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.
With the consent of the parents, blood can be collected from the umbilical cord of a newborn baby shortly after birth. This does not hurt the baby or the mother in any way, and it is blood that would otherwise be discarded as biological waste along with the placenta (another rich source of stem cells) after the birth.
Cord Blood Registry is headquartered in South San Francisco, California. CBR owns their 80,000 square foot laboratory located in Tucson, Arizona. CBR’s laboratory processes cord blood collections seven days a week, 365 days a year. The state-of-the-art facility has the capacity to store the stem cell samples of five million newborns.
Blood from the umbilical cord and placenta is put into a sterile bag. (The blood is put into the bag either before or after the placenta is delivered, depending upon the procedure of the cord blood bank.)
When an immediate family member has a disease that requires a stem cell transplant, cord blood from a newborn baby in the family may be the best option. There is a 25% chance, for example, that cord blood will be a perfect match for a sibling, because each child shares one of its two HLA genes with each parent. Occasionally cord blood will be a good match for a parent if, by chance, both parents share some of the six HLA antigens. The baby’s cord blood is less likely to be a good match for more distant relatives. The inventories of unrelated cord blood units in public cord blood banks are more likely to provide appropriate matches for parents and distant relatives, as well as for siblings that do not match.
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 cord blood of your baby is an abundant source of stem cells that are genetically related to your baby and your family. Stem cells are dominant cells in the way they contribute to the development of all tissues, organs, and systems in the body.
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.
Your free donation will be part of a program that is saving lives and supporting research to discover new uses for cord blood stem cells. Units that meet criteria for storage are made available to anyone, anywhere in the world, who needs a stem cell transplant.
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.
Cord blood is currently approved by the FDA for the treatment for nearly 80 diseases, and cord blood treatments have been performed more than 35,000 times around the globe to treat cancers (including lymphoma and leukemia), anemias, inherited metabolic disorders and some solid tumors and orthopedic repair. Researchers are also exploring how cord blood has the ability to cross the blood–brain barrier and differentiate into neurons and other brain cells, which may be instrumental in treating conditions that have been untreatable up to this point. The most exciting of these are autism, cerebral palsy and Alzheimer’s.
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.
In Europe and other parts of the world, cord blood banking is more often referred to as stem cell banking. As banking cord blood is designed more to collect the blood-forming stem cells and not the actual blood cells themselves, this term may be more appropriate.
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.
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 a child develops a condition that can be treated with stem cells, they undergo transplant. A doctor infuses stem cells from cord blood or bone marrow into the patient’s bloodstream, where they will turn into cells that fight the disease and repair damaged cells—essentially, they replace and rejuvenate the existing immune system.
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.
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The University of Texas Health Science Center at Houston is conducting a pioneering FDA-regulated phase I/II clinical trial to compare the safety and effectiveness of two forms of stem cell therapy in children diagnosed with cerebral palsy. The randomized, double-blinded, placebo-controlled study aims to compare the safety and efficacy of an intravenous infusion of autologous cord blood stem cells to bone marrow stem cells.
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.
Stem cells from cord blood can be used for the newborn, their siblings, and potetinally other relatives. Patients with genetic disorders like cystic fibrosis, cannot use their own cord blood and will need stem cells from a sibling’s cord blood. In the case of leukemia or other blood disorders, a child can use either their own cord blood or their sibling’s for treatment.
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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.
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.
StemCyte is a global cord blood therapeutics company. StemCyte participates in the US network of public cord blood banks operated by Be The Match. In addition, StemCyte operates the National Cord Blood Bank of Taiwan, whose units are also listed with Be The Match.
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.
No one knows how stem cells will be used in the future, but researchers hope that they may be used to treat many conditions, like Alzheimer’s, diabetes, heart failure, spinal cord damage, and other conditions.
The unpredictability of stem cell transportation led CBR to create a crush-resistant, temperature-protected, and electronically tracked collection kit that is designed to preserve the integrity and to help ensure the safe delivery of the blood and/or tissue. CBR’s CellAdvantage® Collection Kit contains everything the healthcare provider needs to easily and safely collect the maximum amount of a newborn’s cord blood following birth.
The stem cells from your baby’s cord blood may also be effective in treating certain diseases or conditions of a parent or sibling. Cord blood stem cells have similar ability to treat disease as bone marrow but with significantly less rejection.
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.
BioInformant is the first and only market research firm to specialize in the stem cell industry. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Xconomy, and Vogue Magazine. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs. BioInformant is your global leader in stem cell industry data.
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.
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.
“Raising a family is expensive enough,” says Jeffrey Ecker, MD, director of obstetrical clinical research at Massachusetts General Hospital, in Boston, and a member of ACOG’s ethics committee. “There’s no reason for parents to take on this additional financial burden when there’s little chance of a child ever using his own cord blood.”
2 Cordblood.com, (2014). Cord Blood Stem Cell Banking | Cord Blood Registry | CBR. [online] Available at: http://www.cordblood.com/cord-blood-banking-cost/cord-blood-stem-cells [Accessed 22 March. 2017].
There are several cord blood banks that are accredited by the American Association of Blood Banks. Most offer information on cord blood banking and provide private cord blood banking services. With a little research, you should be able to locate a credible cord blood bank online.
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.
You certainly should, especially if you have a family history of any diseases or conditions that could be treated with cord blood stem cells. Since there is only a 25% chance of a match, you should bank the cord blood of each individual child if you have the means.
If you feel that the procedure is too expensive for your child, check with the hospital to see if there are any programs and/or grants available that can assist with the procedure. Some companies do offer financial aid.