# US 11,305,035 B2 · Tissue-derived tissuegenic implants, and methods of fabricating and using same

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- Number: US 11,305,035 B2
- Document ID: US11305035B2
- Status: Granted
- Kind: B2
- Application number: 16/229,650
- Filed: 2018-12-21
- Published: 2019-05-09
- Granted: 2022-04-19
- Earliest claimed: 2010-05-14
- Assignees: Musculoskeletal Transplant Foundatiaon
- Applicants: Musculoskeletal Transplant Foundation
- Inventors: Eric Semler; Alex Callahan; Joed Canales; Katrina Carroll; Anouska Dasgupta; Roman Shikanovich
- Web page: https://patentgrep.com/patent/US11305035B2

## CPC

- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61K 35/32: Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
- A61K 38/18: Growth factors; Growth regulators
- A61K 38/1825: {Fibroblast growth factor [FGF]}
- A61K 38/1841: {Transforming growth factor [TGF]}
- A61K 38/19: Cytokines; Lymphokines; Interferons
- A61L 27/00: Materials for {grafts or} prostheses or for coating {grafts or} prostheses (dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14)
- 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 27/3821: {Bone-forming cells, e.g. osteoblasts, osteocytes, osteoprogenitor cells}
- A61L 27/3847: {Bones}
- A61L 27/40: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- C12N 5/0605: {Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly}
- C12N 5/0654: {Osteocytes, Osteoblasts, Odontocytes; Bones, Teeth}
- C12N 5/0667: {Adipose-derived stem cells [ADSC]; Adipose stromal stem cells}
- C12N 5/0668: {Mesenchymal stem cells from other natural sources}
- A61K 35/35: Fat tissue; Adipocytes; Stromal cells; Connective tissues (adipose-derived stem cells A61K35/28; collagen A61K38/39)
- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- A61L 2300/414: Growth factors
- A61L 2300/64: Animal cells
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- C12N 2533/90: Substrates of biological origin, e.g. extracellular matrix, decellularised tissue
- 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)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The disclosure provides implants containing a plurality of particles containing at least one population of viable cells adherent to and resident in soft tissue matrix or at least one viable population of cells caused to be in contact with the soft tissue matrix; methods of fabricating the implants; and use of the implants in tissue repair.

## Claims

### Claim 1

A tissue-derived implant for implantation in a recipient allogeneic to a donor of the implant, the implant as a whole comprising: (a) at least one growth conductive matrix comprising amnion-derived growth conductive matrix, chorion-derived growth conductive matrix, or a combination thereof, of the donor from which measurable immunologically reactive hematopoietic cells have been removed; (b) at least one viable population of nonexpanded tissuegenic cells endogenous to the growth conductive matrix of the donor that remains adherent to and resident in an endogenous milieu of the growth conductive matrix; and (c) at least one growth-inductive matrix which is tissue-derived, comprising at least one growth-inductive component, the tissue selected from one or more of: amnion tissue, chorion tissue, umbilical cord tissue, and Wharton's jelly; with the proviso that, before implantation, the implant is not reconstituted with cells exogenous to the growth conductive matrix of the donor.

### Claim 2 (depends on 1)

The implant according to claim 1, wherein the at least one tissue-derived growth-inductive component comprises at least one cytokine.

### Claim 3 (depends on 1)

The implant according to claim 1, wherein the at least one tissue-derived growth-inductive component comprises at least one growth factor.

### Claim 4 (depends on 3)

The implant according to claim 3, wherein the least one growth factor is selected from the group consisting of fibroblast growth factor-2 (FGF-2), transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), interleukin 6 (IL-6), interleukin 10 (IL-10), and a combination thereof.

### Claim 5 (depends on 1)

The implant according to claim 1, wherein the at least one growth-inductive matrix is decellularized.

### Claim 6 (depends on 1)

The implant according to claim 1, wherein the at least one growth-inductive matrix is dehydrated.

### Claim 7 (depends on 6)

The implant according to claim 6, wherein the at least one growth-inductive matrix is lyophilized.

### Claim 8 (depends on 1)

The implant according to claim 1, wherein the at least one tissue-derived growth- inductive matrix comprises at least one growth-inductive component.

### Claim 9 (depends on 8)

The implant according to claim 8, wherein the at least one growth-inductive component comprises at least one cytokine.

### Claim 10 (depends on 8)

The implant according to claim 8, wherein the at least one growth- inductive component comprises at least one growth factor.

### Claim 11 (depends on 10)

The implant according to claim 10, wherein the least one growth factor is selected from the group consisting of fibroblast growth factor-2 (FGF-2), transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), interleukin 6 (IL-6), interleukin 10 (IL-10), and a combination thereof.