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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.
Ozkaynak MF, Sandoval C, Levendoglu-Tugal O, Jayabose S. A pilot trial of tandem autologous peripheral blood progenitor cell transplantation following high-dose thiotepa and carboplatin in children with poor-risk central nervous system tumors. Pediatr Hematol Oncol.2004;21 :635– 645
Options for Umbilical Cord Blood Banking and Donation—As expectant parents, learn how umbilical cord blood can help others through public donation, family (private) cord blood banking, or directed donation for a biological sibling.
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.
Lamaze International (2010) does not have a policy specific to umbilical cord blood banking; however, the organization has a specific policy that prohibits advertising of private cord blood banks in any Lamaze media vehicle. This policy was most recently updated and revised in July 2010. In addition, in their book, The Official Lamaze Guide: Giving Birth With Confidence, Lothian and DeVries (2010) reinforce the AAP’s position that expectant families are vulnerable to the marketing strategies of private cord blood banks. The authors go on to say that expectant parents should know that banking umbilical cord blood does not guarantee a cure. Likewise, there is no guarantee that a private umbilical cord blood bank will be able to adequately preserve the cord blood until a time when it is needed. One potential reason for being unable to preserve the cord blood is that the private cord blood bank could go out of business.
An accredited lab. In the United States, the FDA requires all public banks to have a Biologics License Application, but not private banks, though they are registered and inspected. Both public and private banks should have extra accreditation, which means banks are evaluated for the quality and accuracy of work. The two companies that handle accreditation are the American Association of Blood Banks (AABB) and the Foundation for the Accreditation of Cellular Therapy (FACT). Look for a bank with its own lab (some banks use labs at other banks), which means more regular quality control and testing standards.
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Since the first unrelated cord blood–banking program was started at the New York Blood Center in 1991,40 a number of public cord blood–banking programs have been established throughout the world to collect, type, screen for infection, and cryogenically store cord blood for potential transplantation to unrelated and related recipients.41–49 Some of these programs had been funded by the National Heart, Lung, and Blood Institute (National Institutes of Health), the National Marrow Donor Program, the American Red Cross, or academic programs based in not-for-profit organizations. One cord blood program initiated by the National Institutes of Health exists solely for sibling donor collection for families who are likely to consider cord blood transplantation because a first-degree relative has been diagnosed with a disease that is treatable with allogeneic transplantation. In this bank, families own the cord blood, and it is shipped to a designated transplant center in the event a medical decision to proceed with cord blood transplantation is made.50
Stem cells in the umbilical cord blood were first discovered in 1978. The stem cells found in cord blood give rise to all the other blood cells and are the foundation of our bodies’ immune system. More recently, scientists discovered a rich supply of a different type of stem cell in the cord tissue. These stem cells give rise to the tissues that comprise our nervous system, sensory organs, circulatory tissues, skin, bone, cartilage and more.
The American Academy of Pediatrics (AAP, 2007) states that the use of banked umbilical cord blood as “biologic insurance” is unwarranted. The AAP also notes that many of the claims of private cord blood banks are unfounded. Unlike ACOG, the AAP recommends cord blood collection and banking for all families; however, their distinction is that all cord blood should be banked in public banks for use by the general population. In one study, the researchers reported that when pediatric transplant specialists were surveyed, overall, they did not recommend private cord blood banking (Thornley et al., 2009). The AAP recommends private cord blood banking only if a full sibling has a medical diagnosis for which stem cells are currently being used for treatment.
Donating your baby’s cord blood to a public bank is always free. The limitations of the public banking network in the United States are: they only collect donations at large birthing hospitals in ethnically diverse communities, the mother must pass a health screening, they prefer registration by 34 weeks of pregnancy, and they only save the largest cord blood collections. The potential reward of public donation is that your baby could Be The Match to save a life!
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.
Priority shipping: Cord blood companies that use priority shipping services have families ship them cord blood in a heavily insulated box, which arrives at the cord bank at a certain time, but does not guarantee that the blood remains at a certain temperature.
Four main types of physical conditions are treated with stem cell transplants: cancers, blood disorders, congenital metabolic disorders, and immunodeficiencies (see Table 1). Examples of cancers that are treated with stem cells are both lymphoma and leukemia. Nonmalignant hemologic disorders also account for a fair share of the recipients of stem cells. Examples of these blood disorders are various types of anemias, such as sickle-cell anemia and Fanconi’s anemia (the first disorder treated with umbilical cord blood stem cells). Stem cells have also been used to treat various metabolic disorders, such as adrenoleukodystrophy. The fourth major category of uses for stem cells is in treating immunodeficiencies, such as Duncan’s disease or adenosine deaminase deficiency (Drew, 2005; Moise, 2005).
Cord Blood Registry is a cord blood storage company that collects, processes and stores stem cells to help families with medical needs later in life. Founded in 1992, it is the world’s largest newborn stem cell company.
Fox N. S., Stevens C., Cuibotariu R., Rubinstein P., McCullough L. B., & Chervenak F. A. (2007). Umbilical cord blood collection: Do patients really understand? Journal of Perinatal Medicine, 35, 314–321 [PubMed]
Harvesting and banking cord blood is a fairly simple procedure that can be performed during vaginal or cesarian deliveries without interrupting the birth process. The doctor or nurse will collect the cord blood after the umbilical cord has been clamped. The collection of cord blood is not painful, intrusive or risky to the mother or baby.
A well-established history. Public banks are affiliated with nonprofit research institutions or hospitals, so they have a better chance of being managed more soundly. For families without a history of diseases treated by cord blood, such as leukemia and sickle cell anemia, the American Academy of Pediatrics (AAP) recommends that cord blood be donated to public banks. Although the 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. Private cord blood banks are affiliated with business corporations, so, like any business, they may go under, says William T. Shearer, M.D., Ph.D., professor of Pediatrics and Immunology at Baylor College of Medicine in Houston.
The blood within your newborn baby’s umbilical cord contains young stem cells that can renew themselves and become specialized. These cord blood stem cells have been proven in treatment to help children replace damaged blood cells with healthy ones and strengthen their immune systems. Cord blood banking is the process of collecting and storing these stem cells for potential medical use.
For much of pregnancy, the umbilical cord is the lifeline of a fetus, tethering it to the placenta. Snaking through the nearly 2-feet-long cord, there’s a vein ferrying nutrients and oxygen from mom’s blood (via the placenta), plus two arteries carrying oxygen- and nutrient-depleted blood from the fetus back to mom. Because mother’s blood and fetal blood don’t actually mix much, the blood in the placenta and umbilical cord at birth belongs mainly to the fetus.
Check if the cord blood bank you’re considering is accredited with the American Association of Blood Banks (AABB). AABB is an international, not-for-profit organization that has been setting standards for both public and private cord blood banking companies for over 20 years. LifebankUSA is registered with the FDA and accredited by AABB. Click here for a list of AABB-accredited cord blood banking companies in the U.S. and around the world.
Prior to transplanting any type of tissue, a “matching” process must occur to increase the success of the transplant and decrease the likelihood that the transplant will be rejected. The rejection of a transplanted tissue is called “graft versus host disease.” The matching process dates back to the late 1950s when the human leukocyte antigens were discovered. There are two classes of human leukocyte antigens. The first class is located on the surface of almost all of the cells with a nucleus within the body of the cell. The second class of human leukocyte antigens is located on the surface of immune cells. Each of the two classes of antigens has three subgroups, creating six antigens for which matching can occur. Thus, a “6 of 6” matching of the antigens represents a “perfect” match. Beyond the matching process, other factors contribute to the success or failure of a stem cell transplant. These factors include, but are not limited to, the age of both the donor and the patient, the type of disease being treated, and the number of stem cells being transplanted (Moise, 2005).
Many public banking proponents believe that the greater good to society is to donate your baby’s cord blood stem cells to a public bank for use by someone who may need it, since the likelihood of your baby needing it is very small.
A number of private for-profit companies have been established that encourage parents to bank their children’s cord blood for their own autologous use or for directed donor allogeneic use for a family member should the need arise. Parents have been encouraged to bank their infants’ cord blood as a form of “biological insurance.” Physicians, employees, and/or consultants of such companies may have potential conflicts of interest in recruiting patients because of their own financial gain. Annual disclosure of the financial interest and potential conflicts of interest must be made to institutional review boards that are charged with the responsibility of mitigation of these disclosures and risks. Families may be vulnerable to the emotional effects of marketing for cord blood banking at the time of birth of a child and may look to their physicians for advice. No accurate estimates exist of the likelihood of children to need their own stored cord blood stem cells in the future. The range of available estimates is from 1 in 1000 to more than 1 in 200000.51 The potential for children needing their own cord blood stem cells for future autologous use is controversial presently.51 There also is no evidence of the safety or effectiveness of autologous cord blood stem cell transplantation for the treatment of malignant neoplasms.51 Indeed, there is evidence demonstrating the presence of DNA mutations in cord blood obtained from children who subsequently develop leukemia.52 Thus, an autologous cord blood transplantation might even be contraindicated in the treatment of a child who develops leukemia.
Some brochures advertising private cord blood banking show children with cerebral palsy, a neurological disorder, who were treated with their own stem cells. In the case of Cord Blood Registry, the company lists all stem cell transplants conducted at Duke University. In a list of individuals treated in their “stem cell therapy data” cerebral palsy is listed. However, transplants were part of an early research study and studies of efficacy are just now underway.
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
Americord offers parents the ability to save stem cells from the umbilical cord and placenta after giving birth. This blood banking service uses new technology to ensure that children can receive treatment for genetic diseases. Find out more
Tracey said she felt lucky since she banked Anthony’s cord blood with a private company. And Osteopetrosis is one of 80 diseases listed by many cord blood companies in their marketing material as treatable with stem cells.
After harvesting, the umbilical cord blood is taken to a cord blood bank where it will be tested to make sure that it is clear of disease and other contaminants. Before being frozen, a cryopreservant is added to the cord blood so that the stem cells are able to be frozen without damaging them, after which they are stored in a liquid nitrogen Cord Blood storage tank at –196 Celsius.
Depending on the predetermined period of storage, the initial fee can range from $900 to $2100. Annual storage fees after the initial storage fee are approximately $100. It is common for storage facilities to offer prepaid plans at a discount and payment plans to help make the initial storage a more attractive option for you and your family.
Finally, there is a significant lack of regulation for umbilical cord blood banking. The lack of quality control, in turn, affects the quality of the specimen available for transplant. Some cord blood banks have submitted to voluntary accreditation, but the process of accreditation varies from bank to bank, whether public or private (McGuckin & Forraz, 2008; Moise, 2005).
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The policy also points out that if cord clamping is done too soon after birth, the infant may be deprived of a placental blood transfusion, resulting in lower blood volume and increased risk for anemia later in life.