# US 8,785,395 B2 · Adult stem cells/progenitor cells and stem cell proteins for treatment of eye injuries and diseases

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- Number: US 8,785,395 B2
- Document ID: US8785395B2
- Status: Granted
- Kind: B2
- Application number: 13/643,592
- Filed: 2011-05-03
- Published: 2013-02-14
- Granted: 2014-07-22
- Earliest claimed: 2010-05-03
- Assignees: The Texas A&M University System; Temple Therapeutics, Inc.
- Applicants: Darwin J. Prockop; Joo Youn Oh; Gavin W. Roddy; Robert Rosa; Barry A. Berkowitz
- Inventors: Darwin J. Prockop; Joo Youn Oh; Gavin W. Roddy; Robert Rosa; Barry A. Berkowitz
- Web page: https://patentgrep.com/patent/US8785395B2

## CPC

- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 9/0051: {Ocular inserts or implants}
- A61K 38/1709: {from mammals}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/10: Antimycotics
- A61P 31/12: Antivirals
- C07K 16/18: against material from animals or humans
- C12N 5/0663: {Bone marrow mesenchymal stem cells (BM-MSC)}
- A61K 2035/124: {the cells being hematopoietic, bone marrow derived or blood cells}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12N 2501/25: Tumour necrosing factors [TNF]
- C12N 2501/48: Regulators of apoptosis
- 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
- 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

The present invention encompasses methods and compositions for treating an ocular disease, disorder or condition in a mammal. The invention includes a population of mesenchymal stromal cells that possess anti-inflammatory, anti-apoptotic, immune modulatory and anti-tumorigenic properties. The invention includes administration of TSG-6, STC-1, or a combination thereof to the ocular as a treatment for an ocular disease, disorder or condition in a mammal.

## Claims

### Claim 1

A method of treating an injury to the cornea in a patient, comprising:
administering to said patient a therapeutic agent for treating an injury to the cornea consisting of TSG-6 protein or a biologically active fragment, or variant thereof, wherein said TSG-6 protein or biologically active fragment, or variant thereof is administered in an amount effective to treat said injury to the cornea in said patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein said injury to the cornea is an injury to the corneal stromal areas.

### Claim 3 (depends on 1)

The method of claim 1 wherein said TSG-6 protein or a biologically active fragment, or variant thereof is administered to said patient in an amount of from about 0.01 mg to about 20 mg per kilogram of body weight.

### Claim 4 (depends on 3)

The method of claim 3 wherein said TSG-6 protein or a biologically active fragment, or variant thereof is administered to said patient in an amount of from about 0.1 mg to about 5 mg per kilogram of body weight.

### Claim 5 (depends on 1)

The method of claim 1 wherein said therapeutic agent for treating an injury to the cornea is administered intraocularly.

### Claim 6

A method of treating an injury to the cornea in a patient, comprising:
administering to the cornea of said patient eye drops containing a therapeutic agent for treating an injury to the cornea consisting of TSG-6 protein or a biologically active fragment, or variant thereof, and wherein said TSG-6 protein or biologically active fragment, variant, or analog thereof is contained in said eye drops in an amount effective to treat said injury to the cornea in said patient.
