Compositions of morselized umbilical cord and/or amniotic membrane and methods of use thereof

Inventors

Tseng, Scheffer • Chua, Lorraine

Assignees

BioTissue Holdings Inc

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Publication Number

US-12551510-B2

Patent

Publication Date

2026-02-17

Expiration Date


Abstract

The invention relates generally to the fields of biology and life sciences. More particularly, the invention relates to compositions and methods for modulating cellular physiology and pathological processing using a combination of compounds that can be found in morselized amniotic membrane tissue and morselized umbilical cord tissue preparations.

Core Innovation

The invention provides a method of preparing a fetal support tissue product in which an amniotic membrane tissue is morselized to produce a morselized amniotic membrane tissue, and an umbilical cord tissue is morselized to produce a morselized umbilical cord tissue. Therapeutically effective amounts of the morselized amniotic membrane tissue and the morselized umbilical cord tissue are mixed to produce a morselized umbilical cord amniotic membrane mixture, and the mixture is homogenized to produce a morselized homogenate.

The method further includes sterilizing the morselized homogenate. The morselized homogenate has a water content of greater than 20% by weight percentage, and is characterized by a particle size of between about 0.1 mm to about 1.0 cm in length, width, and thickness.

The compositions are described as being formulated and preserved in multiple forms including liquid, semi-liquid, lyophilized, and dry formulations. They are described as modulating cellular physiology, including suppressing TGF-β signaling, increasing macrophage apoptosis, decreasing proliferation and migration and increasing apoptosis of vascular endothelial cells, decreasing fibroblast viability, decreasing inflammation, and protecting ocular epithelial cells from apoptosis.

Claims Coverage

The partial content provides one independent claim (clm-00001). The independent claim describes a fetal support tissue product preparation method with three inventive features: source-tissue processing, sterilization under high-water-content conditions, and specified particle-size constraints.

Morselizing, mixing, and homogenizing amniotic membrane and umbilical cord tissues into a morselized homogenate

A method comprising morselizing an amniotic membrane tissue and an umbilical cord tissue, mixing therapeutically effective amounts to produce a morselized umbilical cord amniotic membrane mixture, and homogenizing the mixture to produce a morselized homogenate.

Sterilizing a high-water-content morselized homogenate

Sterilizing the morselized homogenate, wherein the morselized homogenate has a water content of greater than 20% by weight percentage.

Defining particle size and dimensions for the morselized homogenate

The morselized homogenate is characterized by a particle size of between about 0.1 mm to about 1.0 cm in length, width, and thickness.

Independent claim coverage centers on preparing a fetal support tissue product by morselizing and combining amniotic membrane and umbilical cord tissues into a morselized homogenate, sterilizing the homogenate, and maintaining specified water content and particle size dimensions.

Stated Advantages

Modulates cellular physiology including suppressing TGF-β signaling.

Increases macrophage apoptosis.

Decreases proliferation and migration of vascular endothelial cells and increases apoptosis of vascular endothelial cells.

Decreases fibroblast viability and decreases inflammation.

Protects ocular epithelial cells from apoptosis.

Documented Applications

Therapeutic and prophylactic uses.

Cosmetic uses.

Tissue/cell culture uses.

Apparatus formats for applying the compositions on inert supports such as mesh sheets.

Ocular wounds and repairs.

Skin wounds and repairs.

Dermal filler.

Psoriasis.

Rheumatoid arthritis.

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