# US 2026/0053858 A1 · Compositions comprising cell-delivered vesicles and uses thereof

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2026/0053858 A1
- Document ID: US20260053858A1
- Status: Published application
- Kind: A1
- Application number: 19/311,111
- Filed: 2025-08-27
- Published: 2026-02-26
- Earliest claimed: 2018-08-31
- Assignees: ProKidney
- Applicants: ProKidney
- Inventors: Timothy A. BERTRAM; Deepak JAIN
- Web page: https://patentgrep.com/patent/US20260053858A1

## 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 35/22: Urine; Urinary tract, e.g. kidney or bladder; Intraglomerular mesangial cells; Renal mesenchymal cells; Adrenal gland
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 31/713: Double-stranded nucleic acids or oligonucleotides
- A61P 25/00: Drugs for disorders of the nervous system
- C12N 5/0687: {Renal stem cells; Renal progenitors}
- G01N 33/5076: {involving cell organelles, e.g. Golgi complex, endoplasmic reticulum}
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- G01N 33/6803: {General methods of protein analysis not limited to specific proteins or families of proteins}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C12N 2310/141: MicroRNAs, miRNAs
- C12N 2500/25: Insulin-transferrin; Insulin-transferrin-selenium
- C12N 2500/99: Serum-free medium
- C12N 2501/11: Epidermal growth factor [EGF]
- C12N 2501/12: Hepatocyte growth factor [HGF]
- C12N 2502/256: Renal cells
- G01N 2333/70596: Molecules with a "CD"-designation not provided for elsewhere in G01N2333/705
- G01N 2800/347: Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
- 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

Provided herein are, inter alia, extracellular products (e.g., vesicles such as microvesicles, e.g., exosomes) produced by renal cells (such as bioactive renal cells, e.g., selected renal cells). Methods of altering components (such as miRNAs or proteins) of vesicles produced by cells, as well as methods of producing vesicles comprising various compounds are also included. Also provided are diagnostic and treatment methods.

## Claims

### Claim at position 1

1-102. (canceled)

### Claim 103

A method for monitoring treatment with a bioactive renal cell population in a subject who has been administered the bioactive renal cell population, comprising:
obtaining a vesicle from a sample of the subject; and
detecting whether at least one compound is in the vesicle, wherein:
(i) the at least one compound is a protein, and the protein is CD9, CD81, CD146, CD326, CD40, CD42a, CD44, CD49e, and/or SSEA-4:
(ii) the at least one compound comprises miRNAs, wherein the miRNAs include at least two of miR-145, miR-22, miR-7, miR-10a, miR-143, and/or let7b; and/or
(iii) the at least one compound is not expressed or produced by renal cells in a native kidney.

### Claim 104 (depends on 103)

The method of claim 103, comprising detecting whether the at least one compound is present in a vesicle from the subject at a first time point and a second time point.

### Claim 105 (depends on 104)

The method of claim 104, wherein the first time point is before the subject has been administered the bioactive renal cell population and the second time point is after the subject has been administered the bioactive renal cell population.

### Claim 106 (depends on 104)

The method of claim 104, wherein the first time point and the second time point are after the subject has been administered the bioactive renal cell population.

### Claim 107 (depends on 104)

The method of claim 104, further comprising identifying a regenerative effect in the subject if the level of the compound is higher at the first time point compared to the second time point.

### Claim 108 (depends on 103)

The method of claim 103, further comprising identifying a regenerative effect in the subject if the level of the compound is higher than a control.

### Claim 109 (depends on 108)

The method of claim 108, wherein the control is the level in a corresponding subject who has not been administered the bioactive renal cell population.

### Claim 110

(canceled)

### Claim 111

A method of detecting the level of at least one miRNA in vesicles from a bioactive renal cell population, the method comprising-
(i) detecting whether one or more of the following miRNA molecules is increased in the vesicles compared to a control: miR-1248, miR-3168, miR-362-5p, miR-7113-5p, miR-758-3p, miR-937-3p, miR-4455, miR-4521, miR-203a-3p, miR-22-3p, miR-574-3p, miR-181b-5p, miR-1260b, and/or miR-181b-5p; and/or
(ii) detecting whether one or more of the following miRNA molecules is decreased in the vesicles compared to a control: miR-1-3p, miR-1-3p, miR-143-3p, miR-150-5p, miR-509-3p, miR-653-5p, miR-204-5p, miR-192-5p, and/or miR-363-3p.

### Claim 112 (depends on 111)

The method of claim 111, wherein the bioactive renal cell population is a selected renal cell population.

### Claim 113 (depends on 111)

The method of claim 111, wherein the control is the level of the one or more miRNA molecules vesicles from a primary renal cell population.

### Claim 114 (depends on 111)

The method of claim 111, wherein the control is the level of the one or more miRNA molecules vesicles from another bioactive renal cell population.

### Claim at position 14

115-142. (canceled)

### Claim 143 (depends on 111)

The method of claim 111, wherein the vesicle is further identified as being regenerative if:
one or more of miR-1248, miR-3168, miR-362-5p, miR-7113-5p, miR-758-3p, miR-937-3p, miR-4455, miR-4521, miR-203a-3p, miR-22-3p, miR-574-3p, miR-181b-5p, miR-1260b, and/or miR-181b-5p is detected as increased in the vesicles compared to the control; and/or
one or more of miR-1-3p, miR-1-3p, miR-143-3p, miR-150-5p, miR-509-3p, miR-653-5p, miR-204-5p, miR-192-5p, and/or miR-363-3p is detected as decreased in the vesicles compared to the control.

### Claim 144 (depends on 143)

A method of treating a renal disease in a subject, the method comprising:
administering to the subject an effective amount of vesicles from a vesicle preparation, wherein vesicles from the vesicle preparation have been identified as regenerative according to the method of claim 143.
