# US 2017/0281684 A1 · Renal cell populations and uses thereof

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- Number: US 2017/0281684 A1
- Document ID: US20170281684A1
- Status: Published application
- Kind: A1
- Application number: 15/623,197
- Filed: 2017-06-14
- Published: 2017-10-05
- Earliest claimed: 2012-10-24
- Assignees: RegenMed (Cayman) Ltd.
- Applicants: RegenMed (Cayman) Ltd.
- Inventors: Joydeep Basu; Kelly Guthrie; Dominic Justewicz; Teresa Burnette; Andrew Bruce; Russell W. Kelley; John W. Ludlow
- Web page: https://patentgrep.com/patent/US20170281684A1

## CPC

- A61K 35/22: Urine; Urinary tract, e.g. kidney or bladder; Intraglomerular mesangial cells; Renal mesenchymal cells; Adrenal gland
- A61P 13/12: of the kidneys
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 5/0081: {Purging biological preparations of unwanted cells}
- C12N 5/0686: {Kidney cells}
- G01N 33/56966: {Animal cells}
- C12N 2500/02: Atmosphere, e.g. low oxygen conditions
- C12N 2501/58: Adhesion molecules, e.g. ICAM, VCAM, CD18 (ligand), CD11 (ligand), CD49 (ligand)
- C12N 2501/599: with CD designations not provided for elsewhere
- G01N 2333/4742: Keratin; Cytokeratin
- G01N 2333/705: Assays involving receptors, cell surface antigens or cell surface determinants
- G01N 2333/9108: with definite EC number (2.3.2.-)
- 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 concerns enriched heterogeneous mammalian renal cell populations characterized by biomarkers, and methods of making and using the same.

## Claims

### Claim 1

An enriched heterogeneous mammalian renal cell population that express the biomarkers GGT-l and a cytokeratin.

### Claim 2 (depends on 1)

The cell population according to claim 1 wherein the biomarkers are detected by a monoclonal or polyclonal antibody.

### Claim 3 (depends on 1)

The cell population according to claim 1 wherein greater than 18% of the cells express GGT-l.

### Claim 4 (depends on 1)

The cell population according to claim 1 wherein the cytokeratin is selected from CKS, CK18, CK19 and combinations thereof.

### Claim 5 (depends on 4)

The cell population according to claim 4 wherein the level of expression of the cytokeratin is greater than 80%.

### Claim 6 (depends on 1)

The cell population according to claim 1 wherein the cytokeratin is detected by polyclonal antibody,

### Claim 7 (depends on 1)

The cell population according to claim 1 wherein the cell population expresses AQP.

### Claim 8 (depends on 1)

The cell population according to claim 1 wherein less than 40% of the cells express AQP2.

### Claim 9 (depends on 7)

The cell population according to claim 7 wherein the AQP2 is detected by monoclonal antibody.

### Claim 10 (depends on 1)

The cell population according to claim 1 wherein the mammal is human.

### Claim 11

A method of identifying a heterogeneous renal cell population suitable for implantation and/or eliciting a regenerative response said method comprising the steps
Isolating cells from a mammalian kidney sample
Exposing said isolated cells to one or more labeled detection moiety, wherein each labeled detection moiety is directed to a different biomarker and is labeled with a different label
Determining the percentage of cells that express each of said different biomarker.

### Claim 12 (depends on 11)

The method of claim 11 wherein the biomarker is selected from AQP1, AQP2, AQP4, Calbindin, Calponin, CD117, CD133, CD146, CD24, CD31 (PECAM-1), CD54 (ICAM-l), CD73, CK18, CK19, CK40 to 67, CK7, CK8, CK8, CK18, CK19, combinations of CK8, CK18, CK19, Connexin 43, Cubilin, CXCR4 (Fusin), DBA, E-cadherin (CD324), EPO (erythropoeitin), GGTl, GLEPPl (glomerular epithelial protein 1), Haptoglobin, Itgbl (Integrin β1), KIM-l/TIM-1 (kidney injury molecule-l/T-cell immunoglobulin and mucin-containing molecule), MAP-2 (microtubule-associated protein 2), Megalin, N-cadherin, Nephrin, NKCC (Na—K—Cl-cotransporters), OAT-1 (organic anion transporter 1), Osteopontin, Pan-cadherin, PCLP1 (podocalyxin-like 1 molecule), Podocin, SMA (smooth muscle alpha-actin), Synaptopodin, THP (tamm-horsfall protein), Vimentin, □GST-1 (alpha glutathione 5-transferase glutathione S-transferase) and combinations thereof.

### Claim 13 (depends on 11)

The method of claim 11 wherein the labeled detection moiety is an antibody.

### Claim 14

A method of treating kidney disease in a mammal comprising administering a heterogeneous renal cell population to the patient wherein the cell population expresses two or more biomarkers selected from the group consisting of GGT-1, AQP2 and a cytokeratin.

### Claim 15 (depends on 14)

The method of claim 14, wherein cells within the cell population have levels of expression for GGT-1 and CK18 are greater than 18% and 80%, respectively.

### Claim 16 (depends on 14)

The method of claim 14, wherein cells within the cell population express GGT-1, AQP2 and CK18 at levels of expression in Table 12.4.

### Claim 17 (depends on 15)

The method according to claim 15 wherein the cell population is cultured on a matrix.

### Claim 18 (depends on 15)

The method according to claim 15 wherein the cell population is suspended in a gelatin-based biomaterial.

### Claim 19 (depends on 15)

The method according to claim 15 wherein the mammal is human.