IP Library Granted Patent US 12,157,887
Granted Patent B2
US 12,157,887 · App. 17/171,943 · Granted Dec 3, 2024

Bioactive renal cells

Inventors: Timothy A. Bertram (George Town, KY); Roger M. Ilagan (Burlington, NC); Russell W. Kelley (Winston-Salem, NC); Sharon C. Presnell (Lewisville, NC); Sumana Choudhury (Kernersville, NC); Andrew T. Bruce (Lexington, NC); Christopher W. Genheimer (Colfax, NC); Bryan R. Cox (Winston-Salem, NC); Kelly I. Guthrie (Winston-Salem, NC); Joydeep Basu (Winston-Salem, NC); Shay M. Wallace (Winston-Salem, NC); Eric S. Werdin (Lewisville, TX); Oluwatoyin A. Knight (Winston-Salem, NC); Namrata D. Sangha (Winston-Salem, NC); John W. Ludlow (Carrboro, NC); Craig R. Halberstadt (Clemmons, NC); Richard Payne (Winston-Salem, NC); Neil F. Robins, Jr. (Winston-Salem, NC); Darell McCoy (Clemmons, NC); Deepak Jain (Winston-Salem, NC); Manuel J. Jayo (Winston-Salem, NC); Elias A. Rivera (Oak Ridge, NC); Thomas Spencer (Winston-Salem, NC); Benjamin Watts (King, NC)
Assignee: ProKidney
C12N15/113C12N5/0686C12Q1/6883C12N2310/141C12N2320/30C12N2320/32C12Q2600/106C12Q2600/178
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Quick Facts
Patent No.
US 12,157,887
App. No.
17/171,943
Granted
Dec 3, 2024
Kind
B2
Abstract

The present invention concerns bioactive renal cell populations, renal cell constructs, and methods of making and using the same.

Claims (25)

1. A method of assessing whether a kidney disease (KD) patient, comprising chronic kidney failure, is responsive to treatment with a therapeutic comprising an enriched population of renal cells, the method comprising:

detecting amount of a miRNA biomarker comprised in vesicles in a test urine sample obtained from a KD patient treated with the therapeutic, as compared to or relative to the amount of the miRNA biomarker comprised in vesicles in a control urine sample,

wherein a higher amount of the miRNA biomarker comprised in vesicles in the test urine sample as compared to the control urine sample is indicative of the patient's responsiveness to treatment with the therapeutic,

wherein the enriched population of renal cells is enriched for:

(i) tubular cells, and/or

(ii) erythropoietin-producing, glomerular and vascular cells; and

wherein the miRNA biomarker comprises one or more of: miR-22, miR-124, miR-15b, miR-143, let-7a, miR-21, miR-194, miR-130a, miR-23b, miR-30d, miR-429, miR-141, miR-200c, miR-30b-5p, miR-200a, miR-30c, miR-30a, miR-30d*, miR-30e, miR30a*, miR-151, miR-30e*, miR-146a, miR-10a-3p, and miR-449a.

2. The method of claim 1 , wherein the enriched population of renal cells is enriched for tubular cells, and wherein the enriched population of renal cells further comprises epithelial cells of the collecting duct system.

3. The method of claim 1 , wherein the miRNA comprises one or more of miR-30b-5p, miR-449a, miR-146a, miR-130a, miR-23b, miR-21, miR-124, miR-151, miR-30c, miR-15b, miR-30a*, miR-30d, miR-30e*, miR-429, miR-30d*, miR-141, miR-200a, miR-30a, miR-30e, miR-200c, or miR-429.

4. The method of claim 1 , wherein the miRNA comprises one or more of miR-30b-5p, miR-449a, miR-146a, miR-130a, miR-23b, miR-21, miR-124, or miR-151.

5. The method of claim 1 , wherein the miRNA comprises one or more of miR-21, miR-30c, or miR-23b.

6. The method of claim 1 , wherein the miRNA comprises one or more of miR-146a, miR-130a, or miR-23b.

7. The method of claim 1 , wherein the miRNA comprises one or more of miR-15b, miR-30a*, miR-30d, miR-30e*, miR-151, miR-429, miR-21, miR-30b-5p, miR-30d*, miR-141, miR-200a, miR-30a, miR-30c, miR-30e, miR-146a, or miR-200c.

8. The method of claim 5 , wherein the miRNA comprises one or more of miR-30b-5p, miR-429, or miR-200a.

9. The method of claim 1 , wherein the vesicles comprise microvesicles.

10. The method of claim 2 , wherein the therapeutic further comprises a second enriched population of renal cells,

wherein the second enriched population of renal cells is enriched for erythropoietin-producing, glomerular and vascular cells.

11. The method of claim 1 , wherein the chronic kidney failure is secondary to diabetes.

12. The method of claim 1 , wherein the chronic kidney failure is secondary to hypertension.

13. The method of claim 1 , wherein the control urine sample is obtained from the KD patient prior to treatment with the therapeutic.

14. The method of claim 1 , further comprising assessing the KD patient as responsive to treatment with the therapeutic if the miRNA biomarker comprised in vesicles in the test urine sample as compared to the control urine sample is in the higher amount.

15. The method of claim 14 , wherein the enriched population of renal cells is enriched for renal tubular cells.

16. The method of claim 15 , wherein the enriched population of renal cells further comprises epithelial cells of the collecting duct system.

17. The method of claim 14 , wherein the control urine sample is obtained from the KD patient prior to treatment with the therapeutic.

18. The method of claim 8 , wherein the control urine sample is obtained from the KD patient prior to treatment with the therapeutic.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2024
From: BERTRAM, TIMOTHY A.
To: INREGEN
Reel/Frame 067601/0467 →
MERGER Recorded Sep 14, 2021
From: REGENMEDTX, LLC
To: REGENMED (CAYMAN) LTD.
Reel/Frame 057689/0786 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2021
From: ILAGAN, ROGER M.; KELLEY, RUSSELL W.; PRESNELL, SHARON C.; CHOUDHURY, SUMANA; BRUCE, ANDREW T.; GENHEIMER, CHRISTOPHER W.; COX, BRYAN R.; GUTHRIE, KELLY I.; BASU, JOYDEEP; WALLACE, SHAY M.; WERDIN, ERIC S.; KNIGHT, OLUWATOYIN A.; SANGHA, NAMRATA D.; LUDLOW, JOHN W.; HALBERSTADT, CRAIG R.; PAYNE, RICHARD; ROBINS, NEIL F.; MCCOY, DARELL; JAIN, DEEPAK; JAYO, MANUEL J.; RIVERA, ELIAS A.; SPENCER, THOMAS; WATTS, BENJAMIN
To: TENGION, INC.
Reel/Frame 057351/0883 →
CHANGE OF OWNERSHIP Recorded Sep 1, 2021
From: TENGION, INC.
To: REGENMEDTX, LLC
Reel/Frame 057416/0418 →
CHANGE OF NAME Recorded Sep 1, 2021
From: REGENMED (CAYMAN) LTD.
To: INREGEN
Reel/Frame 057416/0505 →
CHANGE OF NAME Recorded Sep 1, 2021
From: INREGEN
To: PROKIDNEY
Reel/Frame 057411/0539 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2021
From: ILAGAN, ROGER M.; KELLEY, RUSSELL W.; PRESNELL, SHARON C.; CHOUDHURY, SUMANA; BRUCE, ANDREW T.; GENHEIMER, CHRISTOPHER W.; COX, BRYAN R.; GUTHRIE, KELLY I.; BASU, JOYDEEP; WALLACE, SHAY M.; WERDIN, ERIC S.; KNIGHT, OLUWATOYIN A.; SANGHA, NAMRATA D.; LUDLOW, JOHN W.; HALBERSTADT, CRAIG R.; PAYNE, RICHARD; ROBBINS, NEIL FRANCES; MCCOY, DARELL; JAIN, DEEPAK; JAYO, MANUEL J.; RIVERA, ELIAS A.; SPENCER, THOMAS; WATTS, BENJAMIN
To: TENGION, INC.
Reel/Frame 057351/0640 →
Continuity (13)
Division 15925172 · Mar 19, 2018
Continuation 13697206
Provisional Application 61473111 · Apr 7, 2011
Provisional Application 61441423 · Feb 10, 2011
Provisional Application 61413382 · Nov 12, 2010
Provisional Application 61412933 · Nov 12, 2010
Provisional Application 61388765 · Oct 1, 2010
Provisional Application 61376586 · Aug 24, 2010
Provisional Application 61371888 · Aug 9, 2010
Provisional Application 61372077 · Aug 9, 2010
Provisional Application 61353895 · Jun 11, 2010
Provisional Application 61334032 · May 12, 2010
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