# US 9,750,771 B2 · Amniotic membrane preparations and purified compositions and anti-inflammation methods

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- Number: US 9,750,771 B2
- Document ID: US9750771B2
- Status: Granted
- Kind: B2
- Application number: 14/848,153
- Filed: 2015-09-08
- Published: 2016-06-02
- Granted: 2017-09-05
- Earliest claimed: 2005-09-27
- Assignees: Tissuetech, Inc.
- Applicants: TissueTech, Inc.
- Inventors: Scheffer Tseng; Hua He; Wei Li
- Web page: https://patentgrep.com/patent/US9750771B2

## CPC

- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- A61K 8/982: {Reproductive organs; Embryos, Eggs}
- 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)}
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- 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)}
- A61K 31/738: Cross-linked polysaccharides
- A61K 35/48: Reproductive organs
- A61K 38/1709: {from mammals}
- A61K 38/39: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- A61K 38/4886: {Metalloendopeptidases (3.4.24), e.g. collagenase}
- A61L 15/40: containing ingredients of undetermined constitution or reaction products thereof {, e.g. plant or animal extracts}
- A61L 15/44: Medicaments
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61Q 19/00: Preparations for care of the skin
- C07K 14/4702: {Regulators; Modulating activity}
- C07K 14/4718: {Cytokine-induced proteins}
- C07K 14/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
- C07K 14/8114: {Kunitz type inhibitors}
- A61K 2800/74: Biological properties of particular ingredients
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61L 2300/64: Animal cells
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## 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

### Claim 1

A method of reducing inflammation in a subject in need thereof, comprising administering to the subject a composition comprising a water-soluble extract of amniotic membrane from frozen or previously frozen placenta, wherein the water-soluble extract comprises tumor necrosis factor-stimulated gene 6 (TSG-6), pentraxin (PTX-3), thrombospondin (TSP-1), and cross-linked high molecular weight hyaluronan (HA).

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject has inflammation associated with vascular diseases, migraine headaches, tension headaches, periarteritis nodosa, thyroiditis, aplastic anemia, Hodgkin's disease, scleroderma, rheumatic fever, type I diabetes, myasthenia gravis, sarcoidosis, nephrotic syndrome, Behcet's syndrome, polymyositis, gingivitis, hypersensitivity, conjunctivitis, ischemia, a brain disorder, Parkinson's disease, Alzheimer's disease, chronic inflammation associated with cranial radiation injury, acute inflammatory conditions resulting from infection, chronic inflammatory conditions resulting from asthma, or inflammation associated with trauma.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject has an inflammatory disorder.

### Claim 4 (depends on 3)

The method of claim 3, wherein the inflammatory disorder is arthritis, asthma, atherosclerosis, osteoporosis, bronchitis, tendonitis, bursitis, a skin inflammation disorder, enuresis, eosinophilic disease, a gastrointestinal disorder, or non-cardiac chest pain.

### Claim 5 (depends on 4)

The method of claim 4, wherein the arthritis is rheumatoid arthritis, osteoarthritis, spondyloarthopathy, gouty arthritis, degenerative joint disease, systemic lupus erythematosus, Sjogren's syndrome, ankylosing spondylitis, undifferentiated spondylitis, Behcet's disease, haemolytic autoimmune anaemia, multiple sclerosis, amyotrophic lateral sclerosis, amylosis, acute painful shoulder, psoriatic, or juvenile arthritis.

### Claim 6 (depends on 4)

The method of claim 4, wherein the skin inflammation disorder is psoriasis, eczema, burns, or dermatitis; or
the gastrointestinal disorder is inflammatory bowel disease, peptic ulcers, regional enteritis, diverticulitis, gastrointestinal bleeding, Crohn's disease, gastritis, diarrhea, irritable bowel syndrome, ulcerative colitis, gastroesophageal reflux disease, eosinophilic esophagitis, gastroparesis, non-ulcerative dyspepsia, or additional food intolerances and food allergies related bowel disorders.

### Claim 7 (depends on 1)

The method of claim 1, wherein the subject has arthritis.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition further comprises a pharmaceutically acceptable diluent, excipient, carrier, or combination thereof.

### Claim 10 (depends on 9)

The method of claim 9, wherein the composition is formulated as a non-solid dosage form, a solution, drops, suspension, aerosol, paste, spray, ointment, oil, emulsion, cream, lotion, gel, a coated bandage, a patch, sticks, balms, or shampoo.

### Claim 11 (depends on 9)

The method of claim 9, wherein the composition is formulated for ophthalmic administration, systemic administration, or topical administration.

### Claim 12 (depends on 9)

The method of claim 9, wherein the composition is formulated for intraocular injection, subretinal injection, intravitreal injection, periocular injection, subconjuctival injection, retrobulbar injection, intracameral injection, sub-Tenon's injection, implantation, ocular implantation, or ocular insertion.

### Claim 13 (depends on 9)

The method of claim 9, wherein the composition further comprises a penetration enhancer and an aqueous adjuvant.

### Claim 14 (depends on 9)

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

### Claim 15 (depends on 9)

The method of claim 9, wherein the composition is formulated for controlled release.