Purified amniotic membrane compositions and methods of use

• US 8,153,162 B2
• Filed: 09/27/2006
• Issued: 04/10/2012
• 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:
  US11/528,980
• Publication Number:
  US 20070071740A1
• Time in Patent Office: 2,022 Days
• Field of Search: 424/583, 424/574, 424/400
• 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 2800/74 Biological properties of particular ingredients
• 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 38/1709 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 38/4886 Metalloendopeptidases (3.4.24), e.g. collagenase
• CPC Class Codes: A61K 8/982 Reproductive organs; Embryos, Eggs
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• 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: A61K 9/19 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 Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• 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 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61Q 19/00 : Preparations for care of the skin
• CPC Class Codes: C07K 14/4702 : Regulators; Modulating activity
• CPC Class Codes: C07K 14/4718 : Cytokine-induced proteins
• CPC Class Codes: C07K 14/78 : Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• CPC Class Codes: C07K 14/8114 : Kunitz type inhibitors

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 pharmaceutical composition comprising:

(a) an AM preparation prepared from pulverized or ground amniotic membrane isolated from placenta that is frozen or previously frozen, 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 pharmaceutical composition is less than 100 parts protein;

1 part HA.

2. The pharmaceutical composition of claim 1, further comprising Smad7.

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

4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated as a solution, suspension, aerosol, paste, ointment, oil, emulsion, cream, lotion, gel, or combination thereof.

5. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated for ophthalmic administration.

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

7. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is for systemic administration.

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

9. The pharmaceutical composition of claim 1, wherein the pharmaceutical 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.

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

11. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated for controlled release.