Methods of sterilizing fetal support tissues

1. A method of sterilizing a fetal support tissue product, comprising:

(a) 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; and

(b) 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 of the fetal support tissue product is substantially maintained.

2. The method of claim 1 , wherein the fetal support tissue product is exposed to the γ-irradiation at a temperature of at or below about −20° C.

3. The method of claim 1 , wherein the fetal support tissue product is exposed to the γ-irradiation on dry ice.

4. The method of claim 1 , further comprising removing the fetal support tissue product from the isotonic solution prior to exposing the fetal support tissue product to the γ-irradiation.

5. The method of claim 1 , wherein the fetal support tissue product is exposed to γ-irradiation for at least about 1 minute.

6. The method of claim 1 , wherein the fetal support tissue product is contacted with the isotonic solution for about 1 hour to about 24 hours.

7. The method of claim 1 , wherein the sterilized fetal support tissue product has a Sterility Assurance Level (SAL) of 10 −6 .

8. The method of claim 1 , wherein structural integrity of the fetal support tissue product is maintained.

9. The method of claim 1 , wherein the sterilized fetal support tissue product is stable at room temperature for at least 1 month.

10. The method of claim 1 , wherein the fetal support tissue product is exposed to γ-irradiation after being dispensed into a container.

11. The method of claim 1 , wherein the effective dosage of the γ-irradiation is between 10 kGy and 60 kGy.

12. The method of claim 1 , wherein the fetal support tissue product is a tissue graft.

13. The method of claim 1 , wherein the fetal support tissue product is a fetal support tissue product powder.

14. The method of claim 1 , wherein the fetal support tissue product is a ground fetal support tissue product.

15. The method of claim 14 , wherein the ground fetal support tissue product is produced by grinding, micronizing, pulverizing, homogenizing, filing, milling, grating, pounding, crushing, or a combination thereof.

16. The method of claim 1 , wherein the sterilized fetal support tissue product is stored at room temperature.

17. The method of claim 1 , wherein the fetal support tissue product is made by a process comprising: first, obtaining a placental tissue comprising amniotic membrane, chorion, amnion-chorion, umbilical cord, placenta, or any combination thereof; and second, washing the placental tissue to remove the blood from the placental tissue.

18. The method of claim 1 , further comprising contacting the fetal support tissue product with a substrate prior to the exposing of step (b).

19. The method of claim 1 , further comprising preparing an extract of the sterilized fetal support tissue product.

20. The method of claim 1 , wherein the HC-HA/PTX3 complex-mediated biological activity is selected from the group consisting of reducing inflammation, reducing scarring, reducing angiogenesis, reducing adhesion, and promoting wound healing.