New York has state legislation around cord blood education that follows the Institute of Medicine guidelines and asks (but does not mandate) physicians to educate expectant parents about ALL forms of cord blood banking. The New York bill was enacted 7 Aug. 2007 and became effective 7 Feb. 2008.
- What questions should parents ask a Family Bank about Company Stability?
- Is the family cord blood bank a publicly-held or privately-held company?
- Is the company affiliated with a hospital or research institution?
- Is the company involved in bio-technology research and development?
- What other medical services does the company perform?
- How long has the company been banking cord blood?
- Who directs the day-to-day business of the company? Many cord blood banks have famous doctors on their Board of Directors; but they are not involved with the day-to-day operations.
- What is the lab inventory of cord blood collections, both public and private? This speaks to their staff's experience with storing cord blood.
- How many cord blood collections has the bank released from their own lab for therapy? This speaks to their staff's experience with releasing cord blood.
- What are TNC, MNC, CD34+, and CFU, and why should I care?
These are all ways of counting cell types, and they tell you whether or not your cord blood collection has lots of stem cells and if they are healthy.
Stem cells happen to be Mono-Nuclear Cells or MNC: when you look at them under a microscope there is only one nucleus. Unfortunately, one of the most difficult aspects of stem cell biology is that you can't identify a stem cell just by looking at it. There are other types of blood cells which are also MNC, such as nucleated red blood cells. The only proof that a cell is a stem cell comes from how it behaves when it multiplies.
Scientists have worked for years to develop various chemical stains which have a high affinity for stem cells. The best known marker for blood-forming stem cells is that they test positive for CD34, a protein found on the surface of stem cells. But, CD34+ counts are not an accurate measure of stem cells: CD34+ results vary between labs, they can vary within a single lab, and only 1-2% of the MNC that have CD34+ are actually stem cells.
The Total Nucleated Cell count or TNC is the test most often reported as a measure of the cell count after cord blood processing. The main advantage of measuring TNC is that the count is highly reproducible within and among labs, so it can be used accurately throughout the blood banking community. Even better, the TNC count can be automated with the use of a device called a flow cytometer.
At present Colony Forming Units or CFU are considered to be the best measure of whether stem cells are "viable", or quite frankly alive. The TNC count includes both living and dead cells. In the CFU test a small portion is watched under controlled conditions to see if stem cells divide and form colonies. This used to be a subjective measure, but recently it has been standardized with technology to image the cells and count colonies in the image. The only remaining problem with the test is that it takes days for colonies to grow.
- 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.