Compositions for promoting the healing of wounds

Abstract

The present invention provides compositions comprising granulocyte-macrophage colony-stimulating factor (GM-CSF), sucrose octasulfate or sucralfate and hyaluronic acid for the treatment, pre-emptive treatmentor prophylaxis of ulcers, wounds and other injuries to the skin or membranes of the body. Other aspects of the invention are methods of treatment or prevention using the compositions described, as well as an application device for use in the methods provided.

1 . A composition comprising:
 a) granulocyte-macrophage-colony stimulating factor (GM-CSF) or a fragment or variant thereof, and   b) sucrose octasulfate (SOS) or a salt thereof, and   c) hyaluronic acid (HA).   
     
     
         2 - 53 . (canceled) 
     
     
         54 . The composition according to  claim 1 , wherein the GM-CSF variant is at least 70% identical to SEQ ID NO:1 or SEQ ID NO:2. 
     
     
         55 . The composition according to  claim 1 , wherein the GM-CSF fragment comprises at least 50 contiguous amino-acid residues of any one of SEQ ID NO:1 or SEQ ID NO:2. 
     
     
         56 . The composition according to  claim 1 , comprising GM-CSF at a concentration of 1 μg/g to 1000 μg/g. 
     
     
         57 . The composition according to  claim 1 , comprising hyaluronic acid at a concentration of 0.01 mg/g to 650 mg/g. 
     
     
         58 . The composition according to  claim 1 , comprising sucrose octasulfate or sucralfate at a concentration of 80 mg/g to 1500 mg/g. 
     
     
         59 . The composition according to  claim 1  further comprising vitamin A and/or an anti-oxidant agent. 
     
     
         60 . The composition according to  claim 1 , wherein the GM-CSF comprises a GM-CSF variant in the form of a conjugate, which prolongs the half-life of the GM-CSF. 
     
     
         61 . The composition according to  claim 1 , wherein the GM-CSF comprises a GM-CSF variant in the form of a conjugate, which prolongs the half-life of the GM-CSF, and wherein the conjugate is albumin or a fatty acid. 
     
     
         62 . The composition according to  claim 1 , wherein the composition has a pH of between 3-10, 4-9, 4-8, 5-8, 6-8, 6.5-7.5, or about 7. 
     
     
         63 . The composition according to  claim 1 , wherein the composition is formulated as a powder, paste, paint, ointment, lotion, gel, cream, salve, emulsion, suspension, solution, spray, sponge, strip, plaster, pad, dressing, a liposomal formulation, a micelle formulation, a microcapsule formulation, a nanoparticle formulation, or in an ostomy plate. 
     
     
         64 . A method of treating or alleviating irritation, a lesion of the skin, mucous membranes or connective tissues, a wound, ulcer, or scar comprising:
 providing the composition according to  claim 1  to a subject in need of a treatment or alleviation of irritation, a lesion of the skin, mucous membranes or connective tissues, a wound, ulcer, scar.   
     
     
         65 . The method according to  claim 64 , wherein the wound and/or ulcer is non-healing. 
     
     
         66 . The method according to  claim 64 , wherein the wound and/or ulcer is acute. 
     
     
         67 . The method according to  claim 64 , wherein the ulcer is a non-healing ulcerous skin lesion. 
     
     
         68 . The method according to  claim 64 , wherein the wound and/or ulcer is associated with an infection. 
     
     
         69 . The method according to  claim 64 , wherein the wound and/or ulcer is associated with diabetes mellitus. 
     
     
         70 . The method according to  claim 64 , wherein the wound and/or ulcer is associated with decreased circulation of blood, a venous leg ulcer, a venous foot ulcer, an arterial leg ulcer, an arterial foot ulcer, or a decubitus ulcer.