IP Library Granted Patent US 12,409,191
Granted Patent B2
US 12,409,191 · App. 17/825,652 · Granted Sep 9, 2025

Renal cell populations and uses thereof

Inventors: Joydeep Basu (Winston-Salem, NC); Kelly Guthrie (Winston-Salem, NC); Dominic Justewicz (Winston-Salem, NC); Teresa Burnette (Winston-Salem, NC); Andrew Bruce (Winston-Salem, NC); Russell W. Kelley (Winston-Salem, NC); John W. Ludlow (Winston-Salem, NC)
Assignee: PROKIDNEY
A61K35/22C12N5/0081C12N5/0686G01N33/56966C12N2500/02C12N2501/58C12N2501/599G01N2333/4742G01N2333/705G01N2333/9108
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Quick Facts
Patent No.
US 12,409,191
App. No.
17/825,652
Granted
Sep 9, 2025
Kind
B2
Abstract

The present invention concerns enriched heterogeneous mammalian renal cell populations characterized by biomarkers, and methods of making and using the same.

Claims (24)

1. A method for preparing a formulation for treatment of kidney disease in a mammal comprising:

characterizing a heterogeneous renal cell population prepared from a kidney sample of the mammal as suitable for implantation and/or eliciting a regenerative response, the characterizing comprising:

(i) determining that cells of the population express gamma-glutamyl transpeptidase (GGT)-1;

(ii) determining that cells of the population express a cytokine cytokeratin (CK); and

(iii) determining that cells of the population secrete vascular endothelial growth factor (VEGF) and kidney injury molecule (KIM)-1; and

formulating the heterogeneous renal cell population, characterized as suitable for implantation and/or eliciting the regenerative response, with a (i) biomaterial or (ii) pharmaceutically acceptable carrier or excipient.

2. The method of claim 1 , wherein the heterogeneous renal cell population is identified as suitable for implantation and/or eliciting a regenerative response if the percentage of cells that express GGT-1 is determined to be greater than 10%.

3. The method of claim 2 , wherein the heterogeneous renal cell population is identified as suitable for implantation and/or eliciting an immune response if the percentage of cells that express GGT-1 is determined to be greater than 20%.

4. The method of claim 3 , wherein the heterogeneous renal cell population is identified as suitable for implantation and/or eliciting an immune response if the percentage of cells that express GGT-1 is determined to be greater than 30%.

5. The method of claim 1 , wherein the CK is CK18.

6. The method of claim 5 , wherein the heterogeneous renal cell population is identified as suitable for implantation and/or eliciting a regenerative response if the percentage of cells that express CK18 is greater than 80%.

7. The method of claim 1 , wherein the heterogeneous renal cell population is identified as suitable for implantation and/or eliciting a regenerative response if the percentage of cells that express the CK is greater than 80%.

8. The method of claim 1 , wherein the heterogeneous renal cell population is prepared from the kidney sample by a method comprising a step of density gradient centrifugation.

9. The method of claim 8 , wherein cells of the heterogeneous renal cell population are iodixanol-resistant.

10. The method of claim 1 further comprising, at the step of characterizing: (iv) determining that cells of the population comprise GGT activity.

11. The method of claim 10 further comprising, at the step of characterizing: (v) determining that cells of the population comprise LAP activity.

12. The method of claim 1 further comprising, at the step of characterizing: (iv) determining that cells of the population comprise leucine aminopeptidase (LAP) activity.

13. The method of claim 1 , wherein the kidney sample is a kidney biopsy.

14. The method of claim 1 , wherein the formulating comprises suspending the heterogeneous renal cell population in the pharmaceutically acceptable carrier or excipient.

15. The method of claim 14 , wherein the pharmaceutically acceptable carrier or excipient comprises one or more of saline, buffered saline, dextrose, water, collagen, alginate, hyaluronic acid, polyethyleneglycol, polyvinylalcohol, and carboxymethylcellulose.

16. The method of claim 1 , wherein the formulating comprises combining the heterogeneous renal cell population with the biomaterial.

17. The method of claim 16 , wherein the biomaterial is a liquid or hydrogel.

18. The method of claim 17 , wherein the hydrogel comprises gelatin or collagen.

19. The method of claim 18 , wherein the hydrogel comprises gelatin.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2023
From: BASU, JOYDEEP; GUTHRIE, KELLY; JUSTEWICZ, DOMINIC; TERESA BURNETTE; BRUCE, ANDREW; KELLEY, RUSSELL; LUDLOW, JOHN W.
To: TENGION, INC.
Reel/Frame 062825/0554 →
MERGER Recorded Feb 28, 2023
From: REGENMEDTX, LLC
To: REGENMED (CAYMAN) LTD.
Reel/Frame 062825/0921 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2023
From: TENGION, INC.
To: REGENMEDTX, LLC
Reel/Frame 062885/0619 →
CHANGE OF NAME Recorded Feb 28, 2023
From: REGENMED (CAYMAN) LTD.
To: INREGEN
Reel/Frame 062886/0217 →
CHANGE OF NAME Recorded Feb 28, 2023
From: INREGEN
To: PROKIDNEY
Reel/Frame 062886/0219 →
Continuity (6)
Continuation 16459141 · Jul 1, 2019
Continuation 15623197 · Jun 14, 2017
Continuation 14438607
Provisional Application 61876616 · Sep 11, 2013
Provisional Application 61718150 · Oct 24, 2012
Related Publication 20220347221A1 · Nov 3, 2022
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