Cell-support matrix having narrowly defined uniformly vertically and non-randomly organized porosity and pore density and a method for preparation thereof

Inventors

Smith, Robert LaneTarrant, Laurence J. B.Kusanagi, AkihikoCLAESSON, HANS P. I.

Assignees

Ocugen Inc

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Publication Number

US-12344860-B2

Patent

Publication Date

2025-07-01

Expiration Date


Abstract

A cell-support matrix having narrowly defined uniformly vertically and non-randomly organized porosity and pore density and a method for preparation thereof. The matrix suitable for preparation of cellular or acellular implants for growth and de novo formation of an articular hyaline-like cartilage. A gel-matrix composite system comprising collagen-based matrix having a narrowly defined porosity capable of inducing hyaline-like cartilage production from chondrocytes in vivo and in vitro.

Core Innovation

The invention relates to a collagen-based cell-support matrix having uniformly vertically oriented, non-random porosity with substantially homogeneous pore size and a defined pore density. The porosity is determined by the pore size, and the pore size is substantially homogeneous in diameter. The matrix is formed as a gel-matrix composite system that creates sterically stable scaffolds.

The collagen-based cell-support matrix is prepared from collagen-based biocompatible material and forms a gel-matrix composite system that induces glycosaminoglycan and Type II collagen deposition. The matrix is described as supporting de novo hyaline or hyaline-like cartilage formation, including in vitro and in vivo cartilage repair or implant applications.

The invention further includes a defined set of pore characteristics intended to increase biological deposition and support cartilage formation. Comparative results are reported showing increased S-GAG and DNA with smaller vs larger pore sizes, aligned with the substantially homogeneous pore size concept, and the document also reports high chondrocyte viability.

Claims Coverage

The partial claims provided include two independent claims. Across these independents, the inventive coverage centers on a collagen-based matrix with narrowly defined, uniformly vertically and non-randomly organized porosity, with pore size determining the porosity and a substantially homogeneous pore size characterized by quantitative ranges and homogeneity.

Narrowly defined, uniformly vertically organized non-random porosity with substantially homogeneous pore size

A collagen-based cell-support matrix having narrowly defined and uniformly vertically and non-randomly organized porosity and pore density wherein said matrix is prepared from a collagen-based biocompatible material, wherein said porosity is determined by pore size and wherein said pore size is substantially homogeneous in diameter.

Type I collagen matrix with pore size about 200–1100 microns and about 95% homogeneous pore size

A collagen-based support matrix having narrowly defined and uniformly vertically and non-randomly organized porosity and pore density wherein said matrix is prepared from a Type I collagen, wherein said porosity is determined by the pore size of about 200–1100 microns and wherein said pore size is about 95% homogeneous.

Overall, the independent claims define collagen-based matrices where porosity and pore density are tightly controlled by uniformly vertically organized non-random porosity and substantially homogeneous pore size, with Type I collagen and quantitative pore-size and homogeneity parameters in one claim.

Stated Advantages

Increased S-GAG and DNA with smaller vs larger pore sizes.

Supports de novo hyaline or hyaline-like cartilage formation.

Reports high chondrocyte viability (98–99%).

Documented Applications

In vitro and in vivo articular cartilage repair or implant applications based on induced glycosaminoglycan and Type II collagen deposition and de novo hyaline or hyaline-like cartilage formation.

In vitro production of hyaline or hyaline-like cartilage, tendon, ligament or meniscus using the matrix.

A cellular or acellular implant for treatment and repair of articular cartilage injuries or damage.

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