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Current Projects
Red Blood Cells : Platelets : Pluripotential Mononuclear Cells : Fresh Frozen Plasma
Hemostasis : Resuscitation

Red Blood Cells

a.  FDA approval for the extension of frozen storage of red blood cells:  One of the things we hope to accomplish is to persuade the FDA to allow for longer frozen storage of red blood cells.  The FDA has approved the frozen storage of red blood cells for up to 10 years.  However, our laboratory has provided data to the Navy Blood Program Office and Armed Services Blood Program Office which shows that red blood cells can be frozen for up to 37 years with no significant damage.   FDA is currently reviewing our submission for extension of the frozen red blood cell storage and a decision is expected soon.

Military significance: The Department of Defense currently has more than 60,000 units of frozen red blood cells stockpiled.  Several thousand of these frozen red blood cell units are nearing the 10-year outdate.  FDA-approval of an extension in the acceptable period for frozen storage of red blood cells will save the Department of Defense the cost of replacing these high-quality frozen red blood cells.

Civilian significance:  Like DOD, some civilian facilities have also stockpiled frozen red blood cells for use in emergency shortages and approval of this extension will also save them the costs of replacing these red cells.

b.  FDA approval of a closed, automated system to glycerolize (freeze) and deglycerolize (wash) red blood cells:  Also as part of our frozen red blood cell program, we have evaluated a new automated machine, the Haemonetics Model 215, which the FDA considers a 'closed' system.  The term 'closed' means that there is no potential for bacterial contamination to occur during the red blood cell freezing and washing procedures.  The current systems are considered 'open', and have the potential for bacterial contamination occurring during either the freezing or washing procedure, and the FDA has determined that these previously frozen red blood cells can be stored for only 24 hours following thawing and washing.  The need for the limited 24-hour post-wash storage period with the current systems is understandable.  If the red blood cells did become contaminated during the freezing or washing procedures, the longer they are stored in the refrigerator following washing, the better the chance the bacteria could repopulate and cause a transfusion reaction.    However, this limited post-wash storage period requires that frozen red blood cells be thawed and washed only when the need to use them within the 24 hour period is certain.  The new 'closed' system eliminates the potential for bacterial contamination.  Data provided to FDA by our laboratory as part of a multi-center study have shown that red blood cells processed using the Haemonetics 215 closed system can be stored for up to 15 days following washing with acceptable results.  Based on these data, the FDA has approved the Haemonetics 215 system with post-wash storage of previously frozen red blood cells for 14 days following washing.  It is expected that this extension will result in an increased use of frozen red blood cells in both the civilian and military communities.

Military significance:  The Department of Defense currently stockpiles frozen red blood cells for use in emergency situations.  This new, automated system will not only allow for increased post-wash storage but will also increase productivity.  Because the new system is automated, 1 technician can operate 8 to 10 machines at 1 time.

Civilian significance:  Approval of a closed, automated system with an extended post-wash storage period will simplify the use of frozen red blood cells allowing civilian centers to use frozen red blood cells for inventory control.  This is especially important in light of the recent American Red Cross blood shortages.

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Platelets

The NBRL is attempting to obtain FDA approval for frozen platelets.  Platelets, the cells in the blood which are used to stop bleeding, can be stored at room temperature for no more than 5 days.  Platelets cannot be stored in the refrigerator at 4 C because they undergo shape changes that reduce their survival following transfusion.  The disadvantage of the warmer room temperature storage is that it increases the risks of bacterial contamination.  Our laboratory began evaluating methods to freeze platelets in 1972.  From that time to the present, we have developed a relatively simple procedure to freeze platelets with a chemical called dimethyl sulfoxide (DMSO) which allows for frozen storage of the platelets at -80 C for up to 2 years.  The data we have obtained using this platelet freezing method have been submitted to FDA and we are currently awaiting their response.    We are currently developing a method where we remove most of the DMSO before the platelets are frozen, thereby eliminating the washing step after freezing.  This would significantly simplify the procedure for use by the civilian and military communities.

Military significance:  The limited 5-day liquid storage period does not allow enough time for the platelets to be collected at fixed facilities and transported to the field.  The Department of Defense currently has stockpiled more than 60,000 units of frozen red blood cells.  Once our platelet program is FDA approved, frozen platelets can be stockpiled along with frozen red blood cells.  The military would then be ensured of a supply of platelets adequate for their needs.

Civilian significance:  Platelet availability in the civilian community is also affected by their limited storage period.  Single-donor platelets are expensive to collect and a method is needed to preserve them when quantities are high.

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Pluripotential Mononuclear Cells

Pluripotential mononuclear cells isolated from peripheral blood can be frozen with 10% DMSO and stored at -80 C for 1½ years. The procedure to freeze pluripotential mononuclear cells has been modified by the removal of supernatant DMSO prior to freezing. This modification eliminates the need for post-thaw washing prior to transfusion.

Military and civilian significance: These HLA and ABO compatible previously frozen mononuclear cells can be used to treat individuals exposed to radiation injury.

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Fresh Frozen Plasma

We are continuing to evaluate prolonged frozen storage of the plasma component of blood.  Plasma is the component of the blood that contains clotting proteins and it is used to treat individuals who are actively