SILK FIBROIN HYDROGELS AND USES THEREOF
The present specification provides for methods for purifying fibroins, purified fibroins, methods of conjugating biological and synthetic molecules to fibroins, fibroins conjugated to such molecules, methods of making fibroin hydrogels, fibroin hydrogels and fibroin hydrogel formulations useful for a variety of medical uses, including, without limitation uses as bulking agents, tissue space fillers, templates for tissue reconstruction or regeneration, cell culture scaffolds for tissue engineering and for disease models, surface coating to improve medical device function, or drug delivery devices.
1 . A method of improving an appearance or a condition of skin in an individual in need thereof, the method comprising the step of administering a silk fibroin hydrogel formulation into a dermal region of the individual, wherein the formulation comprises,
a) a gel phase, the gel phase including hydrogel particles comprising a substantially sericin-depleted silk fibroin, wherein the hydrogel is optically translucent; and
b) a carrier phase.
2 . The method of claim 1 , wherein the hydrogel particles comprises about 1% (w/v) to about 10% (w/v) of silk fibroin.
3 . The method of claim 1 wherein the hydrogel particles comprises a protein structure having a β-sheet conformation of at least 20%.
4 . The method of claim 1 , wherein the hydrogel particles comprises a protein structure having an α-helical and random coil conformation of at most 20%.
5 . The method of claim 1 , wherein the hydrogel particles allow about 75% of the light to diffusely pass through.
6 . The method of claim 1 , wherein the hydrogel particles have a cross-sectional area from about 5 μm 2 to about 1000 μm 2 .
7 . The method of claim 1 , wherein the hydrogel particles have a cross-sectional area from about 20 μm 2 to about 50 μm 2 .
8 . The method of claim 1 , wherein the carrier phase comprises saline.
9 . The method of claim 1 , wherein the carrier phase comprises a surfactant solution.
10 . The method of claim 1 wherein the gel phase is about 50% to about 99% of the total formulation volume, the remainder being a carrier solution.
11 . The method of claim 10 , wherein the gel phase is about 75% of the total formulation volume, the remainder being a carrier solution.
12 . The method of claim 1 , wherein the hydrogel formulation further comprising lidocaine.
13 . The method of claim 1 , wherein the hydrogel particles comprise a cellular component
14 . The method of claim 13 , wherein the cellular component comprises stem cells.
15 . The method of claim 13 , wherein the cellular component comprises adipose cells.
16 . The method of claim 13 , wherein the cellular component comprises stem cells and adipose cells.
17 . The method of claim 1 , wherein the skin appearance treated is skin wrinkles, a lack of skin tautness, or a skin stretch line or mark.
18 . The method of claim 1 , wherein the skin conditions treated is skin dehydration, a lack of skin elasticity, skin roughness, a lack of skin tautness, a skin stretch line or mark, skin paleness, or skin wrinkles.