Thrombin-free biological adhesive and use thereof as a medicament

Abstract

The invention relates to a thrombin-free, fibrinogen-based biological adhesive for therapeutic use, which comprises factor Vila and a source of calcium ions. The invention also relates to the use of the biological adhesive as a medicament, in particular as a dressing for biological tissues, wounds or biomaterials.

1 . A thrombin-free, prothrombin-free, fibrinogen-based stable single-compound liquid biological adhesive for therapeutic use, comprising a solvent and a mixture of fibrinogen, factor VIIa, and calcium ions. 
     
     
         2 . The biological adhesive according to  claim 1 , wherein the solvent is water. 
     
     
         3 . The biological adhesive according to  claim 1 , wherein the fibrinogen has a fibrinogen content between 60 and 120 mg/mL of final liquid biological adhesive solution. 
     
     
         4 . The biological adhesive according to  claim 3 , wherein the fibrinogen content is from 80 to 100 mg/mL of the final liquid biological adhesive solution. 
     
     
         5 . The biological adhesive according to  claim 1  wherein the factor VIIa has an activated factor VII content from 50 to 500 IU of activated factor VII per millilitre of final liquid biological adhesive solution (50-500 IU/mL). 
     
     
         6 . The biological adhesive according to  claim 5 , wherein the activated factor VII content is from 70 to 300 IU/mL of activated factor VII, in particular from 80 to 120 IU/mL. 
     
     
         7 . The biological adhesive according to  claim 1 , wherein the calcium ions are in a concentration comprised between 4 and 30 μmols/mL of final liquid biological adhesive solution. 
     
     
         8 . The biological adhesive according to  claim 7 , wherein the calcium ions are in a concentration comprised between 8 and 20 μmols/mL. 
     
     
         9 . The biological adhesive according to  claims 1 , further comprising the factor XIII. 
     
     
         10 . The biological adhesive according to  claim 9 , wherein the factor XIII is present in an amount from 100 IU to 400 IU per millilitre of final liquid biological adhesive solution (100 IU/mL-400 IU/mL). 
     
     
         11 . The biological adhesive according to  claim 1 , to  10  appearing in a frozen form, suitable for extended storage. 
     
     
         12 . The biological adhesive according to  claim 1 , in a freeze-dried form, suitable for extended storage. 
     
     
         13 . The biological adhesive according to  claim 12 , further comprising constituents of a pharmaceutically acceptable freeze-drying stabilizing formulation, preferably representing a mixture of arginine, at least one hydrophobic amino acid and trisodium citrate. 
     
     
         14 .- 29 . (canceled)