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

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.

1 - 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.