US2008038314A1PendingUtilityA1

Compositions and methods for the treatment and repair of defects or lesions in articular cartilage using synovial-derived tissue or cells

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Individually held — no corporate assignee on recordPriority: Jan 30, 2001Filed: Oct 12, 2007Published: Feb 14, 2008
Est. expiryJan 30, 2021(expired)· nominal 20-yr term from priority
Inventors:Ernst B. Hunziker
A61L 27/3604A61F 2002/4635A61K 38/1841A61L 27/3852A61F 2002/30677A61F 2002/30761A61K 35/32C12N 5/0655A61K 35/12A61P 19/02A61F 2002/2817A61F 2210/0004C12N 2533/56A61L 27/3683A61L 27/3804A61F 2002/30062A61P 19/04A61L 27/3817A61K 38/51A61L 27/3654A61K 38/1875A61L 27/3612A61P 19/00A61K 38/18
62
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Claims

Abstract

Compositions and methods are provided for treatment of cartilage defects in animals and humans. The compositions of the invention include synovial tissue, synovial cells and matrices containing synovial (or cambium) tissue or cells for use in filling a cartilage defect. The matrix and synovial tissue or cell preparations may also contain a proliferation agent, transforming factor or other active agents to promote healing. A controlled-release delivery system may be used to administer the transforming factor. The compositions of the invention also include a synovial covering membrane or devitalized fascial sheet for covering the cartilage defect. The methods of this invention are those in which a minimally invasive surgical intervention is performed to remove a small portion of synovial membrane from a joint. Portions of the synovial membrane, or cells expanded in vitro, are implanted alone or within a matrix, into the defect site, where they produce new cartilage tissue and repair the defect. Alternatively, partially transformed synovial-derived tissue may be formed in situ and implanted into the defect site.

Claims

exact text as granted — not AI-modified
1 . A method for treating an articular cartilage defect in an animal, including a human, comprising: 
 removing a portion of synovial membrane tissue from the animal; and    filling the cartilage defect with the synovial membrane tissue.    
     
     
         2 . The method of  claim 1 , wherein said synovial membrane tissue is mixed with a biodegradable matrix, and both materials are implanted in the defect.  
     
     
         3 . A method for treating an articular cartilage defect in an animal, including a human, comprising: 
 removing pieces of synovial membrane tissue from the animal;    adding to the pieces of synovial membrane tissue an effective amount of a transforming factor capable of transforming the synovial cells in the synovial membrane tissue into chondrocytes; and    filling the articular cartilage defect with the transforming factor and the pieces of synovial membrane tissue.    
     
     
         4 . The method of  claim 3 , wherein the transforming factor is selected from the group consisting of TGF-β's, BMP's, CDMP, IHH, SHH and SOX-9.  
     
     
         5 . The method of any one of claims  1 - 3 , further comprising the step of: 
 transfecting cells present within the synovial membrane tissue with one or more chondrogenic genes selected from the group consisting of BMP, BMP-2, BMP-9, TGF-β, CDMP, IHH, SHH and SOX-9, wherein said transfection results in the production of one or more transforming factors that effect transformation of synovial cells into chondrocytes.    
     
     
         6 . The method of  claim 3 , wherein the transforming factor is associated with a controlled-release delivery system.  
     
     
         7 . The method of  claim 6 , wherein the controlled-release delivery system is selected from the group consisting of liposomes, microspheres, bioerodible polymers, collagen fibers chemically linked to heparin sulfate proteoglycans, and carbohydrate-based corpuscles.  
     
     
         8 . The method of any one of claims  1  and  3 , wherein a synovial covering membrane is used to cover the defect.  
     
     
         9 . The method of  claim 8  wherein the synovial covering membrane is partially devitalized prior to use.  
     
     
         10 . The method of any one of claims  1  and  3 , further comprising treating the defect site with a mineralization inhibitor.  
     
     
         11 . The method of any one of claims  1  and  3 , further comprising treating the defect site with a calcification inhibitor.  
     
     
         12 . A composition for the treatment of articular cartilage defects comprising: 
 a biodegradable matrix or matrix-forming material;    a preparation of pieces of synovial membrane tissue; and    an effective amount of a transforming factor to transform synovial cells in the synovial membrane tissue into chondrocytes.    
     
     
         13 . The composition of  claim 12 , wherein the transforming factor is selected from the group consisting of TGF-β's, BMP's, CDMP, IHH, SHH and SOX-9.  
     
     
         14 . The composition of  claim 12  further comprising an effective amount of a proliferation agent to stimulate proliferation of the synovial cells.  
     
     
         15 . The composition of  claim 12  further comprising an effective amount of an anti-angiogenic agent to prevent ingrowth of blood vessels and bone tissue formation in the cartilage defect.  
     
     
         16 . The composition of  claim 12 , further comprising an effective amount of a mineralization inhibitor.  
     
     
         17 . The composition of  claim 12 , further comprising an effective amount of a calcification inhibitor.  
     
     
         18 . The composition of  claim 12 , further comprising fibrin glue, transglutaminase or fibronectin, to enhance adhesion of the matrix to the defect site.  
     
     
         19 . A method for treating an articular cartilage defect in an animal, including a human, comprising: 
 filling the defect with a therapeutic preparation for repairing the defect; and    covering the defect with a synovial covering membrane.    
     
     
         20 . The method of  claim 19 , wherein the synovial covering membrane is autologous.  
     
     
         21 . The method of  claim 19 , wherein the synovial covering membrane is heterologous.  
     
     
         22 . The method of  claim 19  wherein an effective amount of a transforming factor is present with the synovial covering membrane to promote transformation of synovial cells within the synovial covering membrane into chondrocytes.  
     
     
         23 . The method of  claim 19 , wherein the synovial covering membrane is partially devitalized prior to use.  
     
     
         24 . The method of  claim 22  wherein the transforming factor is selected from the group consisting of TGF-β's, BMP's, CDMP, IHH, SHH and SOX-9.  
     
     
         25 . A composition for the treatment of defects in cartilage comprising a synovial covering membrane.  
     
     
         26 . The composition of  claim 25 , further comprising an effective amount of a transforming factor to promote transformation of synovial cells into chondrocytes.  
     
     
         27 . The composition of  claim 26 , wherein the transforming factor is selected from the group consisting of TGF-β's, BMP's, CDMP, IHH, SHH and SOX-9.  
     
     
         28 . The composition of  claim 25 , wherein the synovial covering membrane is partially devitalized prior to use.  
     
     
         29 . The method of any one of claims  1  and  3 , further comprising treating the defect with an agent to degrade proteoglycans on the surface of the defect and removing the agent prior to the step of filling the defect.  
     
     
         30 . The method of  claim 29  wherein the agent to degrade proteoglycans is chondroitinase AC.  
     
     
         31 . The method of  claim 2 , wherein the matrix is selected from the group consisting of fibrin, collagen, gelatin, agarose, and combinations thereof.  
     
     
         32 . The method of  claim 8 , wherein sutures soaked in a transforming factor are used to attach the covering membrane to the defect border.  
     
     
         33 . A method for treating an articular cartilage defect in an animal, including a human, comprising filling the defect with autologous synovial membrane tissue and covering the defect with an autologous synovial covering membrane.  
     
     
         34 . The method of  claim 33 , wherein an effective amount of a transforming factor is present with the autologous synovial membrane to promote transformation of synovial cells within the synovial membrane into chondrocytes.  
     
     
         35 . The method of  claim 19 , wherein sutures soaked in a transforming factor are used to attach the covering membrane to the defect border.

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