Micronized wharton's jelly

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.

1 . Micronized Wharton's jelly. 
     
     
         2 . The micronized Wharton's jelly of  claim 1  further comprising the amniotic membrane of an umbilical cord. 
     
     
         3 . The micronized Wharton's jelly of  claim 1  substantially free of amniotic membrane of an umbilical cord. 
     
     
         4 . The Micronized Wharton's jelly of  claim 1  comprising 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 particles, 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 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         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 . (canceled) 
     
     
         14 . (canceled) 
     
     
         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 . (canceled) 
     
     
         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 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . A molded composition comprising Micronized Wharton's jelly of  claim 1  dried in a mold. 
     
     
         25 . (canceled) 
     
     
         26 . The molded composition of  claim 24  wherein the composition further comprises a micronized biocompatible polymer. 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . An injectable gel comprising Micronized Wharton's jelly of  claim 1 . 
     
     
         30 . (canceled) 
     
     
         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 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . (canceled) 
     
     
         35 . A method for preventing and/or reducing inflammation and/or restenosis in a patient having an angioplasty procedure and/or a stent implantation, the method comprising administering to the patient at or proximate to the vascular site to which the angioplasty is performed or the stent is implanted the Micronized Wharton's jelly of  claim 1 .