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.
Graft-versus-host disease (GVHD) is a common complication after an allogeneic transplant (from a source other than the patient) where the patient’s immune system recognizes the cells as “foreign” and attacks the newly transplanted cells. This can be a potentially life threatening complication. The risk for developing GVHD is lower with cord blood transplants than with marrow or peripheral blood transplants. Patients who do develop GVHD after a cord blood transplant typically do not develop as severe of a case of GVHD. Cord blood also is less likely to transmit certain viruses such as cytomegalovirus (CMV), which poses serious risks for transplant patients with compromised immune systems.
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.
At present, the odds of undergoing any stem cell transplant by age 70 stands at one in 217, but with the continued advancement of cord blood and related stem and immune cell research, the likelihood of utilizing the preserved cord blood for disease treatment will continue to grow. Read more about cord blood as a regenerative medicine here.
Generally speaking, public cord blood banks collect, process and store your donated cord blood for free. The cord blood you donate to a public bank may be used for transplants or for research purposes, so you may not be able to access your own cord blood. View a list of public cord blood banks in North America.
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.
Umbilical cord blood is the blood left over in the placenta and in the umbilical cord after the birth of the baby. The cord blood is composed of all the elements found in whole blood. It contains red blood cells, white blood cells, plasma, platelets and is also rich in hematopoietic stem cells. There are several methods for collecting cord blood. The method most commonly used in clinical practice is the “closed technique”, which is similar to standard blood collection techniques. With this method, the technician cannulates the vein of the severed umbilical cord using a needle that is connected to a blood bag, and cord blood flows through the needle into the bag. On average, the closed technique enables collection of about 75 ml of cord blood.
The evolution of stem cell therapies has paved the way for further research being conducted through FDA-regulated clinical trials to uncover their potential in regenerative medicine applications. Cord Blood Registry is the first family newborn stem cell company to partner with leading research institutions to establish FDA-regulated clinical trials exploring the potential regenerative ability of cord blood stem cells to help treat conditions that have no cure today, including: acquired hearing loss, autism, cerebral palsy, and pediatric stroke. In fact, 73% of the stem cell units released by CBR have been used for experimental regenerative therapies – more than any other family cord blood bank in the world.
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.
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.
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.
^ 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.
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The Doneses were shocked, however, when doctors told them that Anthony’s cord blood couldn’t be used because the cells contained the same genetic defect that caused his condition. “The materials provided by the bank said this was Anthony’s life insurance and could save him if he needed it. They never mentioned that the cells could be diseased. We felt duped,” Tracey says. The Long Island, New York, couple has since filed a lawsuit against the bank alleging false advertising and consumer fraud.
Cord blood has an abundance of stem cells and immune system cells, and the medical uses of these cells has been expanding at a rapid pace. As these cells help the body re-generate tissues and systems, cord blood is often referred to as a regenerative medicine.
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.
One oft cited argument against cord blood banking is that it is not known how long these cells can remain viable in storage. While it is not known if cells taken from an individual as an infant will be beneficial to them as an adult, units stored for up to 10 years have been transplanted successfully. This indicates that there is no reason to suggest serious deterioration in the quality of cord blood units stored for longer periods of time.
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.
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.
Private cord blood banks allow families to store cord blood stem cells for themselves and their loved ones. They are privately funded, and typically charge a first-year processing fee that ranges from about $1,400 to $2,300, plus annual storage costs of about $115 to $175. (Americord offers cord blood banking for a one-time fee of $3,499, which includes 20 years of storage). The pros and cons of private cord blood banking are listed below.
In fact, the shocking truth is that the majority of all cord blood stored in private banks may be unusable. Approximately 75 percent of the units donated to public banks are discarded or used in research because they don’t contain enough stem cells for transplants, says Mary Halet, manager of cord-blood operations for the Center for Cord Blood at the National Marrow Donor Program, a Minneapolis-based nonprofit organization that maintains the nation’s largest public supply of cord blood. Yet private banks store every unit they collect, which means that you might pay to store blood that won’t be usable if you need it years later.
There are around 20 companies in the United States offering public cord blood banking and 34 companies offering private (or family) cord blood banking. Public cord blood banking is completely free (collecting, testing, processing, and storing), but private cord blood banking costs between $1,400 and $2,300 for collecting, testing, and registering, plus between $95 and $125 per year for storing. Both public and private cord blood banks require moms to be tested for various infections (like hepatitis and HIV).
The cord blood collection process is simple, safe, and painless. The process usually takes no longer than five minutes. Cord blood collection does not interfere with delivery and is possible with both vaginal and cesarean deliveries.
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.
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.
Lack of awareness is the #1 reason why cord blood is most often thrown away. For most pregnant mothers, their doctor does not even mention the topic. If a parent wants to save cord blood, they must be pro-active.
However, cord blood transplants also have limitations. Treatment of adults with cord blood typically requires two units of cord blood to treat one adult. Clinical trials using “double cord blood transplantation” for adults have demonstrated outcomes similar to use of other sources of HSCs, such as bone marrow or mobilized peripheral blood. Current studies are being done to expand a single cord blood unit for use in adults. Cord blood can also only be used to treat blood diseases. No therapies for non-blood-related diseases have yet been developed using HSCs from either cord blood or adult bone marrow.
^ Roura S, Pujal JM, Gálvez-Montón C, Bayes-Genis A (2015). “Impact of umbilical cord blood-derived mesenchymal stem cells on cardiovascular research”. BioMed Research International. 2015: 975302. doi:10.1155/2015/975302. PMC 4377460 . PMID 25861654.
Along with cord blood, Wharton’s jelly and the cord lining have been explored as sources for mesenchymal stem cells (MSC), and as of 2015 had been studied in vitro, in animal models, and in early stage clinical trials for cardiovascular diseases, as well as neurological deficits, liver diseases, immune system diseases, diabetes, lung injury, kidney injury, and leukemia.
Cord Blood Registry’s Newborn Possibilities Program® serves as a catalyst to advance newborn stem cell medicine and science for families that have been identified with a medical need to potentially use newborn stem cells now or in the near future. NPP offers free cord blood and cord tissue processing and five years of storage to qualifying families. To date, the Newborn Possibilities Program has processed and saved stem cells for nearly 6,000 families.
CORD:USE is directed by leading doctors in cord blood transplantation. Public donations collected by CORD:USE are sent to the Carolinas Cord Blood Bank, a FACT-accredited laboratory under the direction of Dr. Joanne Kurtzberg.
Your baby’s cord blood could be a valuable resource for another family. From foundations to non-profit blood banks and medical facilities, there are numerous locations that will collect, process, and use the stem cells from your baby’s cord blood to treat other people.
Phone 1-888-932-6568 to connect with a CBR Cord Blood Education Specialist or submit an online request. International callers should phone 650-635-1420 to connect with a CBR Cord Blood Education Specialist.
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.
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.”
Because the body’s immune system is designed to find and get rid of what it believes to be outside contaminants, stem cells and other cells of the immune system cannot be transfused into just anyone. For stem cell transfusions of any type, the body’s immune system can mistakenly start attacking the patient’s own body. This is known as graft-versus-host disease (GvHD) and is a big problem post-transplant. GvHD can be isolated and minimal, but it can also be acute, chronic and even deadly.
For these and other reasons, the American Academy of Pediatrics (AAP) and many physicians do not recommend private cord blood banking except as “directed donations” in cases where a family member already has a current need or a very high potential risk of needing a bone marrow transplant. In all other cases, the AAP has declared the use of cord blood as “biological insurance” to be “unwise.” [Read the AAP’s news release at http://www.aap.org/advocacy/archives/julcord.htm ]
Currently, ViaCord has released the most cord blood units for medical transplant and has the highest cord blood transplant survival rate among companies who have disclosed complete transplant data. The one-year survival rate of patients who were treated with ViaCord cord blood units is 88%, and the long-term patient survival rate is 82%.1