Preparation of tissue for meniscal implantation
Inventors
Ingham, Eileen • Fisher, John • Stapleton, Thomas • Ingram, Joanne
Assignees
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Publication Number
US-8956411-B2
Publication Date
2015-02-17
Expiration Date
Abstract
The present invention relates to a method of preparing a tissue matrix and its subsequent use in the replacement and/or repair of a damaged or defective meniscus. The invention also provides meniscal tissue that is substantially decellularised.
Core Innovation
The invention provides a method of preparing donor meniscal tissue for subsequent implantation into a host. Frozen meniscal tissue is thawed and incubated in a hypotonic solution, followed by incubation in a hypotonic solution comprising an anionic detergent. The method repeats the hypotonic incubations, then incubates the tissue in a solution comprising at least one nuclease enzyme, and washes the tissue with an oxidising agent.
The method produces meniscal tissue that is devoid of cells in the central area of the meniscal tissue while retaining its original histoarchitecture. In an additional aspect, the method includes ultrasonicating the tissue in a buffered solution before repeating cycles of freezing and thawing, while maintaining the central-area cell-devoid state and original histoarchitecture.
The invention also encompasses a meniscal transplantation product defined by being devoid of cells in the central area of the meniscal tissue and retaining its original histoarchitecture. In further definitions, the transplantation product can be characterized by gDNA content constraints and by being up to 35 mm in thickness, where “absence” means 100% free of cells and “substantial absence” means at least 90% free of cells.
Claims Coverage
The document contains four independent claims. Across these independent claims, the inventive features focus on achieving a central-area cell-devoid meniscal tissue while retaining original histoarchitecture, using hypotonic incubations, an anionic detergent, nuclease enzyme incubation, and oxidising-agent washing, with one method adding ultrasonicating and repeated freezing/thawing cycles and the product claims defining cellular absence, thickness, and quantified absence definitions.
Sequential hypotonic and detergent incubation followed by nuclease and oxidising-agent washing
A method of preparing donor meniscal tissue by thawing frozen meniscal tissue, incubating in a hypotonic solution, incubating in a hypotonic solution comprising an anionic detergent, repeating the hypotonic incubations, incubating in a solution comprising at least one nuclease enzyme, and washing with an oxidising agent, wherein the meniscal tissue is devoid of cells in the central area and retains its original histoarchitecture.
Ultrasonicating plus repeated freeze-thaw cycles with hypotonic detergent incubation, nuclease incubation, and oxidising-agent washing
A method of preparing donor meniscal tissue comprising ultrasonicating the tissue in a buffered solution, repeating cycles of freezing and thawing the tissue, incubating in a hypotonic solution, incubating in a hypotonic solution comprising an anionic detergent, repeating the hypotonic incubations, incubating in a solution comprising at least one nuclease enzyme, and washing the tissue with an oxidising agent, wherein the meniscal tissue is devoid of cells in the central area and retains its original histoarchitecture.
Cell-devoid central-area meniscal transplantation product retaining original histoarchitecture
A meniscal transplantation product that is devoid of cells in the central area of the meniscal tissue and retains its original histoarchitecture.
Thickness-limited cell-absence/substantial-absence central-area meniscal transplantation product retaining original histoarchitecture
A meniscal transplantation product up to 35 mm in thickness having an absence or substantial absence of cells in the central area and retaining its original histoarchitecture, wherein absence means the tissue is 100% free of cells and substantial absence means the tissue is at least 90% free of cells.
Overall, the independent claims define two preparation workflows that converge on a central-area cell-devoid state with preserved original histoarchitecture and two transplantation products defined by central-area cellular absence, with one product further limited by thickness and quantified absence definitions.
Stated Advantages
Produces meniscal tissue that is devoid of cells in the central area of the meniscal tissue.
Retains the tissue’s original histoarchitecture.
Produces a meniscal transplantation product meeting defined cell-devoid or absence/substantial-absence criteria in the central area.
Supports product definitions with quantitative genomic DNA content constraints.
Documented Applications
A treatment method for an individual needing a meniscal transplant, comprising replacing a defective or damaged meniscus with the prepared product.
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