IP Library Granted Patent US 10,500,234
Granted Patent B2
US 10,500,234 · App. 15/661,878 · Granted Dec 10, 2019

Postpartum cells derived from umbilical cord tissue, and methods of making and using the same

Inventors: Sanjay Mistry (Downingtown, PA); Anthony J. Kihm (Princeton, NJ); Ian R. Harris (Radnor, PA); Alexander M. Harmon (Clifton, NJ); Darin J. Messina (Downingtown, PA); Agnieszka Seyda (Edison, NJ); Chin-Feng Yi (Hillsborough, NJ); Anna Gosiewska (Skillman, NJ)
Assignee: DePuy Synthes Products, Inc.
A61K35/51A01N1/0226A61K35/50A61K38/18A61K38/185A61K38/1808A61K38/1825A61K38/1833A61K38/1841A61K38/1858A61K38/1866A61K38/1891A61K38/19A61K38/204A61K38/2053A61K38/27A61K45/06C12N5/0605C12N5/0606C12N5/0607A61K35/12C12N2500/32C12N2500/34C12N2500/44C12N2500/90C12N2500/95C12N2501/12C12N2501/21C12N2501/23C12N2502/02C12N2506/02C12N2506/03C12N2509/00C12N2509/10C12N2533/50
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Quick Facts
Patent No.
US 10,500,234
App. No.
15/661,878
Granted
Dec 10, 2019
Kind
B2
Abstract

Cells derived from human umbilical cords are disclosed along with methods for their therapeutic use. Isolation techniques, culture methods and detailed characterization of the cells with respect to their cell surface markers, gene expression, and their secretion of trophic factors are described.

Claims (19)

1. A cell culture comprising a culture medium and an isolated cell derived from human umbilical cord tissue substantially free of blood, wherein said isolated cell is capable of self-renewal and expansion in culture, has the potential to differentiate into cells of other phenotypes, produces granulocyte chemotactic protein-2 (GCP-2), and can double sufficiently to generate yields of greater than about 1×10 17 cells in about 60 days in culture when seeded at about 5,000 cells/cm 2 in a flask or yields of greater than about 1×10 11 cells in about 60 days in culture when seeded at about 1,000 cells/cm 2 in a flask.

2. The cell culture of claim 1 , wherein the isolated cell can double sufficiently to generate greater than about 1×10 17 cells in about 60 days in culture when seeded at about 5,000 cells/cm 2 in a flask.

3. The cell culture of claim 1 , wherein the isolated cell can double sufficiently to generate greater than about 1×10 11 cells in about 60 days in culture when seeded at about 1,000 cells/cm 2 in a flask.

4. The cell culture of claim 1 , wherein the isolated cell expresses CD10, CD13, CD44, CD73, CD90, PDGFr-alpha, HLA-A, HLA-B, and HLA-C, does not express CD31, CD34, CD45, CD117, CD141, HLA-DR, HLA-DP and HLA-DQ, and has increased expression, relative to a human fibroblast, mesenchymal stem cell, or iliac crest bone marrow cell, of a gene for interleukin 8, reticulon 1 and chemokine (C-X-C motif) ligand 3.

5. The cell culture of claim 1 , wherein the culture medium is a chemically-defined medium or a medium with added mammalian serum.

6. The cell culture of claim 5 , wherein the culture medium comprises L-valine.

7. The cell culture of claim 1 , wherein the isolated cell secretes MCP-1, IL-6, IL-8, GCP-2, HGF, KGF, FGF, HB-EGF, BDNF, TPO, MIP1b, RANTES, and TIMP1, and does not secrete SDF-1alpha, TGF-beta2, ANG2, PDGFbb, MIP1a, and VEGF.

8. The cell culture of claim 1 , wherein the isolated cell is cryopreserved.

9. A kit comprising the cell culture of claim 1 and at least one other component selected from the group consisting of a scaffold, a hydrating agent and a cell culture substrate.

10. A three-dimensional matrix comprising an isolated cell derived from human umbilical cord tissue substantially free of blood, wherein said isolated cell is capable of self-renewal and expansion in culture, has the potential to differentiate into cells of other phenotypes, produces granulocyte chemotactic protein-2 (GCP-2), and can double sufficiently to generate yields of greater than about 1×10 17 cells in about 60 days in culture when seeded at about 5,000 cells/cm 2 in a flask or yields of greater than about 1×10 11 cells in about 60 days in culture when seeded at about 1,000 cells/cm 2 in a flask.

11. The three-dimensional matrix of claim 10 , wherein the isolated cell expresses CD10, CD13, CD44, CD73, CD90, PDGFr-alpha, HLA-A, HLA-B, and HLA-C, does not express CD31, CD34, CD45, CD117, CD141, HLA-DR, HLA-DP and HLA-DQ, and has increased expression, relative to a human fibroblast, mesenchymal stem cell, or iliac crest bone marrow cell, of a gene for interleukin 8, reticulon 1 and chemokine (C-X-C motif) ligand 3.

12. The three-dimensional matrix of claim 10 , wherein the isolated cell secretes MCP-1, IL-6, IL-8, GCP-2, HGF, KGF, FGF, HB-EGF, BDNF, TPO, MIP1b, RANTES, and TIMP1, and does not secrete SDF-1alpha, TGF-beta2, ANG2, PDGFbb, MIP1a, and VEGF.

13. The three-dimensional matrix of claim 10 , wherein said matrix comprises a synthetic biocompatible or bioabsorbable polymer.

14. The three-dimensional matrix of claim 13 , wherein said matrix comprises a nonwoven mat comprising a synthetic copolymer of glycolic and lactic acids, a PCL/PGA copolymer, or self-assembling peptides.

15. A cryopreserved composition comprising an isolated cell derived from human umbilical cord tissue substantially free of blood, wherein said isolated cell is capable of self-renewal and expansion in culture, has the potential to differentiate into cells of other phenotypes, produces granulocyte chemotactic protein-2 (GCP-2), and can double sufficiently to generate yields of greater than about 1×10 17 cells in about 60 days in culture when seeded at about 5,000 cells/cm 2 in a flask or yields of greater than about 1×10 11 cells in about 60 days in culture when seeded at about 1,000 cells/cm 2 in a flask.

16. The cryopreserved composition of claim 15 , wherein the isolated cell can double sufficiently to generate greater than about 1×10 17 cells in about 60 days in culture when seeded at about 5,000 cells/cm 2 in a flask.

17. The cryopreserved composition of claim 15 , wherein the isolated cell can double sufficiently to generate greater than about 1×10 11 cells in about 60 days in culture when seeded at about 1,000 cells/cm 2 in a flask.

18. The cryopreserved composition of claim 15 , wherein the isolated cell expresses CD10, CD13, CD44, CD73, CD90, PDGFr-alpha, HLA-A, HLA-B, and HLA-C, does not express CD31, CD34, CD45, CD117, CD141, HLA-DR, HLA-DP and HLA-DQ, and has increased expression, relative to a human fibroblast, mesenchymal stem cell, or iliac crest bone marrow cell, of a gene for interleukin 8, reticulon 1 and chemokine (C-X-C motif) ligand 3.

19. The cryopreserved composition of claim 15 , wherein the isolated cell secretes MCP-1, IL-6, IL-8, GCP-2, HGF, KGF, FGF, HB-EGF, BDNF, TPO, MIP1b, RANTES, and TIMP1, and does not secrete SDF-1alpha, TGF-beta2, ANG2, PDGFbb, MIP1a, and VEGF.

Continuity (5)
Continuation 14018842 · Sep 5, 2013
Continuation 12389305 · Feb 19, 2009
Continuation 10877012 · Jun 25, 2004
Provisional Application 60483264 · Jun 27, 2003
Related Publication 20170326183A1 · Nov 16, 2017