Pennsylvania has state legislation around cord blood education that follows the Institute of Medicine guidelines and mandates/encourages physicians to educate expectant parents about ALL forms of cord blood banking. The Pennsylvania bill was enacted 3 April 2008 and became effective 2 June 2008.
- Processing: How is cord blood processed before storage?
The three main components of cord blood, like any blood collection, can be separated by weight: the heaviest layer is the red blood cells (RBC), the lightest is the plasma (a clear white liquid), and in the middle is a pinkish layer called the "buffy coat" which contains the white blood cells (WBC), including stem cells. When banks process the cord blood, the final separated component that goes into storage is the buffy coat, even though only about 1% of the cells are actually stem cells. There is no procedure to separate out the stem cells alone.
The vast majority of blood processing methods rely on the different density of the three main blood components. They can be separated by sedimentation, or by centrifuge, or by a combination of the two techniques. The procedure can be performed manually by trained technicians or by automated machine.
- Why is it important to choose a Family Bank that is accredited?
The Parent's Guide to Cord Blood Foundation recommends that parents select a Family Bank whose laboratory has been inspected and accredited by an accreditation agency specific to cord blood banking, as this provides a degree of quality assurance.
In some countries, national regulations hold Family Banks to the same standards as Public Banks, so an independent accreditation is not necessary (Examples: Germany, Israel). But in most countries the federal requirements for Family Banks are not as strict as Public Banks, and then a voluntary accreditation is desirable. For example, in the United States the FDA registers and inspects Family banks, but does not require them to have a BLA License like Public Banks.
Caveat: The process of registering with an accreditation agency and getting inspected can take a year, so it is understandable if a brand new lab does not have an accreditation yet.
- Processing: Must cord blood be processed before storage?
The earliest cord blood transplants were performed with whole cord blood. Thus, it is not absolutely necessary to process cord blood in order to save patient lives. There has never been a prospective randomized trial to compare transplant patient outcomes with cord blood that had been stored whole versus processed.
Most cord blood banks, both public and private, now process cord blood to remove both the plasma and the red cells, and cryo-preserve the remaining buffy coat holding stem cells. Some banks also save the removed red cells and plasma in companion storage. Some banks save a sample of maternal blood.
The removal of plasma is also called volume reduction. The volume reduction enables more collection units to fit in a freezer and requires less cryogenic nitrogen per unit.
Also, the majority of banks remove red blood cells prior to freezing, primarily because these cells often burst during freezing and release iron from hemoglobin that can be toxic. The alternate to removing the red cells before freezing is to wash any broken cells out of the collection upon thaw. Removing the red cells also removes the donor's blood type (the ABO and Rh types). When cord blood goes from a donor to a patient for a transplant, the donor and patient can be compatible on all the HLA types used for transplant matching and still have incompatible red blood types.