Products derived from amniotic fluid and methods of use
Inventors
Daniel, John • Berg, Richard A. • Griffiths, Sarah
Assignees
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Publication Number
US-11559553-B2
Publication Date
2023-01-24
Expiration Date
Abstract
Uncultured amniotic cell and protein fraction products derived from amniotic fluid and methods of preparing and using those compositions are provided. According to the methods of the present invention, uncultured amniotic cell and protein products may be derived from a large sample of amniotic fluid to provide a higher concentration of tissue regeneration components. Described are methods for separating uncultured amniotic cells or protein fractions from other components of amniotic fluid and the resulting uncultured amniotic cell and protein products. Furthermore, the present invention includes methods for delivering the uncultured amniotic cell and protein products to the skin and eye, including before, during, or after a treatment procedure.
Core Innovation
The invention describes a lyophilized product comprising a population of uncultured amniotic cells obtained from amniotic fluid. The product is substantially free of red blood cells and does not contain a cryoprotectant, and it comprises a protein fraction obtained from an amniotic fluid filtrate.
The product further defines composition constraints for the protein fraction and impurities. The protein fraction includes proteins having a molecular weight of less than about 600 kDa, and the product is substantially free of one or more of white blood cells, urea, electrolytes, amino acids, or peptides consisting of 2 amino acids.
In further refinements, hemoglobin is undetectable by an enzyme-linked immunosorbent assay, and urea content per dry mass can be constrained by a urea nitrogen assay. The population of uncultured amniotic cells can include c-kit positive cells, and the protein fraction can comprise growth factors, glycoproteins, glycosaminoglycans (GAGs), polycarbohydrates, or cytokines.
Claims Coverage
The document provides two independent claims directed to a lyophilized product comprising uncultured amniotic cells from amniotic fluid and a protein fraction from an amniotic fluid filtrate. Across the independent claims, the inventive features focus on absence of cryoprotectant, substantial impurity removal, and a molecular-weight defined protein fraction.
Lyophilized uncultured amniotic cells with red blood cell depletion and no cryoprotectant
A lyophilized product comprising a population of uncultured amniotic cells obtained from amniotic fluid, wherein the product is substantially free of red blood cells, wherein the product does not contain a cryoprotectant, and wherein the product comprises a protein fraction obtained from an amniotic fluid filtrate.
Lyophilized uncultured amniotic cells with defined filtrate protein fraction below 600 kDa and multi-component depletion
A lyophilized product comprising a population of uncultured amniotic cells obtained from amniotic fluid, wherein the product is substantially free of red blood cells, wherein the product does not contain a cryoprotectant, wherein the product comprises a protein fraction obtained from an amniotic fluid filtrate, wherein the protein fraction comprises proteins having a molecular weight of less than about 600 kDa, and wherein the product is substantially free of one or more of white blood cells, urea, electrolytes, amino acids, or peptides consisting of 2 amino acids.
Overall claim coverage centers on lyophilized products containing uncultured amniotic cells plus an amniotic-fluid-filtrate-derived protein fraction, while limiting impurities and defining protein fraction molecular-weight criteria. Dependent claim refinements add additional characterization constraints and composition markers.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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