BIOACTIVE RENAL CELLS FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE

1 . A method for the treatment of chronic kidney disease, the method comprising injecting into the renal cortex of at least one kidney of a patient having said chronic kidney disease a therapeutically effective amount of a composition comprising a bioactive renal cell population 5 (BRC).

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 any one of claims 1 to 3 , wherein the composition is administered with a minimum of one injection in one kidney.

5 . The method of any one of claims 1 to 3 , wherein the composition is administered as two or more injections.

6 . The method of claim 5 , wherein the first and second injections are administered at anytime up to 3 months apart, any time up to 6 months apart or at annual intervals.

7 . The method of claim 5 , wherein the second injections is administered any time up to 3 years after the 1 st injection.

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

9 . The method of any one of claims 1 to 8 , wherein the composition is administered to subjects who contemporaneously receive standard-of-care treatment for CKD prior to receiving injections of NKA.

10 . The method of any one of claims 1 to 9 , wherein the composition is injected into one kidney of the patient.

11 . The method of any one of claims 1 to 9 , wherein the composition is injected into both kidneys of the patient.

12 . The method of any one of claims 1 to 11 , wherein single or multiple entry points are used to inject the composition into the kidney of the patient.

13 . The method of any one of claims 1 to 12 , wherein the injection is into the renal parenchyma.

14 . The method of any one of claims 1 to 13 , wherein the patient receives a therapeutic dose at any given injection site.

15 . The method of claim 14 , wherein the patient receives a dose of 1-9×10 6 SRC/g KW est at any given injection site.

16 . The method of claim 1 , wherein the patient's chronic kidney disease is defined by an estimated glomerular filtration rate (eGFR) in the range of 15 to 60 mL/min.

17 . The method of claim 1 , wherein the patient with chronic kidney disease exhibits microalbuminuria may be defined by a urinary albumin-creatinine ratio (UACR)≥30 mg/g or urine albumin excretion≥30 mg/day on 24 hour urine collection.

18 . The method of any one of claims 1 and 16-17 , wherein the patient's kidney function is improved as a result of the treatment.

19 . The method of claim 18 , wherein the improved kidney function is demonstrated by a reduction in the rate of decline or increase in estimated glomerular filtration rate (eGFR).

20 . The method of claim 18 , wherein the improved kidney function is demonstrated by reduction in total serum creatinine or the rate of increase in serum creatine (sCr).

21 . The method of claim 18 , wherein the improved kidney function is demonstrated by improved renal cortical thickness.

22 . The method of claim 18 , wherein the improved kidney function is demonstrated by structural and functional alterations.

23 . The method of claim 18 , wherein the improved kidney function is demonstrated by improvement in one or more of the factors in Table 5.

24 . The method claim 18 , wherein the improved kidney size and/or structure is determined by renal imaging.

25 . The method of claim 24 , wherein the method of renal imaging is selected from ultrasound, MRI, and renal scintigraphy.

26 . The method of claim 18 , wherein the improved renal function is superior to the prior state of the kidney.

27 . The method of claim 1 , wherein the bioactive renal cell population is a selected renal cell (SRC) population obtained after density gradient separation of the expanded renal cells.

28 . The method of claim 1 or 27 , wherein the BRC or SRC contains a greater percentage of one or more cell populations and lacks or is deficient in one or more other cell populations, as compared to a starting kidney cell population.

29 . The method of claim 1 or 27 , wherein the BRC or SRC is derived from a native autologous or allogeneic kidney sample.

30 . The method of claim 1 or 27 , wherein the BRC or SRC is derived from a non-autologous kidney sample.

31 . The method of claim 29 or 30 , wherein the sample is obtained by kidney biopsy.

32 . The method of claim 1 or 27 , wherein the BRC or SRC is formulated in a biomaterial.

33 . The method of claim 32 , wherein the biomaterial comprises a gelatin-based hydrogel.