Human placental collagen compositions, and methods of making and using the same

Abstract

The present invention provides compositions comprising human placental telopeptide collagen, methods of preparing the compositions, methods of their use and kits comprising the compositions. The compositions, kits and methods are useful, for example, for augmenting or replacing tissue of a mammal.

1 - 21 . (canceled) 
     
     
         22 . A process for preparing collagen from mammalian placental tissue, said process comprising the steps of:
 (a) contacting the placental tissue with a high osmotic potential solution to yield a collagen composition;   (b) contacting the collagen composition with a detergent; and   (c) contacting the collagen composition with a low osmotic potential solution.   
     
     
         23 . The process of  claim 22  wherein the low osmotic potential solution comprises water with an osmotic potential less than that of 50 mM NaCl. 
     
     
         24 . The process of  claim 22  wherein the high osmotic potential solution has an osmotic potential of a solution of at least 0.5 M NaCl. 
     
     
         25 . The process of  claim 22  wherein the process further comprises contacting the collagen composition with a basic solution. 
     
     
         26 . The process of  claim 22  further comprising the step of filtering the collagen solution. 
     
     
         27 - 48 . (canceled) 
     
     
         49 . The process of  claim 23 , wherein the low osmotic potential solution is water. 
     
     
         50 . The process of  claim 24 , wherein the high osmotic potential solution comprises at least 1.0M NaCl. 
     
     
         51 . The process of  claim 50 , wherein the high osmotic potential solution comprises at least 2M NaCl. 
     
     
         52 . The process of  claim 25 , wherein the basic solution comprises at least 0.1M NaOH. 
     
     
         53 . The process of  claim 52 , wherein the basic solution comprises at least 0.5M NaOH. 
     
     
         54 . The process of  claim 25 , wherein the collagen composition is treated with the basic solution after step (b) and prior to step (c). 
     
     
         55 . The process of  claim 22 , wherein the placental tissue comprises human placental tissue. 
     
     
         56 . The process of  claim 22 , wherein the placental tissue comprises a placental amniotic membrane that has been separated from a placental chorionic membrane. 
     
     
         57 . The process of  claim 22 , wherein the placental tissue comprises a placental chorionic membrane that has been separated from a placental amniotic membrane. 
     
     
         58 . The process of  claim 22 , wherein the placental tissue comprises a whole placenta. 
     
     
         59 . The process of  claim 22 , wherein the detergent is a TWEEN® detergent or a TRITON-X® detergent. 
     
     
         60 . The process of  claim 25 , wherein the collagen composition is contacted with the basic solution after contacting the collagen composition with the detergent. 
     
     
         61 . The process of  claim 55 , wherein the placental tissue is prepared from a placenta that has been exsanguinated. 
     
     
         62 . The process of  claim 22 , wherein the process further comprises drying the collagen composition. 
     
     
         63 . The process of  claim 62 , wherein the drying comprises vacuum drying, freeze drying, or heat drying. 
     
     
         64 . The process of  claim 62 , wherein the drying is performed after one or more of steps (a), (b), and (c). 
     
     
         65 . The process of  claim 22 , wherein one or more steps of the process are carried out under sterile conditions. 
     
     
         66 . The process of  claim 25 , wherein the contacting of the collagen composition with a basic solution and all subsequent steps of the process are carried out under sterile conditions. 
     
     
         67 . The process of  claim 55 , wherein the placenta is obtained from a donor who has been screened for bacterial, fungal, or viral pathogens. 
     
     
         68 . The process of  claim 22 , wherein the process further comprises contacting the collagen composition with a biomolecule. 
     
     
         69 . The process of  claim 68 , wherein the biomolecule is an antibiotic. 
     
     
         70 . A process for preparing collagen from mammalian placental tissue, said process comprising the steps of:
 (a) contacting the placental tissue with a high osmotic potential solution to yield a collagen composition;   (b) contacting the collagen composition with a basic solution; and   (c) contacting the collagen composition with a low osmotic potential solution.   
     
     
         71 . A process for preparing collagen from mammalian placental tissue, said process comprising the steps of:
 (a) contacting the placental tissue with a high osmotic potential solution to yield a collagen composition;   (b) contacting the collagen composition with a detergent;   (c) contacting the collagen composition with a basic solution; and   (d) contacting the collagen composition with a low osmotic potential solution.