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 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.
The mother signs an informed consent which gives a “public” cord blood bank permission to collect the cord blood after birth and to list it on a database that can be searched by doctors on behalf of patients. The cord blood is listed purely by its genetic type, with no information about the identity of the donor. In the United States, Be The Match maintains a national network of public cord blood banks and registered cord blood donations. However, all the donation registries around the world cooperate with each other, so that a patient who one day benefits from your child’s cord blood may come from anywhere. It is truly a gift to the benefit of humankind.
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.
While donating cord blood is honorable, there is a lot people do not know about the public option. Most public cord blood banks have a limited number of collection sites, and they only retain a small number of collections because of volume and other criteria that must be met. Once cord blood is donated, it is highly unlikely that the donation can ever be attained by the donor or his or her family if the need arises. In addition, it may be hard to find another viable match from what is publically available. While donating is free, retreiving a cord blood sample from a public cord blood bank is not and pales in comparison to the overall cost of privately banking cord blood. These are just some of the reasons why privately banking cord blood may be a better option for some families.
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.
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.
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.
Though uses of cord blood beyond blood and immunological disorders is speculative, some research has been done in other areas. Any such potential beyond blood and immunological uses is limited by the fact that cord cells are hematopoietic stem cells (which can differentiate only into blood cells), and not pluripotent stem cells (such as embryonic stem cells, which can differentiate into any type of tissue). Cord blood has been studied as a treatment for diabetes. However, apart from blood disorders, the use of cord blood for other diseases is not in routine clinical use and remains a major challenge for the stem cell community.
It’s possible that storing your child’s cord blood cells now may be useful one day in combating these diseases. For now, these treatments are only theoretical. It’s also not clear if stem cells from cord blood — as opposed to stem cells from other sources — will be useful in these potential treatments.
Another type of cell that can also be collected from umbilical cord blood are mesenchymal stromal cells. These cells can grown into bone, cartilage and other types of tissues and are being used in many research studies to see if patients could benefit from these cells too.
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.”
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.
Fortunately, those odds should improve soon. In 2005, Congress passed the Stem Cell Therapeutic and Research Act, which provides $79 million in federal funding to create a centralized cord-blood registry much like the one that exists for bone marrow. The goal is to expand the existing inventory of 45,000 donated cord-blood units to 150,000.
The use of cord blood is determined by the treating physician and is influenced by many factors, including the patient’s medical condition, the characteristics of the sample, and whether the cord blood should come from the patient or an appropriately matched donor. Cord blood has established uses in transplant medicine; however, its use in regenerative medicine is still being researched. There is no guarantee that treatments being studied in the laboratory, clinical trials, or other experimental treatments will be available in the future.
Cord blood in public banks is available to unrelated patients who need haematopoietic stem cell transplants. Some banks, such as the NHS bank in the UK, also collect and store umbilical cord blood from children born into families affected by or at risk of a disease for which haematopoietic stem cell transplants may be necessary – either for the child, a sibling or a family member. It is also possible to pay to store cord blood in a private bank for use by your own family only.
Cord blood stem cells are classified as adult (or non-embryonic) stem cells. Embryonic stem cells (ESC) are believed to be more advantageous for the treatment of disease or injury due to their pluripotent nature; that is, they have the ability to differentiate into all the cells present in the human body derived from the three germ layers (endoderm, mesoderm, and ectoderm). Adult stem cells are multipotent, implying that they can only differentiate into a limited number of cells typically within the same “family” (e.g., hematopoietic stem cells give rise to red blood cells, white blood cells, and platelets).
The Cord Blood Bank of Arkansas launched operations in 2011, providing both public donation and family banking services. They accept donations from ANY HOSPITAL IN THE STATE OF ARKANSAS. They also accept donations from bordering states so long as the donor is an Arkansas resident.
While the transplantation of cord blood has its advantages, its main disadvantage is the limited amount of blood contained within a single umbilical cord. Because of this, cord blood is most often transplanted in children. Physicians are currently trying to determine ways that cord blood can be used in larger patients, such as transferring two cord blood units or increasing the number of cells in vitro before transplanting to the patient. It also takes longer for cord blood cells to engraft. This lengthier period means that the patient is at a higher risk for infection until the transplanted cells engraft. Patients also cannot get additional donations from the same donor if the cells do not engraft or if the patient relapses. If this is the case, an additional cord blood unit or an adult donor may be used. While cord blood is screened for a variety of common genetic diseases, rare genetic diseases that manifest after birth may be passed on. The National Cord Blood Program estimates that the risk of transmitting a rare genetic disorder is approximately 1 in 10,000.
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.
Florida Hospital for Children is conducting an FDA-regulated phase I clinical trial to investigate the use of a child’s stem cells derived from their own cord blood as a treatment for acquired sensorineural hearing loss.
Lead image of baby’s umbilical cord from Wikimedia Commons. Possible human blood stem cell image by Rajeev Gupta and George Chennell. Remaining images of blood sample bags and red blood cells from Wellcome Images.
Even if a sick child has a sibling donor, there’s only a 25 percent chance that cord blood will be a perfect match — and an equal chance it won’t match at all. That’s why public donations are so important. So far, many more stem-cell transplants have been done using cord blood stored in public banks. From 2000 to 2004, more than 2,200 unrelated transplants were done nationwide.
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.
There is a high likelihood that immediate biological family members could benefit from the baby’s cord tissue stem cells, with parents having a 100% likelihood of being compatible, siblings having a 75% likelihood of being compatible, and grandparents having a 25% likelihood of being compatible.16,50 Another reason why parents today are choosing to bank their baby’s cord tissue for the future.
Use for Donor Clients can rest assured knowing their cord blood is available if needed. Always available if needed. Donors may never find the stem cells donated if ever needed because of the following:
Complications Side Effects As the donor’s stem cells will always be a perfect match, there will be no incidence of graft versus host disease (GVHD), which can be a chronic and even fatal condition. Graft versus host disease (GVHD) is estimated to occur in 60–80 percent of transplants where the donor and recipient are not related. Perfect match! No incidence of graft versus host disease Graft versus host disease (GVHD) occurs in 60%–80% of non-related transplants.
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There are some hospitals that have dedicated collections staff who can process mothers at the last minute when they arrive to deliver the baby. However, in the United States that is the exception to the rule.
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.
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.”
People who are in need of a transplant are more likely to find a match from a donor of the same ethnic descent. There are fewer racial minorities in the national registries, so finding a match can be more difficult.5
Banking of stem cells from cord blood began in 1994 with the foundation of the New York Blood Centre Cord Blood Bank. The field of umbilical cord blood storage has matured considerably over the last two decades. We continue to learn more about the long-term effects of cryo-preservation on the cells, which has resulted in increased storage times.
Cord blood holds promise for future medical procedures. Scientists are still studying more ways to treat more diseases with cord blood. At Duke University, for example, researchers are using patients’ own cord blood in trials for cerebral palsy and Hypoxic ischemic encephalopathy (a condition in which the brain does not receive enough oxygen). Trials are also under way for the treatment of autism at the Sutter Neuroscience Institute in Sacramento, California.
After your baby is born, the umbilical cord and placenta are usually thrown away. Because you are choosing to donate, the blood left in the umbilical cord and placenta will be collected and tested. Cord blood that meets standards for transplant will be stored at the public cord blood bank until needed by a patient. (It is not saved for your family.)
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.
Stem cells are amazingly powerful. They have the ability to divide and renew themselves and are capable turning into specific types of specialized cells – like blood or nerve. After all, these are the cells responsible for the development of your baby’s organs, tissue and immune system
When considering cord blood, cord tissue, and placenta tissue banking, you want all of the facts. Americord’s® Cord Blood Comparison Chart gives you information not only on our costs and services, but also on how other companies measure up.
Stem cells are able to transform into other types of cells in the body to create new growth and development. They are also the building blocks of the immune system. The transformation of these cells provides doctors with a way to treat leukemia and some inherited health disorders.
Editor’s Note: This article originally appeared in the Volume 16, Number 1, Spring 2009 issue of Dignitas, the Center’s quarterly publication. Subscriptions to Dignitas are available to CBHD Members. To learn more about the benefits of becoming a member click here.
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.