# US 11,992,507 B2 · MAPC therapeutics without adjunctive immunosuppressive treatment

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- Number: US 11,992,507 B2
- Document ID: US11992507B2
- Status: Granted
- Kind: B2
- Application number: 12/161,893
- Filed: 2007-01-23
- Published: 2010-01-14
- Granted: 2024-05-28
- Earliest claimed: 2006-01-23
- Assignees: ABT Holding Company
- Applicants: Robert W. Mays; Robert J. Deans
- Inventors: Robert W. Mays; Robert J. Deans
- Web page: https://patentgrep.com/patent/US11992507B2

## CPC

- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- A61K 31/4353: ortho- or peri-condensed with heterocyclic ring systems
- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 31/52: Purines, e.g. adenine
- A61K 31/661: Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion {or mevinphos}
- A61K 35/12: Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00)
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- 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
- A61K 35/407: Liver; Hepatocytes
- A61K 35/44: Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
- A61K 35/48: Reproductive organs
- A61K 35/51: Umbilical cord; Umbilical cord blood; Umbilical stem cells
- A61K 35/545: Embryonic stem cells; Pluripotent stem cells; Induced pluripotent stem cells; Uncharacterised stem cells
- A61K 38/13: Cyclosporins
- 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 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/04: Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 13/02: of urine or of the urinary tract, e.g. urine acidifiers
- A61P 13/12: of the kidneys
- 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 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- A61P 21/02: Muscle relaxants, e.g. for tetanus or cramps
- A61P 21/04: for myasthenia gravis
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- 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
- A61P 35/00: Antineoplastic agents
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 39/00: General protective or antinoxious agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 5/0607: {Non-embryonic pluripotent stem cells, e.g. MASC (induced pluripotent stem cells C12N5/0696)}
- 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)

## Abstract

The invention relates to the treatment of various injuries, disorders, dysfunctions, diseases, and the like with MAPCs, without the need for adjunctive immunosuppressive treatment.

## Claims

### Claim 1

A method of administering expanded multipotent stem cells to a subject, comprising: administering to a subject in need thereof expanded multipotent stem cells that: are not embryonic stem cells, embryonic germ cells, or germ cells; can differentiate into at least one cell type of each of at least two of the endodermal, ectodermal, and mesodermal embryonic lineages; express telomerase, are allogeneic or xenogeneic to the subject, are not immunogenic to the subject, and have undergone at least 10 to 40 cell doublings in culture, without also administering an immunosuppressive treatment to the subject adjunctively to said cells, wherein said cells have been derived from bone marrow and have not been genetically engineered to improve their immunomodulatory properties, wherein said cells are not administered to the subject to ameliorate a brain injury caused by hypoxia,
wherein said cells are not administered as adjunctive treatment of an immune dysfunction characterized by adverse T-cell activation or proliferation, are not administered to treat diabetes, are not administered to suppress graft versus host disease, are not administered to ameliorate an immune dysfunction, and are not administered to treat multiple sclerosis.

### Claim 2 (depends on 1)

A method according to claim 1, wherein said cells can differentiate into at least one cell type of each of the endodermal, ectodermal, and mesodermal embryonic lineages.

### Claim 3 (depends on 1)

A method according to claim 1, wherein said cells are positive for oct-3/4.

### Claim 4 (depends on 1)

A method according to claim 1 wherein said cells are administered to the subject in one or more doses comprising 104 to 108 of said cells per kilogram of the subject's mass.

### Claim 5 (depends on 1)

A method according to claim 1 wherein said cells are administered to the subject in one or more doses comprising 106 to 5×107 of said cells per kilogram of the subject's mass.

### Claim 6 (depends on 1)

A method according to claim 1 wherein in addition to said cells, one or more growth factors, differentiation factors, cytokines and/or factors that increase homing are administered to said subject.

### Claim 7 (depends on 1)

A method according to claim 1 wherein one or more of an anti-microbial agent, an anti-fungal agent and/or an anti-viral agent is further administered to said subject.

### Claim 8 (depends on 1)

A method according to claim 1 wherein said cells are administered to the subject by a parenteral route.

### Claim 9 (depends on 1)

A method according to claim 1 wherein said cells are administered to the subject by I.V. infusion.

### Claim 10 (depends on 1)

A method according to claim 1 wherein said cells are administered by surgical implantation.

### Claim 11 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10)

A method according to any of claims 1, 2, 3, 4 to 10, wherein said cells are derived from human bone marrow.