SERICIN EXTRACTED SILKWORM FIBROIN FIBERS
The present invention provides a novel silk-fiber-based matrix having a wire-rope geometry for use in producing a ligament or tendon, particularly an anterior cruciate ligament, ex vivo for implantation into a recipient in need thereof. The invention further provides the novel silk-fiber-based matrix which is seeded with pluripotent cells that proliferate and differentiate on the matrix to form a ligament or tendon ex vivo. Also disclosed is a bioengineered ligament comprising the silk-fiber-based matrix seeded with pluripotent cells that proliferate and differentiate on the matrix to form the ligament or tendon. A method for producing a ligament or tendon ex vivo comprising the novel silk-fiber-based matrix is also disclosed.
1 . A composition comprising sericin-extracted silkworm fibroin fibers.
2 . The composition of claim 1 , wherein the composition supports the ingrowth of cells around the fibroin fibers.
3 . The composition of claim 1 , wherein the fibroin fibers are organized into one or more groups of fibers that are further organized into fiber bundles.
4 . The composition of claim 3 , wherein the fibroin fibers are organized into groups in a parallel, helical, braided or mesh-like organization.
5 . The composition of claim 3 , wherein the groups are organized into fibroin fibers in a parallel, helical, braided or mesh-like organization.
6 . The composition of claim 3 , wherein the fiber bundles are further organized into strands.
7 . The composition of claim 6 , wherein the fiber bundles are organized into the strands in a parallel, helical, braided or mesh-like organization.
8 . The composition of claim 6 , wherein the strands are further organized into cords.
9 . The composition of claim 8 , wherein the strands are organized into the cords in a parallel, helical, braided or mesh-like organization.
10 . The composition of claim 1 , further comprising one or more silk foams, films, meshes or sponges in the form of a composite with the fibroin fibers and.
11 . The composition of claim 1 , further comprising one or more degradable polymers selected from group consisting of collagens, polylactic acid or its copolymers, polyglycolic acid or its copolymers, polyanhydrides, elastin, glycosamino glycans, and polysaccharides, in the form of a composite with the fibroin fibers.
12 . The composition of claim 1 , further comprising cells.
13 . The composition of claim 12 , wherein the cells are stem cells, muscle cells, bone marrow stromal cells, pluripotent or fibroblast cells.
14 . The composition of claim 12 , wherein the cells are autologous.
15 . The composition of claim 12 , wherein the cells are allogeneic.
16 . The composition of claim 1 , further comprising a surface modification agent which enhances proliferation and differentiation of the cells on the matrix.
17 . The composition of claim 16 , wherein the surface modification agent comprises an arginine-glycine-aspartate peptide.
18 . The composition of claim 16 , wherein the surface modification agent comprises a growth factor.
19 . The composition of claim 1 wherein the fibroin fibers have a diameter ranging between 20 μm to 40 μm.
20 . A method for producing tissue in an individual, comprising implanting the composition of claim 1 at an anatomical location within the individual that provides the appropriate physiologic environment for the development of the tissue from the implanted composition.
21 . The method of claim 20 , wherein the tissue is connective tissue.
22 . The method of claim 21 , wherein the connective tissue is a ligament or tendon.
23 . The method of claim 20 , wherein the individual is human.