IP Library Granted Patent US 10,307,443
Granted Patent B2
US 10,307,443 · App. 15/166,016 · Granted Jun 4, 2019

Micronized wharton's jelly

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Quick Facts
Patent No.
US 10,307,443
App. No.
15/166,016
Filed
May 26, 2016
Granted
Jun 4, 2019
Kind
B2
Art Unit
1613
USPC
424/489
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 (22)

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.