Amniotic membrane preparations and purified compositions and anti-angiogenesis treatment

• US 8,187,639 B2
• Filed: 09/27/2006
• Issued: 05/29/2012
• 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:
  US11/535,924
• Publication Number:
  US 20070071828A1
• Time in Patent Office: 2,071 Days
• Field of Search: 424/583, 424/574, 424/400, 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 pharmaceutical composition comprising:

(a) an AM preparation prepared from pulverized or ground amniotic membrane isolated from frozen or previously frozen placenta comprising;

(i) 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;

(ii) tumor necrosis factor-stimulated gene 6 (TSG-6);

(iii) pentraxin (PTX-3); and

(iv) thrombospondin (TSP-1); and

(b) a pharmaceutically acceptable diluent, excipient, or carrier;

wherein the ratio of total protein to HA in the composition is less than 100 parts total protein to 1 part HA; and

wherein angiogenesis is reduced.

2. The method of claim 1, wherein the composition further comprises Smad7.

3. The method of claim 1, wherein the composition is formulated as a non-solid dosage form or an extended release solid dosage form.

4. The method of claim 1, wherein the subject is a human.

5. The method of claim 1, wherein the subject has been diagnosed with a cancer.

6. The method of claim 1, wherein the subject has been diagnosed with age-related macular degeneration.

7. The method of claim 1, wherein the composition:

(a). induces apoptosis in an endothelial cell involved in vascular formation;

(b). prevents migration of an endothelial cell involved in vascular formation; and

(c). prevents tube formation of endothelial cells involved in vascular formation.