Treatment Method and Product for Uterine Fibroids using Purified Collagenase

Abstract

The invention relates to compositions and methods for treating uterine fibroids, wherein a uterine fibroid treatment agent comprising collagenase in an amount effective to cause shrinkage of uterine fibroids is injected or inserted into the uterine fibroid.

1 . A method for the treatment of uterine fibroids, said method comprising: providing an injectable or insertable formulation that comprises a uterine fibroid treatment agent in an amount effective to cause shrinkage of uterine fibroids; and injecting or inserting said formulation into the uterine fibroid, wherein the uterine fibroid treatment agent is collagenase. 
     
     
         2 . The method of  claim 1 , wherein the collagenase is obtained from a mammalian, crustacean, fungal or bacterial source. 
     
     
         3 . The method of  claim 2 , wherein the collagenase is obtained from a bacterial source. 
     
     
         4 . The method of  claim 3 , wherein the collagenase is obtained from  Clostridium.    
     
     
         5 . The method of  claim 4 , wherein the  Clostridium  is  Clostridium histolyticum.    
     
     
         6 . The method of  claim 5 , wherein the collagenase is a mixture of collagenase I and collagenase II. 
     
     
         7 . The method of  claim 6 , wherein the collagenase I and collagenase II are present in a mass ration of about 0.5 to about 1.5. 
     
     
         8 . The method of  claim 1 , wherein about 0.06 mg to about 1 mg collagenase is administered per cm 3  of tissue to be treated. 
     
     
         9 . The method of  claim 8 , wherein about 0.1 mg to about 0.8 mg collagenase is administered per cm 3  of tissue to be treated. 
     
     
         10 . The method of  claim 8 , wherein about 0.2 mg to about 0.6 mg collagenase is administered per cm 3  of tissue to be treated. 
     
     
         11 . The method of  claim 1 , wherein said formulation is injected or inserted into said fibroid transabdominally. 
     
     
         12 . The method of  claim 1 , wherein said formulation is injected or inserted into said fibroid transvaginally. 
     
     
         13 . The method of  claim 1 , wherein said formulation is injected or inserted into said fibroid under image guidance. 
     
     
         14 . The method of  claim 13 , wherein said image is at least one of a direct visual image and a non-direct visual image. 
     
     
         15 . The method of  claim 14 , wherein said direct image is scope image. 
     
     
         16 . The method of  claim 14 , wherein said non-direct visual image is an MRI image. 
     
     
         17 . The method of  claim 16 , wherein said formulation comprises an MRI contrast agent. 
     
     
         18 . The method of  claim 16 , wherein said non-direct visual image is an ultrasound image. 
     
     
         19 . The method of  claim 18 , wherein said formulation comprises an ultrasound contrast agent. 
     
     
         20 . The method of  claim 14 , wherein said non-direct visual image is a fluoroscopic image.