IP Library Granted Patent US 11,931,383
Granted Patent B2
US 11,931,383 · App. 17/404,038 · Granted Mar 19, 2024

Bioactive renal cells for the treatment of chronic kidney disease

Inventors: Deepak Jain (Winston-Salem, NC); Timothy A. Bertram (George Town, KY)
Assignee: ProKidney
A61K35/22A61B17/3421A61K9/0019A61K47/42
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Quick Facts
Patent No.
US 11,931,383
App. No.
17/404,038
Granted
Mar 19, 2024
Kind
B2
Abstract

The present invention concerns methods of using bioactive renal cell populations to provide regenerative effects to a native kidney for the treatment of chronic kidney disease.

Claims (26)

1. A method for reducing rate of increase in serum creatinine (sCr) in the treatment of chronic kidney disease (CKD) in a human patient comprising an estimated glomerular filtration rate of 15 to 60 mL/min, the method comprising:

injecting into the renal cortex of at least one kidney of the patient having said CKD a composition comprising 1.0-9.0×10 6 cells of a selected renal cell (SRC) population per gram estimated kidney weight (/gKW est )

wherein the SRC population is enriched for renal tubular cells and exhibits a buoyant density greater than approximately 1.0419 g/mL; and

thereby reducing the rate of increase in sCr of the human patient.

2. The method of claim 1 , wherein the injection is performed using a minimally invasive procedure such as percutaneous, laparoscopic or intravascular procedures.

3. The method of claim 1 , wherein a guiding cannula inserted percutaneously is used to puncture the kidney capsule prior to injection of the composition into the kidney of the patient.

4. The method of claim 1 , wherein the composition is administered with a minimum of one injection in one kidney.

5. The method of claim 1 , wherein the composition is administered as two or more injections.

6. The method of claim 5 , wherein a second of the two or more injections is administered any time up to 3 years after the first injection.

7. The method of claim 1 , wherein the composition is administered to the patient who is contemporaneously receiving standard-of-care treatment for CKD prior to receiving injections of the composition.

8. The method of claim 1 , wherein the composition is injected into one kidney of the patient.

9. The method of claim 1 , wherein the composition is injected into both kidneys of the patient.

10. The method of claim 1 , wherein the injection is into the renal parenchyma.

11. The method of claim 1 , wherein the composition injected to the renal cortex of the at least one kidney comprises 3×10 6 SRC/g KW est .

12. The method of claim 1 , wherein the SRC population exhibits the buoyant density greater than approximately 1.0419 g/mL following density gradient separation.

13. The method of claim 1 , wherein the reducing the rate of increase in sCr of the human patient is by at least 50%.

14. The method of claim 1 , wherein the reducing rate of increase in sCr of the human patient is achieved following a single first injecting step.

15. A method for delaying dialysis in the treatment of chronic kidney disease in a human patient comprising an estimated glomerular filtration rate of 15 to 60 mL/min, the method comprising:

injecting into the renal cortex of at least one kidney of the patient having said CKD a composition comprising 1.0-9.0×10 6 cells of a selected renal cell (SRC) population per gram estimated kidney weight (/gKW est ),

wherein the SRC population is enriched for renal tubular cells and exhibits a buoyant density greater than approximately 1.0419 g/mL;

thereby delaying dialysis of the human patient.

16. The method of claim 15 , wherein the SRC population exhibits the buoyant density greater than approximately 1.0419 g/mL following density gradient separation.

17. The method of claim 15 , wherein the composition injected to the renal cortex of the at least one kidney comprises 3×10 6 SRC/g KW est .

18. The method of claim 15 , wherein the injection is performed using a minimally invasive procedure such as percutaneous, laparoscopic or intravascular procedures.

19. The method of claim 15 , wherein the delaying dialysis of the human patient is by at least 1.5 years.

20. The method of claim 19 , wherein the delaying dialysis is achieved following a single first injecting step.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 17, 2021
From: JAIN, DEEPAK; BERTRAM, TIMOTHY A.
To: PROKIDNEY
Reel/Frame 057199/0129 →
Continuity (4)
Division 15663430 · Jul 28, 2017
Provisional Application 62532338 · Jul 13, 2017
Provisional Application 62368919 · Jul 29, 2016
Related Publication 20220031755A1 · Feb 3, 2022
Cited By (1)
US 12,350,292