September 2012
Dennis Todd, PhD & Frances Verter, PhD
Dennis Todd, PhD,
CEO of Community Blood Services
You've just visited the doctor and the good news is that you're going to have a baby and everything looks good. Thirty years ago, your doctor may have given you a baby book and information about products that sponsors want you to buy for your new addition. Today, along with pretty much the same materials, you'll be asked to consider saving the blood of your newborn that's left over in the umbilical cord and placenta after the delivery. Another big decision, and possibly a costly one.
So what are your options? You have three choices. One is to store the cord blood with a private company at a cost to you ranging from $1,500 to $2,500 and an annual storage fee in the ballpark of $125. Secondly, you can donate the cord blood to a public bank, if there is one working with your hospital, and your doctor is on board with the idea. There are also public banks that accept mail-in donations, if you register during your second trimester and your doctor is willing to take a short training class on-line. Zero cost to you. The third option is to do nothing and have the cord blood, umbilical cord, and placenta destroyed as medical waste.
Why should you consider donating the cord blood to a public bank? Simply because, besides bringing a new life into the world, you could be saving an individual whose best chance at life is a stem cell transplant with your baby's donated cord blood. This can only happen if you donate and if your baby is a close enough match for a patient in need. If you chose to reserve the cord blood for your family, then siblings who have the same parents have a 25% chance of being an exact match.
Are public banks and family banks the same, except for who may use the cord blood and the cost to the parents? No. Public banks are subject to much higher regulatory requirements, and compliance with regulations carries costs. At a family bank you pay the bank enough to cover the cost of storing your baby's cord blood, plus they make a profit. When you donate to a public bank, it costs you nothing, but the bank pays more on processing each blood collection than at a family bank. Let's look at the steps that take place in the laboratory.
Both public and family cord blood banks must register with the US Food and Drug Administration (FDA), and since Oct. 2011 public banks also need to apply for an FDA license. All cord blood banks are required by federal law to test the blood of the mother for infectious diseases. At public banks the screening is usually more extensive, similar to the tests performed when you donate blood. The typical expense to a public bank is $150 per unit.
The next step at either a public or family bank is to process the cord blood to separate the blood component holding stem cells. The final product has a volume of 25 milliliters and includes a cryoprotectant which prevents the cells from bursting when frozen. Typical cost, $250 to $300 per unit.
Prior to freezing the cells, samples are taken for quality testing. Banks measure the number of cells that are positive for the CD34 marker, a protein that is used to estimate the number of blood-forming stem cells present. Typical cost, $150 to $200 per unit. They also measure the number of nucleated cells, another measure of stem cells, both before and after processing to determine the cell recovery rate. Typical expense, $35 per unit. A portion of the sample is submitted to check that there is no bacterial or fungal contamination. Typical expense, $75 per unit. Public banks will also check the ability of the sample to grow new cells by taking a culture called the CFU assay. Typical expense, $200 to $250 per unit.
When all the processing and testing is complete, the cord blood stem cells are frozen in cryogenic nitrogen freezers at -196° C until they are requested for patient therapy. Public banks are required to complete the entire laboratory processing and freeze the cord blood stem cells within 48 hours of collection. This is to insure the highest level of stem cell viability. The accreditation agencies allow family banks a window of 72 hours.
To save money, public banks will not even process a cord blood donation unless they know in advance that they are going to keep it. When the collection first arrives at the lab, it is passed through a cell counting machine. Only collections that have at least 900 million nucleated cells are kept. As a result, over 60%-80% of cord blood donations are discarded. The public bank must absorb the expense of the collection kit and delivery charges for discarded blood; typically $100 per unit.
An additional cost that is borne only by public banks is the "HLA typing" that is used to match donors and patients for transplants. This is an expensive test, running about $75 to $125 per unit. Family banks always defer this test until it is known whether a family member might use the cord blood for therapy.
After all is said and done, the cost to collect, test, process and store a donated cord blood collection at a public bank is estimated to be $1,200 to $1,500 dollars for each unit banked. That does not include the expense for the regulatory and quality systems needed to maintain licensure, or the cost of collecting units that are discarded because they don't meet standards.
When you consider that public banks can only expect to ship 1-2% of their inventory for transplant, you can quickly understand why most public banks are struggling to make ends meet. That struggle means that fewer collection programs are staffed, and there are fewer opportunities for parents to donate to the public good. We said earlier that public banks only keep cord blood donations over a minimum of 900 million cells, but today most public banks have raised that threshold to 1.5 billion cells. The reason is that the largest units are the ones most likely to be used for transplants that bring income to the bank. Family cord blood banks do not need to impose volume thresholds because they have a profit margin on every unit banked.
Dennis Michael Todd, PhD, joined Community Blood Services as its President and CEO in 2000. Community Blood Services operates the NJ Cord Blood Bank and The HLA Registry bone marrow donor center, both of which are affiliated with the National Marrow Donor Program (NMDP). In 2012, the blood center expects to distribute over 85,000 units of red cells and 20,000 platelets to hospitals and medical centers throughout northern NJ and Orange County, NY. Dr. Todd is presently a member of the NMDP Executive Committee and Chairman of the Finance Committee. He is a member of the International Society for Cellular Therapy (ISCT), the International Society for Stem Cell Research (ISSCR), the AABB, the American Association of Bioanalysts, and the New Jersey Society of Blood Bank Professionals.
Frances Verter, PhD, founded the Parent's Guide to Cord Blood in 1998 and has been a Scientific Advisor to Community Blood Services since 2007. In 2011 the NMDP presented her with their Lifeline Award in recognition of her efforts to improve public education about cord blood donation.
