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Publication Number
US-11452744-B2
Publication Date
2022-09-27
Expiration Date
Abstract
A transplant product made from human amniotic fluid has a supernatant from filtered and centrifuged amniotic fluid, the amniotic fluid when recovered aseptically having a clear, translucent to slightly pink or tan color. The supernatant had been taken from the amniotic fluid which had been passed through a 170 to 260 micron blood filter, then centrifuged for 5 minutes or more at 400 g and thereafter the supernatant was separated from a pellet of debris, leaving the biochemical properties intact, wherein the supernatant is cryofrozen in sized cryovials having 0.25 to 2.0 ml of the supernatant at a temperature of −65 degrees or less prior to use and the transplant products method of use. The transplant product contains cellular material, cell fragments, proteins and growth factors maintaining the biochemical properties and is non-immunogenic while having particles up to 170 microns being passable through a 30 gauge syringe for injection.
Core Innovation
The invention provides a liquid amnion transplant product comprising a supernatant from filtered and centrifuged amniotic fluid. The amniotic fluid is recovered aseptically and has a clear, translucent to slightly pink or tan color. The supernatant is taken from amniotic fluid that passes through a 170 to 260 micron blood filter.
The filtered amniotic fluid is centrifuged so that a pellet of debris particles is separated. The debris pellet includes particles having a size as high as 260 microns, leaving the supernatant containing cellular material or cell fragments. The isolated supernatant is set at a particle size so that it does not block a 30 gauge needle (152 microns) and retains biochemical properties.
The disclosed product is characterized as clear or translucent with slightly pink or tan color and is described as non-immunogenic and injectable or non-occluding. The described biochemical properties are associated with preserved proteins and growth factors relevant to wound healing, including TIMP-2, HGF, TIMP-3, TIMP-1, IGF-2, IL-6, TIMP-4, MCP-1, EGF, TGF-B2, TGF-B1, IL-1RA, GRO-alpha, TGF-alpha, and TNF-alpha.
Claims Coverage
The patent text includes two independent claims: one product claim and one method claim. Across these claims, the inventive features focus on a filtered-and-centrifuged supernatant with specific color and contents criteria, defined filtration and debris-pellet particle-size thresholds, preservation of biochemical properties, and an injection-compatibility requirement based on non-blocking of a 30 gauge needle (152 microns).
Liquid supernatant after 170 to 260 micron blood filtration and debris-pellet separation
A liquid amnion transplant product comprising a supernatant from filtered and centrifuged amniotic fluid, where the amniotic fluid recovered aseptically has a clear, translucent to slightly pink or tan color; where the supernatant is taken from amniotic fluid that passes through a 170 to 260 micron blood filter; and where the filtered amniotic fluid is centrifuged to separate a pellet of debris particles up to 260 microns.
Particle-size controlled cellular material that does not block a 30 gauge needle
The supernatant contains cellular material or cell fragments set at a particle size so the isolated supernatant does not block a 30 gauge needle (152 microns) and retains biochemical properties of the tissue intact.
Sterile human amniotic fluid with pink to clear color and no vernix
A method for producing a transplant product comprising obtaining a volume of greater than 100 ml of sterile human amniotic fluid from a woman, wherein the volume has a pink to clear color and contains no vernix.
170 to 260 micron blood filter and centrifugation to yield a supernatant transplant product
Filtering the amniotic fluid through a blood filter with a pore size of 170 to 260 microns; and centrifuging the filtered amniotic fluid to produce a pellet of debris particles of a size as high as 260 microns and a supernatant that is the transplant product.
Supernatant cellular or cell fragments under 260 microns with intact biochemical properties and non-blocking injection compatibility
The supernatant contains cellular material or cell fragments of a particle size less than 260 microns, does not block a 30 gauge needle (152 microns), and has biochemical properties of the tissue intact.
Overall, claim coverage is centered on producing and using a liquid amnion transplant supernatant defined by aseptic recovery with defined appearance, filtration through a 170 to 260 micron blood filter, centrifugation to remove debris particles up to 260 microns, maintaining cellular or cell-fragment particle size below 260 microns for injection compatibility, and retaining tissue biochemical properties.
Stated Advantages
Non-immunogenic product.
Injectable or non-occluding, including that the isolated supernatant does not block a 30 gauge needle (152 microns).
Retention of biochemical properties of the tissue intact.
Documented Applications
Injection into damaged, injured, or degenerative tissue.
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