# US 2014/0154276 A1 · Mesenchymal Stem Cells and Uses Therefor

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- Number: US 2014/0154276 A1
- Document ID: US20140154276A1
- Status: Published application
- Kind: A1
- Application number: 14/087,830
- Filed: 2013-11-22
- Published: 2014-06-05
- Earliest claimed: 2004-03-22
- Assignees: Mesoblast International Sarl
- Applicants: Mesoblast International SáRl
- Inventors: Sudeepta Aggarwal; Mark F. Pittenger; Timothy Varney
- Web page: https://patentgrep.com/patent/US20140154276A1

## CPC

- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 38/2026: {IL-4}
- A61K 38/2066: {IL-10}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/14: of the thyroid hormones, e.g. T3, T4
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 7/06: Antianaemics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/08: of the prostate
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 17/14: for baldness or alopecia
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 5/0662: {Stem cells}
- C12N 5/0663: {Bone marrow mesenchymal stem cells (BM-MSC)}
- C12N 5/0664: {Dental pulp stem cells, Dental follicle stem cells}
- C12N 5/0665: {Blood-borne mesenchymal stem cells, e.g. from umbilical cord blood}
- C12N 5/0666: {Mesenchymal stem cells from hair follicles}
- C12N 5/0667: {Adipose-derived stem cells [ADSC]; Adipose stromal stem cells}
- C12N 5/0668: {Mesenchymal stem cells from other natural sources}
- A61K 2035/124: {the cells being hematopoietic, bone marrow derived or blood cells}
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Methods of treating autoimmune diseases, allergic responses, cancer, or inflammatory diseases in an animal, promoting would healing, repairing epithelial damage and promoting angiogenesis in an organ or tissue of an animal by administering to the animal mesenchymal stem cells in an effective amount.

## Claims

### Claim at position 1

1-13. (canceled)

### Claim 14

A method of reducing inflammation in a human in need thereof, comprising the step of intravenously or intraarterially administering to a human having inflammation a suspension of cells in an amount effective to reduce the inflammation, wherein the cells are allogeneic mesenchymal stem cells, wherein the suspension of mesenchymal stem cells is at least about 95% homogeneous and wherein the mesenchymal stem cells express CD73 and CD105.

### Claim 15 (depends on 14)

The method of claim 14, wherein the suspension further comprises an acceptable pharmaceutical carrier.

### Claim 16 (depends on 15)

The method of claim 15, wherein the acceptable pharmaceutical carrier is a pharmaceutically acceptable liquid medium for injection.

### Claim 17 (depends on 14)

The method of claim 14, wherein the mesenchymal stem cells are capable of binding to an antibody produced from hybridoma cell line SH4, ATCC accession number HB 10745.

### Claim 18 (depends on 14)

The method of claim 14, wherein the suspension is administered in an amount of from about 1×105 cells/kg to about 1×107 cells/kg.

### Claim 19 (depends on 14)

The method of claim 14, wherein the suspension is administered in an amount of from about 1×106 cells/kg to about 5×106 cells/kg.

### Claim 20 (depends on 14)

The method of claim 14, wherein the suspension is administered in an amount of about 3×106 cells/kg.

### Claim 21 (depends on 14)

The method of claim 14, wherein the inflammation is an inflammatory response to an autoimmune or pulmonary disease.

### Claim 22 (depends on 21)

The method of claim 21, wherein the inflammation is an inflammatory response to an autoimmune disease.

### Claim 23 (depends on 22)

The method of claim 22, wherein the inflammation is inflammation in the gut during inflammatory bowel disease.

### Claim 24

A method of reducing inflammation in the gastrointestinal track of a patient in need thereof, comprising the step of intravenously or intraarterially administering to a human suffering from inflammation of the gastrointestinal track a suspension of cells in an amount effective to reduce the inflammation, wherein the cells are allogeneic mesenchymal stem cells, wherein the suspension of mesenchymal stem cells is at least 95% homogeneous and wherein the mesenchymal stem cells express CD73 and CD105.

### Claim 25 (depends on 24)

The method of claim 24, wherein the patient suffers from Crohn's disease, inflammatory bowel disease, gastrointestinal graft-versus-host disease (GVHD), or autoimmune gastritis.

### Claim 26 (depends on 25)

The method of claim 25, wherein the patient suffers from gastrointestinal graft-versus-host disease.

### Claim 27 (depends on 26)

The method of claim 26, wherein the patient was refractory to one or more treatments to GVHD.

### Claim 28 (depends on 24)

The method of claim 24, wherein the suspension further comprises an acceptable pharmaceutical carrier.

### Claim 29 (depends on 28)

The method of claim 28, wherein the acceptable pharmaceutical carrier is a pharmaceutically acceptable liquid medium for injection.

### Claim 30 (depends on 24)

The method of claim 24, wherein the suspension is administered in an amount of from about 1×105 cells/kg to about 1×107 cells/kg.

### Claim 31 (depends on 24)

The method of claim 24, wherein the suspension is administered in an amount of from about 1×106 cells/kg to about 5×106 cells/kg.

### Claim 32 (depends on 24)

The method of claim 24, wherein the suspension is administered in an amount of about 3×106 cells/kg.

### Claim 33

A method of increasing production or secretion of an anti-inflammatory cytokines interleukin-4 or interleukin-10 in a human in need thereof, comprising the step of:
administering to the human a suspension of cells in an amount effective to increase production or secretion of the anti-inflammatory cytokines, wherein the cells are allogeneic mesenchymal stem cells that express cell surface markers CD73 and CD105 and wherein the suspension of mesenchymal stem cells is at least about 95% homogeneous.

### Claim 34 (depends on 33)

The method of claim 33, wherein the suspension is administered in an amount of from about 1×105 cells/kg to about 1×107 cells/kg.

### Claim 35

A method of reducing production or secretion of a pro-inflammatory cytokine in a human in need thereof, comprising the steps of:
administering to the human a suspension of cells in an amount effective to reduce production or secretion of the pro-inflammatory cytokine tumor necrosis factor alpha, interferon gamma or interleukin-17, wherein the cells are allogeneic mesenchymal stem cells expressing cell surface markers CD73 and CD105 and wherein the suspension of mesenchymal stem cells is at least 95% homogeneous.

### Claim 36 (depends on 35)

The method of claim 35, wherein the suspension is administered in an amount of from about 1×105 cells/kg to about 1×107 cells/kg.

### Claim 37

A cell preparation comprising allogeneic adult mesenchymal stem cells in a dose effective to treat an inflammatory response in a subject in need thereof, wherein the adult mesenchymal stem cells are at least 95% homogeneous and express the cell surface markers CD73 and CD105.
