Compositions and methods for treating rotator cuff injuries
View Patent ↗The present invention provides compositions and methods for attaching tendon to bone. The present invention provides compositions and methods for treating rotator cuff injuries. In one embodiment, a method for treating rotator cuff injuries comprises providing a composition comprising PDGF disposed in a biocompatible matrix and applying the composition to at least one site of tendon reattachment on the humeral head.
1. A method for treating damaged or injured tissue comprising:
providing a composition consisting essentially of a scaffolding material having a solution consisting essentially of of platelet-derived growth factor_(PDGF) and a buffer disposed therein, the scaffolding material consisting essentially of i) collagen or ii) collagen and a biocompatible binder, the scaffolding material having a porosity of at least 25%, and the solution having a PDGF concentration ranging from about 0.05 to about 5.0 mg/mL, and
applying the composition to the damaged or injured tissue.
2. The method of claim 1 , further comprising debriding non-viable tissue prior to applying the composition to the damaged or injured tissue.
3. The method of claim 1 , wherein the total amount of PDGF applied to the tissue during a treatment period ranges from about 1 μg to about 50 mg.
4. The method of claim 1 , wherein the total amount of PDGF applied to the tissue during a treatment period ranges from about 10 μg to about 25 mg.
5. The method of claim 1 , wherein the total amount of PDGF applied to the tissue during a treatment period ranges from about 100 μg to about 10 mg.
6. The method of claim 1 , wherein the scaffolding material provides a framework for new tissue growth to occur.
7. The method of claim 1 , wherein the collagen is a collagen patch, pad, gel or paste.
8. The method of claim 1 , wherein the collagen is a collagen patch or pad.
9. The composition of claim 1 , wherein the collagen is a type I, type II or type III bovine collagen.
10. The method of claim 1 , wherein the collagen is soluble type I bovine collagen.
11. The method of claim 1 , wherein the collagen has a density ranging from about 0.75 g/cm3 to about 1.5 g/cm3.
12. The method of claim 1 , wherein the collagen has a wet tear strength ranging from about 0.75 pounds to about 5 pounds.
13. The method of claim 1 , wherein the collagen is capable of absorbing water in an amount ranging from about 1× to 15× the mass of the collagen.
14. The method of claim 1 , wherein the solution has a PDGF concentration ranging from about 0.1 to about 1.0 mg/mL.
15. The method of claim 1 , wherein the solution has a PDGF concentration ranging from about 0.2 to about 0.4 mg/mL.
16. The method of claim 1 , wherein the solution has a PDGF concentration of about 0.3 mg/mL.
17. The method of claim 1 , wherein the scaffolding material comprises pores having a size distribution between about 1 microns to about 1,000 microns.
18. The method of claim 1 , wherein the PDGF solution is disposed within the pores of the scaffolding material.
19. The method of claim 1 , wherein the biocompatible binder is selected from the group consisting of alginic acid, arabic gum, guar gum, xantham gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N,O-carboxymethyl chitosan, α-cyclodextrin, β-cyclodextrin, Υ-cyclodextrin, sodium dextran sulfate, fibrin glue, lecithin, phosphatidylcholine derivatives, glycerol, hyaluronic acid, sodium hyaluronate, methylcellulose, carboxymethylcellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, a glucosamine, a proteoglycan, a starch, lactic acid, a pluronic acid, sodium glycerophosphate, glycogen, a keratin, silk, and derivatives and mixtures thereof.
20. The method of claim 1 , wherein the PDGF is PDGF-BB.
21. The method of claim 1 , wherein the PDGF is recombinant human (rh) PDGF-BB.
22. The method of claim 1 , wherein the buffer is sodium acetate.
23. The method of claim 1 , wherein the PDGF comprises a combination of intact rhPDGF-B (1-109) and fragments thereof.
24. The method of claim 1 , wherein the PDGF comprises at least 65% of intact rhPDGF-B (1-109).
25. The method of claim 1 , wherein the damaged or injured tissue is a soft tissue.
26. The method of claim 1 , wherein the damaged or injured tissue is a wound.
27. A method for treating damaged or injured tissue comprising:
providing a composition consisting of a scaffolding material having a solution consisting of of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) disposed therein, wherein the scaffolding material is a porous collagen patch or pad, the scaffolding having a porosity of at least 25%, and the solution has an rhPDGF-BB and a buffer concentration ranging from about 0.1 to about 1.0 mg/mL in a buffer, and
applying the composition to the damaged or injured tissue.