IP Library Granted Patent US 11,123,372
Granted Patent B2
US 11,123,372 · App. 15/663,430 · Granted Sep 21, 2021

Bioactive renal cells for the treatment of chronic kidney disease

Inventors: Deepak Jain (Winston-Salem, NC); Timothy A. Bertram (Grand Cayman, KY)
Assignee: ProKidney
A61K35/22A61B17/3421A61K9/0019A61K47/42
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Quick Facts
Patent No.
US 11,123,372
App. No.
15/663,430
Granted
Sep 21, 2021
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 decline in estimated glomerular filtration rate (eGFR) in the treatment of chronic kidney disease (CKD) of a human patient comprising an eGFR of 15 to 60 mL/min, the method comprising:

injecting into the renal cortex of at least one kidney of the human patient having an eGFR of 15 to 60 mL/min a composition comprising 1.0—9.0×10 6 cells of a selected renal cell (SRC) population per gram estimated kidney weight,

wherein the SRC population comprises bioactive renal cells exhibiting a buoyant density greater than approximately 1.0419 g/mL following density gradient separation of cultured renal cells of a kidney biopsy of the patient; and

wherein the SRC population is enriched for renal tubular cells; and

thereby reducing the rate of decline in eGFR of the human patient.

2. The method of claim 1 , wherein the injecting is performed using a minimally invasive procedure.

3. The method of claim 1 , wherein a guiding cannula is inserted percutaneously, intravascularly, or transuretherally to puncture the kidney capsule prior to the injecting 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 first and second injections of the two or more injections are administered up to 3 months apart, or up to 6 months apart, or up to one year apart.

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

8. The method of claim 5 , wherein first and second injections of the two or more injections are administered at least 3 months apart.

9. The method of claim 1 , wherein prior to the injecting of the composition, the patient is administered standard-of-care treatment for the CKD.

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

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

12. The method of claim 1 , wherein single or multiple entry points are used to inject the composition into the kidney of the patient.

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

14. The method of claim 1 , wherein the patient receives a therapeutic dose of the composition at any given injection site.

15. The method of claim 1 , wherein the renal tubule cells comprise renal tubule epithelial cells.

16. The method of claim 1 , wherein the SRC population is formulated in a biomaterial.

17. The method of claim 16 , wherein the biomaterial comprises a gelatin-based hydrogel.

18. The method of claim 2 , wherein the minimally invasive procedure is a percutaneous, a laparoscopic, a transureteral or an intravascular procedure.

19. The method of claim 1 , wherein the rate of decline in eGFR of the human patient is reduced by at least 50%.

20. The method of claim 19 , wherein the at least 50% is achieved within 1 year of the injecting of a first therapeutically effective amount of the composition.

21. The method of claim 1 , wherein the reducing the rate of decline in eGFR is achieved following a single first injecting step.

22. The method of claim 19 , wherein the reducing the rate of decline in eGFR is achieved following a single first injecting step.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 4, 2021
From: JAIN, DEEPAK; BERTRAM, TIMOTHY A.
To: PROKIDNEY
Reel/Frame 057080/0642 →
Continuity (3)
Provisional Application 62532338 · Jul 13, 2017
Provisional Application 62368919 · Jul 29, 2016
Related Publication 20180055885A1 · Mar 1, 2018
Cited By (1)
US 12,350,292