Placental tissue compositions

• US 8,071,135 B2
• Filed: 10/04/2007
• Issued: 12/06/2011
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: Celularity, Inc.
• Original Assignee: Anthrogenesis Corporation (Bristol-Myers Squibb Company)
• Inventors: Liu, Qing, Ray, Cynthia
• Primary Examiner(s): FORD, ALLISON M
• Application Number:
  US11/973,125
• Publication Number:
  US 20080181967A1
• Time in Patent Office: 1,524 Days
• Field of Search: None
• US Class Current: 424/583
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution

Abstract

The present invention encompasses compositions, including solutions, gels, and pastes, manufactured from amniotic membrane, umbilical cord membrane, or both. The present invention also encompasses methods of making such compositions, and methods of using the compositions to treat conditions of the eye.

Claims

1. A composition comprising placental tissue components soluble in aqueous solution at acidic and neutral pH, and substantially lacking placental tissue components insoluble in aqueous solution at acidic and neutral pH, wherein the composition is prepared according to the following method:

(a) contacting placental tissue with an acidic solution;

(b) bringing the solution to neutral pH; and

(c) removing insoluble matter within said solution to form the composition.

2. The composition of claim 1, wherein said placental tissue is amniotic membrane (AM).

3. The composition of claim 1, wherein the composition is formulated as a liquid, gel, paste, slurry, cream or ointment.

4. The composition of claim 3, wherein the composition is an ophthalmologically-acceptable liquid.

5. The composition of claim 4, wherein said liquid comprises saline solution, glycerin, hypromellose, or polyethylene glycol.

6. The composition of claim 1 comprising at least 10% placental components by weight.

7. The composition of claim 1, wherein the composition is formulated as a lyophilized composition.

8. The composition of claim 1 further comprising an ophthalmologically-acceptable lubricant.

9. The composition of claim 1 further comprising one or more of an anti-inflammatory compound, an analgesic, an anesthetic or an immune-suppressing agent.

10. The composition of claim 1 further comprising riboflavin.

11. The composition of claim 10, wherein the composition comprises collagen crosslinked with the riboflavin.

12. The composition of claim 1, wherein the insoluble matter in said solution is removed following step (a).

13. The composition of claim 12, wherein the method further comprises removal of the insoluble matter in said solution following step (b).

14. The composition of claim 1, wherein the placental tissue is substantially bloodless.

15. The composition of claim 1, wherein said acidic solution is an acetic acid solution.

16. The composition of claim 1, wherein said acidic solution is between about pH 4.5 and about pH 6.

17. The composition of claim 1, wherein said placental tissue is disrupted at a temperature of between about the freezing point of said solution to about 10°

C.

18. The composition of claim 17 comprising decellularizing said placental tissue prior to said disruption.

19. The composition of claim 1, additionally comprising adjusting the water content of the solution to no greater than about 50%.

20. The composition of claim 1, wherein the insoluble matter is removed by centrifugation.