Native soft tissue matrix for therapeutic applications

Abstract

A product for implantation within a soft tissue site of the human or animal body comprises a pulverized or morselized matrix of a substantially non-mineralized native soft tissue (NSTM) of the human or animal body, provided in a therapeutic amount to induce growth of native tissue or organs and healing at the tissue site. The NSTM is composed of at least one soft tissue selected from the group consisting of cartilage, meniscus, intervertebral disc, ligament, tendon, muscle, fascia, periosteum, pericardium, perichondrium, skin, nerve, blood vessels, and heart valves or from organs such as bladder, lung, kidney, liver, pancreas, thyroid, or thymus. Preferably, the NSTM is composed of a soft tissue of the same type of tissue native to the repair site. In another embodiment, the NSTM includes soft tissue of a different type than the tissue repair site.

1 . A product for introduction within a tissue site of the human or animal body comprising a morselized or pulverized matrix of a substantially non-mineralized native soft tissue (NSTM) of the human or animal body.  
     
     
         2 . The product of  claim 1 , wherein said NSTM is composed of at least one soft tissue selected from the group consisting of cartilage, meniscus, intervertebral disc, ligament, tendon, muscle, fascia, periosteum, perichondrium, skin, nerve, blood vessels and heart valves.  
     
     
         3 . The product of  claim 1 , wherein said NSTM is composed of at least one soft tissue selected from the group consisting of organs such as kidney, liver, pancreas, thyroid, or thymus.  
     
     
         4 . The product of  claim 1 , wherein said NSTM is composed of a soft tissue of the same type of tissue at the soft tissue site.  
     
     
         5 . The product of  claim 1 , wherein said NSTM is composed of a soft tissue of a different type of tissue than the tissue at the tissue site.  
     
     
         6 . The product of  claim 1 , wherein said NSTM includes a combination of soft tissues obtained from multiple soft tissue sites.  
     
     
         7 . The product of  claim 1 , wherein the soft tissue is morselized or pulverized to a particle size of less than about 800 μm.  
     
     
         8 . The product of  claim 7 , wherein the particle size is in the range of 1-100 μm.  
     
     
         9 . The product of  claim 1 , further comprising a moldable material combined with said NSTM.  
     
     
         10 . The product of  claim 9 , wherein said moldable material is a biologic material.  
     
     
         11 . The product of  claim 10 , wherein said moldable material is autologous, allogeneic or xenogenic.  
     
     
         12 . The product of  claim 10 , wherein said moldable material includes one or more of the following constituents: collagen, gelatin, blood derivatives, plasma, synovial fluid, serum, fibrin, hyaluronic acid, proteoglycans and elastin.  
     
     
         13 . The product of  claim 10 , wherein said moldable material is selected from the group consisting of alginate, agarose and chitosan.  
     
     
         14 . The product of  claim 1 , further comprising cells combined with the NSTM.  
     
     
         15 . The product of  claim 14 , wherein said cells could be autologous, allogeneic or xenogeneic cells.  
     
     
         16 . The product of  claim 14 , wherein said cells are differentiated, phenotype-specific cells, committed progenitor cells, or toti-, pluri- or multi-potential stem cells.  
     
     
         17 . The product of  claim 1 , further comprising bioactive molecules combined with said NSTM.  
     
     
         18 . The product of  claim 17 , wherein said bioactive molecules include growth factors selected from the group consisting of TGF-β, IGF, bFGF, PDGF, VEGF and BMP.  
     
     
         19 . The product of  claim 17 , wherein said bioactive molecules are selected from DNA and vectors capable of delivering therapeutic genes to the tissue site.  
     
     
         20 . The product of  claim 10 , wherein said moldable material is bioresorbable or biodegradable.  
     
     
         21 . The product of  claim 20 , wherein said moldable product includes a bioresorbable or biodegradable constituent selected from the group consisting of polyglycolic acid, polylactic acid, polyorthoesters, polyglycolide-co-lactide, polyanhydrides, polycaprolactones, poly(amino acids), pluronic/F-12, PEO/PEG or other synthetic hydrogels or mixtures thereof.  
     
     
         22 . The product of  claim 10 , wherein said moldable material is non-resorbable and non-biodegradable.  
     
     
         23 . The product of  claim 22 , wherein said moldable material includes a non-resorbable and non-biodegradable constituent selected from the group consisting of acrylics, polycarbonates, polyesters, polyethers, poly(ether ketone), poly(ether, ether ketone), poly(aryl ether ketones), poly(ether ether ketone ether ketone), poly(ethylene terephthalate), poly(methyl (meth)acrylate), polyolefins, polysulfones, polyurethane, polyethylene, polypropylene, poly(vinyl chloride), carbon fiber reinforced composites, glass fiber reinforced composites, or mixtures thereof.  
     
     
         24 . The product of  claim 1 , further comprising a flowable material combined with said NSTM.  
     
     
         25 . The product of  claim 1 , wherein said flowable material is selected from the group consisting of collagen, gelatin, blood derivatives, plasma, synovial fluid, serum, fibrin, hyaluronic acid, proteoglycans and elastin.  
     
     
         26 . A method for repairing a lesion or defect at a tissue site in the human or animal body comprising the steps of: 
 obtaining a devitalized native soft tissue from a substantially non-mineralized soft tissue of the human or animal body prepared in the form of morselized or pulverized morsels (NSTM);    substantially filling the lesion or defect with a composition including the NSTM.    
     
     
         27 . The method for repairing a lesion or defect at a tissue site of  claim 26 , wherein the composition includes the NSTM in combination with carrier material(s), cells, and bioactive molecules.