Cartilage repair mixture containing allograft chondrocytes

Abstract

The invention is directed toward a sterile cartilage defect implant material comprising milled lyophilized allograft cartilage pieces ranging from 0.01 mm to 1.0 mm in size in a bioabsorbable carrier taken from a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran or mixed polymers with allograft chondrocytes added in an amount ranging from 2.5×10 5 to 2.5×10 7 .

1 . A sterile cartilage defect implant material comprising milled allograft articular cartilage pieces ranging from 0.01 mm to 1.0 mm in size ranging from about 25% to about 50% by weight in a bioabsorbable carrier taken from a group consisting of sodium hyaluronate, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran or polymers and allograft chondrocytes taken from a human donor ranging in age from about 3 months to about 20 years in an amount ranging from 2.5×10 5  to 2.5×10 7 .  
     
     
         2 . A sterile cartilage defect implant material as claimed in  claim 1  wherein said allograft articular cartilage is hyaline cartilage.  
     
     
         3 . A sterile allograft cartilage defect implant material as claimed in  claim 1  wherein said milled cartilage is fibrous cartilage.  
     
     
         4 . A sterile allograft cartilage defect implant material as claimed in  claim 1  wherein said milled cartilage is hyaline and fibrous cartilage.  
     
     
         5 . A sterile cartilage repair material as claimed in  claim 1  wherein said implant material includes an additive consisting of one or more of a group consisting of growth factors, human allogenic cells, human allogenic bone marrow cells, human autologous bone marrow cells, human allogenic stem cells, human autologous stem cells, demineralized bone matrix, and insulin.  
     
     
         6 . A sterile cartilage repair material as claimed in  claim 5  wherein said growth factors are one or more of a group consisting of FGF-2, FGF-5, IGF-1, TGF-β, BMP-2, BMP-7, PDGF, VEGF.  
     
     
         7 . A sterile cartilage defect implant material as claimed in  claim 1  wherein said milled cartilage has been lyophilized so that its water content ranges from about 0.01% to about 8.0% and the carrier ranges from about 70% to about 85% by weight.  
     
     
         8 . A sterile cartilage defect implant material as claimed in  claim 1  wherein said milled allograft articular cartilage pieces are taken from a human donor ranging in age from 3 months to 20 years.  
     
     
         9 . A sterile cartilage defect implant material as claimed in  claim 1  wherein said allograft chondrocytes are taken from a human donor ranging in age from 3 months to 12 years.  
     
     
         10 . A sterile cartilage defect implant material comprising lyophilized milled allograft articular cartilage pieces ranging from 0.01 mm to 1.0 mm in size ranging from about 15% to about 50% by weight in a bioabsorbable carrier taken from a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, and allograft chondrocytes taken from the same donor as the milled allograft articular cartilage pieces in an amount ranging from 2.5×10 5  to about 2.5×10 7 , said human donor ranging about in age from about 3 months to 20 years.  
     
     
         11 . A sterile cartilage defect implant material as claimed in  claim 10  wherein said allograft chondrocytes are taken from a human donor ranging in age from about 3 months to 12 years.  
     
     
         12 . A sterile cartilage defect repair material as claimed in  claim 10  including an additive in said implant material which consists of one or more of a group consisting of growth factors, human allogenic cells, demineralized bone matrix, and insulin.  
     
     
         13 . A sterile cartilage defect repair material as claimed in  claim 10  wherein said allograft chondrocytes are added in an amount of about 2.5×10 6 .  
     
     
         14 . A sterile cartilage repair material as claimed in claim 12 wherein said growth factors are one or more of a group consisting of FGF-2, FGF-5, IGF-1, TGF-β, BMP-2, BMP-7, PDGF, VEGF.  
     
     
         15 . A sterile cartilage defect implant material as claimed in  claim 10  wherein said allograft chondrocytes are expanded growth chondrocytes.  
     
     
         16 . A sterile cartilage defect implant material comprising lyophilized milled allograft articular cartilage pieces having a water content ranging from 0.1% to about 8.0% ranging from 0.01 mm to 1.0 mm in size in a bioabsorbable carrier taken from a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran or polymers and allograft chondrocytes in an amount exceeding the natural occurrence of same in a patient being treated.  
     
     
         17 . A sterile cartilage defect implant material as claimed in  claim 16  wherein said allograft chondrocytes are taken from a human donor ranging in age from 3 months to 12 years.  
     
     
         18 . A method of placing a cartilage defect material in a cartilage defect, said material comprising allograft articular cartilage which has been lyophilized and mixed in a bioabsorbable carrier comprising the steps of: 
 (a) cutting patient tissue at a site of a cartilage defect to remove the diseased area of cartilage;    (b) placing a mixture of milled allograft cartilage in a bioabsorbable carrier in the area where cartilage has been removed;    (c) adding allograft chondrocytes taken from a human donor having an age ranging from about 3 months to about 20 years to said mixture of milled allograft cartilage in a bioabsorbable carrier;    (d) sealing a cover with a biological glue over the mixture of milled allograft cartilage in a bioabsorbable carrier and added allograft chondrocytes to contain the mixture in cartilage defect site for a predetermined period of time to allow the formation of cartilage.    
     
     
         19 . A sterile cartilage defect material as claimed in  claim 18  wherein said milled cartilage pieces have been lyophilized to have a water content ranging from about 0.1% to about 8.0%.  
     
     
         20 . A sterile cartilage repair material as claimed in  claim 18  wherein said allograft chondrocytes are expanded growth chondrocytes added in amount ranging from 2.5×10 5  to about 2.5×10 7 .