Methods of sterilizing fetal support tissues
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-9682160-B2
Publication Date
2017-06-20
Expiration Date
Abstract
Disclosed herein, are methods of preparing sterilized amniotic tissues. Further disclosed herein, are methods of using the sterilized amniotic tissues.
Core Innovation
The invention provides a method of sterilizing a fetal support tissue product while substantially maintaining HC-HA/PTX3 complex-mediated biological activity. The fetal support tissue product is from placental amniotic membrane, umbilical cord amniotic membrane, chorion, amnion-chorion, placenta, umbilical cord, or any combination thereof. The method includes contacting the fetal support tissue product with an isotonic solution comprising about 10% glycerol, or about 20% to about 70% glycerol.
After contacting with the isotonic glycerol solution, the fetal support tissue product is exposed at a temperature of at or below about 0° C. to an effective dosage of γ-irradiation for an effective duration of time. This sterilizes the fetal support tissue product and produces a sterilized fetal support tissue product in which HC-HA/PTX3 complex-mediated biological activity is substantially maintained.
The described approach is directed to preserving structural integrity and biological activity while achieving sterility assurance (SAL 10^-6). The content further describes preservation of HC-HA/PTX3 complex-mediated functions such as anti-inflammation and reduced scarring, including related outcomes discussed for wound healing applications.
Claims Coverage
The claims center on one independent method claim covering sterilization of specified fetal support tissue products by combining an isotonic glycerol-based composition with γ-irradiation at or below about 0° C. The claim includes two core inventive aspects: contacting with a glycerol-containing isotonic solution at specified glycerol levels and exposing at low temperature to an effective γ-irradiation dosage/time to sterilize while substantially maintaining HC-HA/PTX3 complex-mediated biological activity.
Sterilizing fetal support tissue product with isotonic glycerol solution contacting
Contacting the fetal support tissue product with an isotonic solution comprising about 10% glycerol, or about 20% to about 70% glycerol, wherein the fetal support tissue product is from placental amniotic membrane, umbilical cord amniotic membrane, chorion, amnion-chorion, placenta, umbilical cord, or any combination thereof.
Gamma irradiation at or below about 0° C. to sterilize while maintaining HC-HA/PTX3 complex-mediated activity
Exposing the fetal support tissue product at a temperature of at or below about 0° C. to an effective dosage of γ-irradiation for an effective duration of time to sterilize the fetal support tissue product and produce a sterilized fetal support tissue product in which HC-HA/PTX3 complex-mediated biological activity is substantially maintained.
Dry ice irradiation at gamma irradiation conditions
Providing exposing the fetal support tissue product to gamma irradiation while on dry ice.
Effective gamma irradiation dose range of 10 kGy to 60 kGy
Using an effective dosage of γ-irradiation between 10 kGy and 60 kGy.
Room temperature stability of at least one month
Specifying that the sterilized fetal support tissue product remains stable at room temperature for at least one month.
Biological activity maintained as a selected set of effects
Defining that the HC-HA/PTX3 complex-mediated biological activity is chosen from reducing inflammation, reducing scarring, reducing angiogenesis, reducing adhesion, or promoting wound healing.
The claims focus on sterilizing specified fetal support tissue products using low-temperature γ-irradiation preceded by contacting with an isotonic glycerol solution, while substantially maintaining HC-HA/PTX3 complex-mediated biological activity. Dependent refinements further narrow irradiation dose range and low-temperature maintenance, and define stability and specific selected biological activity outcomes.
Stated Advantages
Sterility assurance while substantially maintaining HC-HA/PTX3 complex-mediated biological activity.
Maintains HC-HA/PTX3 complex-mediated functions, including anti-inflammation and reduced scarring.
Preserves structural integrity and biological activity during sterilization under the described approach.
Documented Applications
Wound coverings and adhesion barriers.
Dermal fillers.
Ophthalmic and orthopedic/neurologic repair.
Wound healing-related therapeutic outcomes.
Interested in licensing this patent?