Compositions derived from placenta and methods of producing the same
Inventors
Daniel, John • Griffiths, Sarah • Berg, Richard
Assignees
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Publication Number
US-11413372-B2
Publication Date
2022-08-16
Expiration Date
Abstract
Compositions comprising unseparated amnion/chorion derived from the placenta and methods of preparing and using those compositions are provided. Washing or preservation of placental tissue according to the methods of the disclosure may allow for one or more benefits such as more efficient removal of blood remnants, retention of wound healing and tissue regeneration components, better handling characteristics, increased absorption potential, or improved healing capacity. The present invention also includes methods of healing a wound of the skin, eye, nerve, tendon, or dura comprising applying the compositions of the invention to the wound.
Core Innovation
The invention provides an unseparated amnion/chorion sheet, including a sheet detached from the placental disc and umbilical cord, having a hemoglobin content of less than about 5 ng per mg of dry mass of the sheet. The unseparated amnion/chorion sheet is dehydrated and retains wound-healing components by avoiding separation, thereby improving handling while preserving key biomolecules.
The invention further includes embodiments in which the unseparated amnion/chorion sheet includes an intermediate layer and may have specified structural characteristics, such as mean thickness and, in some cases, perforation with holes through or partially through layers. The sheet may also include embodiments with partial or substantial removal of an epithelial layer, while maintaining the unseparated amnion/chorion configuration.
In additional embodiments, dehydrated compositions include at least one unseparated amnion/chorion sheet having an intermediate layer with a mean thickness greater than about 5 µm, wherein the composition has a hemoglobin content of less than about 5 ng per mg of dry mass, and wherein the unseparated amnion/chorion is detached from the placental disc and umbilical cord. The document describes compositions that incorporate intermediate-layer presence and optional perforations for wound healing applications.
Claims Coverage
The independent claim set includes 2 independent claims, covering both an unseparated amnion/chorion sheet and a dehydrated composition comprising one or more such sheets. Each independent claim emphasizes low hemoglobin content, dehydration, and detachment from the placental disc and umbilical cord, with additional claim-anchored structural focus on intermediate-layer presence and thickness for the composition.
Low-hemoglobin dehydrated unseparated amnion/chorion sheet detached from placental disc and umbilical cord
An unseparated amnion/chorion sheet having a hemoglobin content of less than about 5 ng per mg of dry mass of the sheet, wherein the unseparated amnion/chorion sheet is dehydrated, and wherein the unseparated amnion/chorion sheet is detached from the placental disc and umbilical cord.
Low-hemoglobin dehydrated composition with intermediate layer thickness greater than about 5 µm
A composition comprising at least one unseparated amnion/chorion sheet, wherein the at least one unseparated amnion/chorion sheet comprises an intermediate layer having a mean thickness of greater than about 5 µm, and wherein the composition has a hemoglobin content of less than about 5 ng per mg of dry mass of the composition, wherein the composition is dehydrated, and wherein the unseparated amnion/chorion is detached from the placental disc and umbilical cord.
Overall, the claim coverage centers on dehydrated unseparated amnion/chorion materials detached from the placental disc and umbilical cord, constrained by low hemoglobin content (< about 5 ng/mg dry mass), and—at least for the composition claim—further defined by inclusion of an intermediate layer with mean thickness greater than about 5 µm.
Stated Advantages
Avoiding separation can preserve wound-healing components while improving handling.
Dehydrated unseparated amnion/chorion products can be characterized with reduced hemoglobin content and altered properties while retaining growth factors/ECM biomolecules and cellular/histological staining across layers.
Documented Applications
Treating wounds of a subject by applying the composition comprising at least one unseparated amnion/chorion sheet.
The wound is an eye wound, skin wound, nerve wound, tendon wound, or dura wound.
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