The American Academy of Pediatrics supports efforts to provide information about the potential benefits and limitations of cord blood banking and transplantation so that parents can make an informed decision. In addition, the American College of Obstetricians and Gynecologists recommends that if a patient requests information on umbilical cord blood banking, balanced information should be given. Cord blood education is also supported by legislators at the federal and state levels. In 2005, the National Academy of Sciences published an Institute of Medicine (IoM) report titled “Establishing a National Cord Blood Stem Cell Bank Program”.
Cord tissue use is still in early research stages, and there is no guarantee that treatments using cord tissue will be available in the future. Cord tissue is stored whole. Additional processing prior to use will be required to extract and prepare any of the multiple cell types from cryopreserved cord tissue. Cbr Systems, Inc.’s activities for New York State residents are limited to collection of umbilical cord tissue and long-term storage of umbilical cord–derived stem cells. Cbr Systems, Inc.’s possession of a New York State license for such collection and long-term storage does not indicate approval or endorsement of possible future uses or future suitability of these cells.
^ Roura, S; Pujal, JM; Gálvez-Montón, C; Bayes-Genis, A (2 July 2015). “The role and potential of umbilical cord blood in an era of new therapies: a review”. Stem cell research & therapy. 6: 123. doi:10.1186/s13287-015-0113-2. PMC 4489204 . PMID 26133757.
There was a time before the 1990s when the umbilical cord and its blood were considered medical waste. Today, parents bank or store their baby’s umbilical cord blood because the stem cells it contains are currently utilized or show promise in the treatment of life-threatening and debilitating diseases.
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Donating cord blood to a public cord blood bank involves talking with your doctor or midwife about your decision to donate and then calling a cord blood bank (if donation can be done at your hospital). Upon arriving at the hospital, tell the labor and delivery nurse that you are donating umbilical cord blood.
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The main reason for this requirement is to give the cord blood bank enough time to complete the enrollment process. For the safety of any person who might receive the cord blood donation, the mother must pass a health history screening. And for ethical reasons, the mother must give informed consent.
Most stored cord blood is discarded. At public cord blood banks, a unit of stored cord blood has a greater chance of being used to help a sick child or used toward stem cell research. Private cord blood banks, on the other hand, eventually throw away blood that a family no longer wants to store or use.
Therapies with cord blood have gotten more successful. “The outcomes of cord blood transplants have improved over the past 10 years because researchers and clinicians have learned more about dosing cord blood, picking better matches, and giving the patient better supportive care as they go through the transplant,” says Joanne Kurtzberg, M.D., director of the pediatric bone marrow and stem cell transplant program at Duke University.
*Fee schedule subject to change without notice. If a client has received a kit and discontinues services prior to collection, there is no cancelation fee if the kit is returned unused within two weeks from cancelation notice; otherwise, a $150 kit replacement fee will be assessed. †Additional courier service fee applies for Alaska, Hawai’i and Puerto Rico. ††Applies to one-year plan and promotional plan only. After the first year, an annual storage fee will apply. Cryo-Cell guarantees to match any written offer for product determined to be similar at Cryo-Cell’s sole discretion. ** Promotional Plan cannot be combined with any other promotional offers, coupons or financing.
Cord Blood banking is a confusing topic. Many parents get bombarded with information when searching to see if cord blood banking is right for them. There is information that private cord blood banking companies, like Viacord and Cord Blood Registry, will not tell you, until now.
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.
They aren’t the only ones questioning the business practices of private cord-blood banks. Both the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) issued statements in the late 1990s opposing the use of for-profit banks — and criticizing their marketing tactics. Instead, they recommended that parents donate cord blood to public banks, which make it available for free to anyone who needs it. Globally, other organizations have done the same. Italy and France have banned private cord-blood banking altogether.
CBR was the first family bank accredited by AABB (formerly the American Association of Blood Banks) and the company’s quality standards have been recognized through ISO 9001:2008 certification—the global business standard for quality. The Federal Drug Administration (FDA) has issued cord blood regulations, and the states of California, Illinois, Maryland, New York and New Jersey have mandatory licensing for cord blood banking. The stringent laboratory processes, record keeping, quality control and quality assurance of CBR are designed to meet all federal and state guidelines and regulations.
In addition to the benefits related to transplanting HSCs derived from cord blood, HSCs are relatively easy to isolate, giving them an advantage over other adult stem cell types. Cord blood HSCs are also believed to have greater plasticity than HSCs found in bone marrow or the blood stream. The limits and possibilities of using HSCs to repair tissues and treat non-blood related disorders are currently being studied.
Part of the reason for the dominance of these three companies in terms of the total number of units stored is that they are three of the oldest cord blood banks within the U.S., founded in 1992, 1993, and 1989, respectively. All three of these cord blood banks also support cord blood research and clinical trials.
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.
ViaCord’s Lab is FDA registered, AABB accredited, CLIA certified and equipped with the same freezers used by major research institutions such as Centers for Disease Control and Prevention and the National Institutes of Health.
In terms of performance, our PrepaCyte-CB processing method has taken the lead. PrepaCyte-CB greatly improves on parents’ returns on investment because it yields the highest number of stem cells while showing the greatest reduction in red blood cells.1–4 Clinical transplant data show that cord blood processed with PrepaCyte-CB engrafts more quickly than other processing methods.7 This means patients may start feeling better more quickly, may spend less time in the hospital and are less likely to suffer from an infection. The ability to get better more quickly and a reduced chance of infection can prove vital in certain cases. Learn more about PrepaCyte®-CB here.
But considering the average cost of a new car or top-of-the-line stroller these days, many expectant parents feel it’s not an unreasonable price to pay to give their child the best chance in life. “Ultimately, my conscience wouldn’t let me not do it,” says Merilee Kern, of San Diego. “We could afford it, and the blood could someday save my daughter.”
The baby’s cord blood will be processed and stored in a laboratory facility, often referred to as a blood bank. The cord blood should be processed and stored in a facility that is accredited by the American Association of Blood Banks (AABB) for the purpose of handling stem cells.
Private storage of one’s own cord blood is unlawful in Italy and France, and it is also discouraged in some other European countries. The American Medical Association states “Private banking should be considered in the unusual circumstance when there exists a family predisposition to a condition in which umbilical cord stem cells are therapeutically indicated. However, because of its cost, limited likelihood of use, and inaccessibility to others, private banking should not be recommended to low-risk families.” The American Society for Blood and Marrow Transplantation and the American Congress of Obstetricians and Gynecologists also encourage public cord banking and discourage private cord blood banking. Nearly all cord blood transplantations come from public banks, rather than private banks, partly because most treatable conditions can’t use a person’s own cord blood. The World Marrow Donor Association and European Group on Ethics in Science and New Technologies states “The possibility of using one’s own cord blood stem cells for regenerative medicine is currently purely hypothetical….It is therefore highly hypothetical that cord blood cells kept for autologous use will be of any value in the future” and “the 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.”
There are a number of different processing methods out there for a cord blood bank to use, and the processing method can ultimately affect the purity of the final product, which we’ll explain in a minute. Once the stem and immune system cells have been isolated and extracted from the plasma and red blood cell, they are mixed with a cryo-protectant and stored in a cryo-bag. We overwrap our bags for added protection and use a technique called “controlled-rate freezing” to prepare the cells for long-term storage. The overwrapped cryo-bag is housed in a protective metal cassette and placed in vapor-phase liquid nitrogen freezer for long-term preservation.
Companies throughout Europe also offer commercial (private) banking of umbilical cord blood. A baby’s cord blood is stored in case they or a family member develop a condition that could be treated by a cord blood transplant. Typically, companies charge an upfront collection fee plus an annual storage fee.
For example, in the UK the NHS Cord Blood Bank has been collecting and banking altruistically donated umbilical cord blood since 1996. The cord blood in public banks like this is stored indefinitely for possible transplant, and is available for any patient that needs this special tissue type. There is no charge to the donor but the blood is not stored specifically for that person or their family.
As noted earlier, with better matching, there is a greater chance of success and less risk of graft-versus-host disease (GvHD) in any stem cell transplant. With cord blood, the baby’s own cells are always a perfect match and share little risk. When using cord blood across identical twins, there is also a very low chance of GvHD although mutations and biological changes caused by epigenetic factors can occur. Other blood-related family members have a 35%–45% chance of GvHD, and unrelated persons have a 60%–80% chance of suffering from GvHD.
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.
Public cord blood banks offer free cord blood banking to anyone who meets their donation requirements. They are usually supported by federal or private funding, which is why they can perform these collections at no cost to the family. The pros and cons of public cord blood banking are listed below.
A major limitation of cord blood transplantation is that the blood obtained from a single umbilical cord does not contain as many haematopoeitic stem cells as a bone marrow donation. Scientists believe this is the main reason that treating adult patients with cord blood is so difficult: adults are larger and need more HSCs than children. A transplant containing too few HSCs may fail or could lead to slow formation of new blood in the body in the early days after transplantation. This serious complication has been partially overcome by transplanting blood from two umbilical cords into larger children and adults. Results of clinical trials into double cord blood transplants (in place of bone marrow transplants) have shown the technique to be very successful. Some researchers have also tried to increase the total number of HSCs obtained from each umbilical cord by collecting additional blood from the placenta.
Banking a baby’s blood and stem cells in a cord blood bank is a type of insurance. Ideally, you would not need to access your baby’s stem cells in order to address a medical concern. However, using a cord blood bank can provide peace of mind in knowing that you have a valuable resource if you need it.
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.
Umbilical cord blood was once discarded as waste material but is now known to be a useful source of blood stem cells. Cord blood has been used to treat children with certain blood diseases since 1989 and research on using it to treat adults is making progress. So what are the current challenges for cord blood research and how may it be used – now and in the future?