# US 9,433,701 B2 · Extracellular matrix for the treatment of intestinal disease and methods thereof

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- Number: US 9,433,701 B2
- Document ID: US9433701B2
- Status: Granted
- Kind: B2
- Application number: 14/926,132
- Filed: 2015-10-29
- Published: 2016-03-10
- Granted: 2016-09-06
- Earliest claimed: 1999-12-22
- Assignees: ACell, Inc.
- Applicants: ACell, Inc.
- Inventors: Alan R. Spievack
- Web page: https://patentgrep.com/patent/US9433701B2

## CPC

- A61L 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents}
- 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}
- A61L 27/362: {Skin, e.g. dermal papillae}
- A61L 27/3629: {Intestinal tissue, e.g. small intestinal submucosa}
- A61L 27/3633: {Extracellular matrix [ECM]}
- A61L 27/3679: {Hollow organs, e.g. bladder, esophagus, urether, uterus, intestine}
- 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}
- A61L 27/3691: {characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/20: for reconstruction of the heart, e.g. heart valves
- A61L 2430/22: for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
- A61L 2430/40: Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
- 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)

## Abstract

A matrix, including epithelial basement membrane, for inducing repair of mammalian tissue defects and in vitro cell propagation derived from epithelial tissues of a warm-blooded vertebrate.

## Claims

### Claim 1

A composition, comprising:
an isolated mammalian epithelial basement membrane derived from an epithelial tissue and free of epithelial cells of said epithelial tissue and cellular remnants of said epithelial cells of said epithelial tissue, and tunica propria, wherein said composition induces restoration, replacement, remodeling, or repair of a tissue of the gastrointestinal tract when placed in contact with a diseased, damaged, or defective tissue of the gastrointestinal tract.

### Claim 2 (depends on 1)

The composition of claim 1 wherein said composition is shaped to conform to said diseased, damaged, or defective tissue of the gastrointestinal tract.

### Claim 3 (depends on 1)

The composition of claim 1 wherein said composition comprises an injectable form.

### Claim 4 (depends on 1)

The composition of claim 1 wherein said composition further comprises a pharmaceutical agent.

### Claim 5 (depends on 1)

The composition of claim 1 wherein said diseased, damaged, or defective tissue of the gastrointestinal tract is esophagus.

### Claim 6 (depends on 1)

The composition of claim 1 wherein said diseased, damaged, or defective tissue of the gastrointestinal tract is stomach.

### Claim 7 (depends on 1)

The composition of claim 1 wherein said diseased, damaged, or defective tissue of the gastrointestinal tract is intestine.

### Claim 8 (depends on 1)

The composition of claim 1 wherein said composition is shaped to conform to a missing tissue of the gastrointestinal tract.

### Claim 9 (depends on 1)

The composition of claim 1 wherein said composition comprises a solution.

### Claim 10 (depends on 1)

The composition of claim 1 wherein said composition comprises a particulate form.

### Claim 11 (depends on 1)

The composition of claim 1 wherein said composition comprises a gel form.

### Claim 12 (depends on 1)

The composition of claim 1 wherein said composition comprises a liquid form.

### Claim 13 (depends on 1)

The composition of claim 1 wherein said composition comprises a dehydrated form.

### Claim 14 (depends on 1)

The composition of claim 1 wherein said composition comprises a gene product.

### Claim 15 (depends on 1)

The composition of claim 1 further comprising submucosa.

### Claim 16 (depends on 1)

The composition of claim 1 further comprising at least a portion of the tunica muscularis.

### Claim 17 (depends on 1)

The composition of claim 1 wherein said composition further comprises a cell.

### Claim 18 (depends on 1)

The composition of claim 1 wherein said epithelial tissue is intestine.

### Claim 19 (depends on 1)

The composition of claim 1 wherein said epithelial tissue is urinary bladder.

### Claim 20

A method for inducing repair of diseased, defective, or damaged tissue of the gastrointestinal tract in an animal, comprising:
providing to the diseased, defective or damaged tissue, a composition derived from an epithelial tissue comprising tunica propria and epithelial basement membrane, wherein the epithelial basement membrane is free of epithelial cells of said epithelial tissue and cellular elements of said epithelial cells and said composition induces repair of said diseased, defective or damaged tissue when placed in contact with said diseased defective or damaged tissue of the gastrointestinal tract.

### Claim 21 (depends on 20)

The method of claim 20 wherein said tissue of the gastrointestinal tract is the esophagus.

### Claim 22 (depends on 20)

The method of claim 20 wherein said tissue of the gastrointestinal tract is the stomach.

### Claim 23 (depends on 20)

The method of claim 20 wherein said tissue of the gastrointestinal tract is the intestine.

### Claim 24 (depends on 20)

The method of claim 20 wherein said composition comprises a fluid.

### Claim 25 (depends on 20)

The method of claim 20 wherein said composition comprises a gel.

### Claim 26 (depends on 20)

The method of claim 20 wherein said composition comprises a sheet.

### Claim 27 (depends on 20)

The method of claim 20 wherein said composition comprises a tube.

### Claim 28 (depends on 20)

The method of claim 20 wherein said composition is an injectable form.

### Claim 29 (depends on 20)

The method of claim 20 wherein said epithelial tissue is intestine.

### Claim 30 (depends on 2)

The method of claim 2 wherein said epithelial tissue is urinary bladder.
