# US 2025/0164484 A1 · Marker for selecting high-quality stem cells, and method for selecting high-quality stem cells using same

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- Number: US 2025/0164484 A1
- Document ID: US20250164484A1
- Status: Published application
- Kind: A1
- Application number: 18/258,042
- Filed: 2021-12-22
- Published: 2025-05-22
- Earliest claimed: 2020-12-22
- Assignees: Cell2In, Inc.
- Applicants: Cell2in, Inc.
- Inventors: Heunsoo Kang; Ji Woong Shin; Hyewon Kang; Hye Mi Kim; Kibaek Lee; Hatnim Jeon
- Web page: https://patentgrep.com/patent/US20250164484A1

## CPC

- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- G01N 33/56966: {Animal cells}
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- C12Q 1/6876: Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- G01N 33/5073: {Stem cells}
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/158: Expression markers
- G01N 2333/475: Assays involving growth factors
- G01N 2333/5412: IL-6
- G01N 2333/5421: IL-8
- G01N 2333/70582: CD71
- G01N 2333/90245: acting on paired donors with incorporation of molecular oxygen (1.14)
- G01N 2800/7009: Oxidative stress
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)
- 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)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

The present invention relates to a composition and a kit for assessing the quality of stem cells, and a method for producing stem cells, and may provide a cell therapy product and a composition for preventing or treating immune-related disease.

## Claims

### Claim at position 1

1-15. (canceled)

### Claim 16

A method for selection of activated stem cells, the method comprising:
obtaining stem cells; and
measuring an expression level of a CD71 (Cluster of Differentiation 71) protein or a gene encoding a CD71 protein in the stem cells.

### Claim 17 (depends on 16)

The method according to claim 16, wherein, when the expression level of the CD71 protein or the gene encoding the CD71 protein in the stem cells is lower than a control, the stem cells are selected as being of high quality.

### Claim 18 (depends on 17)

The method according to claim 17, wherein a phenotype of the selected stem cells are CD71low stem cells.

### Claim 19 (depends on 16)

The method according to claim 16, further comprising a step of measuring an oxidative stress of the stem cells.

### Claim 20 (depends on 19)

The method according to claim 19, wherein the step of measuring the oxidative stress is performed by measuring a glutathione (GSH) level in the stem cells.

### Claim 21 (depends on 16)

The method according to claim 16, wherein the stem cells are mesenchymal stem cells (MSCs).

### Claim 22 (depends on 16)

The method according to claim 16, wherein an expression level of vascular endothelial growth factor (VEGF) in the selected stem cells is higher than a control.

### Claim 23 (depends on 16)

The method according to claim 16, wherein an expression level of at least one of interleukin 6 (IL-6), interleukin 8 (IL-8), and heme oxygenase 1 (HMOX1) in the selected stem cells is lower than a control.

### Claim 24 (depends on 16)

A method for treating an immune-related disease, the method comprising:
performing the method according to claim 16 to select activated stem cells; and
administering to a patient, as an active ingredient, the selective activated stem cells.

### Claim 25 (depends on 24)

The method according to claim 24, wherein the immune-related disease is at least one selected from the group consisting of autoimmune disease, graft-versus-host disease, organ transplant rejection, asthma, atopy, idiopathic pulmonary fibrosis, acute inflammation, and chronic inflammation.

### Claim 26 (depends on 16)

A method for providing cell therapy to a patient, the method comprising:
performing the method according to claim 16 to select activated stem cells; and
administering to a patient, as an active ingredient, the selective activated stem cells.

### Claim 27

A cell therapy product comprising, as an active ingredient, stem cells exhibiting a CD71low phenotype.

### Claim 28 (depends on 27)

A method for providing cell therapy to a patient, the method comprising administering to the patient the cell therapy product according to claim 27.

### Claim 29

A pharmaceutical composition for preventing or treating an immune-related disease, the pharmaceutical composition comprising, as an active ingredient, stem cells exhibiting a CD71low phenotype.

### Claim 30 (depends on 29)

A method for treating an immune-related disease, the method comprising administering to a patient in need thereof the pharmaceutical composition according to claim 29.

### Claim 31 (depends on 30)

The method according to claim 30, wherein the immune-related disease is at least one selected from the group consisting of autoimmune disease, graft-versus-host disease, organ transplant rejection, asthma, atopy, idiopathic pulmonary fibrosis, acute inflammation, and chronic inflammation.

### Claim 32

A composition for assessing quality of stem cells, the composition comprising an agent for measuring an expression level of a CD71 (Cluster of Differentiation 71) protein or a gene encoding a CD71 protein.

### Claim 33 (depends on 32)

The composition according to claim 32, wherein, when the expression level of the CD71 protein or the gene encoding the CD71 protein is lower than a control, the stem cells are determined to be of high quality.

### Claim 34 (depends on 32)

The composition according to claim 32, wherein the stem cells are mesenchymal stem cells (MSCs).

### Claim 35 (depends on 32)

A kit for assessing quality of stem cells, the kit comprising the composition according to claim 32.
