# US 9,517,199 B2 · Treatment for chronic myocardial infarct

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- Number: US 9,517,199 B2
- Document ID: US9517199B2
- Status: Granted
- Kind: B2
- Application number: 14/630,305
- Filed: 2015-02-24
- Published: 2015-06-18
- Granted: 2016-12-13
- Earliest claimed: 2007-04-16
- Assignees: BioCardia, Inc.
- Applicants: BioCardia, Inc.
- Inventors: Luis M. de la Fuente; Simon H. Stertzer; Julio Argentieri; Eduardo Penaloza; Peter A. Altman
- Web page: https://patentgrep.com/patent/US9517199B2

## CPC

- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 35/14: Blood; Artificial blood (perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42)
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 35/32: Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
- A61K 35/35: Fat tissue; Adipocytes; Stromal cells; Connective tissues (adipose-derived stem cells A61K35/28; collagen A61K38/39)
- A61P 9/00: Drugs for disorders of the cardiovascular system
- 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

## Abstract

A method of treating chronic post-myocardial infarction including helical needle transendocardial delivery of autologous bone marrow (ABM) mononuclear cells around regions of hypo or akinesia in chronic post-myocardial infarction (MI) patients. The treatment is safe and improves ejection fraction (EF).

## Claims

### Claim 1

A method of treating chronic myocardial infarction comprising:
identifying a patient with chronic myocardial infarction with areas of chronic myocardial infarct within the patient's myocardium; and
transendocardially injecting a therapeutic preparation comprising 30,000,000 to 264,000,000 concentrated mononuclear cells into myocardium of the patient near or in an area of chronic infarcted tissue resulting from chronic myocardial infarct, where said mononuclear cells were harvested from autologous bone marrow cells from the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein said at least 40% of said concentrated mononuclear cells are
(a) CD-34 positive cells,
(b) CD-90 positive cells,
(c) CD-133 positive cells, or
(d) a combination of CD-34 positive cells, CD-90 positive cells, and/or CD-133 positive cells.

### Claim 3 (depends on 1)

The method of claim 1 wherein said concentrated mononuclear cells comprises at least 40% CD-34 positive cells.

### Claim 4 (depends on 1)

The method of claim 1 wherein said concentrated mononuclear cells comprises at least 40% CD-133 positive cells.

### Claim 5

A method of treating chronic myocardial infarction comprising:
identifying a patient with chronic myocardial infarction with areas of chronic myocardial infarct within the patient's myocardium;
transendocardially injecting a therapeutic preparation into the myocardium of the patient near or in areas of chronic myocardial infarct, where said therapeutic preparation comprises concentrated CD-34 positive cells and CD-133 positive cells harvested from autologous bone marrow cells of the patient and suspended in solution.

### Claim 6 (depends on 4)

The method of claim 4, wherein said at least 40% of said concentrated mononuclear cells are
(a) CD-34 positive cells,
(b) CD-90 positive cells,
(c) CD-133 positive cells, or
(d) a combination of CD-34 positive cells, CD-90 positive cells, and/or CD-133 positive cells.

### Claim 7 (depends on 5)

The method of claim 5 wherein said therapeutic preparation comprising at least 40% CD-34 positive cells.

### Claim 8 (depends on 5)

The method of claim 5 wherein said therapeutic preparation of the cells comprising at least 40% CD-133 positive cells.

### Claim 9 (depends on 5)

The method of claim 5 wherein a concentration of mononuclear cells including CD-34 positive cells, CD-133 positive cells or a combination thereof is in the range from 108 concentrated cells/ml of solution to 1.2×108 concentrated cells/ml of solution.

### Claim 10

A method of treating chronic myocardial infarction comprising:
identifying a patient with chronic myocardial infarction having an ejection fraction less than 40%; and
transendocardially injecting a therapeutic preparation comprising concentrated CD-34 positive and CD-133 positive mononuclear cells into myocardium of the patient, where said mononuclear cells were harvested from autologous bone marrow cells from the patient.

### Claim 11 (depends on 10)

The method of claim 10 wherein the therapeutic preparation comprises 30,000,000 to 264,000,000 concentrated mononuclear cells comprising CD-34 positive and CD-133 positive mononuclear cells.

### Claim 12 (depends on 10)

The method of claim 10, wherein said at least 40% of said concentrated mononuclear cells are
(a) CD-34 positive cells,
(b) CD-90 positive cells,
(c) CD-133 positive cells, or
(d) a combination of CD-34 positive cells, CD-90 positive cells, and/or CD-133 positive cells.

### Claim 13 (depends on 10)

The method of claim 10 wherein said therapeutic preparation comprises at least 40% CD-34 positive cells.

### Claim 14 (depends on 10)

The method of claim 10 wherein said therapeutic preparation comprises at least 40% CD-133 positive cells.

### Claim 15

A method of treating chronic myocardial infarction comprising:
identifying a patient with areas of chronic myocardial infarct and/or ischemic tissue within the patient's myocardium 10-13 are directed at treat; and
transendocardially injecting a therapeutic preparation comprising concentrated CD-34 positive and CD-133 positive mononuclear cells into myocardium of the patient near or in said areas of chronic infarcted tissue and/or ischemic tissue, where said mononuclear cells were harvested from autologous bone marrow cells from the patient and were injected with a helical needle.

### Claim 16 (depends on 15)

The method of claim 15 wherein the therapeutic preparation comprises 30,000,000 to 264,000,000 000 concentrated mononuclear cells comprising concentrated CD-34 positive and CD-133 positive mononuclear cells.

### Claim 17 (depends on 15)

The method of claim 15, wherein said at least 40% of said concentrated mononuclear cells are
(a) CD-34 positive cells,
(b) CD-90 positive cells,
(c) CD-133 positive cells, or
(d) a combination of CD-34 positive cells, CD-90 positive cells, and/or CD-133 positive cells.

### Claim 18 (depends on 15)

The method of claim 15 wherein said therapeutic preparation comprises at least 40% CD-34 positive cells.

### Claim 19 (depends on 15)

The method of claim 15 wherein said therapeutic preparation comprises at least 40% CD-133 positive cells.

### Claim 20

A method of treating chronic myocardial infarction comprising:
identifying a patient with areas of chronic myocardial infarct and/or ischemic tissue within the patient's myocardium; and
transendocardially injecting a therapeutic preparation comprising concentrated CD-34 positive and CD-133 positive mononuclear cells into myocardium of the patient proximate said areas of chronic infarcted tissue and/or ischemic tissue, where said mononuclear cells were harvested from autologous bone marrow cells from a posterior iliac crest of the patient.

### Claim 21 (depends on 20)

The method of claim 20 wherein the therapeutic preparation comprises 30,000,000 to 264,000,000 000 concentrated mononuclear cells comprising concentrated CD-34 positive and CD-133 positive mononuclear cells.

### Claim 22 (depends on 20)

The method of claim 20, wherein said at least 40% of said concentrated mononuclear cells are
(a) CD-34 positive cells,
(b) CD-90 positive cells,
(c) CD-133 positive cells, or
(d) a combination of CD-34 positive cells, CD-90 positive cells, and/or CD-133 positive cells.

### Claim 23 (depends on 20)

The method of claim 20 wherein said therapeutic preparation comprises at least 40% CD-34 positive cells.

### Claim 24 (depends on 20)

The method of claim 20 wherein said therapeutic preparation comprises at least 40% CD-133 positive cells.

### Claim 25

A method of treating chronic myocardial infarction comprising:
identifying a patient with areas of chronic myocardial infarct and/or ischemic tissue within the patient's myocardium; and
transendocardially injecting a therapeutic preparation comprising concentrated CD-34 positive and CD-133 positive mononuclear cells into myocardium of the patient near or in said areas of chronic infarcted tissue and/or ischemic tissue, where said mononuclear cells were harvested from autologous bone marrow cells, filtered and resuspended.

### Claim 26 (depends on 25)

The method of claim 25 wherein the mononuclear cells were filtered through a 100 μm mesh to remove cell aggregations.

### Claim 27 (depends on 25)

The method of claim 25 wherein the therapeutic preparation comprises 30,000,000 to 264,000,000 000 concentrated mononuclear cells comprising concentrated CD-34 positive and CD-133 positive mononuclear cells.

### Claim 28 (depends on 25)

The method of claim 25, wherein said at least 40% of said concentrated mononuclear cells are
(a) CD-34 positive cells,
(b) CD-90 positive cells,
(c) CD-133 positive cells, or
(d) a combination of CD-34 positive cells, CD-90 positive cells, and/or CD-133 positive cells.

### Claim 29 (depends on 25)

The method of claim 25 wherein said therapeutic preparation comprises at least 40% CD-34 positive cells.

### Claim 30 (depends on 25)

The method of claim 25 wherein said therapeutic preparation comprises at least 40% CD-133 positive cells.

### Claim 31

A method of treating chronic myocardial infarction comprising:
identifying a patient with areas of chronic myocardial infarct and/or ischemic tissue within the patient's myocardium; and
transendocardially injecting a therapeutic preparation comprising concentrated CD-34 positive and CD-133 positive mononuclear cells into myocardium of the patient near or in said areas of chronic infarcted tissue and/or ischemic tissue, where said mononuclear cells were harvested from adipose tissue from the patient.

### Claim 32 (depends on 31)

The method of claim 31 wherein the therapeutic preparation comprises 30,000,000 to 264,000,000 000 concentrated mononuclear cells comprising concentrated CD-34 positive and CD-133 positive mononuclear cells.

### Claim 33 (depends on 31)

The method of claim 31, wherein said at least 40% of said concentrated mononuclear cells are
(a) CD-34 positive cells,
(b) CD-90 positive cells,
(c) CD-133 positive cells, or
(d) a combination of CD-34 positive cells, CD-90 positive cells, and/or CD-133 positive cells.

### Claim 34 (depends on 31)

The method of claim 31 wherein said therapeutic preparation comprises at least 40% CD-34 positive cells.

### Claim 35 (depends on 31)

The method of claim 31 wherein said therapeutic preparation comprises at least 40% CD-133 positive cells.

### Claim 36

A method of treating chronic myocardial infarction comprising:
identifying a patient with areas of chronic myocardial infarct and/or ischemic tissue within the patient's myocardium; and
transendocardially injecting a therapeutic preparation comprising concentrated CD-34 positive and CD-133 positive mononuclear cells into myocardium of the patient near or in said areas of chronic infarcted tissue and/or ischemic tissue, where said mononuclear cells were harvested from peripheral blood from the patient.

### Claim 37 (depends on 36)

The method of claim 36 wherein the therapeutic preparation comprises 30,000,000 to 264,000,000 000 concentrated mononuclear cells comprising concentrated CD-34 positive and CD-133 positive mononuclear cells.

### Claim 38 (depends on 36)

The method of claim 36, wherein said at least 40% of said concentrated mononuclear cells are
(a) CD-34 positive cells,
(b) CD-90 positive cells,
(c) CD-133 positive cells, or
(d) a combination of CD-34 positive cells, CD-90 positive cells, and/or CD-133 positive cells.

### Claim 39 (depends on 36)

The method of claim 36 wherein said therapeutic preparation comprises at least 40% CD-34 positive cells.

### Claim 40 (depends on 36)

The method of claim 36 wherein said therapeutic preparation comprises at least 40% CD-133 positive cells.