Treatment Method and Product for Uterine Fibroids using Purified Collagenase
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.