Muscle-based grafts/implants

Abstract

The present invention is directed to a composition comprising a matrix suitable for implantation in humans, comprising defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried in a predetermined shape. Also disclosed is a tissue graft or implant comprising a matrix suitable for implantation in humans, comprising defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried in a predetermined shape. The composition and/or tissue graft or implant of the invention is usable in combination with seeded cells, a tissue growth factor, and/or a chemotactic agent to attract a desired cell.

1 . A composition comprising a matrix suitable for implantation in humans, said matrix comprising a dried aqueous slurry of shredded, allogeneic human muscle tissue.  
   
   
       2 . The composition of  claim 1 , wherein said muscle tissue is striated muscle tissue.  
   
   
       3 . The composition of  claim 2 , wherein said striated muscle tissue is skeletal muscle.  
   
   
       4 . The composition of  claim 1 , wherein said shredded allogeneic human muscle tissue is also defatted.  
   
   
       5 . The composition of  claim 1 , wherein said shredded allogeneic human muscle tissue was also lyophilized prior to shredding.  
   
   
       6 . The composition of  claim 1 , further comprising a particulate component selected from the group consisting of demineralized bone matrix (DBM), mineralized bone matrix, cortical cancellous chips (CCC), crushed cancellous chips, tricalcium phosphate, hydroxyapatite, or biphasic calcium phosphate and a combination thereof.  
   
   
       7 . The composition of  claim 6 , wherein the particulate component constitutes from 50% to 99% of the dry weight of the composition.  
   
   
       8 . The composition of  claim 7 , wherein the particulate component constitutes from 90% to 99% of the dry weight of the composition.  
   
   
       9 . The composition of  claim 1 , further comprising an effective amount of a bone morphogenic protein (BMP), a LIM mineralization protein, or RUNX-2 protein.  
   
   
       10 . The composition of  claim 9 , wherein said BMP is selected from the group consisting of BMP-2, BMP-4 and BMP-7.  
   
   
       11 . The composition of  claim 10 , wherein said BMP is BMP-2.  
   
   
       12 . The composition of  claim 11 , wherein said BMP-2 is a recombinant human BMP-2.  
   
   
       13 . An implant suitable for implantation in humans comprising a matrix of defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried into a predetermined shape.  
   
   
       14 . The implant of  claim 13 , wherein said muscle tissue is striated muscle tissue.  
   
   
       15 . The implant of  claim 14 , wherein said striated muscle tissue is skeletal muscle.  
   
   
       16 . The implant of  claim 13 , wherein said shredded allogeneic human muscle tissue is also defatted.  
   
   
       17 . The implant of  claim 13 , wherein said shredded allogeneic human muscle tissue was also lyophilized prior to shredding.  
   
   
       18 . The implant of  claim 13 , further comprising a particulate component selected from the group consisting of DBM, mineralized bone matrix, CCC, crushed cancellous chips, tricalcium phosphate, hydroxyapatite, or biphasic calcium phosphate and a combination thereof.  
   
   
       19 . The implant of  claim 18 , wherein the particulate component constitutes from 50% to 99% of the dry weight of the implant.  
   
   
       20 . The implant of  claim 19 , wherein the particulate component constitutes from 90% to 99% of the dry weight of the implant.  
   
   
       21 . The implant of  claim 13 , further comprising an effective amount of a bone morphogenic protein (BMP), a LIM mineralization protein, or RUNX-2 protein.  
   
   
       22 . The implant of  claim 21 , wherein said BMP is selected from the group consisting of BMP-2, BMP-4 and BMP-7.  
   
   
       23 . The implant of  claim 22 , wherein said BMP is BMP-2.  
   
   
       24 . The implant of  claim 23 , wherein said BMP-2 is a recombinant human BMP-2.  
   
   
       25 . The implant of  claim 13 , wherein said matrix of digested allogeneic human muscle comprises from about 1% to about 100% of the final weight of said implant.  
   
   
       26 . The implant of  claim 25 , wherein said matrix of digested allogeneic human muscle comprises from 25% to about 85% of the weight of said tissue implant.  
   
   
       27 . The implant of  claim 18 , wherein said particulate component is DBM.  
   
   
       28 . The implant of  claim 27 , wherein said DBM is uniformly distributed throughout the matrix.  
   
   
       29 . The implant of  claim 27 , wherein said DBM is layered within said matrix.  
   
   
       30 . The implant of  claim 18 , wherein said particulate component is CCC.  
   
   
       31 . The implant of  claim 30 , wherein said CCC is uniformly distributed throughout the matrix.  
   
   
       32 . The implant of  claim 30 , wherein said CCC is layered within said matrix.  
   
   
       33 . The implant of  claim 13  further comprising digested allogeneic human tendon.  
   
   
       34 . A method for making an implantable tissue comprising the steps of: 
 i. removing the fat and soluble proteins from allogeneic or xenogeneic mammalian muscle tissue;    ii. lyophilizing the muscle tissue from step (i);    iii. shredding the lyophilized muscle tissue;    iv. mixing the shredded muscle tissue in an aqueous carrier to form a muscle tissue slurry having a viscosity within the range of 1 centistoke to 20,000 centistokes;    v. transferring the muscle tissue slurry to an appropriate shaped mold: and    vi. drying the slurry in the mold to form the tissue implant having the corresponding shape of said mold.    
   
   
       35 . The method of  claim 34 , wherein the tissue implant is a shaped sponge.