# US 10,307,443 B2 · Micronized wharton's jelly > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,443 B2 - Document ID: US10307443B2 - Status: Granted - Kind: B2 - Application number: 15/166,016 - Filed: 2016-05-26 - Published: 2016-12-01 - Granted: 2019-06-04 - Earliest claimed: 2014-07-08 - Assignees: MiMedx Group, Inc. - Applicants: MiMedx Group, Inc. - Inventors: Randall Spencer; Somaly Sith; Tom Koob - Web page: https://patentgrep.com/patent/US10307443B2 ## CPC - A61K 35/51: Umbilical cord; Umbilical cord blood; Umbilical stem cells - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)} - A61K 9/16: Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)} - A61P 9/14: Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers - A61P 19/02: for joint disorders, e.g. arthritis, arthrosis - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - C12N 5/065: {Thymocytes} - C12N 2509/10: Mechanical dissociation - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract The present invention provides compositions and formulations of micronized Wharton's jelly having a controlled viscosity such that when delivered to the injured region of a subject, it remains substantially localized with little or no migration out of the injured region for the repair and/or regeneration thereof. Micronized Wharton's Jelly can be suspended in a pharmaceutically acceptable aqueous carrier, such as saline, sterile water, or any suitable buffer, to form a suspension or a gelatinous gel composition, or it can be in the form of a paste, suitable for delivery into the space adjacent the articular surface cartilage injured region of a subject. The micronized Wharton's jelly when employed at sufficient concentrations can be hydrated into a gel or paste and administered topically, or it can be injected into the body through the use of a needle and syringe. Accordingly, micronized Wharton's Jelly, compositions, or formulations thereof, can be delivered in a manner that is more convenient than Wharton's jelly that has not been micronized in accordance with the present invention. ## Claims ### Claim 1 A method for inducing hyaline cartilage formation in a patient in need thereof, said method comprising introducing a composition comprising Wharton's jelly including one or more growth factors found in Wharton's jelly into a joint of said patient, wherein said composition is substantially free of umbilical cord tissue. ### Claim 2 (depends on 1) The method of claim 1, wherein the growth factor is selected from the group consisting of fibroblast growth factor (FGF), insulin-like growth factor I (IGF-I), transforming growth factor beta (TGF-beta), platelet-derived growth factor (PDGF), and epidermal growth factor (EGF). ### Claim 3 (depends on 1) The method of claim 1, wherein the composition further comprises a pharmaceutically acceptable carrier. ### Claim 4 (depends on 3) The method of claim 3, wherein the pharmaceutically acceptable carrier is selected from the group consisting of water, saline, and phosphate buffered saline. ### Claim 5 (depends on 1) The method of claim 1, wherein the composition further comprises a surfactant or an emulsifier. ### Claim 6 (depends on 1) The method of claim 1, wherein the composition further comprises a plasticizer. ### Claim 7 (depends on 1) The method of claim 1, wherein the composition is injectable. ### Claim 8 (depends on 7) The method of claim 7, wherein the injectable composition further comprises one or more of an osmotic agent, a hydrophobic agent, and a surface active agent. ### Claim 9 (depends on 1) The method of claim 1, wherein the composition is a liquid, a gel or a paste. ### Claim 10 (depends on 1) The method of claim 1, wherein the composition further comprises a biocompatible polymer. ### Claim 11 (depends on 10) The method of claim 10, wherein the biocompatible polymer is a plasticizer. ### Claim 12 (depends on 11) The method of claim 11, wherein the plasticizer is cross-linked with a biocompatible cross-linking agent. ### Claim 13 (depends on 1) The method of claim 1, wherein the composition further comprises amniotic membrane of an umbilical cord. ### Claim 14 (depends on 1) The method of claim 1, wherein the composition is substantially free of amniotic membrane of an umbilical cord. ### Claim 15 (depends on 1) The method of claim 1, wherein said patient suffers from an articular surface defect. ### Claim 16 (depends on 15) The method of claim 15, wherein the articular surface defect is localized at a joint of shoulder, elbows, knee, hip, feet, ankle, hand, and/or wrist of said patient. ### Claim 17 (depends on 16) The method of claim 16, wherein the composition is administered to the site of the articular surface defect. ### Claim 18 (depends on 1) The method of claim 1, wherein the composition is administered to the patient during a micro-fracture procedure. ### Claim 19 (depends on 1) The method of claim 1, wherein the composition is administered to a drill fracture site during a micro-fracture procedure. ### Claim 20 (depends on 1) The method of claim 1, wherein the composition is added to an autogenous bone tissue. ### Claim 21 (depends on 1) The method of claim 1, wherein the composition is administered to a synovial joint of said patient. ### Claim 22 (depends on 1) The method of claim 1, wherein the Wharton's jelly is micronized.