Human placental collagen compositions, and methods of making and using the same

• US 20080181935A1
• Filed: 10/09/2007
• Published: 07/31/2008
• Est. Priority Date: 10/06/2006
• Status: Abandoned Application

• Current Assignee: Celularity, Inc.
• Original Assignee: Celularity, Inc.
• Inventors: Ye, Qian, Edinger, James W., Lugo, Chris, Bhatia, Mohit
• Application Number:
  US11/973,902
• Publication Number:
  US 20080181935A1
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 2800/92 Oral administration
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61K 8/65 Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations
• CPC Class Codes: C07K 1/02 in solution C07K1/003, C07K1/006 take precedence
• CPC Class Codes: C07K 1/34 by filtration, ultrafiltration or reverse osmosis
• CPC Class Codes: C07K 14/78 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• CPC Class Codes: G02B 2006/12147 Coupler
• CPC Class Codes: G02B 6/12004 Combinations of two or more optical elements
• CPC Class Codes: G02B 6/122 Basic optical elements, e.g. light-guiding paths
• CPC Class Codes: G02B 6/1228 Tapered waveguides, e.g. integrated spot-size transformers for coupling with fibres G02B6/305
• CPC Class Codes: G02B 6/124 Geodesic lenses or integrated gratings
• CPC Class Codes: G02B 6/2746 comprising non-reciprocal devices, e.g. isolators, FRM, circulators, quasi-isolators magneto-optic non-reciprocal devices G02F1/093
• CPC Class Codes: H01S 5/0064 Anti-reflection components, e.g. optical isolators
• CPC Class Codes: H01S 5/02326 Arrangements for relative positioning of laser diodes and optical components, e.g. grooves in the mount to fix optical fibres or lenses
• CPC Class Codes: H01S 5/026 Monolithically integrated components, e.g. waveguides, monitoring photo-detectors, drivers stabilisation of output H01S5/06
• CPC Class Codes: H01S 5/1032 : Coupling to elements comprising an optical axis that is not aligned with the optical axis of the active region
• CPC Class Codes: H01S 5/1035 : Forward coupled structures [DFC]
• CPC Class Codes: H01S 5/125 : Distributed Bragg reflector [DBR] lasers
• CPC Class Codes: H01S 5/187 : using Bragg reflection
• CPC Class Codes: H01S 5/2027 : Reflecting region or layer, parallel to the active layer, e.g. to modify propagation of the mode in the laser or to influence transverse modes
• CPC Class Codes: H01S 5/22 : having a ridge or stripe structure
• CPC Class Codes: H01S 5/3013 : AIIIBV compounds

Abstract

The present invention provides compositions comprising human placental telopeptide collagen, methods of preparing the compositions, methods of their use and kits comprising the compositions. The compositions, kits and methods are useful, for example, for augmenting or replacing tissue of a mammal.

Claims

1. Base-treated, detergent-treated telopeptide collagen.

2. The collagen of claim 1 that is mammalian collagen.

3. The collagen of claim 1 that is bovine, ovine or rat collagen.

4. The collagen of claim 1 that is human collagen.

5. The collagen of claim 1 that is placental collagen.

6. The collagen of claim 1 that is human placental collagen.

7. The collagen of claim 1 that is cross-linked.

8. The collagen of claim 1 that is cross-linked with glutaraldehyde.

10. The composition of claim 1 or claim 9 comprising a plurality of stem cells.

11. The composition of claim 10 wherein the stem cells are embryonic stem cells, embryonic germ cells, mesenchymal stem cells, bone marrow-derived stem cells, hematopoietic stem cells from peripheral blood, hematopoietic stem cells from fetal blood, hematopoietic stem cells from placental blood, hematopoietic stem cells from umbilical cord blood, hematopoietic stem cells from placental perfusate, somatic stem cells, neural stem cells, hepatic stem cells, pancreatic stem cells, endothelial stem cells, cardiac stem cells, muscle stem cells, adipose stem cells, or CD34⁻

placental stem cells.

12. The composition of claim 11 wherein said CD34⁻

placental stem cells are CD200⁺.

13. The composition of claim 11 wherein said CD34⁻

placental stem cells are;

a. CD200⁺ or HLA-G⁺;

b. CD73⁺, CD105⁺, and CD200⁺;

c. CD200⁺ and OCT-4⁺;

d. CD73⁺, CD105⁺ and HLA-G⁺, CD73⁺ and CD105⁺, and, when in a population of placental cells, facilitate formation of one or more embryoid-like bodies under conditions that allow formation of embryoid-like bodies;

or

e. OCT-4⁺ and, when in a population of placental cells, facilitate formation of one or more embryoid-like bodies in a population of isolated placental cells comprising said stem cell when cultured under conditions that allow formation of embryoid-like bodies.

14. The composition of claim 10 comprising more than one type of stem cell.

15. The composition of claim 10 comprising a plurality of non-stem cells.

16. The composition of claim 10 shaped as a sheet.

17. The composition of claim 10 shaped as a tube.

18. The composition of claim 10 shaped as a mesh.

19. The composition of claim 10, wherein said composition is shaped to fit to a site of a wound or injury.

20. A method of augmenting, bulking or replacing tissue of a mammal comprising administering the collagen of claim 1 to the tissue of the mammal.

21. A kit for augmenting, bulking or replacing tissue of a mammal comprising the collagen of claim 1 and a label with instructions for administering the cross-linked telopeptide collagen.

32. A method of promoting healing of a wound comprising contacting the wound with a collagen composition of claim 1, wherein said contacting results in detectably greater improvement of an aspect of the wound compared to a wound not contacted with the composition.

33. The method of claim 32, additionally comprising contacting said wound with a plurality of stem cells.

34. The method of claim 33, wherein said stem cells are contacted with said wound separately from contacting said composition with said wound.

35. The method of claim 32, wherein said composition comprises said stem cells.

36. The method of claim 35, wherein said composition is shaped as a sheet having two sides, and said stem cells are present on at least one of said sides.

37. The method of claim 35, wherein the stem cells are adhered to the composition.

38. The method of claim 35, wherein the stem cells secrete IL-6, IL-8 and/or MCP-1.

39. The method of claim 35, wherein said stem cells are placental stem cells.

40. The method of claim 39, wherein said placental stem cells are CD34⁻

and CD200⁺.

41. The method of claim 32, wherein said wound is a leg ulcer.

42. The method of claim 41, wherein said leg ulcer is a venous leg ulcer, arterial leg ulcer, diabetic leg ulcer or decubitus leg ulcer.

43. The method of claim 32, wherein said composition is used as a wound filler.

44. A method of making a composition, comprising contacting the composition of claim 1 with a plurality of stem cells.

45. The method of claim 44, comprising allowing at least some of said plurality of stem cells to adhere to said composition.

46. The method of claim 45, comprising allowing said stem cells to proliferate on said composition.

47. The method of claim 46, wherein said stem cells proliferate on said composition to confluency.

48. The method of claim 46, wherein said stem cells produce detectable amounts of IL-6, IL-8 and/or MCP-1 when contacted with said composition.

9. Detergent-treated telopeptide collagen comprising a detectable amount of fibronectin.

22. A process for preparing telopeptide collagen from tissue of a mammal that comprises collagen, said process comprising the steps of:

a. contacting the tissue with an osmotic shock solution to yield a collagen composition;

b. contacting the collagen composition with a detergent; and

c. contacting the detergent-treated collagen solution with a basic solution.

23. The process of claim 22 wherein the osmotic shock solution comprises water with an osmotic potential less than that of 50 mM NaCl.

24. The process of claim 22 wherein step (a) is preceded or followed by contacting the tissue with a solution having an osmotic potential of a solution of at least 0.5 M NaCl.

25. The process of claim 22 wherein the basic solution comprises at least 0.5 M NaOH.

26. The process of claim 22 further comprising the step of filtering the base-treated, detergent-treated collagen solution.

27. The process of claim 22 further comprising the step of cross-linking the collagen to yield cross-linked collagen.

28. The process of claim 27 wherein the collagen is cross-linked with glutaraldehyde.

29. The process of claim 22 further comprising the step of shearing the cross-linked collagen.

30. The process of claim 22 further comprising the step of contacting the collagen composition with a filter of a size that allows one or more viral particles to pass through the filter while retaining the collagen composition.

31. The process of claim 30 wherein the filter is about 500 kDa, about 750 kDa or about 1000 kDa.