factor, connective tissue activating peptides, β-thromboglobulin, insulin-like growth factors, tumor necrosis factors, interleukins, colony stimulating factors, erythropoietin, nerve growth factors, interferons, osteogenic factors and bone morphogenic proteins.