Compositions and methods for repairing cartilage defects
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Publication Number
US-11857576-B2
Publication Date
2024-01-02
Expiration Date
Abstract
The present disclosure provides compositions and methods for repairing cartilage defects.
Core Innovation
The invention provides a composition comprising cultured allogeneic cells comprising chondrocytes grown from a cryogenically frozen cell bank sample and a resorbable collagen membrane. The resorbable collagen membrane comprises a combination of type I and type III porcine collagen derived from porcine peritoneum, and the cultured allogeneic cells are seeded on the membrane at a density of at least 250,000 cells per cm2 in a monolayer.
A method of manufacturing an allogeneic cartilage matrix is also provided by thawing a cryogenically frozen cell bank sample comprising chondrocytes, culturing the cells of the sample, characterizing the sample, preparing a resorbable collagen membrane, seeding the membrane with the cultured cells, and packaging the membrane. Characterizing the sample comprises one or more control assays, including an agarose assay with an acceptance criterion comprising at least 6.8% of cells forming colonies for at least two divisions.
Further embodiments provide a composition where the resorbable collagen membrane is coated with a fibrin adhesive and the composition comprises at least one of a chondrocyte marker and a non-chondrocyte marker. The cultured allogeneic cells are dedifferentiated, with a fibroblastic phenotype, and are described as down regulating expression of a gene encoding ECM and/or producing and/or secreting a lesser amount of collagen and aggrecan.
Claims Coverage
The independent claims cover three inventive features: a composition of cryogenically bank-derived cultured dedifferentiated allogeneic chondrocytes seeded as a monolayer on a specific resorbable porcine collagen membrane, a manufacturing method for an allogeneic cartilage matrix using control assays with quantitative acceptance criteria, and a composition variant requiring a fibrin adhesive coating and marker inclusion.
Cryogenically bank-derived cultured allogeneic dedifferentiated chondrocytes on monolayer resorbable collagen membrane
A composition comprising cultured allogeneic cells comprising chondrocytes grown from a cryogenically frozen cell bank sample and a resorbable collagen membrane comprising a combination of type I and type III porcine collagen derived from porcine peritoneum, wherein the cultured allogeneic cells are seeded on the membrane at a density of at least 250,000 cells per cm2, arranged in a monolayer, and dedifferentiated.
Manufacturing an allogeneic cartilage matrix using control assays with agarose acceptance criterion
A method of manufacturing an allogeneic cartilage matrix comprising thawing a cryogenically frozen cell bank sample comprising chondrocytes, culturing the cells of the sample, characterizing the sample, preparing a resorbable collagen membrane, seeding the membrane with the cultured cells, and packaging the membrane, wherein characterizing the sample comprises one or more control assays including an agarose assay with an acceptance criterion comprising at least 6.8% of cells forming colonies for at least two divisions.
Fibrin adhesive-coated resorbable porcine collagen membrane with marker inclusion
A composition comprising cultured allogeneic cells comprising chondrocytes grown from a cryogenically frozen cell bank sample and a resorbable collagen membrane comprising a combination of type I and type III porcine collagen derived from porcine peritoneum, the membrane being coated with a fibrin adhesive, wherein the cultured allogeneic cells are seeded at a density of at least 250,000 cells per cm2, are dedifferentiated, and the composition comprises at least one of a chondrocyte marker and a non-chondrocyte marker.
Overall, the claims define compositions and manufacturing of an allogeneic cartilage matrix based on cryogenically frozen cell bank-derived cultured chondrocytes on a resorbable collagen membrane made from a type I/type III porcine collagen blend from porcine peritoneum, with monolayer arrangement, minimum seeding density, quantitative sample characterization, and an embodiment with fibrin adhesive coating and marker requirements.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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