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 . Base-treated, detergent-treated telopeptide collagen. 
     
     
         2 . The collagen of  claim 1  that is mammalian collagen. 
     
     
         3 . The collagen of  claim 1  that is bovine, ovine or rat collagen. 
     
     
         4 . The collagen of  claim 1  that is human collagen. 
     
     
         5 . The collagen of  claim 1  that is placental collagen. 
     
     
         6 . The collagen of  claim 1  that is human placental collagen. 
     
     
         7 . The collagen of  claim 1  that is cross-linked. 
     
     
         8 . The collagen of  claim 1  that is cross-linked with glutaraldehyde. 
     
     
         9 . Detergent-treated telopeptide collagen comprising a detectable amount of fibronectin. 
     
     
         10 . The composition of  claim 1  or  claim 9  comprising a plurality of stem cells. 
     
     
         11 . The composition of  claim 10  wherein the stem cells are embryonic stem cells, embryonic germ cells, mesenchymal stem cells, bone marrow-derived stem cells, hematopoietic stem cells from peripheral blood, hematopoietic stem cells from fetal blood, hematopoietic stem cells from placental blood, hematopoietic stem cells from umbilical cord blood, hematopoietic stem cells from placental perfusate, somatic stem cells, neural stem cells, hepatic stem cells, pancreatic stem cells, endothelial stem cells, cardiac stem cells, muscle stem cells, adipose stem cells, or CD34 −  placental stem cells. 
     
     
         12 . The composition of  claim 11  wherein said CD34 −  placental stem cells are CD200 + . 
     
     
         13 . The composition of  claim 11  wherein said CD34 −  placental stem cells are:
 a. CD200 +  or HLA-G + ;   b. CD73 + , CD105 + , and CD200 + ;   c. CD200 +  and OCT-4 + ;   d. CD73 + , CD105 +  and HLA-G + , CD73 +  and CD105 + , and, when in a population of placental cells, facilitate formation of one or more embryoid-like bodies under conditions that allow formation of embryoid-like bodies; or   e. OCT-4 +  and, when in a population of placental cells, facilitate formation of one or more embryoid-like bodies in a population of isolated placental cells comprising said stem cell when cultured under conditions that allow formation of embryoid-like bodies.   
     
     
         14 . The composition of  claim 10  comprising more than one type of stem cell. 
     
     
         15 . The composition of  claim 10  comprising a plurality of non-stem cells. 
     
     
         16 . The composition of  claim 10  shaped as a sheet. 
     
     
         17 . The composition of  claim 10  shaped as a tube. 
     
     
         18 . The composition of  claim 10  shaped as a mesh. 
     
     
         19 . The composition of  claim 10 , wherein said composition is shaped to fit to a site of a wound or injury. 
     
     
         20 . A method of augmenting, bulking or replacing tissue of a mammal comprising administering the collagen of  claim 1  to the tissue of the mammal. 
     
     
         21 . A kit for augmenting, bulking or replacing tissue of a mammal comprising the collagen of  claim 1  and a label with instructions for administering the cross-linked telopeptide collagen. 
     
     
         22 . A process for preparing telopeptide collagen from tissue of a mammal that comprises collagen, said process comprising the steps of:
 a. contacting the tissue with an osmotic shock solution to yield a collagen composition;   b. contacting the collagen composition with a detergent; and   c. contacting the detergent-treated collagen solution with a basic solution.   
     
     
         23 . The process of  claim 22  wherein the osmotic shock solution comprises water with an osmotic potential less than that of 50 mM NaCl. 
     
     
         24 . The process of  claim 22  wherein step (a) is preceded or followed by contacting the tissue with a solution having an osmotic potential of a solution of at least 0.5 M NaCl. 
     
     
         25 . The process of  claim 22  wherein the basic solution comprises at least 0.5 M NaOH. 
     
     
         26 . The process of  claim 22  further comprising the step of filtering the base-treated, detergent-treated collagen solution. 
     
     
         27 . The process of  claim 22  further comprising the step of cross-linking the collagen to yield cross-linked collagen. 
     
     
         28 . The process of  claim 27  wherein the collagen is cross-linked with glutaraldehyde. 
     
     
         29 . The process of  claim 22  further comprising the step of shearing the cross-linked collagen. 
     
     
         30 . The process of  claim 22  further comprising the step of contacting the collagen composition with a filter of a size that allows one or more viral particles to pass through the filter while retaining the collagen composition. 
     
     
         31 . The process of  claim 30  wherein the filter is about 500 kDa, about 750 kDa or about 1000 kDa. 
     
     
         32 . A method of promoting healing of a wound comprising contacting the wound with a collagen composition of  claim 1 , wherein said contacting results in detectably greater improvement of an aspect of the wound compared to a wound not contacted with the composition. 
     
     
         33 . The method of  claim 32 , additionally comprising contacting said wound with a plurality of stem cells. 
     
     
         34 . The method of  claim 33 , wherein said stem cells are contacted with said wound separately from contacting said composition with said wound. 
     
     
         35 . The method of  claim 32 , wherein said composition comprises said stem cells. 
     
     
         36 . The method of  claim 35 , wherein said composition is shaped as a sheet having two sides, and said stem cells are present on at least one of said sides. 
     
     
         37 . The method of  claim 35 , wherein the stem cells are adhered to the composition. 
     
     
         38 . The method of  claim 35 , wherein the stem cells secrete IL-6, IL-8 and/or MCP-1. 
     
     
         39 . The method of  claim 35 , wherein said stem cells are placental stem cells. 
     
     
         40 . The method of  claim 39 , wherein said placental stem cells are CD34 −  and CD200 + . 
     
     
         41 . The method of  claim 32 , wherein said wound is a leg ulcer. 
     
     
         42 . The method of  claim 41 , wherein said leg ulcer is a venous leg ulcer, arterial leg ulcer, diabetic leg ulcer or decubitus leg ulcer. 
     
     
         43 . The method of  claim 32 , wherein said composition is used as a wound filler. 
     
     
         44 . A method of making a composition, comprising contacting the composition of  claim 1  with a plurality of stem cells. 
     
     
         45 . The method of  claim 44 , comprising allowing at least some of said plurality of stem cells to adhere to said composition. 
     
     
         46 . The method of  claim 45 , comprising allowing said stem cells to proliferate on said composition. 
     
     
         47 . The method of  claim 46 , wherein said stem cells proliferate on said composition to confluency. 
     
     
         48 . The method of  claim 46 , wherein said stem cells produce detectable amounts of IL-6, IL-8 and/or MCP-1 when contacted with said composition.