Soft tissue repair and regeneration using postpartum-derived cells and cell products

• US 10,039,793 B2
• Filed: 11/28/2016
• Issued: 08/07/2018
• Est. Priority Date: 06/27/2003
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Brown, Laura J., Harmon, Alexander M., Gosiewska, Anna
• Primary Examiner(s): Fox, Allison M
• Application Number:
  US15/362,453
• Publication Number:
  US 20170143770A1
• Time in Patent Office: 617 Days
• 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 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61K 35/51 Umbilical cord; Umbilical cord blood; Umbilical stem cells
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1808 Epidermal growth factor [EGF] urogastrone
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61K 38/1833 Hepatocyte growth factor; Scatter factor; Tumor cytotoxic factor II
• CPC Class Codes: A61K 38/1841 Transforming growth factor [TGF]
• CPC Class Codes: A61K 38/185 Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3
• CPC Class Codes: A61K 38/1858 Platelet-derived growth factor [PDGF]
• CPC Class Codes: A61K 38/1866 Vascular endothelial growth factor [VEGF]
• CPC Class Codes: A61K 38/1891 Angiogenesic factors; Angiogenin
• CPC Class Codes: A61K 38/19 Cytokines; Lymphokines; Interferons
• CPC Class Codes: A61K 38/204 IL-6
• CPC Class Codes: A61K 38/2053 IL-8
• CPC Class Codes: A61K 38/27 Growth hormone [GH], i.e. somatotropin
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 13/12 : of the kidneys
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: A61P 19/04 : for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 19/08 : for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 : for osteoporosis
• CPC Class Codes: A61P 21/00 : Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 : for peripheral neuropathies
• CPC Class Codes: A61P 25/14 : for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/16 : Anti-Parkinson drugs
• CPC Class Codes: A61P 25/28 : for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 27/02 : Ophthalmic agents
• CPC Class Codes: A61P 27/06 : Antiglaucoma agents or miotics
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 39/06 : Free radical scavengers or antioxidants
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 : Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C12N 2500/32 : Amino acids
• CPC Class Codes: C12N 2500/34 : Sugars
• CPC Class Codes: C12N 2500/44 : Thiols, e.g. mercaptoethanol
• CPC Class Codes: C12N 2500/90 : Serum-free medium, which may still contain naturally-sourced components
• CPC Class Codes: C12N 2500/95 : Protein-free medium and culture conditions
• CPC Class Codes: C12N 2501/12 : Hepatocyte growth factor [HGF]
• CPC Class Codes: C12N 2501/21 : Chemokines, e.g. MIP-1, MIP-2, RANTES, MCP, PF-4
• CPC Class Codes: C12N 2501/23 : Interleukins [IL]
• CPC Class Codes: C12N 2502/02 : embryonic cells
• CPC Class Codes: C12N 2506/02 : from embryonic cells
• CPC Class Codes: C12N 2506/03 : from non-embryonic pluripotent stem cells
• CPC Class Codes: C12N 2509/00 : Methods for the dissociation of cells, e.g. specific use of enzymes
• CPC Class Codes: C12N 2533/50 : Proteins
• CPC Class Codes: C12N 5/0605 : Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly
• CPC Class Codes: C12N 5/0606 : Pluripotent embryonic cells, e.g. embryonic stem cells [ES] embryonic germ cells C12N5/0611, induced pluripotent stem cells C12N5/0696
• CPC Class Codes: C12N 5/0607 : Non-embryonic pluripotent stem cells, e.g. MASC induced pluripotent stem cells C12N5/0696

Abstract

Cells derived from postpartum tissue and products thereof having the potential to support cells of and/or differentiate to cells of a soft tissue lineage, and methods of preparation and use of those postpartum tissue-derived cells, are provided by the invention. The invention also provides methods for the use of such postpartum-derived cells and products related thereto in therapies for conditions of soft tissue.

Claims

1. A method of treating a soft tissue defect in a subject by administering to said soft tissue defect in said subject a cell lysate produced by lysing cells of a homogenous human umbilical cord cell population in an amount effective to treat the soft tissue defect, wherein the umbilical cord cell population is isolated from human umbilical cord tissue substantially free of blood, is capable of self-renewal and expansion in culture, has the potential to differentiate, and has the following characteristics:

a) potential for at least 40 doublings in culture;

b) production of CD10, CD13, CD44, CD73, CD90 and HLA-A,B,C;

c) lack of production of CD31, CD34, CD45, CD117, CD141 and HLA-DR, HLA-DP and HLA-DQ;

d) secretes MCP-1, IL-6, IL-8, GCP-2, HGF, KGF, FGF, HB-EGF, BDNF, TPO, MIP1b, RANTES, and TIMP1; and

e) increased expression of endogenous genes encoding interleukin 8 and reticulon 1 relative to endogenous expression of interleukin 8 and reticulon 1 in a human cell that is a fibroblast, a mesenchymal stem cell, or an ileac crest bone marrow cell.

2. The method of claim 1, wherein the population of cells does not secrete SDF-1alpha, TGF-beta2, ANG2, PDGFbb, MIP1a, and VEGF.

3. The method of claim 1, wherein treatment of a soft tissue defect includes tissue repair, tissue reconstruction, tissue bulking, cosmetic treatment, tissue augmentation and tissue sealing.

4. The method of claim 1, wherein the lysate comprises HGF, FGF, IL-8, TIMP1 and BDNF.

5. The method of claim 4, wherein the lysate further comprises ANG2, HB-EGF, KGF, PDGFbb, VEGF, IL-6, MCP1, TGFa, TIMP2 and HGH.

6. The method of claim 1, wherein a matrix is added to the cell lysate to form a complex, and the complex is administered to the soft tissue defect in said subject.

7. A method of inducing cell infiltration and tissue formation in a subject by administering a cell lysate matrix complex, wherein the cell lysate is produced by lysing cells of a homogeneous population of human umbilical cord tissue-derived cells, wherein the cell lysate is added to a matrix to form a complex, and wherein the population of umbilical cord tissue-derived cells is isolated from human umbilical cord tissue substantially free of blood, is capable of self-renewal and expansion in culture, has the potential to differentiate, and has the following characteristics:

a) potential for at least 40 doublings in culture;

b) production of CD10, CD13, CD44, CD73, CD90 and HLA-A,B,C;

c) lack of production of CD31, CD34, CD45, CD117, CD141 and HLA-DR, HLA-DP and HLA-DQ;

d) secretes MCP-1, IL-6, IL-8, GCP-2, HGF, KGF, FGF, HB-EGF, BDNF, TPO, MIP1b, RANTES, and TIMP1; and

e) increased expression of endogenous genes encoding interleukin 8 and reticulon 1 relative to endogenous expression of interleukin 8 and reticulon 1 in a human cell that is a fibroblast, a mesenchymal stem cell, or an ileac crest bone marrow cell.

8. The method of claim 7, wherein the cell population does not secrete SDF-1 alpha, TGF-beta2, ANG2, PDGFbb, MIP1a, and VEGF.

9. The method of claim 7, wherein the method is effective to achieve at least one of tissue repair, tissue reconstruction, tissue bulking, cosmetic treatment, tissue augmentation and tissue sealing.

10. The method of claim 7, wherein the lysate comprises HGF, FGF, IL-8, TIMP1 and BDNF.

11. The method of claim 10, wherein the lysate further comprises ANG2, HB-EGF, KGF, PDGFbb, VEGF, IL-6, MCP1, TGFa, TIMP2 and HGH.

12. A method of treating a soft tissue defect in a subject, comprising administering to said soft tissue defect in said subject a homogeneous population of umbilical cord tissue-derived cells in an amount effective to treat the soft tissue defect, wherein the population of umbilical cord tissue-derived cells is isolated from human umbilical cord tissue substantially free of blood, is capable of self-renewal and expansion in culture, has the potential to differentiate, and has the following characteristics:

a) potential for at least 40 doublings in culture;

b) production of CD10, CD13, CD44, CD73, CD90 and HLA-A,B,C;

c) lack of production of CD31, CD34, CD45, CD117, CD141 and HLA-DR, HLA-DP and HLA-DQ;

d) secretes MCP-1, IL-6, IL-8, GCP-2, HGF, KGF, FGF, HB-EGF, BDNF, TPO, MIP1b, RANTES, and TIMP1; and

e) increased expression of endogenous genes encoding interleukin 8 and reticulon 1 relative to endogenous expression of interleukin 8 and reticulon 1 in a human cell that is a fibroblast, a mesenchymal stem cell, or an ileac crest bone marrow cell.

13. The method of claim 12, wherein the cell population does not secrete SDF-1 alpha, TGF-beta2, ANG2, PDGFbb, MIP1a, and VEGF.

14. The method of claim 12, wherein treatment of a soft tissue defect includes tissue repair, tissue reconstruction, tissue bulking, cosmetic treatment, tissue augmentation and tissue sealing.