Human amniotic fluid preparation having long-term stability
AssigneeMAM Holdings of West Florida, L.L.C.
InventorCarl Randall Harrell
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Abstract
Methods of preparing sterile de-cellularized human amniotic fluid that is amenable for long-term storage without loss of biological functions have been developed. In particular, the methods involve refrigeration steps to maximize shelf-life while retaining most of the important growth factors and other molecules present in the fresh amniotic fluid for effective therapeutic application. Use of the compositions is intended for therapeutic purposes and will alleviate pain or discomfort associated with any disorders or diseases, particularly those involving eyes and joints, or fibrotic disorders such as COPD.
Claims22
A method for preparing a composition of sterile, de-cellularized human amniotic fluid (D-HAF) comprising:
- (a) collecting amniotic fluid under sterile conditions from a subject to produce a sample of raw amniotic fluid;
- (b) de-cellularizing the raw amniotic fluid to remove only cells and/or particulate matter by a series of centrifugation and filtration steps to produce a de-cellularized amniotic fluid, wherein the quantity of the proteins in the de-cellularized amniotic fluid is between 50% to 100% of the raw amniotic fluid;
- and
- (c) placing the de-cellularized amniotic fluid in a sterile vessel at a temperature from about 1° C. to about 20° C. for one or more days, weeks, months, or up to a year, or more than a year,
- wherein the de-cellularized amniotic fluid is not concentrated, diluted, fractionated, heat- or alcohol-treated relative to the raw fluid.
Dependencies are inferred from the claim text.