MICRONIZED WHARTON'S JELLY
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.
1 . Micronized Wharton's jelly.
2 . The micronized Wharton's jelly of claim 1 comprising the amniotic membrane of an umbilical cord.
3 . The micronized Wharton's jelly of claim 1 which is substantially free of an amniotic membrane of an umbilical cord.
4 . The micronized Wharton's jelly of claim 1 comprising micronized Wharton's jelly particles having a diameter of from about 10 μM to about 100 μM.
5 . The micronized Wharton's jelly of claim 1 comprising particles having a diameter of from about 25 μm to about 75 μM.
6 . The micronized Wharton's jelly of claim 1 comprising a mixture of particle sizes, wherein about 50% of the particles have a diameter of less than about 40 μm, about 25% of the particles have a diameter of from about 40 μM to less than about 60 μm, and about 25% of the particles have a diameter of about 60 μm or more.
7 . The micronized Wharton's jelly of claim 1 comprising a mixture of particles, wherein about 25% of the particles have a diameter of less than about 40 μm, about 25% of the particles have a diameter of from about 40 μm to less than about 60 μm, and about 50% of the particles have a diameter of about 60 μm or more.
8 . A composition comprising the micronized Wharton's jelly of claim 1 and a pharmaceutically acceptable carrier.
9 . The composition of claim 8 , wherein the pharmaceutically acceptable carrier is an aqueous carrier.
10 . The composition of claim 8 , wherein the pharmaceutically acceptable carrier is water, saline, or phosphate buffered saline.
11 . The composition of claim 8 , wherein the pharmaceutically acceptable carrier is water.
12 . The composition of claim 8 , wherein the concentration of micronized Wharton's jelly is about 0.01 g/mL to about 1 g/mL.
13 . The composition of claim 12 , wherein the concentration of micronized Wharton's jelly is about 0.1 g/mL to about 0.5 g/mL.
14 . The composition of claim 12 , wherein the concentration of micronized Wharton's jelly is about 0.2 g/mL.
15 . The composition of claim 8 which is free of placental tissue.
16 . The composition of claim 8 , further comprising placental tissue.
17 . The composition of claim 16 , wherein the placental tissue is micronized amnion.
18 . The composition of claim 17 , wherein the amnion is cross-linked with a biocompatible cross-linking agent.
19 . The composition of claim 8 , wherein the composition is injectable.
20 . The composition of claim 8 , wherein the composition is a liquid, gel, or paste.
21 . A solid pellet comprising a dried droplet of the composition of claim 8 .
22 . The solid pellet of claim 21 having a diameter of from about 1 mm to about 5 mm.
23 . The solid pellet of claim 22 having a diameter of about 2.5 mm.
24 . A molded composition comprising micronized Wharton's jelly of claim 1 dried in a mold.
25 . A molded composition comprising the composition of claim 8 dried in a mold.
26 . The molded composition of claim 24 , wherein the composition further comprises a micronized biocompatible polymer.
27 . The molded composition of claim 26 , wherein the micronized biocompatible polymer is a plasticizing polymer.
28 . The molded composition of claim 27 , wherein the plasticizing polymer is cross-linked with a biocompatible cross-linking agent.
29 . An injectable gel comprising micronized Wharton's jelly of claim 1 .
30 . An injectable gel comprising the composition of claim 8 .
31 . A method for treating an articular surface defect, the method comprising administering to a patient in need thereof the micronized Wharton's jelly of claim 1 .
32 . The method of claim 31 , wherein the micronized Wharton's jelly administered to the site of the articular surface defect.
33 . The method of claim 31 , wherein the micronized Wharton's jelly is administered to the subject during a micro-fracture procedure.
34 . The method of claim 33 , wherein the micronized Wharton's jelly is administered to the drill fracture site during the micro-fracture procedure.