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Bioabsorbable implant of hyaluronic acid derivative for treatment of osteochondral and chondral defects

Inactive Publication Date: 2007-08-30
ANIKA THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007] The natural repair of osteochondral or chondral defects can be enhanced with a proper matrix that provides structural support and molecular cuing to stimulate repair. For example, in the current invention, subject's own cells, such as healthy cartilage cells or mesenchymal stem cells, can be harvested and impregnated in, or coupled to, the hyaluronic acid derivative or the hyaluronic acid derivative and one or more biocompatible, biodegradable supports. The hyaluronic acid derivative optionally together with the biocompatible support can provide structural support and molecular cuing for the impregnated or coupled cells to migrate, multiply and stimulate regeneration of cartilage. Likewise, the cellular growth and differentiation factors can be loaded into the matrix and provide additional molecular cuing for the cells to produce cartilage or bone tissue, or provide signals for the cells to differentiate down the chondrogenic or osteogenic lineage. The biocompatible, biodegradable support and / or hyaluronic acid derivative will be absorbed by the body while the cartilage tissue regeneration takes place. Thus, there is no need to remove the support and hyaluronic acid derivative from the subject after the regenerated articular cartilage restores its function, leaving no artificial materials at the treatment site.

Problems solved by technology

The repair of damaged articular cartilage represents one of the most challenging problems in orthopedics today.
When articular cartilage is damaged, it does not heal as rapidly or effectively as other tissues in the body.
Rather, the damage tends to spread and the bones may rub directly against each other, which results in pain, reduced mobility and loss of joint function.

Method used

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  • Bioabsorbable implant of hyaluronic acid derivative for treatment of osteochondral and chondral defects
  • Bioabsorbable implant of hyaluronic acid derivative for treatment of osteochondral and chondral defects
  • Bioabsorbable implant of hyaluronic acid derivative for treatment of osteochondral and chondral defects

Examples

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example 1

[0081] This example illustrates an embodiment of the invention in which a biscarbodiimide, p-phenylene-bis(ethylcarbodiimide), and HA are reacted at a molar equivalent ratio of 16.0%.

[0082] A solution of HA (5.4 mg / ml; 200-ml; 2.69 mequiv) was reacted with a solution of p-phenylene-bis(ethylcarbodiimide) (1 mg / ml in acetone; 46.1-ml; 0.215 mmol; 0.43 mequiv) according to a procedure described in U.S. Pat. Nos. 5,356,883, 5,502,081 and 6,013,679, the teachings of which are incorporated herein by reference in their entirety. The precipitate of the crosslinked HA was separated from the solution, washed, and resuspended in saline. The suspension was stirred for 2 days in a cold room to form a water-insoluble gel of about 4 mg / ml concentration. Chloroform equal to ½ of the volume of the aqueous solution was added to the solution and contents were vigorously stirred for seven days in the cold room. The reaction mixture was then centrifuged at 4° C. and 43 k rpm for one hour to remove chl...

example 2

[0083] This example illustrates an embodiment of the invention in which a biscarbodiimide, p-phenylene-bis(ethylcarbodiimide), and HA are reacted at a molar equivalent ratio of 8.0%.

[0084] A solution of HA (5.4 mg / ml; 200-ml; 2.69 mequiv) was reacted with a solution of p-phenylene-bis(ethylcarbodiimide) (1 mg / ml in acetone; 23.0-ml; 0.108 mmol; 0.216 mequiv) according to a procedure described in U.S. Pat. Nos. 5,356,883, 5,502,081 and 6,013,679, the teachings of which are incorporated herein by reference in their entirety. The precipitate of the crosslinked HA was separated from the solution, washed, and resuspended in saline. The suspension was stirred for 2 days in a cold room to form a water-insoluble gel of about 4 mg / ml concentration. Chloroform equal to ½ of the volume of the aqueous solution was added to the solution and contents were vigorously stirred for seven days in the cold room. The reaction mixture was then centrifuged at 4° C. and 43 k rpm for one hour to remove chl...

example 3

[0085] This example illustrates an embodiment of the invention in which a biscarbodiimide, p-phenylene-bis(ethylcarbodiimide), and HA are reacted at a molar equivalent ratio of 8.0% in MES buffer.

[0086] A solution of HA (15.0 mg / ml; 133.3-ml; 4.99 mequiv) in MES buffer (pH 5.5) was reacted with a solution of p-phenylene-bis(ethylcarbodiimide) (15 mg / ml in acetone; 2.8-ml; 0.2 mmol; 0.4 mequiv) according to a procedure described in U.S. Patent Application 2005 / 0136122 A1. The reaction mixture was thoroughly mixed (mixing with either a glass rod or an overhead mechanical stirrer, e.g., for about 1 minute, results in a white paste from the clear reaction mixture), and the mixture was allowed to stand at room temperature for about 96 hours. Sodium chloride (6.5 g, to make the mixture 5% by weight of sodium chloride) was mixed into the resulting gel, which was allowed to stand for 1 hour. The crosslinked HA gel was precipitated by addition into about 1.2 L of vigorously stirred ethanol....

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Abstract

A method for treating an osteochondral defect or a chondral defect in a subject includes implanting a composite in a site of the osteochondral or chondral defect. The composite includes a hyaluronic acid derivative; and at least one member of the group consisting of a cell, a cellular growth factor and a cellular differentiation factor, which is impregnated in, or coupled to, the hyaluronic acid derivative. In one embodiment, carboxyl functionalities of the hyaluronic acid derivative are each independently derivatized to include an N-acylurea or O-acyl isourea, or both N-acylurea and O-acyl isourea. In another embodiment, the hyaluronic acid derivative is prepared by reacting an uncrosslinked hyaluronic acid with a biscarbodimide in the presence of a pH buffer in a range of between about 4 and about 8. The composite can be used for regenerating or stimulating regeneration of meniscal tissues in a subject in need thereof.

Description

INCORPORATION BY REFERENCE [0001] This application claims the benefit of U.S. Provisional Application Nos. 60 / 751,237; 60 / 751,381; and 60 / 751,414, all of which were filed Dec. 14, 2005. The entire teachings of the above-mentioned applications are incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] Articular cartilage is an elastic tissue that covers the ends of bones in joints and enables the bones to move smoothly. The repair of damaged articular cartilage represents one of the most challenging problems in orthopedics today. When articular cartilage is damaged, it does not heal as rapidly or effectively as other tissues in the body. Rather, the damage tends to spread and the bones may rub directly against each other, which results in pain, reduced mobility and loss of joint function. [0003] Various therapeutic approaches to stimulate regeneration of articular cartilage and subchondral bone have been developed with varying degrees of success. Examples of such therape...

Claims

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Application Information

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IPC IPC(8): A61K48/00A61K35/12A61K31/728
CPCA61K9/0024C08L5/08A61K31/573A61K31/728A61K31/729A61K35/28A61K35/32A61K38/1841A61K47/36A61L27/20A61L27/227A61L27/3817A61L27/3834A61L27/3843A61L27/48A61L27/52A61L27/56A61L2430/06A61K9/06A61K2300/00A61P19/02A61K9/0019A61K45/06A61M5/178
Inventor SADOZAI, KHALID K.JOTH, CAROL A.SHERWOOD, CHARLES H.
Owner ANIKA THERAPEUTICS INC
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