Method for obtaining sterile human amniotic fluid and uses thereof
Provided herein is a pre-Caesarean method for collecting amniotic fluid from a patient. A needle is inserted into the incision site for the future C-section, which may be under ultrasound guidance, through which the amniotic fluid is drawn under a low level suction and, optionally, gravity to a sterile collection container. The method encompasses filtering and/or irradiating the amniotic fluid to collect biomolecules of interest such as growth factors and/or stem cells. Also provided is the sterile amniotic fluid or filtrates thereof collected by the method described herein.
1. A method for enhancing wound healing, cosmetic, orthopedic, or ophthalmic applications, comprising:
administering an effective amount of a sterile filtered, cell-free, non-irradiated human amniotic fluid to a site in need thereof;
wherein the sterile filtered, cell-free, non-irradiated human amniotic fluid comprises serially filtered human amniotic fluid prepared by a process comprising:
collecting amniotic fluid under sterile conditions from a woman;
removing cells, large particles, and other undissolvables from the human amniotic fluid by centrifuging the human amniotic fluid to obtain clarified amniotic fluid; and
serially filtering the clarified amniotic fluid through multiple filters selected from the group consisting of depth filters and membrane filters with a pore size of 0.45 μm and 0.2 μm to obtain a sterile filtrate that is not irradiated.
2. The method of claim 1 , wherein the sterile filtered, cell-free, non-irradiated human amniotic fluid has a 10 6 sterility assurance level.
3. The method of claim 1 , wherein the ophthalmic application is for treating dry eyes in a human.
4. The method of claim 3 , wherein the sterile filtered, cell-free, non-irradiated human amniotic fluid is in an amount effective to decrease corneal inflammation associated with dry eyes.
5. The method of claim 1 , wherein the sterile filtered, cell-free, non-irradiated human amniotic fluid is sterilely packaged into syringes or vials suitable for administration.
6. The method of claim 1 , wherein the sterile filtered, cell-free, non-irradiated human amniotic fluid has been lyophilized and formulated for administration to the site in need thereof, optionally in combination with a reconstituting or dissolution agent.
7. The method of claim 3 , wherein the sterile filtered, cell-free, non-irradiated human amniotic fluid has been lyophilized and formulated for administration to dry eyes, optionally in combination with a reconstituting or dissolution agent.
8. The method of claim 6 or claim 7 , wherein the lyophilizate of amniotic fluid is sterilely packaged into vials ready for reconstitution into a fluid.
9. The method of claim 6 or claim 7 , wherein the reconstituting or dissolution agent is sterile water.
10. The method of claim 1 , wherein the site in need thereof is a wound.