Method for obtaining sterile human amniotic fluid and uses thereof
AssigneeMAM Holdings of West Florida, L.L.C.
InventorCarl Randall Harrell
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Abstract
Provided herein is a method for sterilely filtering amniotic fluid from selected caesarean sections of an individual. The amniotic fluid is first centrifuged at 5,000 to 10,000 rpm for 30 to 60 minutes and filtered through filters with about 5 to about 10 μm pore size. Next, the fluid is sequentially filtered through a series of membrane filters with the pore sizes 1 μm and 0.45 or/and 0.2 μm. The filtrate is then aseptically transferred to and sealed in syringes or vials. The fluid is subsequently lyophilized to obtain the lyophilisate of amniotic fluid. Amniotic fluid is reconstituted by adding sterile water to the lyophilisate, and the reconstituted fluid is used for wound healing, cosmetic, orthopedic or ophthalmic applications, particularly for the treatment of dry eyes.
Claims20
A method for obtaining sterilely filtered, cell-free, non-irradiated human amniotic fluid, the method comprising serially filtering the human amniotic fluid, the steps of the method 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.
Dependencies are inferred from the claim text.