Use of a human amniotic membrane composition for prophylaxis and treatment of diseases and conditions of the eye and skin

Abstract

A method of preparing an amniotic membrane extract including the steps of obtaining a healthy amniotic membrane from a pregnant mammal, such as a pig, cow, horse or human, homogenizing the membrane to obtain a homogenate solution, freezing the homogenate solution, and lyophilizing the frozen homogenate solution to dryness is disclosed. Preferably, the lyophilized homogenate is pulverized to a powder. The lyophilized homogenate is then reconstituted before use, e.g., in a liquid, such as a balanced salt solution or fresh amniotic fluid, or in another substance, such a gel, an ointment, a cream or a soap, depending on the intended use. Also disclosed is a pharmaceutical composition prepared according to the method of the invention, for prophylaxis and/or treatment of a disease or condition, especially of the eye or the skin. Exemplary pharmaceutically acceptable carriers for the compositin of the invention include an ophthalmic solution for eye drops, a gel, an ointment, an emulsion, a cream, a powder and a spray.

What is claimed is:  
     
         1 . A method of preparing an amniotic membrane extract, said method comprising the steps of: 
 obtaining a healthy amniotic membrane from a pregnant mammal;    homogenizing said membrane to obtain a homogenate solution;    freezing said homogenate solution; and    lyophilizing said frozen homogenate solution to dryness.    
     
     
         2 . The method of  claim 1 , further comprising the step of processing said lyophilized homogenate to a powder.  
     
     
         3 . The method of  claim 1 , further comprising the step of reconstituting said lyophilized homogenate.  
     
     
         4 . The method of  claim 3 , wherein said lyophilized homogenate is reconstituted in a liquid.  
     
     
         5 . The method of  claim 4 , wherein said liquid is selected from the group consisting of balanced salt solution and fresh amniotic fluid.  
     
     
         6 . The method of  claim 3 , wherein said lyophilized homogenate is reconstituted in a gel, an ointment, a cream or a soap.  
     
     
         7 . The method of  claim 1 , wherein said amniotic membrane is a human amniotic membrane.  
     
     
         8 . The method of  claim 1 , wherein said amniotic membrane is obtained from a mammal selected from the group consisting of pig, cow or horse.  
     
     
         9 . The method of  claim 1 , wherein said amniotic membrane is freshly obtained.  
     
     
         10 . A pharmaceutical composition for prophylaxis and/or treatment of a disease or condition, said composition comprising: 
 a therapeutically effective amount of an amniotic membrane extract prepared according to the method of  claim 1;  and    a pharmaceutically acceptable carrier for administering said amniotic membrane extract to a patient in need of said prophylaxis and/or treatment.    
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein said pharmaceutically acceptable carrier is selected from the group consisting of an ophthalmic solution for eye drops, a gel, an ointment, an emulsion, a cream, a powder and a spray.  
     
     
         12 . The pharmaceutical composition of  claim 10 , wherein said pharmaceutically acceptable carrier is a bandage or a medicinal contact lens for local administration to said patient.  
     
     
         13 . A method of prophylaxis and/or treatment of a disease or condition, said method comprising the steps of: 
 providing a patient in need of such prophylaxis and/or treatment; and    administering an effective amount of the pharmaceutical composition of  claim 11  to said patient.    
     
     
         14 . The method of  claim 13 , wherein said disease or condition is selected from the group consisting of persistent corneal ulcer, Ocular Cicatritial Pemphigoid, Stevens-Johnson syndrome, conjunctival inflammation, dry eye, Sjögren's syndrome, chemical or thermal injuries, multi-surgery effects, contact lenses over-wear, severe microbial infections, neurotrophic keratitis, ischemic keratitis, peripheral ulcerative or inflammatory keratitis, limbitis aniridia, pterigium or pseudopterigium, and multiple endocrine deficiency.  
     
     
         15 . The method of  claim 13 , wherein said carrier in said pharmaceutical composition for said amniotic membrane extract is preservative free eye drops.  
     
     
         16 . A kit for prophylaxis and/or treatment of a disease or condition, wherein said kit comprises: 
 a therapeutically effective amount of an amniotic membrane extract prepared according to the method of  claim 1;  and    instructions for the use thereof.    
     
     
         17 . The kit of  claim 16 , said kit further comprising a pharmaceutically acceptable carrier for administering said amniotic membrane extract to a patient in need of said prophylaxis and/or treatment.