# US 11,078,461 B2 · Compositions and methods for implantation of processed adipose tissue and processed adipose tissue products

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- Number: US 11,078,461 B2
- Document ID: US11078461B2
- Status: Granted
- Kind: B2
- Application number: 15/796,089
- Filed: 2017-10-27
- Published: 2018-05-10
- Granted: 2021-08-03
- Earliest claimed: 2009-08-11
- Assignees: The Johns Hopkins University
- Applicants: The Johns Hopkins University
- Inventors: Zayna Nahas; Jennifer H. Elisseeff; Iwen Wu
- Web page: https://patentgrep.com/patent/US11078461B2

## CPC

- C12N 5/0653: {Adipocytes; Adipose tissue}
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 35/35: Fat tissue; Adipocytes; Stromal cells; Connective tissues (adipose-derived stem cells A61K35/28; collagen A61K38/39)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61L 27/3633: {Extracellular matrix [ECM]}
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61L 2430/34: for soft tissue reconstruction
- A61L 2430/40: Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
- C12N 2533/90: Substrates of biological origin, e.g. extracellular matrix, decellularised tissue
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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

## Abstract

The invention provides compositions and methods for the preparation of processed adipose tissue. The invention further provides methods of use of the processed adipose tissue.

## Claims

### Claim 1

An acellular delipidized biocompatible biomaterial comprising a mammalian adipose tissue extracellular matrix (ECM) derived from cadaveric adipose tissue, the biomaterial having between 1% to 0.001% adipose lipid by weight and a complex viscosity of 1×104 to 9×105 Pas, wherein the biomaterial is non-inflammatory when implanted.

### Claim 2 (depends on 1)

The biomaterial of claim 1, wherein the complex viscosity is 1×104 to 8×105 Pas.

### Claim 3 (depends on 1)

The biomaterial of claim 1, wherein the complex viscosity is 1×104 to 3×105 Pas.

### Claim 4 (depends on 1)

The biomaterial of claim 1, further comprising a cross-linking agent.

### Claim 5 (depends on 4)

The biomaterial of claim 4, wherein the cross-linking agent is selected from the group consisting of carbodiimide (EDC), hexamethylene diisocyanate (HMDC), gluteraldehyde, proanthocyanidin, ribose, threose, and lysyl oxidase, carbodiimide, polyepoxy ethers, divinyl sulfone (DVS), genipin, polyaldehyde and diphenylphosphoryl azide (DPPA), genipin, epoxy compounds, dialdehyde starch, glutaraldehyde, formaldehyde, dimethyl suberimidate, carbodiimides, succinimidyls, diisocyanates, and acyl azide.

### Claim 6 (depends on 1)

The biomaterial of claim 1, wherein the biomaterial is injectable.

### Claim 7 (depends on 1)

The biomaterial of claim 1, wherein the biomaterial is sterilized.

### Claim 8

An acellular delipidized biocompatible biomaterial comprising a mammalian adipose tissue extracellular matrix (ECM) derived from cadaveric adipose tissue, the biomaterial having between 1% to 0.001% adipose lipid by weight and a complex modulus of 5×103 to 1×105 Pa, wherein the biomaterial is non-inflammatory when implanted.

### Claim 9 (depends on 8)

The biomaterial of claim 8, wherein the complex modulus is 1×104 to 1×105 Pa.

### Claim 10 (depends on 8)

The biomaterial of claim 8, wherein the complex modulus is 1×104 to 9×104 Pa.

### Claim 11 (depends on 8)

The biomaterial of claim 8, further comprising a cross-linking agent.

### Claim 12 (depends on 11)

The biomaterial of claim 11, wherein the cross-linking agent is selected from the group consisting of carbodiimide (EDC), hexamethylene diisocyanate (HMDC), gluteraldehyde, proanthocyanidin, ribose, threose, and lysyl oxidase, carbodiimide, polyepoxy ethers, divinyl sulfone (DVS), genipin, polyaldehyde and diphenylphosphoryl azide (DPPA), genipin, epoxy compounds, dialdehyde starch, glutaraldehyde, formaldehyde, dimethyl suberimidate, carbodiimides, succinimidyls, diisocyanates, and acyl azide.

### Claim 13 (depends on 8)

The biomaterial of claim 8, wherein the biomaterial is injectable.

### Claim 14

An acellular delipidized biocompatible biomaterial comprising a mammalian adipose tissue extracellular matrix (ECM) derived from cadaveric adipose tissue, the biomaterial having between 1% to 0.001% adipose lipid by weight and an elastic modulus of 5×103 to 1×105 Pa, wherein the biomaterial is non-inflammatory when implanted.

### Claim 15 (depends on 14)

The biomaterial of claim 14, wherein the elastic modulus is 1×104 to 1×105 Pa.

### Claim 16 (depends on 14)

The biomaterial of claim 14, wherein the elastic modulus is 1×104 to 9×104 Pa.

### Claim 17 (depends on 14)

The biomaterial of claim 14, further comprising a cross-linking agent.

### Claim 18 (depends on 17)

The biomaterial of claim 17, wherein the cross-linking agent is selected from the group consisting of carbodiimide (EDC), hexamethylene diisocyanate (HMDC), gluteraldehyde, proanthocyanidin, ribose, threose, and lysyl oxidase, carbodiimide, polyepoxy ethers, divinyl sulfone (DVS), genipin, polyaldehyde and diphenylphosphoryl azide (DPPA), genipin, epoxy compounds, dialdehyde starch, glutaraldehyde, formaldehyde, dimethyl suberimidate, carbodiimides, succinimidyls, diisocyanates, and acyl azide.

### Claim 19 (depends on 14)

The biomaterial of claim 14, wherein the biomaterial is injectable.

### Claim 20

An acellular delipidized biocompatible biomaterial comprising a mammalian adipose tissue extracellular matrix (ECM) derived from cadaveric adipose tissue, the biomaterial having between 1% to 0.001% adipose lipid by weight and a viscous modulus of 5×103 to 1×105 Pa, wherein the biomaterial is non-inflammatory when implanted.

### Claim 21 (depends on 20)

The biomaterial of claim 20, wherein the viscous modulus is 1×104 to 1×105 Pa.

### Claim 22 (depends on 20)

The biomaterial of claim 20, wherein the viscous modulus is 1×104 to 9×104 Pa.

### Claim 23 (depends on 20)

The biomaterial of claim 20, further comprising a cross-linking agent.

### Claim 24 (depends on 23)

The biomaterial of claim 23, wherein the cross-linking agent is selected from the group consisting of carbodiimide (EDC), hexamethylene diisocyanate (HMDC), gluteraldehyde, proanthocyanidin, ribose, threose, and lysyl oxidase, carbodiimide, polyepoxy ethers, divinyl sulfone (DVS), genipin, polyaldehyde and diphenylphosphoryl azide (DPPA), genipin, epoxy compounds, dialdehyde starch, glutaraldehyde, formaldehyde, dimethyl suberimidate, carbodiimides, succinimidyls, diisocyanates, and acyl azide.

### Claim 25 (depends on 20)

The biomaterial of claim 20, wherein the biomaterial is injectable.

### Claim 26

An acellular delipidized biocompatible biomaterial comprising a mammalian adipose tissue extracellular matrix (ECM) derived from cadaveric adipose tissue, the biomaterial having between 1% to 0.001% adipose lipid by weight and a tan (δ) of 0.05 to 2.0, wherein the biomaterial is non-inflammatory when implanted.

### Claim 27 (depends on 26)

The biomaterial of claim 26, wherein the tan (δ) is 0.1 to 1.0.

### Claim 28 (depends on 26)

The biomaterial of claim 26, wherein the tan (δ) of 0.1 to 0.75.

### Claim 29 (depends on 26)

The biomaterial of claim 26, further comprising a cross-linking agent.

### Claim 30 (depends on 29)

The biomaterial of claim 29, wherein the cross-linking agent is selected from the group consisting of carbodiimide (EDC), hexamethylene diisocyanate (HMDC), gluteraldehyde, proanthocyanidin, ribose, threose, and lysyl oxidase, carbodiimide, polyepoxy ethers, divinyl sulfone (DVS), genipin, polyaldehyde and diphenylphosphoryl azide (DPPA), genipin, epoxy compounds, dialdehyde starch, glutaraldehyde, formaldehyde, dimethyl suberimidate, carbodiimides, succinimidyls, diisocyanates, and acyl azide.

### Claim 31 (depends on 26)

The biomaterial of claim 26, wherein the biomaterial is injectable.

### Claim 32 (depends on 1)

A composition comprising at least one biomaterial of claim 1 and at least one pharmaceutically acceptable carrier or adjuvant.

### Claim 33 (depends on 8)

A composition comprising at least one biomaterial of claim 8 and at least one pharmaceutically acceptable carrier or adjuvant.

### Claim 34 (depends on 14)

A composition comprising at least one biomaterial of claim 14 and at least one pharmaceutically acceptable carrier or adjuvant.

### Claim 35 (depends on 20)

A composition comprising at least one biomaterial of claim 20 and at least one pharmaceutically acceptable carrier or adjuvant.

### Claim 36 (depends on 26)

A composition comprising at least one biomaterial of claim 26 and at least one pharmaceutically acceptable carrier or adjuvant.