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One of the key things you’ll want the cord blood bank’s representative to explain to you is how the cord blood bank collects and stores cord blood. Collection and storage methods may differ across cord blood banking companies, and you’ll want to be sure that the cord blood bank complies with all federal standards.2
Hard numbers are tricky to pin down, but between that first transplant in 1988 and 2015, an estimated 35,000 umbilical cord blood transplants had been performed globally. That number includes people treated for leukemia and other types of cancer, blood disorders and immune diseases. And the utility of umbilical cord cells may stretch well beyond the disorders that the cells are currently being used for. “If you read the literature, it’s pretty exciting,” says pediatrician and immunologist William Shearer of Baylor College of Medicine and Texas Children’s Hospital.
The FDA regulates cord blood bank operations with strict guidelines. However, additional licenses maybe required in some states. Laboratories should also be AABB accredited. The AABB promotes the highest standards of care for both patients and donors in all aspects of blood banking, transfusion medicine, relationship testing, hematopoietic, cord blood and other cellular therapies.
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.
All cord blood banks in the US are required to register with Food and Drug Administration. To ensure safety, cord blood banks must comply with FDA regulations, including current good tissue practice regulations, donor screening and testing for infectious diseases, including HIV I & II (the virus that causes AIDS), Hepatitis B & C, which can cause liver disease, Cytomegalovirus (CMV) a virus that can lead to pneumonia, Human T-cell Lymphotropic Virus (HTLV) 1 & 2, which can suppress the immune system, West Nile Virus, Zika Virus, Treponema pallidum (the bacterium that can cause syphilis) and Variant Creutzfeldt-Jakob Disease (vCJD), a rare virus that can cause brain disease. Since 2011, the FDA has required public cord blood banks to obtain a license under a Biologics License Application.
As a trusted resource for families, CBR offers Genetic Counselors on staff to help families make informed choices about newborn stem cell banking. Our team of certified professionals are available to:
In recent years, umbilical cord blood has been used successfully to treat a variety of pediatric genetic, hematologic and oncologic disorders. This advance has resulted in both not-for-profit and for-profit cord blood banking programs. The AAP’s statement is intended to help guide physicians in answering parents’ questions about cord blood banking.
The primary benefit to cord blood banking is that it provides a type of medical insurance. This insurance is not from a financial perspective, but rather takes the form of having the necessary medical building blocks available should they be needed in the event of certain illnesses and diseases. Those medical building blocks are the stem cells found in umbilical cord blood.
Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, Miller JS, Wagner JE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood.2003;102 :1915– 1919
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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.
The next step at either a public or family bank is to process the cord blood to separate the blood component holding stem cells. The final product has a volume of 25 milliliters and includes a cryoprotectant which prevents the cells from bursting when frozen. Typical cost, $250 to $300 per unit.
CorCell has almost 20 years of experience banking cord blood, cord tissue and DNA. The company is one of the first licensed private cord blood programs in the United States and has its own AABB-accredited laboratory.
Research on stem cell transplants began in the 1950s, with successful bone marrow transplants occurring in the 1970s, often to treat cancer patients whose own bone marrow was destroyed by chemotherapy and radiation. The first successful umbilical cord blood stem cell transplant was reported as occurring in the late 1980s. The recipient was a 6-year-old American boy from North Carolina who was treated for Fanconi’s anemia (a genetic disorder) at Hospital St. Louis in Paris, France, using cord blood obtained from his younger sister’s birth. Interestingly, more than 20 years after the transplant, this young man is alive and well. Not only did he survive long term, but both his immune system and his blood were transformed by the transplant of his sister’s cord blood stem cells. Soon after this first documented cord blood stem cell transplant, the first public umbilical cord blood bank was established in 1991 in New York (McGuckin & Forraz, 2008).
Cord blood transplantation has been shown to be curative in patients with a variety of serious diseases. Physicians should be familiar with the rationale for cord blood banking and with the types of cord blood–banking programs available. Physicians consulted by prospective parents about cord blood banking can provide the following information:
Cord tissue is rich in another type of stem cell. Although there are no current uses, researchers are excited about the benefits cord tissue stem cells may offer in potential future users, such as regenerative medicine. By storing both, you’ll have potential access to more possibilities
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.
To begin a discussion of umbilical cord blood banking, it must first be understood that the component from the blood that is salvaged is the stem cells. Stem cells are unspecialized cells that are the basis of all tissue and organ cells of the body. There are three main sources of stem cells in humans: embryonic stem cells, adult stem cells, and umbilical cord stem cells. Embryonic stem cells are generally used in research but not in clinical practice. Adult stem cells are found in various locations in the human body, but they are most commonly found in bone marrow (McGuckin & Forraz, 2008). Over the years, transplants of bone marrow stem cells have been used clinically to treat disease processes in which stem cells are beneficial. Umbilical cord blood stem cells were historically considered a waste product of the birthing process but are now known to have up to 10 times more stem cells than adult bone marrow (Gunning, 2007).
Recently, it was shown that umbilical cord blood contains a sufficient number of hematopoietic stem cells to be used for transplantation. More than 5500 unrelated-donor cord blood stem cell transplants for a variety of pediatric genetic,22,24–31 hematologic,22,24,25,29,32 immunologic,28 metabolic,26,27,30 and oncologic19,20,33–36 disorders have been performed to date (Table 1). The 1-year survival may be as high as 75% to 90% after sibling HLA-matched cord blood donor stem cell transplantation21,24,29 and 40% to 80% after unrelated cord blood stem cell transplantation.19,20,26,27,33,35,36 Advantages of the use of cord blood include the fact that it is readily available, carries less risk of transmission of blood-borne infectious diseases, and is transplantable across HLA barriers with diminished risk of graft-versus-host disease compared with similarly mismatched stem cells from the peripheral blood or bone marrow of related or unrelated donors.21,34,35,37 Autologous stem cells38,39 have been used for gene therapy in infants with severe combined immunodeficiency, but the appearance of T-lymphocyte leukemia in some patients has indicated the need for more basic research before additional clinical trials of gene therapy can be undertaken.
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.
Americord offers parents the ability to collect stem cells from the placenta and umbilical cord soon after the child’s birth. These stem cells, obtained from cord blood, cord tissue and placenta tissue, can be used to help treat genetic diseases and other threats to the baby’s life. Placenta tissue stem cells can also be used to benefit the mother.
Wagner JE, Rosenthal J, Sweetman R, et al. Successful transplantation of HLA-matched and HLA-mismatched umbilical cord blood from unrelated donors: analysis of engraftment and acute graft-versus-host disease. Blood.1996;88 :795– 802
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.
Regulatory agencies (eg, FDA, Federal Trade Commission, and state equivalents of these federal agencies) are encouraged to have an active role in providing oversight of the cord blood program. All cord blood–banking programs should comply with FACT or equivalent accreditation standards.
Professionals affiliated with institutions or organizations that promote for-profit placental blood stem cell banking should make annual financial-disclosure and potential-conflicts-of-interest statements to an appropriate institutional review committee that possesses oversight authority.
6. Lou Gehrig’s disease. There’s hope that stem cells could help those with Lou Gehrig’s disease, also known as amyotrophic lateral sclerosis, or ALS. The crippling disease comes with a grim prognosis: Many die within three to five years of diagnosis, as their bodies progressively damage muscle-controlling motor neurons in the brain and spinal cord. Scientists are exploring ways to coax stem cells into becoming motor neurons that could be transplanted into ALS patients, restoring their ability to move.