# US 2021/0330870 A1 · Compositions and materials for regeneration of skeletal muscle

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- Number: US 2021/0330870 A1
- Document ID: US20210330870A1
- Status: Published application
- Kind: A1
- Application number: 17/184,231
- Filed: 2021-02-24
- Published: 2021-10-28
- Earliest claimed: 2020-04-28
- Assignees: Purdue Research Foundation
- Applicants: Purdue Research Foundation
- Inventors: Meng Deng; Naagarajan Narayanan; Shihuan Kuang
- Web page: https://patentgrep.com/patent/US20210330870A1

## CPC

- 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 31/145: {Hydrogels or hydrocolloids}
- A61K 35/30: Nerves; Brain; Eyes; Corneal cells; Cerebrospinal fluid; Neuronal stem cells; Neuronal precursor cells; Glial cells; Oligodendrocytes; Schwann cells; Astroglia; Astrocytes; Choroid plexus; Spinal cord tissue
- A61L 27/367: {Muscle tissue, e.g. sphincter}
- A61L 27/383: {Nerve cells, e.g. dendritic cells, Schwann cells}
- A61L 27/3873: {Muscle tissue, e.g. sphincter}
- A61L 27/52: Hydrogels or hydrocolloids
- C07K 14/47: from mammals
- C07K 14/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
- C12N 5/0012: {Cell encapsulation}
- C12N 5/0618: {Cells of the nervous system}
- C12N 5/0619: {Neurons}
- 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)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A composition for regeneration of skeletal muscle includes a nerve cell secretome or an isolate thereof. An implantable therapeutic material for regeneration of skeletal muscle includes a hydrogel and nerve cells encapsulated within the hydrogel, wherein at least some of the nerve cells are living. A method of regenerating skeletal muscle includes applying the composition or implanting the implantable material adjacent to skeletal muscle myoblasts and/or myogenic cells to regenerate skeletal muscle therefrom.

## Claims

### Claim 1

A composition for regeneration of skeletal muscle, the composition comprising:
a nerve cell secretome or an isolate thereof.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the nerve cell secretome or the isolate thereof comprises one or more signaling factors that are effective to modulate skeletal muscle cell behavior, and wherein the nerve cell secretome or the isolate thereof is effective to promote regeneration of skeletal muscle, promote innervation of skeletal muscle, promote survival and proliferation of myoblasts and/or myogenic cells, promote myofiber formation, promote muscle innervation, promote angiogenesis, or a combination thereof.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the nerve cell secretome comprises Galectin-1, Progranulin, CathepsinB, Glypican-1, Prosaposin, or a combination thereof.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the nerve cells comprise a catecholamine nerve cell.

### Claim 5 (depends on 1)

A medical implant comprising the composition of claim 1.

### Claim 6 (depends on 5)

The medical implant of claim 5, wherein the medical implant further comprises a synthetic fiber scaffold comprising skeletal muscle myoblasts and/or myogenic cells, wherein at least some of the skeletal muscle myoblasts and/or myogenic cells are added to and/or cultured on the fiber scaffold prior to implantation of the medical implant.

### Claim 7

An implantable therapeutic material for regeneration of skeletal muscle comprising:
a hydrogel; and
nerve cells encapsulated within the hydrogel, wherein at least some of the nerve cells are living.

### Claim 8 (depends on 7)

The implantable therapeutic material of claim 7, wherein the nerve cells comprise a catecholamine nerve cell.

### Claim 9 (depends on 7)

The implantable therapeutic material of claim 7, wherein the hydrogel is a reaction product of hyaluronic acid, chondroitin sulfate, polyethylene glycol or a copolymer thereof, or a combination thereof.

### Claim 10 (depends on 7)

The implantable therapeutic material of claim 7, wherein the hydrogel has a concentration of the nerve cells of 10,000 cells per 20 microliters of the hydrogel to 10,000,000 cells per 20 microliters of the hydrogel.

### Claim 11 (depends on 7)

The implantable therapeutic material of claim 7, wherein the hydrogel has a storage modulus of 12 kPa to 14 kPa.

### Claim 12 (depends on 7)

A medical implant comprising the implantable therapeutic material of claim 7.

### Claim 13 (depends on 12)

The medical implant of claim 12, further comprising a synthetic fiber scaffold in contact with the implantable therapeutic material.

### Claim 14 (depends on 13)

The medical implant of claim 13, wherein the fiber scaffold comprises skeletal muscle myoblasts and/or myogenic cells, wherein at least some of the skeletal muscle myoblasts and/or myogenic cells are added to and/or cultured on the fiber scaffold prior to implantation of the medical implant.

### Claim 15 (depends on 7)

A method of forming the implantable therapeutic material of claim 7, the method comprising:
adding the nerve cells to a hydrogel precursor composition;
forming the hydrogel from the hydrogel precursor composition to form the implantable therapeutic material.

### Claim 16 (depends on 1)

A method of regenerating skeletal muscle, the method comprising:
applying the composition of claim 1 adjacent to skeletal muscle myoblasts and/or myogenic cells to regenerate skeletal muscle therefrom.

### Claim 17 (depends on 16)

The method of claim 16, wherein the applying comprises injecting the composition into skeletal muscle or adjacent thereto, implanting an implant that releases the composition to the skeletal muscle myoblasts and/or myogenic cells, applying the composition adjacent to an implanted synthetic fiber scaffold, or a combination thereof.

### Claim 18 (depends on 5)

A method of regenerating skeletal muscle, the method comprising:
implanting the medical implant of claim 5 adjacent to skeletal muscle myoblasts and/or myogenic cells to regenerate skeletal muscle therefrom.

### Claim 19 (depends on 7)

A method of regenerating skeletal muscle, the method comprising:
implanting the implantable material of claim 7 adjacent to skeletal muscle myoblasts and/or myogenic cells to regenerate skeletal muscle therefrom.

### Claim 20 (depends on 12)

A method of regenerating skeletal muscle, the method comprising:
implanting the medical implant of claim 12 adjacent to skeletal muscle myoblasts and/or myogenic cells to regenerate skeletal muscle therefrom.
