Amnion-derived cell compositions, methods of making and uses thereof

• US 8,685,390 B2
• Filed: 10/03/2012
• Issued: 04/01/2014
• Est. Priority Date: 03/31/2005
• Status: Active Grant

• Current Assignee: Stemnion, Inc.
• Original Assignee: Stemnion, Inc.
• Inventors: Emig, Charlotte, Marshall, Vivienne S.
• Primary Examiner(s): Driscoll, Lora E Barnhart
• Application Number:
  US13/644,052
• Publication Number:
  US 20130115197A1
• Time in Patent Office: 545 Days
• Field of Search: None
• US Class Current: 424/93.7
• CPC Class Codes: A61K 2800/10 General cosmetic use
• 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 8/982 Reproductive organs; Embryos, Eggs
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: C12N 2501/11 Epidermal growth factor [EGF]
• CPC Class Codes: C12N 2502/02 embryonic cells
• CPC Class Codes: C12N 5/0605 Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly
• CPC Class Codes: C12N 5/0629 Keratinocytes; Whole skin

Abstract

The invention is directed to substantially purified amnion-derived cell populations, compositions comprising the substantially purified amnion-derived cell populations, and to methods of creating such substantially purified amnion-derived cell populations, as well as methods of use. The invention is further directed to antibodies, in particular, monoclonal antibodies, that bind to amnion-derived cells or, alternatively, to one or more amnion-derived cell surface protein markers. The invention is further directed to methods for producing the antibodies, methods for using the antibodies, and kits comprising the antibodies.

Claims

1. A method for accelerating wound healing of a chronic, infected wound as compared to the healing rate of a non-treated chronic, infected wound in a patient in need thereof comprising treating the chronic, infected wound by topically administering to the patient'"'"'s chronic, infected wound about 0.25-1.0×

10⁶ cultured amnion-derived epithelial cells, wherein the cultured amnion-derived epithelial cells are made by the method comprising the steps of

a) obtaining a placenta and isolating an amnion from the placenta,

b) enzymatically releasing amnion-derived epithelial cells from the amnion,

c) collecting the released amnion-derived epithelial cells, and

d) culturing the collected amnion-derived epithelial cells of step (c) in basal culture medium that is supplemented with human serum albumin and recombinant human EGF.

2. The method of claim 1 wherein the basal medium is IMDM.

3. The method of claim 2 wherein the IMDM is supplemented with 0.5% human serum albumin.

4. The method of claim 1 wherein the recombinant human EGF is at a concentration of 10 ng/mL of culture medium.

5. The method of claim 1 wherein the s amnion-derived epithelial cells, the basal medium, all medium supplements, and any additional process steps are free of xeno-contamination.