Methods of sterilizing fetal support tissues
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Publication Number
US-9931423-B2
Publication Date
2018-04-03
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 relates to a sterilized fetal support tissue product comprising a fetal support tissue that is not dry and an isotonic solution. The fetal support tissue product is sterilized by exposing the fetal support tissue in combination with the isotonic solution to γ-irradiation at a temperature less than or equal to 0°C, and the γ-irradiation is applied at a dosage sufficient to sterilize the fetal support tissue product. The formulation further comprises cells, substantially all of which are dead.
A central aspect of the invention is that anti-inflammatory activity of HC-HA/PTX3 of the fetal support tissue is substantially maintained in the sterilized fetal support tissue product. The anti-inflammatory activity is stable at room temperature for at least 1 month, with dependent refinement to at least 6 months. The described approach preserves biological activity and structural integrity of fetal support tissues under γ-irradiation sterilization.
The associated disclosure further describes quantitative and comparative performance under γ-irradiation for lyophilized or cryopreserved amniotic membrane (AM) and umbilical/chorion amniotic material (UCAM). It includes findings linked to maintained histological, biochemical, and functional performance after accelerated aging and storage, including Western blot/HAase digestion confirmation of HC-HA/PTX3 presence and reduced band intensity after γ-irradiation.
Claims Coverage
The independent claim defines a sterilized fetal support tissue product with three core inventive features: γ-irradiation at ≤0°C in combination with a non-dry fetal support tissue and an isotonic solution, substantial maintenance of HC-HA/PTX3 anti-inflammatory activity with room-temperature stability for at least 1 month, and a cellular condition of substantially all dead cells. Dependent claims further refine sterility, stability, structural integrity, tissue source, and graft format.
Sterilized non-dry fetal support tissue in isotonic solution by γ-irradiation at ≤0°C
A sterilized fetal support tissue product comprising a fetal support tissue that is not dry and an isotonic solution, wherein the fetal support tissue product is sterilized by exposing the fetal support tissue in combination with the isotonic solution to γ-irradiation at a temperature of less than or equal to 0°C, and at a dosage sufficient to sterilize the fetal support tissue product.
Substantially maintained and room-temperature-stable HC-HA/PTX3 anti-inflammatory activity
The fetal support tissue product wherein anti-inflammatory activity of HC-HA/PTX3 of the fetal support tissue is substantially maintained in the sterilized fetal support tissue product, and is stable at room temperature for at least 1 month.
Substantially all cells dead in the sterilized product
The sterilized fetal support tissue product comprises cells, substantially all of which are dead.
Sterility Assurance Level (SAL) of 10^-6
The sterilized fetal support tissue product has a Sterility Assurance Level (SAL) of 10^-6.
Room-temperature stability for at least 6 months
The sterilized fetal support tissue product remains stable at room temperature for at least 6 months.
Maintained structural integrity of the fetal support tissue
The sterilized fetal support tissue product in which the structural integrity of the fetal support tissue is maintained.
Fetal support tissue derived from specified fetal/placental tissues or combinations
A sterilized fetal support tissue product where the fetal support tissue is derived from placental amniotic membrane, umbilical cord amniotic membrane, chorion, amnion-chorion, placenta, umbilical cord, or any combination thereof.
Provided as a tissue graft
The sterilized fetal support tissue product where the fetal support tissue is provided as a tissue graft.
Overall claim coverage centers on γ-irradiation sterilization of a non-dry fetal support tissue in an isotonic solution at ≤0°C, while substantially maintaining HC-HA/PTX3 anti-inflammatory activity and ensuring substantially all cells are dead. Dependent claims further add a sterility assurance level constraint, a maintained structural integrity requirement, specified tissue sources, and a tissue graft presentation.
Stated Advantages
Anti-inflammatory activity of HC-HA/PTX3 is substantially maintained in the sterilized fetal support tissue product.
HC-HA/PTX3 anti-inflammatory activity is stable at room temperature for at least 1 month.
Substantially all cells are dead in the sterilized fetal support tissue product.
Sterility Assurance Level (SAL) of 10^-6.
Stability at room temperature for at least 6 months.
Structural integrity of the fetal support tissue is maintained.
Defined tissue sources are used (placental amniotic membrane, umbilical cord amniotic membrane, chorion, amnion-chorion, placenta, umbilical cord, or combinations).
The product is provided as a tissue graft.
Documented Applications
Assessment of cryo/radioprotectant performance for lyophilized or cryopreserved amniotic membrane (AM) and umbilical/chorion amniotic material (UCAM) under γ-irradiation, including maintenance of histological, biochemical, and functional performance after accelerated aging and storage.
Functional osteoclast/TRAP assay evaluation indicating preserved inhibitory activity for select formulations after γ-irradiation and/or room-temperature storage.
Verification of HC-HA/PTX3 presence post-γ-irradiation using Western blot/HAase digestion, and evaluation of tissue structural integrity using histology-based methods after γ-irradiation.
Wound healing applications.
Reduction of adhesion/scar/inflammation.
Ophthalmic tissue repair applications.
Spinal tissue repair applications.
Arthritic tissue repair applications.
Nerve/bone/tendon tissue repair applications.
Dermal filler applications.
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