# US 12,178,943 B2 · Compositions and materials for regeneration of skeletal muscle > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,943 B2 - Document ID: US12178943B2 - Status: Granted - Kind: B2 - Application number: 17/184,231 - Filed: 2021-02-24 - Published: 2021-10-28 - Granted: 2024-12-31 - 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/US12178943B2 ## 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 medical implant comprising: an implantable therapeutic material for regeneration of skeletal muscle comprising a hydrogel comprising a reaction product of a composition comprising hyaluronic acid, chondroitin sulfate, and polyethylene glycol or a copolymer thereof, wherein the hydrogel is injectable and has a storage modulus of 10 kPa to 16 kPa, and nerve cells encapsulated within the hydrogel, wherein at least some of the nerve cells are living; and a fiber scaffold in contact with the implantable therapeutic material, wherein the fiber scaffold is an aligned electrospun fiber scaffold that is a fiber mat, and wherein the fiber scaffold comprises skeletal muscle myoblasts and/or myogenic cells. ### Claim 2 (depends on 1) The medical implant of claim 1, wherein the hydrogel is a 3D matrix that encapsulates the nerve cells. ### Claim 3 (depends on 1) The medical implant of claim 1, wherein the nerve cells comprise a unipolar nerve cell, a bipolar nerve cell, a multipolar nerve cell, an anaxonic nerve cell, a pseudounipolar nerve cell, a basket nerve cell, a Betz nerve cell, a Lugaro nerve cell, a medium spiny nerve cell, a Purkinje nerve cell, a Renshaw nerve cell, a unipolar brush nerve cell, a granule nerve cell, an anterior horn nerve cell, a spindle nerve cell, an afferent nerve cell, an efferent nerve cell, an interneuron nerve cell, a cholinergic nerve cell, an adrenergic nerve cell, a GABAergic nerve cell, a glutamatergic nerve cell, a dopaminergic nerve cell, a serotonergic nerve cell, a purinergic nerve cell, a histaminergic nerve cell, a catecholamine nerve cell, or a combination thereof. ### Claim 4 (depends on 1) The medical implant of claim 1, wherein the nerve cells comprise a catecholamine nerve cell. ### Claim 5 (depends on 1) The medical implant of claim 1, wherein the nerve cells comprise an adrenal pheochromocytoma PC12 cell line. ### Claim 6 (depends on 1) The medical implant of claim 1, wherein the nerve cells encapsulated within the hydrogel release a nerve cell secretome such that the hydrogel releases the secretome. ### Claim 7 (depends on 6) The medical implant of claim 6, wherein the secretome comprises Galectin-1, Progranulin, CathepsinB, Glypican-1, Prosaposin, or a combination thereof. ### Claim 8 (depends on 1) The medical implant of claim 1, wherein the composition comprising hyaluronic acid, chondroitin sulfate, and polyethylene glycol or a copolymer thereof further comprises polyvinyl alcohol, sodium polyacrylate, an acrylate polymer, an acrylate copolymer, polylactic acid, a polylactic acid copolymer, polyglycolic acid, a polyglycolic acid copolymer, poly(lactic-co-glycolic acid), poly(amino acids), polyphosphazenes, poly(phosphoesters), collagen, gelatin, fibrin, agarose, chitosan, cellulose, a cellulose derivative, methylcellulose, elastin, dextran, agarose, alginate, heparin, an elastin-like-polypeptide (ELP), or a combination thereof. ### Claim 9 (depends on 1) The medical implant of claim 1, wherein the hydrogel has a storage modulus of 11 kPa to 16 kPa. ### Claim 10 (depends on 1) The medical implant of claim 1, wherein the hydrogel has a storage modulus of 11.5 kPa to 16 kPa. ### Claim 11 (depends on 1) The medical implant of claim 1, wherein the fiber scaffold comprises polyester, poly(lactide-co-glycolide), or a combination thereof. ### Claim 12 (depends on 1) The medical implant of claim 1, 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 13 (depends on 1) The medical implant of claim 1, wherein the aligned electrospun fiber scaffold is formed by a method comprising collecting electrospun fibers on a rotating drum. ### Claim 14 (depends on 1) The medical implant of claim 1, wherein the hydrogel comprises an interconnected, microporous structure. ### Claim 15 (depends on 1) A method of forming the medical implant of claim 1, 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; and contacting the implantable therapeutic material with a fiber scaffold comprising skeletal muscle myoblasts and/or myogenic cells to form the medical implant. ### Claim 16 (depends on 1) A method of regenerating skeletal muscle, the method comprising: implanting the medical implant of claim 1 adjacent to skeletal muscle myoblasts and/or myogenic cells to regenerate skeletal muscle therefrom. ### Claim 17 A method of regenerating skeletal muscle, the method comprising: implanting a medical implant adjacent to skeletal muscle myoblasts and/or myogenic cells to regenerate skeletal muscle therefrom, the medical implant comprising an implantable therapeutic material for the regeneration of skeletal muscle comprising a hydrogel and nerve cells encapsulated within the hydrogel, wherein at least some of the nerve cells are living, wherein the nerve cells encapsulated within the hydrogel release a nerve cell secretome such that the hydrogel releases the secretome, and wherein the hydrogel is injectable and has a storage modulus of 10 kPa to 16 kPa, and a fiber scaffold in contact with the implantable therapeutic material, wherein the fiber scaffold is an aligned electrospun fiber scaffold that is a fiber mat.