Treatment method and product for uterine fibroids using purified collagenase
View Patent ↗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 in a patient comprising administering into the uterine fibroid a composition comprising an amount of collagenase from Clostridium histolyticum sufficient to cleave disordered collagen fibrils of types I, III and V in said uterine fibroids, wherein said administering is by injecting or inserting into the fibroid about 0.06 to about 1 mg of said collagenase per 1 cm 3 uterine fibroid tissue.
2. The method of claim 1 , wherein the collagenase is a mixture of collagenase I and collagenase II.
3. The method of claim 1 , wherein about 0.1 mg to about 0.8 mg collagenase is administered per cm 3 of tissue to be treated.
4. The method of claim 1 , wherein about 0.2 mg to about 0.6 mg collagenase is administered per cm 3 of tissue to be treated.
5. The method of claim 1 , wherein said composition is injected or inserted into said fibroid transabdominally.
6. The method of claim 1 , wherein said composition is injected or inserted into said fibroid transvaginally.
7. The method of claim 1 , wherein said composition is injected or inserted into said fibroid under image guidance.
8. The method of claim 7 , wherein said image is at least one of a direct visual image and a non-direct visual image.
9. The method of claim 8 , wherein said direct visual image is a scope image.
10. The method of claim 8 , wherein said non-direct visual image is an MRI image.
11. The method of claim 10 , wherein said composition comprises an MRI contrast agent.
12. The method of claim 8 , wherein said non-direct visual image is an ultrasound image.
13. The method of claim 12 , wherein said composition comprises an ultrasound contrast agent.
14. The method of claim 8 , wherein said non-direct visual image is a fluoroscopic image.
15. The method of claim 14 , wherein said composition comprises an x-ray contrast agent.
16. The method of claim 1 , wherein said composition further comprises a chemical ablation agent, a non-steroidal anti-inflammatory drug, an oral contraceptive, a GnRH agonist, an antiprogestogen, or a selective progesterone receptor modulator.
17. The method of claim 16 , wherein said composition comprises a chemical ablation agent.
18. The method of claim 17 , wherein said chemical ablation agent is a salt.
19. The method of claim 17 , wherein said chemical ablation agent is selected from an enzyme, an acid, a base and an oxidizing agent.
20. The method of claim 1 , wherein said composition comprises one or more uterine fibroid treatment agents.
21. The method of claim 1 , wherein said composition is a solid dosage form having a largest dimension between 1 mm and 20 mm.
22. The method of claim 1 , wherein said composition is delivered through a delivery channel into said fibroid, wherein the delivery channel is in a needle, syringe, cannula, catheter or jet injector.
23. The method of claim 1 , wherein said composition is encapsulated.
24. The method of claim 1 , wherein said composition is a powder.
25. The method of claim 24 , wherein said powder is introduced into said fibroid by jet injection.
26. The method of claim 1 , wherein the composition further comprises a viscosity adjusting agent is present in an amount effective to provide a viscosity ranging from 10,000 centipoise to 50,000 centipoise.
27. The method of claim 1 , wherein said composition is a fluid formulation that is crosslinked in vivo.
28. The method of claim 1 , wherein said composition comprises an alginate polymer.
29. The method of claim 1 , wherein said composition comprises gelatin.
30. The method of claim 1 , wherein the composition provides sustained release of an amount of said collagenase sufficient to treat said uterine fibroids.
31. The method of claim 1 , wherein 100 μL of said composition is injected or inserted into 1 cm 3 uterine fibroid tissue.
32. A method for the treatment of uterine fibroids in a patient, comprising administering into the uterine fibroid a composition comprising an amount of collagenase from Clostridium histolyticum sufficient to cleave disordered collagen fibrils of types I, III and V in said uterine fibroids, wherein said amount is 0.25-2.0 mg/mL collagenase from Clostridium histolyticum , and wherein said administering is by injecting or inserting said composition into the uterine fibroid tissue.
33. The method of claim 32 , wherein said composition comprises 0.25 mg/mL collagenase from Clostridium histolyticum.
34. The method of claim 32 , wherein said composition comprises 0.5 mg/mL collagenase from Clostridium histolyticum.
35. The method of claim 32 , wherein said composition comprises 1.0 mg/mL collagenase from Clostridium histolyticum.
36. The method of claim 32 , wherein said composition comprises 2.0 mg/mL collagenase from Clostridium histolyticum.