Methods for making cytokine compositions from tissues using non-centrifugal methods

• US 9,556,243 B2
• Filed: 10/10/2013
• Issued: 01/31/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Biologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Leach, Michael D., Woodell-May, Jennifer E., Higgins, Joel C., O'Shaughnessey, Krista
• Primary Examiner(s): Ford, Vanessa L
• Assistant Examiner(s): DILLAHUNT, SANDRA E
• Application Number:
  US14/050,950
• Publication Number:
  US 20140275497A1
• Time in Patent Office: 1,209 Days
• Field of Search: None
• US Class Current: 1/1
• 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 35/14 Blood; Artificial blood perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/35 Fat tissue; Adipocytes; Stromal cells; Connective tissues adipose-derived stem cells A61K35/28; collagen A61K38/39
• CPC Class Codes: A61K 38/1793 for cytokines; for lymphokines; for interferons
• CPC Class Codes: A61K 38/1808 Epidermal growth factor [EGF] urogastrone
• 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 38/1866 Vascular endothelial growth factor [VEGF]
• CPC Class Codes: A61K 38/191 Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
• CPC Class Codes: A61K 38/2006 IL-1
• CPC Class Codes: A61M 1/0281 Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
• CPC Class Codes: A61M 1/029 Separating blood components present in distinct layers in a container, not otherwise provided for containers for storing blood or blood components A61J1/05; sampling or analysing blood by separating blood components G01N33/491
• CPC Class Codes: C07K 1/34 by filtration, ultrafiltration or reverse osmosis
• CPC Class Codes: C07K 14/435 from animals; from humans
• CPC Class Codes: C07K 14/52 Cytokines; Lymphokines; Interferons
• CPC Class Codes: C07K 14/545 IL-1
• CPC Class Codes: G01N 33/5002 Partitioning blood components
• CPC Class Codes: G01N 33/5005 involving human or animal cells immunoassay G01N33/56966; immunoassays of protozoa G01N33/56905; protozoa in screening assays C12Q1/025

Abstract

Apparatus and methods for generating a solution rich in interleukin-1 receptor antagonist from a tissue comprising cytokine-producing cells. The apparatus can include a filter used with a separation system. The separation system can include a float.

Claims

1. A system for the production of a solution rich in interleukin-1 receptor antagonist (IL-1ra) from a multiple component material, comprising:

a filter configured to filter a first component from the multiple component material and to allow a remaining multiple component material to pass;

a separation system to receive the remaining multiple component material, including;

a withdrawal port;

a separation container;

a buoy system positioned within the separation container;

wherein a second component comprising a buffy coat of the remaining multiple component material is operable to be separated from a third component of the remaining multiple component material within the separation container by the buoy system;

a withdrawal container connected to the filter;

non-centrifugal means for isolating cytokine-producing cells; and

a solid extraction material for producing a liquid volume comprising a solution rich in IL-1ra;

wherein the withdrawal container is configured to be connected to the withdrawal port and draw the second component from the separation container through the withdrawal port and through the filter into the withdrawal container;

wherein the first component includes cytokine-producing cells; and

wherein the second component is operable to separate the cytokine-producing cells from the filter to obtain a liquid volume comprising cytokine-producing cells.

2. The system of claim 1, wherein the multiple component material is whole blood and the first component is white blood cells.

3. The system of claim 2, wherein the second component is a buffy coat.

4. The system of claim 2, wherein the third component is plasma.

5. The system of claim 1, wherein the buoy system includes:

a first buoy member and a second buoy member, wherein the second component is contained between the first buoy member and the second buoy member after separation of the second component and the third component.

6. The system of claim 5, wherein the first buoy member and the second buoy member are moveable relative to one another.

7. A system for the production of a solution rich in interleukin-1 receptor antagonist (IL-1ra) from a multiple component material, comprising:

a filter configured to filter a white blood cell component from the multiple component material and to allow a remaining multiple component material to pass;

a separation system to receive the remaining multiple component material, including;

a withdrawal port;

a separation container defining an internal volume;

a buoy system positioned in the internal volume of the separation container, wherein the buoy system includes a first buoy member and a second buoy member;

a withdrawal container configured to connect to the separation system to withdraw a second component comprising a buffy coat from the separation system, wherein the withdrawal container is connected to the filter;

non-centrifugal means for isolating cytokine-producing cells; and

a solid extraction material for producing a liquid volume comprising a solution rich in IL-1ra;

wherein the second component of the remaining multiple component material is operable to be separated from a third component of the remaining multiple component material within the separation container;

wherein the second component is able to be positioned between the first buoy member and the second buoy member;

wherein the third component is able to be positioned between the first buoy member and an end of the separation container

wherein the withdrawal container is configured to be connected to the withdrawal port and draw the second component from the separation container through the withdrawal port and through the filter into the withdrawal container;

wherein the first component comprises cytokine-producing cells; and

wherein the second component is operable to separate the cytokine-producing cells from the filter to obtain a liquid volume comprising cytokine-producing cells.

8. The system of claim 7, wherein the filter is configured to be backwashed with the withdrawn second component.

9. The system of claim 7, wherein the first buoy member is moveable relative to the second buoy member.

10. The system of claim 7, wherein the filter is a size exclusion hollow fiber array.