Platelet-derived growth factor compositions and methods for the treatment of tendon and ligament injuries
View Patent ↗The invention provides compositions and methods for treatment of tendon and ligament injuries and/or repair of damaged tendons and ligament. The invention provides compositions comprising a biocompatible matrix and platelet-derived growth factor (PDGF).
1. A method for treatment of a ligament injury not involving a bone in an individual comprising administering to an affected site of the injury of the individual an effective amount of a composition comprising at the time of administration: a solution of platelet-derived growth factor (PDGF) at a concentration of 0.1 to 2.0 mg/mL disposed in a biocompatible collagen matrix, wherein the biocompatible matrix comprises pores, wherein the biocompatible matrix has a porosity of at least 80%, and wherein at least 50% of the PDGF is released within 24 hours.
2. The method of claim 1 , wherein the biocompatible matrix has a porosity of at least 85%.
3. The method of claim 1 , wherein the biocompatible matrix has a porosity of at least 90%.
4. The method of claim 1 , wherein the biocompatible matrix has a porosity of at least 92%.
5. The method of claim 1 , wherein the biocompatible matrix has a porosity of at least 95%.
6. The method of claim 1 , wherein the pores have an average area ranging from 2500 μm 2 to 20,000 μm 2 .
7. The method of claim 1 , wherein the pores have an average perimeter ranging from 200 μm to 600 μm.
8. The method of claim 1 , wherein the pores have diameters ranging from 1 μm to 1 mm.
9. The method of claim 8 , wherein the pores have diameters ranging from 5 μm to 1 mm.
10. The method of claim 1 , wherein the pores are interconnected pores.
11. The method of claim 1 , wherein at least 60% of the PDGF is released within 24 hours.
12. The method of claim 1 , wherein at least 70% of the PDGF is released within 24 hours.
13. The method of claim 1 , wherein at least 80% of the PDGF is released within 24 hours.
14. The method of claim 1 , wherein the biocompatible matrix is resorbed within 21 days of in vivo administration.
15. The method of claim 1 , wherein the biocompatible matrix is resorbed within 18 days of in vivo administration.
16. The method of claim 1 , wherein the biocompatible matrix is resorbed within 15 days of in vivo administration.
17. The method of claim 1 , wherein the biocompatible collagen matrix comprises bovine type I collagen.
18. The method of claim 1 , wherein the collagen is soluble.
19. The method of claim 1 , wherein the collagen is cross-linked.
20. The method of claim 1 , wherein the biocompatible matrix further comprises a glycosaminoglycan.
21. The method of claim 20 , wherein the glycosaminoglycan is chondroitin sulfate.
22. The method of claim 1 , wherein the composition is a gel, particle, powder, sheet, pad, paste, patch, or sponge.
23. The method of claim 1 , wherein the composition is flowable.
24. The method of claim 1 , wherein the concentration of PDGF in the solution is 0.1 mg/ml to 0.4 mg/ml.
25. The method of claim 1 , wherein the concentration of PDGF in the solution is 0.9 mg/ml to 1.5 mg/ml.
26. The method of claim 1 , wherein cells infiltrate the composition within 4 days after exposure to the composition.
27. The method of claim 1 , wherein the method further comprising a step of stabilizing the ligament injury comprises suturing the ligament injury, whereby the sutured ligament is positioned such that the ends of the injured ligament are substantially re-approximated.
28. The method of claim 1 , wherein the step of administering comprises administering to the affected site of the injury of said individual the effective amount of the composition using a syringe.
29. The method of claim 1 , wherein the ligament is selected from the group consisting of anterior cruciate ligament, lateral collateral ligament, posterior cruciate ligament, medial collateral ligament, cranial cruciate ligament, caudal cruciate ligament, cricothyroid ligament, periodontal ligament, suspensory ligament of the lens, anterior sacroiliac ligament, posterior sacroiliac ligament, sacrotuberous ligament, sacrospinous ligament, inferior pubic ligament, superior pubic ligament, suspensory ligament, palmar radiocarpal ligament, dorsal radiocarpal ligament, ulnar collateral ligament, and radial collateral ligament.
30. The method of claim 1 , wherein the ligament injury is ligament rupture, severance, tearing, delamination, strain, or deformation.