| Biocompatible tissue sealant for treatment of osteochondral and bone defects using an acellular matrix implant -> Monitor Keywords |
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  Biocompatible tissue sealant for treatment of osteochondral and bone defects using an acellular matrix implantRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Enzyme Or Coenzyme ContainingThe Patent Description & Claims data below is from USPTO Patent Application 20060083729. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This application is based on and claims priority of the Provisional Application Ser. No. 60/496,971, filed Aug. 20, 2003, which is incorporated herein by reference. BACKGROUND OF THE INVENTION Field of Invention [0002] The current invention concerns acellular matrix implants and compositions for treatment of articular cartilage, bone or osteochondral defects and injuries and a method for treatment of such osteochondral defects and/or injured, damaged, diseased or aged articular cartilage or bone using an acellular matrix implant implanted into a joint cartilage lesion and/or into the osteochondral defect in situ wherein the osteochondral or bone defect is further implanted with a bone inducing composition or a carrier comprising said composition. The acellular matrix implant of the invention comprises a two or three dimensional biodegradable scaffold structure implanted into the joint cartilage lesion typically below or over one, two or several layers, or between two layers of biologically acceptable sealants. The implant and the method are particularly useful for repair and restoration of function of the injured or traumatized articular cartilage, bone or osteochondral defects of younger individuals. In particular, the invention concerns a method where the implantation of the acellular matrix implant of the invention initiates and achieves natural healing of the cartilage by activation and migration of chondrocytes from a native, surrounding cartilage into the cartilage defect and/or by inducing bone formation by depositing a bone inducing composition into the osteochondral and/or bone defect in conjunction with the acellular matrix implant or without the implant. [0003] The method further concerns a formation of a new superficial cartilage layer overgrowing and sealing the lesion in the joint cartilage by applying a top sealant over the cartilage lesion as well as insulation of the lesion from the cell and blood debris, by applying a bottom sealant. Such formation of the superficial cartilage layer is also applicable to osteochondral cartilage and bone lesions where the bottom sealant is used for sealing and separating the cartilage and bone lesions and the top sealant is used to form the superficial cartilage layer. [0004] The method for treatment of articular cartilage comprises preparation of the acellular implant, preparation of the lesion for implantation of said implant including a step of depositing a bottom sealant at the bottom of the cartilage lesion for sealing the joint cartilage lesion and protecting the implant from effects of blood-borne agents, implanting the implant of the invention into the lesion and depositing the top sealant over the implant. The method for treatment of osteochondral defects additionally typically comprises depositing a bone inducing composition or a carrier comprising said composition into the bone lesion wherein said bone lesion is covered by the bottom sealant thereby separating said bone and cartilage lesions. The method for treatment of bone defects comprises depositing the bone inducing composition or a carrier comprising said composition in a bone lesion which may optionally be lined with or covered with a bottom or top sealant. [0005] The invention further concerns a method for repair and restoration of the injured, damaged, diseased or aged cartilage or bone into its full functionality and for treatment of injured cartilage by implanting the acellular matrix implant into the cartilage lesion between two or more layers of biologically acceptable sealants and/or depositing the bone inducing composition or a carrier comprising said composition into the bone lesion, covering said bone inducing composition or a carrier comprising said composition with the bottom sealant, depositing the acellular matrix implant into the cartilage lesion and covering said implant with the top sealant. [0006] Additionally, the invention concerns a method for fabrication of an acellular implant of the invention for use in treatment of cartilage defects and for preparation of a bone inducing composition or a carrier comprising said composition for use in treatment of bone or osteochondral defects. BACKGROUND AND RELATED DISCLOSURES [0007] Damage to the articular cartilage which occurs in active individuals and older generation adults as a result of either acute or repetitive traumatic injury or aging is quite common. Such damaged cartilage leads to pain, affects mobility and results in debilitating disability. [0008] Typical treatment choices, depending on lesion and symptom severity, are the rest and other conservative treatments, minor arthroscopic surgery to clean up and smooth the surface of the damaged cartilage area, and other surgical procedures such as microfracture, drilling, and abrasion. All of these may provide symptomatic relief, but the benefit is usually only temporary, especially if the person's pre-injury activity level is maintained. For example, severe and chronic forms of knee joint cartilage damage can lead to greater deterioration of the joint cartilage and may eventually lead to a total knee joint replacement. Nowadays, approximately 200,000 total knee replacement operations are performed annually. The artificial joint generally lasts only 10 to 15 years and the operation is, therefore, typically not recommended for people under the age of fifty. [0009] Osteochondral diseases or injuries, which are a combination lesions of bone and cartilage, present yet another challenge for a treatment of which need is not being met by the currently available procedures and methods. For example, treatment of osteochondritis dissecans with autologous chondrocyte transplantation, described in J. Bone and Joint Surgery, 85A-Supplement 2: 17-24 (2003), requires multiple surgeries and at least three weeks for cell cultivation and growth. [0010] It would, therefore, be extremely advantageous to have available a method for in situ treatment of these injuries which would effectively restore the cartilage or bone to its pre-injury state during one surgery and with minimal time needed for recovery, which treatment would be especially suitable for younger individuals who are more active and have better recovery capabilities. [0011] Attempts to provide means and methods for repair of articular cartilage are disclosed, for example, in U.S. Pat. Nos. 5,723,331; 5,786,217; 6,150,163; 6,294,202; 6,322,563 and in the U.S. patent application Ser. No. 09/896,912, filed on Jun. 29, 2001. [0012] U.S. Pat. No. 5,723,331 describes methods and compositions for preparation of synthetic cartilage for the repair of articular cartilage using ex vivo proliferated denuded chondrogenic cells seeded ex vivo, in the wells containing adhesive surface. These cells redifferentiate and begin to secrete cartilage-specific extracellular matrix thereby providing an unlimited amount of synthetic cartilage for surgical delivery to a site of the articular defect. [0013] U.S. Pat. No. 5,786,217 describes methods for preparing a multi-cell layered synthetic cartilage patch prepared essentially by the same method as described in '331 patent except that the denuded cells are non-differentiated, and culturing these cells for a time necessary for these cells to differentiate and form a multicell layered synthetic cartilage. [0014] U.S. application Ser. No. 09/896,912, filed on Jun. 29, 2001 concerns a method for repairing cartilage, meniscus, ligament, tendon, bone, skin, cornea, periodontal tissues, abscesses, resected tumors and ulcers by introducing into tissue a temperature dependent polymer gel in conjunction with at least one blood component which adheres to the tissue and promotes support for cell proliferation for repairing the tissue. [0015] U.S. patent application Ser. Nos. 10/104,677; 10/625,822; 10/625,245 and 10/626,459 filed on Jul. 22, 2003, by inventors, hereby incorporated by reference, disclose neo-cartilage constructs subjected to an algorithm of certain specific conditions suitable for repair of injured or damaged articular cartilage. [0016] None of the above cited references, however, results in repair and regeneration of cartilage or bone in situ without a need for several surgeries. [0017] It is thus a primary objective of this invention to provide a method and a means for treatment of injured or traumatized cartilage, bone or cartilage-bone defects by depositing at least two separate layers of biologically acceptable adhesive sealants thereby forming a cavity in the injured lesion of the cartilage and implanting an acellular implant into said cavity between these two layers and, additionally, by providing a bone inducing composition or a carrier comprising said composition containing bone inducing agents and implanting said composition into the bone lesion of the osteochondral defects followed by the implantation of the acellular matrix implant into the cartilage defect. The method according to the invention results in induction of chondrocyte activation and migration from the surrounding native cartilage into the acellular implant's matrix and in the growth of the superficial cartilage layer over the implant thereby sealing the lesion and, when used for treatment of osteochondral defects, in migration of osteoblast into the bone lesion and in healing of the bone defect as well as defect of the articular cartilage. [0018] All patents, patent applications and publications cited herein are hereby incorporated by reference. SUMMARY [0019] One aspect of the current invention is an acellular matrix implant for treatment of defects and injuries of articular cartilage. [0020] Another aspect of the current invention is an acellular matrix implant in combination with a bone inducing composition or a carrier comprising said composition for treatment of osteochondral defects and injuries. Continue reading... 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