Biomaterial from Wharton's jelly umbilical cord

Inventors

Font Perez, Julio • Castro Feo, Maria Begoña • Del Olmo Basterrechea, Maite

Assignees

Histocell SL

Abstract

The present invention relates to a biomaterial, specifically a hydrogel, based on the extracellular matrix of the umbilical cord for its application in regenerative medicine. The invention particularly relates to a biomaterial made up of glycosaminoglycans present exclusively in the Wharton's jelly of the umbilical cord (which can optionally be combined with cells as a combination therapy), and also to the methods for the production and use thereof.

Core Innovation

The invention describes a hydrogel biomaterial formed from a crosslinked extract of Wharton’s Jelly of a non-human animal umbilical cord. The extract consists of a mixture of glycosaminoglycans (GAGs) including hyaluronic acid, keratan sulfate, chondroitin-6-sulfate, heparan sulfate, chondroitin-4-sulfate, dermatan sulfate, and heparin, and is free of non-human animal umbilical cord membrane, blood vessels, and cells or cell remnants originally present in Wharton’s Jelly.

The hydrogel biomaterial includes optional added components, including an added crosslinking agent, optionally cells not originally present in Wharton’s Jelly, and optionally a pharmaceutically acceptable carrier. Crosslinking produces a crosslinked hydrogel biomaterial suitable as an injectable and/or solid hydrogel biomaterial for regenerative medicine.

The described material composition and crosslinked structure are used to tune properties such as viscosity and pore size, including ionic/covalent crosslinking and covalent crosslinking via EDC chemistry. The document reports characterization including GAG quantification, histology for cell absence, and SEM porosity, and describes biological performance including non-cytotoxicity, improved viability/proliferation versus hyaluronic acid, modulation of chondrocyte gene markers, chemotaxis/cell recruitment, and in vivo osteoarthritis cartilage regeneration and chronic ulcer healing.

Claims Coverage

The document includes one independent claim with multiple dependent claims that add further inventive limitations. The independent claim provides the core coverage for a crosslinked Wharton’s Jelly extract defined by a specific GAG mixture composition and by being free of umbilical cord membrane, blood vessels, and original cells or cell remnants, with optional crosslinking agent, optional cells, and optional pharmaceutically acceptable carrier.

Overall, claim coverage centers on the defined crosslinked hydrogel made from a Wharton’s Jelly extract characterized by a defined GAG mixture and removal of membrane, blood vessels, and original cells/cell remnants, with optional inclusion of an added crosslinking agent, optional added cells, and optional pharmaceutically acceptable carrier.

Stated Advantages

Documented Applications