Micronized wharton's jelly

Patent metadata

Field	Value
Publication number	US-10307443-B2
Application number	US-201615166016-A
Country	US
Kind code	B2
Filing date	May 26, 2016
Priority date	Jul 8, 2014
Publication date	Jun 4, 2019
Grant date	Jun 4, 2019

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.

First claim

What is claimed:

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.

2. 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).

3. The method of claim 1 , wherein the composition further comprises a pharmaceutically acceptable carrier.

4. The method of claim 3 , wherein the pharmaceutically acceptable carrier is selected from the group consisting of water, saline, and phosphate buffered saline.

5. The method of claim 1 , wherein the composition further comprises a surfactant or an emulsifier.

6. The method of claim 1 , wherein the composition further comprises a plasticizer.

7. The method of claim 1 , wherein the composition is injectable.

8. 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.

9. The method of claim 1 , wherein the composition is a liquid, a gel or a paste.

10. The method of claim 1 , wherein the composition further comprises a biocompatible polymer.

11. The method of claim 10 , wherein the biocompatible polymer is a plasticizer.

12. The method of claim 11 , wherein the plasticizer is cross-linked with a biocompatible cross-linking agent.

13. The method of claim 1 , wherein the composition further comprises amniotic membrane of an umbilical cord.

14. The method of claim 1 , wherein the composition is substantially free of amniotic membrane of an umbilical cord.

15. The method of claim 1 , wherein said patient suffers from an articular surface defect.

16. 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.

17. The method of claim 16 , wherein the composition is administered to the site of the articular surface defect.

18. The method of claim 1 , wherein the composition is administered to the patient during a micro-fracture procedure.

19. The method of claim 1 , wherein the composition is administered to a drill fracture site during a micro-fracture procedure.

20. The method of claim 1 , wherein the composition is added to an autogenous bone tissue.

21. The method of claim 1 , wherein the composition is administered to a synovial joint of said patient.

22. The method of claim 1 , wherein the Wharton's jelly is micronized.

Assignees

• Mimedx Group Inc

Inventors

• Spencer Randall
• Sith Somaly
• Koob Tom

Classifications

• A61P9/14

  Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers · CPC title

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61P19/02

  for joint disorders, e.g. arthritis, arthrosis · CPC title

• A61K9/16

  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)} · CPC title

• A61K9/0019

  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) · CPC title