High concentration white cells, a method for agglomeration of the high concentration and a bag set for use in conjunction therewith

• US 5,928,214 A
• Filed: 08/03/1998
• Issued: 07/27/1999
• Est. Priority Date: 12/05/1994
• Status: Expired due to Term

• Current Assignee: New York Blood Center Incorporated
• Original Assignee: New York Blood Center Incorporated
• Inventors: Rubinstein, Pablo, Stevens, Cladd E., Coelho, Philip Henry
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US09/128,208
• Time in Patent Office: 358 Days
• Field of Search: 604/406, 604/403, 604/408, 604/409, 604/410, 604/4, 604/5, 210/206, 210/767, 210/257.1, 210/782, 210/787, 210/806, 422/41, 422/44, 435/2
• US Class Current: 604/410
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0221 Freeze-process protecting agents, i.e. substances protecting cells from effects of the physical process, e.g. cryoprotectants, osmolarity regulators like oncotic agents
• CPC Class Codes: A01N 1/0263 Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
• CPC Class Codes: A61B 5/150038 for blood from umbilical cord
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61M 1/0236 with sampling means, e.g. sample bag or sampling port
• CPC Class Codes: A61M 2202/0071 product to be retained or harvested, e.g. by pheresis
• CPC Class Codes: A61M 2202/0439 White blood cells; Leucocytes lymphocytes A61M2202/0407
• CPC Class Codes: A61M 2202/0462 Placental blood, umbilical cord blood
• CPC Class Codes: Y10S 206/828 Medicinal content

Abstract

A therapeutic product formed from a high concentration of white blood cells having a high degree of cell viability. The white blood cells are sequestered from their normal population presence in whole blood by placing the blood into a container and preventing coagulation of the blood, separating the blood into two components, one of which is extremely rich in white blood cells through the use of a reagent and centrifugation, sequestering the white cell concentration, and freezing the white cells.

Claims

1. A system for concentrating blood cells, comprising:

a first bag for containing blood and an anticoagulant,

a container, removably coupled to said first bag through a coupling system, for containing a red blood cell sedimentation reagent,

a second bag removably coupled to said first bag through a coupling system for receiving from said first bag a first supernatant containing at least 80% of white blood cells contained in said first bag after said blood is mixed with said red blood cell sedimentation reagent, and after said first bag is centrifuged at a speed sufficient to obtain said first supernatant and a first sediment containing at least 90% of said red blood cells contained in said first bag,

a third bag removably coupled to said second bag through a coupling system for receiving from said second bag all or a portion of a second supernatant contained in said second bag after said second bag is centrifuged at a speed sufficient to obtain a second supernatant and a second sediment, and

a freezer bag removably coupled to said second bag through a coupling system for receiving from said second bag a resulting composition remaining after transfer of said all or a portion of said second supernatant to said third bag, said resulting composition including at least 80% of white blood cells contained in said blood and less than all of plasma contained in said blood.

2. The system of claim 1, further comprising a second container for containing a cryoprotective agent, said second container removably coupled to said second bag or said freezer bag through a coupling system for introducing said cryoprotective agent into said second bag or said freezer bag.

3. The system of claim 2, wherein said coupling system includes at least one tube.

4. The system of claim 1, wherein said freezer bag contains a plurality of compartments therewithin, said compartments being interconnected.

5. The system of claim 4, wherein said compartments are separated by heat sealable regions.

6. The system of claim 4, wherein said plurality of compartments in said freezer bag includes a major chamber and a minor chamber.

7. The system of claim 6, wherein said freezer bag further includes a first portal for said major chamber and a second portal for said minor chamber.

8. The system of claim 1, wherein said freezer bag further contains a stand tube having a plurality of stand tube compartments, each of said stand tube compartments being separable from an adjacent stand tube compartment by a heat-sealable region of said stand tube.

9. The system of claim 2, further comprising an apparatus for controlling flow of said cryoprotective agent into said second bag or said freezer bag.

10. The system of claim 9, wherein said apparatus is a valve, a clamp, a pump, or a syringe.

11. The system of claim 1, wherein said red blood cell sedimentation reagent comprises hydroxyethyl starch.

12. The system of claim 11, wherein said reagent is a six percent solution of hydroxyethyl starch.

13. The system of claim 2, wherein said cryoprotective agent comprises dimethyl sulfoxide.

14. The system of claim 2, wherein said cryoprotective agent comprises dextran.

15. The system of claim 13, wherein said dimethyl sulfoxide is diluted to 50% with dextran.