Methods and compositions for regenerating connective tissue

Inactive Publication Date: 2005-06-02
ENCELLE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0024] According to another aspect of the present invention, the bioactive hydrogel matrix can be used for attaching or reattaching two or more connective tissues. In one embodiment of this aspect of the invention, the method comprises: coating at least a portion of at least one of a first and second connective tissue with a bioactive hydrogel matrix comprising a polypeptide and a long chain carbohydrate; contacting the first connective tissue to the second connective tissue at a point of attachment; and attaching the first connective tissue to the second connective tissue using sutures, staples or other appropriate means. Such a method is particularly useful for attaching connective tissue, such as tendon or ligament, to bone. The method is further useful for attaching soft connective tissue to other soft connective tissue, such as tendon to tendon or ligament to ligament.
[0025] According to another aspect of the invention, the bioactive hydrogel matrix is used in a method for treating degenerative diseases of the natural joint of a patient in need of treatment thereof. In one embodiment, the method comprises: applying

Problems solved by technology

Bone injuries beyond simple fractures, however, present greater challenges in treatment.
Such conditions often result in cavitation of the bone or complete loss of bone tissue across an extended length of the bone (i.e., a critical bone

Method used

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  • Methods and compositions for regenerating connective tissue
  • Methods and compositions for regenerating connective tissue
  • Methods and compositions for regenerating connective tissue

Examples

Experimental program
Comparison scheme
Effect test

example 1

Matrix Preparation

[0139] In one embodiment, the bioactive hydrogel matrix was compounded to yield a final formulation as described above in Table 1. Modified Medium 199 (2.282 L) was placed into a stirred beaker. To the beaker were added L-cysteine, L-glutamic acid, L-lysine, L-alanyl-L-glutamine, and EDTA. While stirring, the solution was heated to 50° C. Next, dextran was added, followed by the addition of gelatin. NaOH (10%) was used to adjust the pH of the matrix solution to a final pH of 7.50±0.05. Finally, additional L-glutamic acid, L-arginine, and L-cysteine were added followed by the addition of zinc sulfate. The amounts of each component used were the amounts necessary to bring the final concentration of each component to the preferred concentration provided in Table 1.

example 2

Effect of Bioactive Hydrogel Matrix on Critical Size Defect in Bone

[0140] The in vivo effect of the matrix on bone repair was examined using the critical size defect model in the rabbit ulna. A defect in a rabbit ulna was created in which the length of the defect was purposefully made to be three times the diameter of the bone, i.e., a 15 mm defect was created in each ulna (the diameter of the bone was approximately 4 mm). It is well documented in the literature that defects of this size will not spontaneously heal (i.e., a critical size defect). Seven rabbits had 15 mm defects surgically created in the ulna of each forelimb. Further, the periosteum of the radius parallel to the defect was scraped off. In each rabbit, the defect in one forelimb was treated with the bioactive hydrogel matrix, and the other was treated with a collagen sponge soaked with the bioactive hydrogel matrix. The muscle surrounding the bone defect was sutured closed and the limb tightly wrapped.

[0141] The fo...

example 3

Effect of Bioactive Hydrogel Matrix on Tendon Re-Growth and Strength

[0142] Four sheep had a 4 mm length of the central portion of the patellar tendon removed from the point of attachment of the tibia to the patella of one leg. A small block of the patella with the attached patellar tendon was also removed. The contra-lateral leg served as the unoperated control. Two defects were filled with a collagen sponge (DuraGen®, Integra LifeSciences) infiltrated with the bioactive hydrogel matrix of the invention, and two defects were filled with a DuraGen® collagen sponge infiltrated with saline. The implants were sutured into the patellar tendon defect and surgical site was sutured closed. After 12 weeks, the patellar tendons were removed for gross observation and mechanical testing for stiffness. The tendons treated with the bioactive hydrogel matrix appeared thicker than the control tendons. Further, the tendons treated with the bioactive hydrogel matrix had an average increase in stiffn...

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Abstract

Connective tissue regenerative compositions and methods of repairing and regenerating connective tissue using such compositions are provided. The compositions generally comprise a bioactive hydrogel matrix comprising a polypeptide, such as gelatin, and a long chain carbohydrate, such as dextran. The hydrogel matrix may further include polar amino acids, as well as additional beneficial additives. Advantageously, the compositions include further components, such as osteoinductive or osteoconductive materials, medicaments, stem or progenitor cells, and three-dimensional structural frameworks. The compositions are useful for regenerating connective tissue, and can be administered to an area having injury to, or a loss of, connective tissue, such as bone, cartilage, tendon, and ligament.

Description

CROSS-REFERENCE TO RELATED APPLICATION [0001] The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 60 / 513,392, filed Oct. 22, 2003, which is hereby incorporated by reference for all purposes.FIELD OF THE INVENTION [0002] The present invention is related to methods and compositions for regenerating connective tissue, such as bone, cartilage, ligament, tendon, and the like. In particular, the invention is related to methods for regenerating connective tissue through application of a hydrogel matrix, wherein the matrix is comprised of a polypeptide, such as gelatin, and a long chain carbohydrate, such as dextran. BACKGROUND OF THE INVENTION [0003] Injuries to bone, such as partial or complete fracture, can be slow to heal, but such injuries generally heal on their own accord with external immobilization as needed, such as by applying a cast to the affected area. In more severe cases, more aggressive internal immobilization, such as permanently reco...

Claims

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Application Information

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IPC IPC(8): A61K35/32A61K38/18A61K38/19A61K38/30A61K38/38A61K38/39A61K45/00A61L26/00A61L27/26A61L27/48A61L27/52
CPCA61K38/1875A61L26/0052A61L26/0057A61L26/008A61L27/26A61L27/48A61L27/3834A61L2430/10A61L27/52A61K35/32A61K38/014A61L27/3608C08L5/02A61K2300/00C08L89/06A61L27/3645A61P19/02A61P19/04A61P29/00A61P31/04A61P31/12A61P37/06A61P7/02
Inventor HILL, RONALD STEWARTKLANN, RICHARD CHRISLAMBERTI, FRANCIS V.
Owner ENCELLE INC
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