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In the United States, the Food and Drug Administration regulates any facility that stores cord blood; cord blood intended for use in the person from whom it came is not regulated, but cord blood for use in others is regulated as a drug and as a biologic. Several states also have regulations for cord blood banks.
In March 2004, the European Union Group on Ethics (EGE) has issued Opinion No.19 titled Ethical Aspects of Umbilical Cord Blood Banking. The EGE concluded that “[t]he legitimacy of commercial cord blood banks for autologous use should be questioned as they sell a service, which has presently, no real use regarding therapeutic options. Thus they promise more than they can deliver. The activities of such banks raise serious ethical criticisms.”
It’s hard to ignore the ads for cord blood banks, offering a lifetime of protection for your children. If you’re an expectant mom, there’s information coming at you constantly from your doctor’s office, magazines, online, and perhaps even your yoga class.
The process used to collect cord blood is simple and painless. After the baby is born, the umbilical cord is cut and clamped. Blood is drawn from the cord with a needle that has a bag attached. The process takes about 10 minutes.
There are so many things to think about when you have a child. One of them is the blood from your baby’s umbilical cord (which connects the baby to the mother while in the womb). It used to be thrown away at birth, but now, many parents store the blood for the future health of their child. Should you do it?
Cord blood (short for umbilical cord blood) is the blood that remains in the umbilical cord and placenta post-delivery. At or near term, there is a maternal–fetal transfer of cells to boost the immune systems of both the mother and baby in preparation for labor. This makes cord blood at the time of delivery a rich source of stem cells and other cells of the immune system. Cord blood banking is the process of collecting the cord blood and extracting and cryogenically freezing its stem cells and other cells of the immune system for potential future medical use.
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Your child may never need it. Stem cell-rich cord blood can be used to treat a range of diseases, but Frances Verter, Ph.D., founder and director of Parent’s Guide to Cord Blood Foundation, estimates that there’s only a 1 in 217 chance that your child will ever need a stem cell transplant with cord blood (or bone marrow). This is particularly true if the child doesn’t have a family history of diseases such as leukemia, lymphoma, or sickle cell anemia. Although the American Academy of Pediatrics (AAP) states cord blood has been used to treat certain diseases successfully, there isn’t strong evidence to support cord blood banking. If a family does choose to bank cord blood, the AAP recommends public cord blood banking (instead of private) to cut down on expenditures.
In addition, CBR offers Genetic Counselors on staff to help families make informed decisions about newborn stem cell banking. Phone 1-888-CORDBLOOD1-888-CORDBLOOD to speak with a CBR Genetic Counselor.
We’d like to extend our sincere gratitude to the thousands of obstetricians, nurses, midwives, and childbirth educators who support placenta and umbilical cord blood banking. There is no doubt that these efforts save lives.
A limitation of cord blood is that it contains fewer HSCs than a bone marrow donation does, meaning adult patients often require two volumes of cord blood for treatments. Researchers are studying ways to expand the number of HSCs from cord blood in labs so that a single cord blood donation could supply enough cells for one or more HSC transplants.
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 the medical courier delivers the cord blood collection kit to the cord blood bank, it is quickly processed to ensure the continued viability of the stem cells and immune system cells found in the cord blood. Firstly, a sample of the cord blood is tested for microbiological contamination, and the mother’s blood is tested for infectious diseases. As these tests are being conducted, the cord blood is processed to reduce the number of red blood cells and its total volume and isolate the stem cells and immune cells.
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.
Even if you don’t want to store the cord blood, highly consider donating the cord blood to local public banks. This cord blood can help patients that are on waiting lists with diseases such as leukemia.
Current research aims to answer these questions in order to establish whether safe and effective treatments for non-blood diseases could be developed in the future using cord blood. An early clinical trial investigating cord blood treatment of childhood type 1 diabetes was unsuccessful. Other very early stage clinical trials are now exploring the use of cord blood transplants to treat children with brain disorders such as cerebral palsy or traumatic brain injury. However, such trials have not yet shown any positive effects and most scientists believe much more laboratory research is needed to understand how cord blood cells behave and whether they may be useful in these kinds of treatments
A cord blood bank may be private (i.e. the blood is stored for and the costs paid by donor families) or public (i.e. stored and made available for use by unrelated donors). While public cord blood banking is widely supported, private cord banking is controversial in both the medical and parenting community. Although umbilical cord blood is well-recognized to be useful for treating hematopoietic and genetic disorders, some controversy surrounds the collection and storage of umbilical cord blood by private banks for the baby’s use. Only a small percentage of babies (estimated at between 1 in 1,000 to 1 in 200,000) ever use the umbilical cord blood that is stored. The American Academy of Pediatrics 2007 Policy Statement on Cord Blood Banking stated: “Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in cord blood.” and “private storage of cord blood as ‘biological insurance’ is unwise” unless there is a family member with a current or potential need to undergo a stem cell transplantation. The American Academy of Pediatrics also notes that the odds of using a person’s own cord blood is 1 in 200,000 while the Institute of Medicine says that only 14 such procedures have ever been performed.
The American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics don’t recommend routine cord blood storage. The groups say private banks should only be used when there’s a sibling with a medical condition who could benefit from the stem cells. Families are encouraged to donate stem cells to a public bank to help others.
Bone marrow is the soft, sponge-like material found inside bones. It contains immature cells known as hematopoietic or blood-forming stem cells. (Hematopoietic stem cells are different from embryonic stem cells. Embryonic stem cells can develop into every type of cell in the body.) Hematopoietic stem cells divide to form more blood-forming stem cells, or they mature into one of three types of blood cells: white blood cells, which fight infection; red blood cells, which carry oxygen; and platelets, which help the blood to clot. Most hematopoietic stem cells are found in the bone marrow, but some cells, called peripheral blood stem cells (PBSCs), are found in the bloodstream. Blood in the umbilical cord also contains hematopoietic stem cells. Cells from any of these sources can be used in transplants.
Advances in treatment methods, including the use of PBSCT, have reduced the amount of time many patients must spend in the hospital by speeding recovery. This shorter recovery time has brought about a reduction in cost. However, because BMT and PBSCT are complicated technical procedures, they are very expensive. Many health insurance companies cover some of the costs of transplantation for certain types of cancer. Insurers may also cover a portion of the costs if special care is required when the patient returns home.
Hematopoietic stem cells can be used to treat more than 70 types of diseases, including diseases of the immune system, genetic disorders, neurologic disorders, and some forms of cancer, including leukemia and lymphoma. For some of these diseases, stem cells are the primary treatment. For others, treatment with stem cells may be used when other treatments have not worked or in experimental research programs.
^ Reddi, AS; Kuppasani, K; Ende, N (December 2010). “Human umbilical cord blood as an emerging stem cell therapy for diabetes mellitus”. Current stem cell research & therapy. 5 (4): 356–61. doi:10.2174/157488810793351668. PMID 20528762.
In 1989, Cryo-Cell International was founded in Oldsmar, FL, making it the oldest cord blood bank in the world. By 1992, it began to store cord blood. In addition to pursuing a wide variety of accreditations (AABB, cGMP, and ISO 1345), it was the first private cord blood bank in the U.S. to be awarded FACT accreditation. In 2017, it initiated a $100,000 Engraftment Guarantee (previously $75,000), the highest quality guarantee of any U.S. cord blood bank.
The blood that remains in the umbilical cord and the placenta after birth is called “cord blood”. Umbilical cord blood, umbilical cord tissue, and the placenta are all very rich sources of newborn stem cells. The stem cells in the after birth are not embryonic. Most of the stem cells in cord blood are blood-forming or hematopoietic stem cells. Most of the stem cells in cord tissue and the placenta are mesenchymal stem cells.
As most parents would like to bank their babies’ cord blood to help safeguard their families, it is often the cost of cord blood banking that is the one reason why they do not. Most cord blood banks have an upfront fee for collecting, processing and cryo-preserving the cord blood that runs between $1,000 and $2,000. This upfront fee often also includes the price of the kit provided to collect and safely transport the cord blood, the medical courier service used to expedite the kit’s safe shipment, the testing of the mother’s blood for any infectious diseases, the testing of the baby’s blood for any contamination, and the cost of the first full year of storage. There is then often a yearly fee on the baby’s birthday for continued storage that runs around $100 to $200 a year.
CBR collection kits have been designed to shield the samples from extreme temperatures (shielding for more than 1 hour at extreme hot and cold). Samples remain at room temperature and are shipped directly to the CBR lab for processing.
Cord Blood Registry® (CBR®) is the world’s largest newborn stem cell company. Founded in 1992, CBR is entrusted by parents with storing samples from more than 600,000 children. CBR is dedicated to advancing the clinical application of cord blood and cord tissue stem cells by partnering with institutions to establish FDA-regulated clinical trials for conditions that have no cure today.CBR has helped more than 400 families use their cord blood stem cells for established and experimental medical treatments, more than any other family cord blood bank. CBR’s goal is to expand the potential scope of newborn stem cell therapies that may be available to patients and their families.
Depending on the predetermined period of storage, the initial fee can range from $900 to $2100. Annual storage fees after the initial storage fee are approximately $100. It is common for storage facilities to offer prepaid plans at a discount and payment plans to help make the initial storage a more attractive option for you and your family.
^ a b Walther, Mary Margaret (2009). “Chapter 39. Cord Blood Hematopoietic Cell Transplantation”. In Appelbaum, Frederick R.; Forman, Stephen J.; Negrin, Robert S.; Blume, Karl G. Thomas’ hematopoietic cell transplantation stem cell transplantation (4th ed.). Oxford: Wiley-Blackwell. ISBN 9781444303537.