Micronized wharton's jelly

Patent metadata

Field	Value
Publication number	US-2016346332-A1
Application number	US-201615166016-A
Country	US
Kind code	A1
Filing date	May 26, 2016
Priority date	Jul 8, 2014
Publication date	Dec 1, 2016
Grant date	—

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

1 - 35 . (canceled)

36 . A method for inducing hyaline cartilage formation in a patient in need thereof, said method comprising introducing a composition comprising one or more growth factors found in Wharton's jelly into a joint of said patient.

37 . The method of claim 36 , wherein said composition comprises Wharton's jelly.

38 . The method of claim 36 , 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).

39 . The method of claim 36 , wherein the composition further comprises a pharmaceutically acceptable carrier.

40 . The method of claim 39 , wherein the pharmaceutically acceptable carrier is selected from the group consisting of water, saline, and phosphate buffered saline.

41 . The method of claim 36 , wherein the composition further comprises a surfactant or an emulsifier.

42 . The method of claim 36 , wherein the composition further comprises a plasticizer.

43 . The method of claim 36 , wherein the composition is injectable.

44 . The method of claim 43 , wherein the injectable composition further comprises one or more of an osmotic agent, a hydrophobic agent, and a surface active agent.

45 . The method of claim 36 , wherein the composition is a liquid, a gel or a paste.

46 . The method of claim 36 , wherein the composition further comprises a biocompatible polymer.

47 . The method of claim 46 , wherein the biocompatible polymer is a plasticizer.

48 . The method of claim 47 , wherein the plasticizer is cross-linked with a biocompatible cross-linking agent.

49 . The method of claim 36 , wherein the composition further comprises amniotic membrane of an umbilical cord.

50 . The method of claim 36 , wherein the composition is substantially free of amniotic membrane of an umbilical cord.

51 . The method of claim 36 , wherein said patient suffers from an articular surface defect.

52 . The method of claim 51 , wherein the articular surface defect is localized at a joint of shoulder, elbows, knee, hip, feet, ankle, hand, and/or wrist of said patient.

53 . The method of claim 52 , wherein the composition is administered to the site of the articular surface defect.

54 . The method of claim 36 , wherein the composition is administered to the patient during a micro-fracture procedure.

55 . The method of claim 36 , wherein the composition is administered to a drill fracture site during a micro-fracture procedure.

56 . The method of claim 36 , wherein the composition is added to an autogenous bone tissue.

57 . The method of claim 36 , wherein the composition is administered to a synovial joint of said patient.

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

• C12N2509/10

  Mechanical dissociation · CPC title