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Publication Number
US-10842825-B2
Publication Date
2020-11-24
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
A transplant product made from human amniotic fluid is prepared by aseptically recovering a volume greater than 100 ml of sterile human amniotic fluid from a woman and visually confirming the removed volume has a pink to clear color and contains no vernix. The filtered product is intended so that the process of filtering the amniotic fluid ensures the biochemical properties of the tissue remain intact.
The aseptically recovered amniotic fluid is filtered through a blood filter with a pore size of 170 to 260 microns. The filtered amniotic fluid is placed in a plurality of centrifuge tubes, and a centrifugation and separation is performed to obtain a supernatant fraction suitable for further processing.
The separated supernatant is processed as a cryopreserved transplant product in sized cryovials, with the supernatant packaged for storage at temperatures of −25°C or colder without a cryopreservative. When thawed and resuspended, the supernatant has a water-like viscosity and is injectable, supporting treatment administration using the transplant product.
Claims Coverage
The provided partial content identifies one independent claim (clm-00001) and describes its key inventive scope as a method for producing a transplant product from human amniotic fluid, emphasizing aseptic recovery, visual confirmation criteria, filtration through a specified pore-size blood filter, and preservation of biochemical properties via the filtering process.
Aseptically recovered sterile human amniotic fluid with visual criteria
A method for a transplant product made from human amniotic fluid that includes aseptically recovering a volume of greater than 100 ml of sterile human amniotic fluid from a woman and visualizing the removed volume as having a pink to clear color and containing no vernix.
Blood filter with 170 to 260 micron pore size to preserve biochemical properties
A method for a transplant product made from human amniotic fluid that includes filtering the amniotic fluid through a blood filter with a pore size of 170 to 260 microns, and performing the filtering to ensure the biochemical properties of the tissue remain intact.
Across the independent claim, the main inventive coverage centers on producing a transplant product from human amniotic fluid with specified aseptic recovery and visual verification criteria, followed by filtration through a 170 to 260 micron blood filter to preserve biochemical properties of the tissue.
Stated Advantages
Preserves biochemical properties of the tissue by performing the filtering to ensure the biochemical properties remain intact.
Stated to be non-immunogenic.
Allows injection administration, including via a 30-gauge syringe, with passable particles up to about 170 microns.
Documented Applications
A treatment method using an amniotic fluid supernatant injection for a patient having damaged or injured tissue or a degenerative tissue condition.
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