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

• US 8,278,095 B2
• Filed: 07/17/2008
• Issued: 10/02/2012
• Est. Priority Date: 03/31/2005
• Status: Active Grant

• Current Assignee: Stemnion, Inc.
• Original Assignee: Stemnion, Inc.
• Inventors: Clarke, Diana L., Smith, Charlotte A., Marshall, Vivienne S.
• Primary Examiner(s): Driscoll, Lora E Barnhart
• Application Number:
  US12/218,655
• Publication Number:
  US 20090075381A1
• Time in Patent Office: 1,538 Days
• Field of Search: None
• US Class Current: 435/325
• 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 substantially purified population of cultured amnion-derived epithelial cells that is 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 population of claim 1 wherein the basal medium is IMDM.

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

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

5. The substantially purified population of claim 1 wherein the substantially purified population, the basal medium, and all medium supplements are free of xeno-contamination.

6. The substantially purified population of claim 1 wherein the collected cells of step c) are negative for expression of the protein markers CD90, CD117 and CD105.

7. A pharmaceutical composition comprising the substantially purified population of claim 1.

8. The cultured amnion-derived epithelial cells of claim 1 which are further processed by the step of (e) expanding the cells to a ratio of at least 500×

10⁶ amnion-derived epithelial cells/g of starting amnion.

9. The substantially purified population of claim 6, wherein the collected cells in step c) are further negative for telomerase expression.