METHODS FOR MAKING ACELLULAR TISSUE MATRICES
The present disclosure provides a variety of methods and compositions e.g., solutions) useful for making, sterilizing, and preserving tissues (e.g., acellular tissue matrices). The disclosure also features the acellular tissue matrices made by the methods, which matrices can be used for a variety of applications such as, but not limited to, treating an injury to, or repairing, a large number of tissues and/or organs (e.g., fascia, bones, and/or cartilage) in a mammal (e.g., a human).
1 . A composition comprising:
an acellular tissue matrix; and
a solution, wherein the solution comprises:
a biocompatible buffer;
a salt; and
at least one polyhydroxy compound,
wherein the solution has a pH ranging from about 4.0 to about 7.5.
2 . The composition of claim 1 , wherein the biocompatible buffer is a citrate buffer.
3 . The composition of claim 1 , wherein the biocompatible buffer is a combination of a citrate buffer and a phosphate buffer.
4 . The composition of claim 1 , wherein the biocompatible buffer is selected from the group consisting of an acetate buffer, a citrate buffer, a phosphate buffer, and a combination of a citrate buffer and a phosphate buffer.
5 . The composition of claim 1 , wherein the salt comprises sodium chloride.
6 . The composition of claim 1 , wherein the salt is at a concentration of up to about 150 MM in the solution.
7 . The composition of claim 1 , wherein the at least one polyhydroxy compound comprises at least one of a surfactant, a metal chelating agent, a tissue stabilizer, and a biocompatible co-solute.
8 . The composition of claim 7 , wherein the surfactant comprises a non-ionic surfactant.
9 . The composition of claim 8 , wherein the non-ionic surfactant comprises TWEEN 20, TWEEN 80, alkyl poly(ethylene oxide), copolymers of poly(ethylene oxide) and poly(propylene oxide), octyl glucoside, decyl maltoside, cetyl alcohol, oleyl alcohol, cocamide MEA, cocamide DEA, and cocamide TEA.
10 . The composition of claim 7 , wherein the surfactant is present in the solution in an amount of about 0.2% (W/v) or less.
11 . The composition of claim 7 , wherein the metal chelating agent comprises EDTA, EGTA, DMPS, DMSA, or DTPA.
12 . The composition of claim 7 , wherein the metal chelating agent is at a concentration of between about 1 mM to about 50 mM.
13 . The composition of claim 7 , wherein the tissue stabilizer comprises glycerol, dimethyl sulfoxide, sodium glycerophosphate, poly-glycerol, ethylene glycol, propylene glycol, polyethylene glycol, polyvinyl alcohol, or a combination thereof.
14 . The composition of claim 7 , wherein the tissue stabilizer is present in the solution in an amount of about 10% (W/v) or less.
15 . The composition of claim 7 , wherein the tissue stabilizer is present in the solution at a concentration of about 500 mM or less.
16 . The composition of claim 7 , wherein the biocompatible co-solute comprises a sugar or a sugar alcohol.
17 . The composition of claim 16 , wherein the biocompatible co-solute comprises trehalose, mannitol, sorbitol, xylitol, erythritol, arabitol, isomalt, maltitol, lactitol, or a combination thereof.
18 . The composition of claim 7 , wherein the biocompatible co-solute is present in the solution in an amount of about 20% (W/v) or less.
19 . The composition of claim 7 , wherein the biocompatible co-solute is present in the solution at a concentration of about 1 M or less.
20 . The composition of claim 1 , wherein the solution has a pH ranging from about 5.4 to about 6.0.