Amniotic membrane preparations and purified compositions and anti-angiogenesis treatment

• US 8,420,126 B2
• Filed: 04/23/2012
• Issued: 04/16/2013
• Est. Priority Date: 09/27/2005
• Status: Active Grant

• Current Assignee: Biotissue Holdings Incorporated
• Original Assignee: Tissuetech, Inc.
• Inventors: Tseng, Scheffer, He, Hua, Li, Wei
• Primary Examiner(s): Kim, Taeyoon
• Application Number:
  US13/453,840
• Publication Number:
  US 20120207849A1
• Time in Patent Office: 358 Days
• Field of Search: 424/400, 424/574, 424/583, 514/13.3
• US Class Current: 424/583
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 31/738 Cross-linked polysaccharides
• CPC Class Codes: A61K 35/48 Reproductive organs
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61K 38/17 from animals; from humans enzyme inhibitors A61K38/005
• CPC Class Codes: A61K 38/1709 from mammals
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

Compositions having a combination of specific biological components have been found to exert a number of useful effects in mammalian cells, including modulating TGF β signaling, apoptosis, and proliferation of mammalian cells, as well as decreasing inflammation in mice. These components can be obtained commercially, or can be prepared from biological tissues such as placental tissues. Placental amniotic membrane (AM) preparations described herein include AM pieces, AM extracts, AM jelly, AM stroma, and mixtures of these compositions with additional components. The compositions can be used to treat various diseases, such as wound healing, inflammation and angiogenesis-related diseases.

Claims

1. A method for reducing angiogenesis in a subject in need thereof comprising, administering to the subject a composition comprising:

a pulverized or ground amniotic membrane preparation prepared from placenta that is frozen or previously frozen, wherein angiogenesis is reduced.

2. The method of claim 1, wherein the composition is formulated as a non-solid dosage form.

3. The method of claim 1, wherein the composition is formulated as a solution, drops, suspension, aerosol, paste, spray, ointment, oil, emulsion, cream, lotion, gel, a coated bandage, a patch, sticks, balms, shampoo, or combination thereof.

4. The method of claim 1, wherein the composition is formulated for ophthalmic administration.

5. The method of claim 4, wherein the composition is formulated for intraocular injection, subretinal injection, intravitreal injection, periocular injection, subconjunctival injection, retrobulbar injection, intracameral injection, sub-Tenon'"'"'s injection, ocular implantation or ocular insertion.

6. The method of claim 1, wherein the composition is for topical administration.

7. The method of claim 1, wherein the composition further comprises a penetration enhancer and an aqueous adjuvant.

8. The method of claim 1, wherein the composition is for systemic administration.

9. The method of claim 1, wherein the composition is formulated as a solid dosage form.

10. The method of claim 1, wherein the composition is formulated as a solid dosage form, and wherein the solid dosage form is for inserting between an eye and an eyelid, or in a conjunctival sac.

11. The method of claim 1, wherein the composition is formulated as a solid oral dosage form.

12. The method of claim 1, wherein the composition is formulated as a capsule or tablet.

13. The method of claim 1, wherein the composition is formulated for controlled release.

14. The method of claim 1, wherein the composition is formulated as an enteric coated oral dosage form.

15. The method of claim 1, wherein the amniotic membrane (AM) preparation comprises high molecular weight hyaluronan (HA) that is cross-linked by a covalent bond to the heavy chain of inter-α

-trypsin inhibitor (Iα

I), the high molecular weight HA having a molecular weight greater than 1000 kDa.

16. The method of claim 1, wherein the amniotic membrane (AM) preparation comprises tumor necrosis factor-stimulated gene 6 (TSG-6).

17. The method of claim 1, wherein the composition is a pharmaceutical composition and further comprises a pharmaceutically acceptable excipient.