Composition for treating fibrocartilage tissue damage

Patent metadata

Field	Value
Publication number	US-11426425-B2
Application number	US-201816489436-A
Country	US
Kind code	B2
Filing date	Mar 1, 2018
Priority date	Mar 2, 2017
Publication date	Aug 30, 2022
Grant date	Aug 30, 2022

Abstract

The present invention has an objective of providing a novel composition for treating a fibrocartilaginous tissue injury. The present invention provides a composition for treating a fibrocartilaginous tissue injury, which is to be applied to an injured fibrocartilaginous tissue part of a target and which comprises a monovalent metal salt of alginic acid, more preferably a low endotoxin monovalent metal salt of alginic acid.

First claim

The invention claimed is:

1. A method for treating a fibrocartilaginous tissue injury with a composition, comprising applying the composition to an injured fibrocartilaginous tissue part of a target, wherein the composition has fluidity or is flaky or powdery when applied to the injured fibrocartilaginous tissue part, and wherein the composition comprises a monovalent metal salt of alginic acid, wherein said applying results in regenerating of the injured fibrocartilaginous tissue part, wherein the fibrocartilaginous tissue part is a part of at least one selected from the group consisting of a meniscus, a triangular fibrocartilage, an articular disc and an annulus fibrosus of an intervertebral disc.

2. A method according to claim 1 , wherein the monovalent metal salt of alginic acid is a low endotoxin monovalent metal salt of alginic acid.

3. The method according to claim 1 , wherein applying the composition to the injured fibrocartilaginous tissue part comprises bringing the composition into contact with the injured fibrocartilaginous tissue part, and wherein the composition has fluidity when brought into contact with the injured fibrocartilaginous tissue part.

4. The method according to claim 1 , wherein the composition having fluidity is at least partially cured after the application to the injured fibrocartilaginous tissue part.

5. The method according to claim 4 , wherein the composition having fluidity is cured by bringing a crosslinking agent into contact with at least a part of the surface of the composition.

6. The method according to claim 1 , wherein the apparent viscosity of the composition having fluidity is 100 mPa·s-30000 mPa·s as measured with a cone-plate viscometer (sensor: 35/1) under a condition wherein the measurement temperature is 20° C., the rotation speed is 0.5 rpm, and the reading time is 2.5 minutes of measurement to obtain an average value between 0.5 to 2.5 minutes after the start of the measurement.

7. The method according to claim 1 , wherein the weight-average molecular weight (absolute molecular weight) of the monovalent metal salt of alginic acid is 30,000 or more as measured by a GPC-MALS method.

8. The method according to claim 1 , wherein the concentration of the monovalent metal salt of alginic acid in the composition having fluidity is 0.1 w/w % to 5 w/w %.

9. The method according to claim 3 , wherein the composition having fluidity does not contain a crosslinking agent in an amount that allows curing of the composition upon making contact with the injured fibrocartilaginous tissue part of the target.

10. The method according to claim 3 , wherein the composition having fluidity is brought into contact with a crosslinking agent for curing the composition after applying the composition to the injured fibrocartilaginous tissue part of the target.

11. The method according to claim 1 , wherein the composition having fluidity has fluidity that allows injection with a 21 G needle after leaving the composition to stand at 20° C. for an hour.

12. The method according to claim 5 , wherein the crosslinking agent is a divalent or higher valent metal ion compound.

13. The method according to claim 1 , wherein the fibrocartilaginous tissue injury is at least one condition or disease selected from the group consisting of a meniscus injury, a traumatic meniscus injury, a degenerative meniscus, a discoid meniscus, osteochondritis dissecans, cartilage degeneration, an intracapsular ligament injury, a sports injury, osteoarthritis and a triangular fibrocartilage complex injury and/or degeneration.

14. The method according to claim 1 , wherein the injured fibrocartilaginous tissue part is a sutured injured fibrocartilaginous tissue part.

15. The method according to claim 1 , wherein the composition is applied to the injured fibrocartilaginous tissue part in combination with suturing.

16. The method according to claim 1 , wherein the composition is in a dry state or a solution state before being applied to the injured fibrocartilaginous tissue part.

17. The method according to claim 16 , wherein the composition in a dry state is a lyophilizate.

18. The method according to claim 1 comprising the steps of:
(a) enabling visual recognition of the injured fibrocartilaginous tissue part through an incision or with an arthroscope or an endoscope;
(b) if necessary, removing an unnecessary tissue from the injured fibrocartilaginous tissue part and the peripheral part thereof;
(c) if necessary, suturing the injured fibrocartilaginous tissue part;
(d) applying the composition containing the monovalent metal salt of alginic acid to the injured fibrocartilaginous tissue part;
(e) if necessary, adding a crosslinking agent to the surface of the applied composition, and leaving the resultant for a predetermined period of time to bring the composition into contact with the crosslinking agent;
(f) if necessary, washing the site where the crosslinking agent had been added; and
(g) if necessary, closing the incision or the opening resulting from insertion of the arthroscope, the endoscope or other instrument.

19. The method according to claim 1 , further comprising providing a kit comprising at least a monovalent metal salt of alginic acid and a crosslinking agent before applying the composition.

20. The method according to claim 1 , wherein the composition does not contain a growth factor and is free of cells.

Assignees

• Mochida Pharm Co Ltd
• Univ Hokkaido Nat Univ Corp

Inventors

• Kondo Eiji
• Iwasaki Norimasa
• Onodera Tomohiro
• Kim Wooyoung
• Kawaguchi Yasuyuki

Classifications

• A61L2430/06

  for cartilage reconstruction, e.g. meniscus · CPC title

• A61P19/04

  for non-specific disorders of the connective tissue · CPC title

• A61K9/19 Primary

  lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} · CPC title

• A61L26/0023

  Polysaccharides · CPC title

• A61L27/20

  Polysaccharides · CPC title