Methods of sterilizing fetal support tissues
Disclosed herein, are methods of preparing sterilized amniotic tissues. Further disclosed herein, are methods of using the sterilized amniotic tissues.
1. A sterilized fetal support tissue product, comprising: (i) a fetal support tissue that is not dry, and (ii) an isotonic solution; wherein:
a) 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;
b) 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; and
c) the sterilized fetal support tissue product comprises cells, substantially all of which are dead.
2. The sterilized fetal support tissue product of claim 1 , wherein the sterilized fetal support tissue product has a Sterility Assurance Level (SAL) of 10 −6 .
3. The sterilized fetal support tissue product of claim 1 , wherein structural integrity of the fetal support tissue is maintained.
4. The sterilized fetal support tissue product of claim 1 , wherein the sterilized fetal support tissue is stable at room temperature for at least 6 months.
5. The sterilized fetal support tissue product of claim 1 , wherein the fetal support tissue is from placental amniotic membrane, umbilical cord amniotic membrane, chorion, amnion-chorion, placenta, umbilical cord, or a any combination thereof.
6. The sterilized fetal support tissue product of claim 1 , wherein the fetal support tissue is a tissue graft.