Treatment of leg ulcers using placenta derived collagen biofabric

• US 7,928,280 B2
• Filed: 07/12/2006
• Issued: 04/19/2011
• Est. Priority Date: 07/13/2005
• Status: Active Grant

• Current Assignee: Celularity, Inc.
• Original Assignee: Anthrogenesis Corporation (Bristol-Myers Squibb Company)
• Inventors: Smiell, Janice M., Hariri, Robert J.
• Primary Examiner(s): Lewis; Kim M
• Application Number:
  US11/485,840
• Publication Number:
  US 20070021704A1
• Time in Patent Office: 1,742 Days
• Field of Search: 602/48, 602/42, 424443-449, 604304-308
• US Class Current: 602/48
• CPC Class Codes: A61F 13/069 Decubitus ulcer bandages
• CPC Class Codes: A61F 15/001 Packages or dispensers for bandages, cotton balls, drapes, dressings, gauze, gowns, sheets, sponges, swabsticks or towels A61F15/007 takes precedence
• CPC Class Codes: A61F 2013/0054 for deep wounds
• CPC Class Codes: A61F 2013/00548 net wound bandages with net structure A61F2013/00097
• CPC Class Codes: A61F 2013/0091 with disinfecting or anaesthetics means, e.g. anti-mycrobic
• CPC Class Codes: A61F 2013/00927 with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
• 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 31/728 Hyaluronic acid
• CPC Class Codes: A61K 38/1841 Transforming growth factor [TGF]
• CPC Class Codes: A61K 38/1858 Platelet-derived growth factor [PDGF]
• CPC Class Codes: A61K 38/2292 Thymosin; Related peptides
• CPC Class Codes: A61K 38/363 Fibrinogen
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61K 38/4833 Thrombin (3.4.21.5)
• CPC Class Codes: A61L 15/32 Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin A61L15/225 takes precedence
• CPC Class Codes: A61L 15/325 Collagen
• CPC Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/34 : for soft tissue reconstruction
• CPC Class Codes: A61L 2430/40 : Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 26/0033 : Collagen
• CPC Class Codes: A61L 26/0057 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/60 : Materials for use in artificial skin
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like
• 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 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/10 : Antimycotics
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: Y10T 428/249921 : Web or sheet containing structurally defined element or component

Abstract

The present invention provides a method of treating a leg ulcer comprising contacting the leg ulcer with a collagen biofabric. The leg ulcer may be a venous, arterial, diabetic or decubitus (pressure) ulcer. The invention further provides kits comprising one or more pieces of collagen biofabric for the treatment of a leg ulcer.

Claims

1. A method of treating a leg ulcer, comprising contacting said ulcer with a first collagen biofabric for a first period of two to five weeks, followed by contacting said ulcer with a second collagen biofabric for a second period of time, wherein said contacting with said first or second collagen biofabric improves at least one aspect of the leg ulcer, or prevents or reduces the worsening of at least one aspect of the leg ulcer, wherein the first and second collagen biofabric is decellularized and dehydrated prior to contacting said ulcer.

2. The method of claim 1, wherein said first or second collagen biofabric is not artificially crosslinked.

3. The method of claim 1, wherein said first or second collagen biofabric is not protease-treated during production.

4. The method of claim 1, wherein said contacting for the first period of time or the second period of time is for a time sufficient for at least one aspect of the leg ulcer to measurably improve compared to a leg ulcer not contacted with the collagen biofabric.

5. The method of claim 1, wherein said contacting for the first period of time or the second period of time is for a time sufficient to prevent or reduce the worsening of at least one aspect of a leg ulcer.

6. The method of claim 1, wherein said leg ulcer is a venous leg ulcer, arterial leg ulcer, diabetic leg ulcer or decubitus ulcer.

7. The method of claim 1, wherein said leg ulcer is a venous leg ulcer.

8. The method of claim 1, wherein said first or second collagen biofabric is provided as a sheet or membrane.

9. The method of claim 1, wherein said first or second collagen biofabric is provided as a netting or webbing.

10. The method of claim 1, wherein said first or second collagen biofabric is mounted on a support.

11. The method of claim 10, wherein said support is a bandage.

12. The method of claim 1, wherein said contacting comprises placing the collagen biofabric on the leg ulcer so that substantially all of the surface area of the biofabric contacts the leg ulcer.

13. The method of claim 1, wherein said first or second collagen biofabric additionally comprises a bioactive compound not naturally-occurring in the collagen biofabric, or present in a different concentration than in collagen biofabric to which the bioactive compound has not been added.

14. The method of claim 13, wherein said bioactive compound is a small organic molecule, an antibiotic, pain medication, anti-inflammatory agent, cytokine, growth factor, enzyme inhibitor, kinase inhibitor, an anti-tumor agent, an anti-fungal agent, an anti-viral agent, an anti-infective agent, a wound sealant or a wound healing or sealing agent.

15. The method of claim 14, wherein said wound healing or sealing agent is platelet-derived growth factor (PDGF), transforming growth factor (TGF), thymosin, hyaluronic acid, fibrin, fibronectin or thrombin, or a combination thereof.

16. The method of claim 1, wherein the first period of time is four to five weeks.