In situ method for treatment and repair of meniscal injuries

• US 7,560,432 B2
• Filed: 11/23/2005
• Issued: 07/14/2009
• Est. Priority Date: 11/26/2003
• Status: Active Grant

• Current Assignee: Ocugen, Inc., Purpose Co., Ltd.
• Original Assignee: Histogenics Corporation (Ocugen, Inc.)
• Inventors: Schmidt, Mary Beth, Kusanagi, Akihiko, Tarrant, Laurence J. B.
• Primary Examiner(s): KAM, CHIH MIN
• Application Number:
  US11/285,928
• Publication Number:
  US 20060160734A1
• Time in Patent Office: 1,329 Days
• Field of Search: None
• US Class Current: 514/1.1
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

A method for in situ repair of meniscal injuries comprising induction of meniscal repair and regeneration by introducing an adhesive collagen-polyethylene glycol (PEG) hydrogel to a site of injury alone, supplemented with a synovial tissue or in conjunction with a support matrix.

Claims

1. A method for in situ treatment and repair of a meniscal injury, tear or lesion, said method comprising steps:

a) performing an arthroscopic surgical incision in a patient;

b) determining the size and extent of the meniscal injury, tear or lesion;

c) depositing into said meniscal injury, tear or lesion during said arthroscopic surgery an adhesive hydrogel complex consisting essentially of methylated collagen-polyethylene glycol by filling said injury, tear or lesion completely with said hydrogel complex;

d) allowing said hydrogel complex to gel, adhere to a surrounding meniscal tissue and to bond with said surrounding tissue,

wherein said gelled hydrogel complex bonds to the surrounding meniscal tissue and holds a torn area or lesion together during a period of healing and induces cell migration and extracellular matrix formation during such period of healing;

e) suturing the arthroscopic incision after gelling and adhering of said hydrogel to the surrounding tissue and bonding of said collagen matrix to said surrounding meniscal tissue; and

f) instructing the patient to begin to walk and exercise within a day or two days following the surgery.

2. The method of claim 1 wherein said meniscal injury, tear or lesion is in a white zone of the meniscus.

3. The method of claim 1 wherein the polyethylene glycol in said methylated collagen-polyethylene glycol is further derivatized with tetra-hydroxysuccinimidyl ester, tetra-thiol, or a combination thereof.

4. The method of claim 1 wherein said methylated collagen-polyethylene glycol hydrogel is supplemented with a minced synovial tissue.

5. The method of claim 1 wherein said hydrogel complex is deposited into said meniscal tear or lesion in a combination with a Type I collagen scaffold having horizontally positioned fibers.

6. The method of claim 5 wherein said hydrogel complex is further supplemented with fibroblasts, synovial tissue, autologous blot clot, a healing accelerator, a growth factor, platelet-derived growth factor (PDFG) or pleuropotent cells.

7. A method for in situ treatment and repair of a meniscal tear or lesion, said method comprising steps:

a) performing an arthroscopic surgical incision in a patient;

b) determining the size and extent of the meniscal injury, tear or lesion;

c) depositing into said meniscal injury, tear or lesion during said arthroscopic surgery a porous collagen matrix and applying an adhesive hydrogel complex around said collagen matrix to affix said matrix to the site of meniscal injury, tear or lesion and to a surrounding meniscal tissue,

wherein said adhesive hydrogel complex is consisting essentially of a methylated collagen-polyethylene glycol,

wherein said hydrogel complex is deposited either before or after depositing said collagen matrix into said tear or lesion, and

wherein said hydrogel complex binds said collagen matrix to a surrounding meniscal tissue;

d) allowing said hydrogel complex to gel, adhere to a surrounding meniscal tissue and to bond with said surrounding tissue,

wherein said gelled hydrogel complex bonded to the surrounding meniscal tissue holds a torn area or lesion together during a period of healing and induces cell migration and extracellular matrix formation during such period of healing;

e) suturing the arthroscopic incision after gelling and adhering of said hydrogel to the surrounding tissue and bonding of said collagen matrix to said surrounding meniscal tissue; and

f) instructing the patient to begin to walk and exercise within a day or two days following the surgery.

8. The method of claim 7 wherein said meniscal injury, tear or lesion is in a white zone of the meniscus.

9. The method of claim 8 wherein the polyethylene glycol in said methylated collagen-polyethylene glycol is further derivatized with tetra-hydroxysuccinimidyl ester, tetra-thiol, or a combination thereof.

10. The method of claim 9 wherein said support matrix is prepared from a Type I collagen, Type II collagen, Type IV collagen, collagen containing proteoglycan, collagen containing glycosaminoglycan, collagen containing glycoprotein, collagen containing fibronectin, collagen containing laminin, collagen containing a peptide growth factor, collagen containing cytokine, collagen containing elastin, collagen containing fibrin, collagen containing synthetic polymeric fiber made of polycaprolactone, polyamino acid, or polypeptide, or a combination thereof.

11. The method of claim 10 wherein said support matrix is prepared from Type I collagen as a porous collagen honeycomb, sponge or scaffold.

12. The method of claim 11 wherein said support matrix is the porous scaffold having horizontally positioned fibers.

13. The method of claim 12 wherein said hydrogel complex is further supplemented with fibroblasts, synovial tissue, autologous blot clot, a healing accelerator, a growth factor, platelet-derived growth factor (PDFG) or pleuropotent cells.