IP Library › Granted Patent US 12,447,179
Granted Patent B2
US 12,447,179 · App. 17/271,469 · Granted Oct 21, 2025

Compositions comprising cell-delivered vesicles and uses thereof

Inventors: Timothy A. Bertram (George Town, KY); Deepak Jain (Winston-Salem, NC)
Assignee: PROKIDNEY
A61K35/22C12N5/0687G01N33/5076G01N33/6803C12N2501/11C12N2501/12C12N2502/256
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Quick Facts
Patent No.
US 12,447,179
App. No.
17/271,469
Granted
Oct 21, 2025
Kind
B2
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 (33)

1. A method for detecting whether a vesicle secreted by a renal cell is regenerative and for treatment of a renal disease in a subject with a vesicle preparation comprising the vesicle having been identified as regenerative, the method comprising:

(i) obtaining the vesicle secreted by the renal cell;

(ii) detecting whether at least one protein is upregulated in the vesicle compared to vesicles secreted by unpassaged primary renal cells,

wherein the at least one protein is CD9, CD326, CD40, and/or CD49e;

(iii) identifying the vesicle as regenerative if the at least one protein is upregulated in the vesicle; and

(iv) administering to a subject in need of treatment for renal disease a vesicle preparation comprising an effective amount of the vesicle having been identified in (iii) as regenerative.

2. The method of claim 1 , wherein the vesicle is obtained in or from a biological sample from a subject.

3. The method of claim 2 , wherein the biological sample is urine.

4. The method of claim 1 , wherein the vesicle is obtained in or from a supernatant of a culture of renal cells.

5. The method of claim 2 , wherein the renal cell is a bioactive renal cell.

6. The method of claim 5 , wherein the bioactive renal cell is a selected renal cell.

7. The method of claim 3 , wherein the renal cell is a bioactive renal cell.

8. The method of claim 7 , wherein the bioactive renal cell is a selected renal cell.

9. The method of claim 4 , wherein the renal cells are bioactive renal cells.

10. The method of claim 9 , wherein the bioactive renal cells are selected renal cells.

11. The method of claim 1 , wherein the at least one protein is CD326 and/or CD49e.

12. The method of claim 1 , wherein the vesicle is an exosome or a microvesicle.

13. A method for detecting whether a vesicle secreted by a renal cell is regenerative and for treatment of a renal disease in a subject with a vesicle preparation comprising the vesicle having been identified as regenerative, the method comprising:

(i) obtaining the vesicle secreted by the renal cell;

(ii) detecting whether at least one protein is downregulated in the vesicle compared to vesicles secreted by unpassaged primary renal cells,

wherein the at least one protein is CD42a, and/or SSEA-4;

(iii) identifying the vesicle as regenerative if the at least one protein is downregulated in the vesicle; and

(iv) administering to a subject in need of treatment for renal disease a vesicle preparation comprising an effective amount of the vesicle having been identified in (iii) as regenerative.

14. The method of claim 13 , wherein the vesicle is obtained in or from a biological sample from a subject.

15. The method of claim 14 , wherein the biological sample is urine.

16. The method of claim 13 , wherein the vesicle is obtained in or from a supernatant of a culture of renal cells.

17. The method of claim 14 , wherein the renal cell is a bioactive renal cell.

18. The method of claim 17 , wherein the bioactive renal cell is a selected renal cell.

19. The method of claim 15 , wherein the renal cell is a bioactive renal cell.

20. The method of claim 19 , wherein the bioactive renal cell is a selected renal cell.

21. The method of claim 16 , wherein the renal cells are bioactive renal cells.

22. The method of claim 21 , wherein the bioactive renal cells are selected renal cells.

23. The method of claim 13 , wherein the vesicle is an exosome or a microvesicle.

Assignments (3)
REDOMESTICATION Recorded Sep 16, 2025
From: PROKIDNEY IPCO, LLC
To: PROKIDNEY IPCO, LLC
Reel/Frame 072881/0850 →
CHANGE OF NAME Recorded Sep 16, 2025
From: PROKIDNEY
To: PROKIDNEY IPCO, LLC
Reel/Frame 072886/0085 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2023
From: JAIN, DEEPAK; BERTRAM, TIMOTHY A.
To: PROKIDNEY
Reel/Frame 062645/0153 →
Continuity (2)
Provisional Application 62725651 · Aug 31, 2018
Related Publication 20210386786A1 · Dec 16, 2021
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