Granted Patent
B2
US 12,350,292 · App. 18/435,911 · Granted Jul 8, 2025
Bioactive renal cells for the treatment of chronic kidney disease
Assignee:
ProKidney
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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 (14)
1. A method for reducing rate of decline in eGFR (estimated glomerular filtration rate) in the treatment of chronic kidney disease (CKD) in a human patient comprising an eGFR of 15 to 60 mL/min, the method comprising:
percutaneously injecting into the renal cortex of at least one kidney of the patient having said CKD a composition, the composition comprising: (i) a selected renal cell (SRC) population and (ii) a pharmaceutically acceptable carrier or excipient,
wherein the composition is injected at a dose comprising approximately 3.0×10 6 cells of the SRC population per gram estimated kidney weight (/gkW est ),
wherein the SRC population:
is derived from a kidney biopsy sample of the patient;
exhibits a buoyant density greater than approximately 1.0419 g/mL; and
is enriched for renal epithelial cells;
thereby reducing rate of decline in eGFR of the human patient.
2. The method of claim 1 , wherein the SRC population is derived from the kidney biopsy sample by: (i) expanding kidney cells isolated from the kidney biopsy sample; (ii) subjecting the expanded kidney cells to density gradient centrifugation; and (iii) selecting, from the density gradient centrifugation, cells exhibiting the buoyant density greater than approximately 1.0419 g/mL.
3. The method of claim 1 , wherein the SRC population is derived from the kidney biopsy sample by: (i) expanding kidney cells isolated from the kidney biopsy sample; (ii) culturing the expanded cells under hypoxic conditions; (iii) subjecting the cells cultured under the hypoxic conditions to density gradient centrifugation; and (iv) selecting, from the density gradient centrifugation, cells exhibiting the buoyant density greater than approximately 1.0419 g/mL.
4. The method of claim 1 , wherein the pharmaceutically acceptable carrier or excipient comprises saline, buffered saline, dextrose, or water.
5. The method of claim 2 , wherein the pharmaceutically acceptable carrier or excipient comprises saline, buffered saline, dextrose, or water.
6. The method of claim 3 , wherein the pharmaceutically acceptable carrier or excipient comprises saline, buffered saline, dextrose, or water.
7. The method of claim 1 , wherein the renal epithelial cells comprise a tubular epithelial phenotype.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 19, 2024
From: JAIN, DEEPAK; BERTRAM, TIMOTHY A.
To: PROKIDNEY
Reel/Frame 067171/0211 →
Continuity (5)
Provisional Application
62532338
· Jul 13, 2017
Provisional Application
62368919
· Jul 29, 2016
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