REPAIR AND REGENERATION OF RENAL TISSUE USING HUMAN UMBILICAL CORD TISSUE-DERIVED CELLS

• US 20090092653A1
• Filed: 10/03/2008
• Published: 04/09/2009
• Est. Priority Date: 10/05/2007
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: COLTER, David C., Gosiewska, Anna
• Granted Patent: US 8,034,329 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: C12N 5/0605 Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly

Abstract

Methods for treating a patient having a disease or damage to at least one kidney are provided. The methods comprise administering cells obtained from human umbilical cord tissue, or administering pharmaceutical compositions comprising such cells or prepared from such cells. When administered, the cells promote and support the repair and regeneration of the diseased or damaged kidney tissue in the patient. Pharmaceutical compositions for use in the inventive methods, as well as kits for practicing the methods are also provided.

Claims

1. A method of treating a patient having a disease of or damage to at least one kidney, comprising administering to the patient cells obtained from human umbilical cord tissue in an amount effective to treat the disease or damage, wherein the umbilical cord tissue is substantially free of blood, and wherein the cells are capable of self-renewal and expansion in culture and have the potential to differentiate;

require L-valine for growth;

can grow in at least about 5% oxygen;

do not produce CD117 or HLA-DR;

express alpha smooth muscle actin; and

express, relative to a human fibroblast, mesenchymal stem cell, or iliac crest bone marrow cell increased levels of oxidized low density lipoprotein receptor 1, interleukin 8, or reticulon 1.

2. The method of claim 1, wherein the cells express oxidized low density lipoprotein receptor 1, reticulon, chemokine receptor ligand 3, and/or granulocyte chemotactic protein 2.

3. The method of claim 1, wherein the cells express CD10, CD13, CD44, CD73, and CD90.

4. The method of claim 1, wherein the cells are administered by injection or infusion.

5. The method of claim 1, wherein the cells are administered encapsulated within an implantable device.

6. The method of claim 1, wherein the cells are administered by implantation of a matrix comprising the cells.

7. The method of claim 1, wherein the cells are administered with at least one other cell type.

8. The method of claim 7, wherein the at least one other cell type is administered simultaneously with, or before, or after, the cells obtained from human umbilical cord tissue.

9. The method of claim 1, wherein the cells are administered with at least one agent.

10. The method of claim 9, wherein the at least one agent is administered simultaneously with, before, or after administration of the cells obtained from human umbilical cord tissue.

11. The method of claim 1, wherein the cells exert a trophic effect on the kidney of the patient.

12. The method of claim 1, wherein the damage to the kidney is induced by age, trauma, toxin exposure, drug exposure, radiation exposure, oxidation, immune-complex deposition, or transplant rejection.

13. A pharmaceutical composition for treating a patient having a disease of or damage to at least one kidney, comprising a pharmaceutically acceptable carrier and cells obtained from human umbilical cord tissue in an amount effective to treat the disease or injury, wherein the umbilical cord tissue is substantially free of blood, and wherein the cells are capable of self-renewal and expansion in culture and have the potential to differentiate;

require L-valine for growth;

can grow in at least about 5% oxygen;

do not produce CD117 or HLA-DR;

express alpha smooth muscle actin; and

express, relative to a human fibroblast, mesenchymal stem cell, or iliac crest bone marrow cell increased levels of oxidized low density lipoprotein receptor 1, interleukin 8, or reticulon 1.

14. The pharmaceutical composition of claim 13, wherein the damage to the kidney is induced by age, trauma, toxin exposure, drug exposure, radiation exposure, oxidation, immune-complex deposition, or transplant rejection.

15. The pharmaceutical composition of claim 13, further comprising at least one other cell type.

16. The pharmaceutical composition of claim 13, further comprising at least one agent.

17. The pharmaceutical composition of claim 13, formulated for administration by injection or infusion.

18. The pharmaceutical composition of claim 13, wherein the cells are encapsulated within an implantable device.

19. The pharmaceutical composition of claim 13, wherein the cells are seeded on a matrix.

20. A kit for treating a patient having a disease of or damage to at least one kidney, comprising a pharmaceutically acceptable carrier, cells obtained from human umbilical cord tissue in an amount effective to treat the disease or injury, wherein the umbilical cord tissue is substantially free of blood, and wherein the cells are capable of self-renewal and expansion in culture and have the potential to differentiate;

require L-valine for growth;

can grow in at least about 5% oxygen;

do not produce CD117 or HLA-DR;

express alpha smooth muscle actin; and

express, relative to a human fibroblast, mesenchymal stem cell, or iliac crest bone marrow cell increased levels of oxidized low density lipoprotein receptor 1, interleukin 8, or reticulon 1, and instructions for using the kit in a method for treating a patient having a disease of or damage to at least one kidney.

21. The kit of claim 20, further comprising at least one reagent for and instructions for culturing the cells.

22. The kit of claim 20, further comprising a population of at least one other cell type.

23. The kit of claim 20, further comprising at least one agent.

24. A method of treating a patient having a disease of or damage to at least one kidney, comprising administering to the patient a composition comprising a soluble cell fraction, lysate, extracellular matrix, or conditioned medium prepared from cells obtained from human umbilical cord tissue, wherein the umbilical cord tissue is substantially free of blood, and wherein the cells are capable of self-renewal and expansion in culture and have the potential to differentiate;

require L-valine for growth;

can grow in at least about 5% oxygen;

do not produce CD117 or HLA-DR;

express alpha smooth muscle actin; and

express, relative to a human fibroblast, mesenchymal stem cell, or iliac crest bone marrow cell increased levels of oxidized low density lipoprotein receptor 1, interleukin 8, or reticulon 1.

25. A pharmaceutical composition for treating a patient having a disease of or damage to at least one kidney, comprising a pharmaceutically acceptable carrier and a lysate, extracellular matrix, or conditioned medium prepared from cells obtained from human umbilical cord tissue, wherein the umbilical cord tissue is substantially free of blood, and wherein the cells are capable of self-renewal and expansion in culture and have the potential to differentiate;

require L-valine for growth;

can grow in at least about 5% oxygen;

do not produce CD117 or HLA-DR;

express alpha smooth muscle actin; and

express, relative to a human fibroblast, mesenchymal stem cell, or iliac crest bone marrow cell increased levels of oxidized low density lipoprotein receptor 1, interleukin 8, or reticulon 1.