Cell-support matrix having narrowly defined uniformly vertically and non-randomly organized porosity and pore density and a method for preparation thereof
Inventors
Smith, R. Lane • Tarrant, Laurence J. B. • Kusanagi, Akihiko • CLAESSON, HANS P. I.
Assignees
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Publication Number
US-9701940-B2
Publication Date
2017-07-11
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 an implant comprising a collagen scaffold with pores and a suspension of chondrocytes seeded into the scaffold. The collagen scaffold has a basal surface and an apical surface, each with openings to the pores, and at least 85% of the pores in the scaffold are vertically oriented.
The scaffold is described as non-random and uniformly distributed, with pore homogeneity at or above 85%, preferably 95–99%. In preferred embodiments, the pore openings are defined to have diameters centered around about 200–1100 μm, often about 200–150 μm, and pore density is also specified.
Using the vertically oriented, uniformly distributed pore structure, the implant is described as enabling de novo formation of hyaline or hyaline-like cartilage in vitro and in vivo. Reported results indicate increased S-GAG accumulation with time, significant differences in extracellular matrix production depending on pore size, and high chondrocyte viability of about 98–99%.
Claims Coverage
The partial claim set includes one independent claim. The independent claim covers a porous collagen scaffold with basal and apical pore openings, vertically oriented pores (at least 85%), and chondrocyte seeding via a chondrocyte suspension; dependent claims further specify pore-opening diameter ranges, pore density, tightened vertical orientation percentages, collagen formulation, and polymerizing the scaffold in the presence of ammonia vapor.
Vertically oriented porous collagen scaffold with basal and apical pore openings
A collagen scaffold comprising pores, having a basal surface and an apical surface each with openings to the pores, wherein at least 85% of the pores in the scaffold are vertically oriented.
Chondrocyte-seeded scaffold implant
An implant comprising a suspension of chondrocytes seeded into the scaffold.
Apical pore openings with 200–1100 μm diameter criteria
At least 85% of the openings on the apical surface have a diameter of 200–1100 micrometers.
Apical pore density constraint
The apical surface has a pore density of 25–10 pores per mm2.
Basal and apical openings with tightened 200–1100 μm diameter criteria
At least 95% of the basal and apical openings have diameters of 200–1100 micrometers.
Polymerizing collagen solution in the presence of ammonia vapor
The scaffold is formed by polymerizing a collagen solution in the presence of ammonia vapor.
Chondrocyte suspension cell concentration range
The collagen chondrocyte suspension has a concentration of 1 million to 12 million chondrocyte cells per mL of collagen solution.
Overall, the claim coverage centers on an implant that combines a vertically oriented porous collagen scaffold with basal and apical pore openings and at least 85% vertically oriented pores, together with a chondrocyte suspension seeded into the scaffold, with dependent refinements specifying pore-opening dimensions, pore density, and scaffold formation in the presence of ammonia vapor.
Stated Advantages
Increased S-GAG accumulation with time.
Significant differences in extracellular matrix production depending on pore size (small vs large pores).
High chondrocyte viability (about 98–99%).
Supports de novo formation of hyaline or hyaline-like cartilage in vitro and in vivo.
Documented Applications
De novo formation of hyaline or hyaline-like cartilage in vitro.
De novo formation of hyaline or hyaline-like cartilage in vivo.
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