# US 12,758,685 B2 · Acellular soft tissue-derived matrices and methods for preparing same

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- Number: US 12,758,685 B2
- Document ID: US12758685B2
- Status: Granted
- Kind: B2
- Application number: 19/073,617
- Filed: 2025-03-07
- Published: 2025-07-31
- Granted: 2026-10-13
- Earliest claimed: 2015-07-24
- Assignees: Musculoskeletal Transplant Foundation
- Applicants: Musculoskeletal Transplant Foundation
- Inventors: Benjamin Schilling; Andrew Madans; Abigail Phipps; Thomas Tylutki; Todd Nilsen; Yen-Chen Huang; Evangelia Chnari
- Web page: https://patentgrep.com/patent/US12758685B2

## CPC

- A61L 27/3886: {comprising two or more cell types}
- A61L 27/3839: {characterised by the site of application in the body (materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60)}
- A61L 27/3895: {using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions}
- 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

Compositions including a first soft tissue-derived matrix and a second soft tissue-derived matrix are provided, as well as methods of making such compositions. In some embodiments, the composition comprises delipidated, decellularized adipose tissue-derived matrix and delipidated, decellularized fascial tissue-derived matrix, which may be combined in various proportions. Such adipose-fascia matrix compositions provide improved volume retention when implanted into a patient. The composition may further include exogenous cells or other substances, and/or a carrier. The composition is suitable for use in plastic surgery procedures, including reconstructive or cosmetic surgery procedures, as well as procedures for wound treatment and tissue regeneration. The methods for making the compositions may involve separation of first and second soft tissues from one another, followed by performing one or more treatments on the separated soft tissues, then combining the treated soft tissues and, optionally, performing one or more additional treatments on the combined soft tissues.

## Claims

### Claim 1

A method for treatment of a condition of a body feature in a patient, comprising a step of implanting an acellular soft tissue-derived matrix in, on, proximate to, or a combination thereof the body feature to be treated in the patient, thereby forming an implantation site, wherein the acellular soft tissue-derived matrix comprises:
(a) an adipose component which is a delipidized, decellularized adipose tissue-derived matrix; and
(b) a fascia component which is a decellularized fascial tissue-derived matrix;
wherein the adipose component and fascia component are present in the acellular soft tissue-derived matrix in a predetermined ratio of adipose component:fascia component in a range of from about 99:1 to about 1:99 on a weight basis;
whereby the acellular soft tissue-derived matrix provides greater volume retention at an implantation site after passage of at least three weeks from implantation of the acellular soft tissue-derived matrix in a subject; and
wherein volume retention is greater compared to an acellular soft tissue-derived matrix having a predetermined ratio of 100:0.

### Claim 2 (depends on 1)

The method of claim 1, wherein the treatment further comprises one or more therapeutic benefits selected from the group consisting of: volume restoration or replacement; volume augmentation; increasing, enhancing, or improving volume retention; deficit management; cushioning or padding areas where tissue is missing or has been removed; healing, repair or reconstruction of a wound; providing a stimulus to host tissue; reconstructing or reshaping at least a portion of a body feature; reduction or elimination of undesirable defects or attributes; and restoration of damaged or atrophied tissue.

### Claim 3 (depends on 2)

The method of claim 2, wherein the treatment is selected from the group consisting of: filling, cushioning, padding, reshaping, or augmenting a facial defect or attribute; rejuvenating a facial defect or attribute; and repairing or regenerating tissue of a facial defect or attribute.

### Claim 4 (depends on 3)

The method of claim 3, wherein the treatment is selected from the group consisting of: rejuvenation of facial skin, a lip, an eyelid, a cheek, a chin, or a temple; reshaping or recontouring a lip, a check, a temple, a jawline, or a temple; reducing or eliminating wrinkles, nasolabial folds, a dimple, a dip, a divot, a scar, or a combination thereof; augmentation of a lip, a cheek, a chin, or a temple; and craniofacial repair or reconstruction.

### Claim 5 (depends on 2)

The method of claim 2, wherein the treatment is selected from the group consisting of: face volumization; hand volumization; fat pad volumization; temple volumization; breast volumization; and volumization of an atrophied, diseased, or cosmetically undesirable body feature.

### Claim 6 (depends on 2)

The method of claim 2, wherein the treatment is selected from the group consisting of breast reconstruction; breast reshaping; breast augmentation; or a combination thereof.

### Claim 7 (depends on 1)

The method of claim 1, wherein the condition of a body feature in a patient comprises one or more selected from the group consisting of: atrophy; diseased tissue; a congenital defect; weak or strained body feature; a tunneling wound; a chronic or acute wound; a void, cavity, space, or pocket in a tissue or body feature resulting from disease, trauma or therapeutic treatment; lipoatrophy; age-related defects or attributes; and aesthetically undesirable attributes.

### Claim 8 (depends on 7)

The method of claim 7, wherein the condition of a body feature in a patient comprises one or more selected from the group consisting of: fat pad atrophy; temple atrophy; cheek atrophy; a void, pocket or other defect in a breast created during a surgical procedure; cleft lip; cleft palate; cleft chin; HIV lipoatrophy; radiation fibrosis syndrome; a superficial burn; wrinkles; a dimple; a dip, a divot; drooping eyelid; nasolabial folds; jowls; insufficiently cushioned bony prominence; asymmetry; weakened or strained vocal chords; and other undesirable attributes.

### Claim 9 (depends on 1)

The method of claim 1, wherein the body feature is one or more selected from the group consisting of: a face or portion thereof; a craniofacial feature; an extremity; a joint; a buttock; a torso or portion thereof; a back or portion thereof; dermis; muscle; and nerve.

### Claim 10 (depends on 9)

The method of claim 9, wherein the body feature is one or more selected from the group consisting of: a mouth a forehead, a cheek, a chin, pre-jowls, a temple, an eyelid, a nose, an arm, a shoulder, a wrist, a hand, a finger, a chest, a breast, an abdomen, a leg, a hip, a knee, a calf, a shin, a foot, a toe, a joint, a fat pad, dermis, a muscle, a nerve, a blood vessel, a bone, a tendon, a ligament, a heart, and a lung.

### Claim 11 (depends on 1)

The method of claim 1, wherein the delipidated, decellularized adipose tissue matrix has a particulate form, an injectable form, or a combination thereof.

### Claim 12 (depends on 1)

The method of claim 1, wherein the delipidated, decellularized adipose tissue matrix is dehydrated, partially dehydrated, or not dehydrated.

### Claim 13 (depends on 1)

The method of claim 1, wherein the delipidated, decellularized adipose tissue matrix is a component of an implant and the method comprises implanting the implant.

### Claim 14 (depends on 13)

The method of claim 13, wherein the implant is a particulate form, an injectable form, or a combination thereof.

### Claim 15 (depends on 13)

The method of claim 13, wherein the implant is dehydrated, partially dehydrated, or not dehydrated.

### Claim 16 (depends on 13)

The method of claim 13, wherein the implant further comprises a carrier.

### Claim 17 (depends on 13)

The method of claim 13, wherein the implant is a slurry, paste or gel.

### Claim 18 (depends on 13)

The method of claim 13, wherein the implant further comprises tissuegenic cells exogenous to the first sample of adipose tissue, growth factors exogenous to the first sample of adipose tissue, or a combination thereof.

### Claim 19 (depends on 1)

The method of claim 1, wherein the treatment further comprises at least one selected from the group consisting of a cosmetic surgical procedure and a reconstructive surgical procedure.
