# US 10,869,886 B2 · Cell suspension for use in the treatment of lower extremity peripheral artery disease

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- Number: US 10,869,886 B2
- Document ID: US10869886B2
- Status: Granted
- Kind: B2
- Application number: 15/688,555
- Filed: 2017-08-28
- Published: 2018-03-01
- Granted: 2020-12-22
- Earliest claimed: 2017-08-28
- Assignees: Rexgenero Biosciences S.L.; Servicio Andaluz De Salud; FundaciüBlica Andaluza Progreso Y Salud
- Applicants: Rexgenero Biosciences S.L.; Servicio Andaluz de Salud; Fundación Pública Andaluza Progreso y Salud
- Inventors: Jonathan Robert Barclay Dupere; Liesbeth de Jong; Edwin J. Wagena; Inmaculada Concepción Herrera Arroyo
- Web page: https://patentgrep.com/patent/US10869886B2

## CPC

- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 40/10: characterised by the cell type used
- A61K 40/40: characterised by antigens that are targeted or presented by cells of the immune system
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- C12N 5/0634: {Cells from the blood or the immune system}
- C12N 5/0647: {Haematopoietic stem cells; Uncommitted or multipotent progenitors}
- A61K 2035/124: {the cells being hematopoietic, bone marrow derived or blood cells}
- A61K 2239/31: characterized by the route of administration
- A61K 2239/38: characterised by the dose, timing or administration schedule
- 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 present invention refers to a cell suspension of autologous or allogeneic, preferably autologous, adult bone marrow-derived white blood cells, preferably derived from the crest of the ilium (or iliac crest), enriched for mononuclear cells, meaning more than 25% of the white blood cells (WBCs) present in the cell suspension are mononuclear cells, and comprising: A. Mononuclear cells (MNC) selected from the list comprising or consisting of: i. A population of Lymphocytes; ii. A population of Monocytes; and iii. A population of Hematopoietic stem cells expressing CD34; and wherein the cell suspension further comprises: B. Granulocytes; for use in the treatment or amelioration of lower extremity peripheral artery disease.

## Claims

### Claim 1

A cell suspension comprising from 4×108 to 1.2×109 white blood cells derived from the bone marrow of a human subject, wherein of the total number of from 4×108 to 1.2×109 white blood cells:
i. 20% to 51% are lymphocytes, and 3.9% to 22.3% are monocytes;
ii. 1.4% to 10% are hematopoietic stem cells that express CD34;
iii. 25.3% to 83.3% of the total number of white blood cells are mononuclear cells;
iv. 16.7% to 74.7% of the total number of white blood cells are granulocytes;
v. 5.4% to 38.8% of the total number of white blood cells express CXCR4;
vi. 0.07% to 24.7% of total number of white blood cells express VEGFR2;
vii. of the total number of hematopoietic stem cells that express CD34, 7.7% to 55.5% are early, non-committed hematopoietic stem cells that do not express CD38 and 0.7% to 10.3% are stem cells that express CXCR4; and
viii. the maximum ratio of red blood cells to leucocyte cells is 6.7 and the maximum ratio of platelets to leucocyte cells is 32;
wherein the cell suspension is for use in the treatment or amelioration of lower extremity peripheral artery disease; and wherein the cell suspension is derived from the same subject that is intended to receive the cell suspension or is derived from a different subject that is intended to receive the cell suspension.

### Claim 2 (depends on 1)

The cell suspension according to claim 1, wherein of the total number of white blood cells, 32.3% to 80.0% are mononuclear cells selected from the list consisting of lymphocytes, monocytes and hematopoietic stem cells that express CD34 and 20.0% to 67.7% are granulocytes.

### Claim 3 (depends on 1)

The cell suspension according to claim 1, wherein the cell suspension comprises 5×108 to 1.2×109 white blood cells derived from the bone marrow of a human subject.

### Claim 4 (depends on 1)

The cell suspension according to claim 1, wherein the cell suspension comprises 8×108 to 1.2×109 white blood cells derived from the bone marrow of a human subject.

### Claim 5 (depends on 1)

The cell suspension according to claim 1, wherein the cell suspension comprises 9×108 to 1.1×109 white blood cells derived from the bone marrow of a human subject.

### Claim 6 (depends on 1)

The cell suspension according to claim 1, wherein the cell suspension comprises 9.5×108 to 1.05×109 white blood cells derived from the bone marrow of a human subject.

### Claim 7 (depends on 1)

The cell suspension according to claim 1, wherein the cell suspension comprises 9.8×108 to 1.02×109 white blood cells derived from the bone marrow of a human subject.

### Claim 8 (depends on 1)

The cell suspension according to claim 1, wherein the lower extremity peripheral artery disease is critical limb ischemia.

### Claim 9 (depends on 1)

The cell suspension according to claim 1, wherein the cells of such cell suspension are suspended in a volume of from 5 to 30 ml of a heparinized saline solution or lactated Ringer solution, comprising about 1% HSA and about 2.5% glucose.

### Claim 10 (depends on 1)

One or several pre-filled syringe/s comprising a cell suspension as defined in claim 1.

### Claim 11 (depends on 10)

The syringe/S according to claim 10, wherein said suspension is provided as a single dose.