# US 2019/0167732 A1 · Therapeutic uses of microvesicles and related micrornas

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- Number: US 2019/0167732 A1
- Document ID: US20190167732A1
- Status: Published application
- Kind: A1
- Application number: 16/034,059
- Filed: 2018-07-12
- Published: 2019-06-06
- Earliest claimed: 2010-08-13
- Assignees: The University Court of the University of Glasgow
- Applicants: The University Court of the University of Glasgow
- Inventors: Paul Shiels; Wayne Davies
- Web page: https://patentgrep.com/patent/US20190167732A1

## CPC

- A61K 35/407: Liver; Hepatocytes
- A61K 9/5068: {Cell membranes or bacterial membranes enclosing drugs (liposomes with additional exogenous lipids A61K9/127)}
- A61K 35/14: Blood; Artificial blood (perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42)
- A61K 35/22: Urine; Urinary tract, e.g. kidney or bladder; Intraglomerular mesangial cells; Renal mesenchymal cells; Adrenal gland
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 35/39: Pancreas; Islets of Langerhans (Langerhans cells of epidermis A61K35/36)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- 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 13/12: of the kidneys
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/02: for peripheral neuropathies
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 15/113: Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; {Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing (when used in plants C12N15/8218)}
- C12N 15/88: using microencapsulation, e.g. using {amphiphile} liposome vesicle
- G01N 33/5061: {Muscle cells}
- G01N 33/507: {Pancreatic cells}
- G01N 33/5073: {Stem cells}
- A61K 2035/124: {the cells being hematopoietic, bone marrow derived or blood cells}
- C12N 2310/141: MicroRNAs, miRNAs
- C12N 2320/11: for the determination of target sites, i.e. of active nucleic acids
- C12N 2320/30: Special therapeutic applications
- C12N 2330/10: naturally occurring
- 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)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention provides improved methods and compositions based on microvesicles for the treatment of various diseases, disorders and conditions. In particular, the present invention encompasses the recognition that microvesicles contain specific microRNAs which may function as intercellular regulators involved in cell or tissue regeneration, remodeling, reconstruction, reprogramming or transdifferentiation. Thus, among other things, the present invention provides methods and compositions based on microvesicles and/or associated microRNAs that provide more predictable and effective therapeutic results.

## Claims

### Claim 1

A composition comprising purified microvesicles derived from pathfinder cells.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the pathfinder cells are derived from pancreas, kidney, liver, spleen, lymph node, myometrium, peripheral blood, cord blood, bone marrow, serum, mesenchymal tissue, or a combination thereof.

### Claim 3

(canceled)

### Claim 4 (depends on 1)

The composition of claim 1, wherein the pathfinder cells are mammalian.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the mammalian cells are rat.

### Claim 6 (depends on 4)

The composition of claim 4, wherein the mammalian cells are human.

### Claim at position 7

7-9. (canceled)

### Claim 10 (depends on 1)

The composition of claim 1, wherein the microvesicles have a mean diameter of from about 100 nm to about 1000 nm.

### Claim 11 (depends on 1)

The composition of claim 1, wherein the pathfinder cells are cultured under hypoxic conditions.

### Claim 12 (depends on 1)

The composition of claim 1, wherein the pathfinder cells are cultured in a medium that is substantially free of serum.

### Claim 13 (depends on 1)

The composition of claim 1, wherein the microvesicles are characterized by an ability to increase the proliferation of cells.

### Claim 14 (depends on 13)

The composition of claim 13, wherein the microvesicles are characterized by an ability to increase the proliferation of cells in an in vitro culture system.

### Claim 15 (depends on 14)

The composition of claim 14, wherein the proliferation of cells is measured by doubling time.

### Claim 16 (depends on 1)

The composition of claim 1, wherein the microvesicles are characterized by an ability to stimulate migration or regrowth of cells.

### Claim 17

A method for increasing the proliferation of cells comprising the step of contacting the cells with a composition comprising purified microvesicles derived from pathfinder cells.

### Claim 18 (depends on 17)

The method of claim 17, wherein the wherein the pathfinder cells are derived from pancreas, kidney, or lymph node pancreas, kidney, liver, spleen, lymph node, myometrium, peripheral blood, cord blood, bone marrow, serum, mesenchymal tissue, or a combination thereof.

### Claim at position 17

19-21. (canceled)

### Claim 22 (depends on 17)

The method of claim 17, wherein the microvesicles are administered in vivo.

### Claim 23 (depends on 17)

The method of claim 17, wherein the microvesicles are administered in vitro.

### Claim 24

A method of treating a disease, disorder, or condition associated with tissue damage in a subject comprising the step of administering to the subject a composition comprising purified microvesicles derived from pathfinder cells.

### Claim 25 (depends on 24)

The method of claim 24, wherein the pathfinder cells are derived from pancreas, kidney, liver, spleen, lymph node, myometrium, peripheral blood, cord blood, bone marrow, serum, mesenchymal tissue, or a combination thereof.

### Claim 26 (depends on 24)

The method of claim 24, wherein the disease, disorder, or condition is selected from the group consisting of diabetes mellitus, congestive myocardial failure, myocardial infarct, acute renal disease, chronic renal disease, and traumatic injury.

### Claim 27

A method of preparing a purified population of microvesicles derived from pathfinder cells comprising steps of:
a. centrifuging the pathfinder cells one or more times at a centrifugal force of approximately 120,000 g or less to produce a pellet; and
b. harvesting microvesicles from the pellet.

### Claim at position 24

28-30. (canceled)