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

• US 20070179424A1
• Filed: 12/15/2006
• Published: 08/02/2007
• Est. Priority Date: 12/05/1994
• Status: Abandoned Application

• Current Assignee: New York Blood Center Incorporated
• Original Assignee: New York Blood Center Incorporated
• Inventors: Rubinstein, Pablo, Stevens, Cladd, Coelho, Philip
• Application Number:
  US11/640,138
• Publication Number:
  US 20070179424A1
• Time in Patent Office: Days
• US Class Current: 604/6.40
• CPC Class Codes: A01N 1/02 Preservation of living parts
• 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: A61J 1/12 with means for holding samples of contents
• CPC Class Codes: A61K 35/14 Blood; Artificial blood perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0236 with sampling means, e.g. sample bag or sampling port
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• 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 1/3693 using separation based on different densities of components, e.g. centrifuging
• 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

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

1-24. -24. (canceled)

25. A therapeutic product produced by a process comprising performing the following sequential steps in a series of removably coupled, interconnected bags under aseptic conditions:

(a) centrifuging a sample of placental, umbilical cord and/or peripheral donor blood, which has been contacted with an anticoagulant to prevent coagulation of the donor blood, in a blood bag in the presence of a red blood cell sedimentation reagent at a speed sufficient to obtain a first sediment and a first supernatant, wherein the first sediment comprises at least 90% of red blood cells contained in the blood sample and the first supernatant comprises at least 80% of white blood cells contained in the blood sample;

(b) introducing the first supernatant into a white cell bag;

(c) centrifuging the white cell bag to obtain a second sediment and a second supernatant; and

(d) removing all or a portion of the second supernatant so as to retain in the white cell bag a composition comprising at least 80% of white blood cells contained in the blood sample, less than 10% of red blood cells contained in the blood sample, and less than all of plasma contained in the blood sample.

26. The therapeutic product of claim 25, wherein the sedimentation reagent comprises hydroxyethyl starch.

27. The therapeutic product of claim 25, wherein the process further comprises contacting the composition with a cryoprotectant at a rate and an amount sufficient to obtain a cryoprotected composition without damaging cells contained in the composition;

and freezing the cryoprotected composition.

28. The therapeutic product of claim 27, wherein the cryoprotectant comprises dimethylsulfoxide.

29. The therapeutic product of claim 28, wherein the cryoprotectant further comprises dextran.

30. The therapeutic product of claim 28, wherein the final concentration of dimethylsulfoxide in the cryoprotected composition is 10%.

31. The therapeutic product of claim 25, wherein the donor blood is placental blood.

32. The therapeutic product of claim 25, wherein the donor blood is umbilical cord blood.

33. The therapeutic product of claim 25, wherein the donor blood is peripheral blood.

34. The therapeutic product of claim 25, which comprises at least 80% of white blood cells contained in the blood sample, less than 10% of red blood cells contained in the blood sample, and less than all of plasma contained in the blood sample.

35. The therapeutic product of claim 25, which comprises a red blood cell sedimentation reagent.

36. The therapeutic product of claim 25, which has a volume of 10 milliliters to 20 milliliters.

37. The therapeutic product of claim 25, which has an osmolarity of not more than 300 milliosmols.

38. The therapeutic product of claim 25, wherein the red cell to white cell count is approximately one hundred (100) to one (1).

39. The therapeutic product of claim 25, which comprises an anticoagulant.

40. The therapeutic product of claim 39, wherein the anticoagulant comprises Citrate, Phosphate, and Dextrose (CPD).

41. The therapeutic product of claim 27, wherein the therapeutic product comprises a cryoprotectant.

42. The therapeutic product of claim 28, wherein the therapeutic product comprises dimethylsulfoxide.

43. The therapeutic product of claim 29, wherein the therapeutic product comprises dextran.

44. The therapeutic product of claim 29, wherein the therapeutic product comprises dimethylsulfoxide diluted to 50% with dextran.