Abstract: A system and method for decellularizing tissue is provided. The system includes a pretreatment chamber including a pretreatment solution (e.g., a surfactant), a decellularization solution comprising carbon dioxide and one or more polar solvents, as well as an environmental chamber comprising a treatment chamber. The environmental chamber is maintained at a temperature greater than 31.1° C. and the carbon dioxide is maintained at a pressure greater than 7.38 megapascals to form supercritical CO2. Tissue treated with the decellularization system and method can contain less than 0.05 micrograms of DNA per milligram of dry tissue after the tissue is exposed to the decellularization solution for a time period ranging from about 1 minute to about 2 hours with minimal ECM fiber disruption. A two-part decellularization solution comprising a surfactant as well as supercritical CO2 and one or more polar solvents is also provided.

Abstract: Decellularization methods for tissue are provided. The method can include: exposing a tissue to a water-saturated, supercritical CO2. The method can further comprise, prior to exposing the tissue to the water-saturated, supercritical CO2, saturating a stream of supercritical CO2. The tissue can be exposed to the water-saturated, supercritical CO2 at a treatment temperature of about 35° C. to about 40° C. (e.g., about 37° C.). In one embodiment, the water-saturated, supercritical CO2 is completely saturated with water at the treatment temperature. The tissue can be exposed to the water-saturated, supercritical CO2 at a constant flow rate, such as less than 3 mL/min (e.g., about 0.5 mL/min to about 2.5 mL/min).

Abstract: A system and method for removing residual glutaraldehyde from a natural polymer scaffold crosslinked with glutaraldehyde is provided. The system includes a cleaning solution comprising carbon dioxide and one or more polar solvents and an environmental chamber that can include and a treatment chamber. The environmental chamber is maintained at a temperature greater than 31.1° C. and the carbon dioxide is maintained at a pressure greater than 7.38 megapascals to form supercritical carbon dioxide. A crosslinked natural polymer scaffold treated via the glutaraldehyde removal system and method can have a glutaraldehyde content of less than about 3 parts per million. A crosslinked natural polymer scaffold cleaning solution comprising supercritical carbon dioxide and one or more polar solvents is also provided.

Abstract: A system and method for removing residual glutaraldehyde from a natural polymer scaffold crosslinked with glutaraldehyde is provided. The system includes a cleaning solution comprising carbon dioxide and one or more polar solvents and an environmental chamber that can include and a treatment chamber. The environmental chamber is maintained at a temperature greater than 31.1° C. and the carbon dioxide is maintained at a pressure greater than 7.38 megapascals to form supercritical carbon dioxide. A crosslinked natural polymer scaffold treated via the glutaraldehyde removal system and method can have a glutaraldehyde content of less than about 3 parts per million. A crosslinked natural polymer scaffold cleaning solution comprising supercritical carbon dioxide and one or more polar solvents is also provided.

Abstract: A system and method for decellularizing tissue is provided. The system includes a pretreatment chamber including a pretreatment solution (e.g., a surfactant), a decellularization solution comprising carbon dioxide and one or more polar solvents, as well as an environmental chamber comprising a treatment chamber. The environmental chamber is maintained at a temperature greater than 31.1° C. and the carbon dioxide is maintained at a pressure greater than 7.38 megapascals to form supercritical carbon dioxide. Tissue treated with the decellularization system and method can contain less than 0.05 micrograms of DNA per milligram of dry tissue after the tissue is exposed to the decellularization solution for a time period ranging from about 1 minute to about 2 hours with minimal ECM fiber disruption. A two-part decellularization solution comprising a surfactant as well as supercritical carbon dioxide and one or more polar solvents is also provided.

Abstract: Decellularization methods for tissue are provided. The method can include: exposing a tissue to a water-saturated, supercritical CO2. The method can further comprise, prior to exposing the tissue to the water-saturated, supercritical CO2, saturating a stream of supercritical CO2. The tissue can be exposed to the water-saturated, supercritical CO2 at a treatment temperature of about 35° C. to about 40° C. (e.g., about 37° C.). In one embodiment, the water-saturated, supercritical CO2 is completely saturated with water at the treatment temperature. The tissue can be exposed to the water-saturated, supercritical CO2 at a constant flow rate, such as less than 3 mL/min (e.g., about 0.5 mL/min to about 2.5 mL/min).