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Bielorai B, Trakhtenbrot L, Amariglio N, et al. Multilineage hematopoietic engraftment after allogeneic peripheral blood stem cell transplantation without conditioning in SCID patients. Bone Marrow Transplant.2004;34 :317– 320
Families that are predisposed to certain diseases, that are ethnically mixed, that are adopting a newborn child, or that have a family member who may need a stem cell transplant should take special care to understand the value the cells may provide and their storage options.
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.
Private cord blood banking is recommended for families with a history of certain diseases. Specifically, these are families with diseases that harm the blood and immune system, such as leukemia and certain cancers, sickle-cell anemia, and some metabolic disorders. Why? The type of stem cells in cord blood can form all kinds of blood cells that can help treat these diseases.
Cade Hildreth is the Founder of BioInformant.com, the world’s largest publisher of stem cell industry news. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, Xconomy, and Vogue Magazine.
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.
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.
CBR works with Quick International, a private courier service with 30 years of experience as the market leader in the transport of cord blood, tissue, organs, and the U.S. blood inventory. CBR offers our clients a unique “Track My Kit” system to provide progress updates as the kit containing the cord blood travels to our lab. If it gets lost or damaged while in transit with Quick International, you are covered by a $2,500 warranty.
Cord blood is extracted from a newborn’s umbilical cord immediately after birth. It contains stem cells, which can be used to treat hemotopoietic and genetic disorders, like certain blood or immune diseases.
A courier collection service. Private banks have a person pick up your donated cord blood, which helps ensure that it arrives at your chosen bank quickly and doesn’t get lost along the way, and that the temperature will remain consistent enough to be accepted at the lab. (Public banks usually send an insulated kit for you to preserve and mail the cord blood.)
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).
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.
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.
In recent years, umbilical cord blood, which contains a rich source of hematopoietic stem and progenitor cells, has been used successfully as an alternative allogeneic donor source to treat a variety of pediatric genetic, hematologic, immunologic, and oncologic disorders. Because there is diminished risk of graft-versus-host disease after transplantation of cord stem cells using matched related donors, the use of less-than-completely matched HLA cord blood stem cells may incur less risk of graft-versus-host disease than mismatched cells from either a related or unrelated “walking” donor, although this remains to be proven. Gene-therapy research involving modification of autologous cord blood stem cells for the treatment of childhood genetic disorders, although experimental at the present time, may prove to be of value. These scientific advances have resulted in the establishment of not-for-profit and for-profit cord blood–banking programs for allogeneic and autologous cord blood transplantation. Many issues confront institutions that wish to establish or participate in such programs. Parents often seek information from their physicians about this new biotechnology option. This document is intended to provide information to guide physicians in responding to parents’ questions about cord blood donation and banking and the types and quality of cord blood banks. Provided also are recommendations about appropriate ethical and operational standards, including informed consent policies, financial disclosures, and conflict-of-interest policies for physicians, institutions, and organizations that operate or have a relationship with cord blood–banking programs.
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).
The American College of Obstetricians and Gynecologists (ACOG, 2008) recommends giving pregnant women information about umbilical cord blood banking that is free from bias. According to ACOG, the chance of a child or family member needing a stem cell transplant is about 1 in 2,700. Therefore, ACOG recommends the collection and banking of cord blood only when an immediate family member has a known diagnosis for which stem cells are currently being used for treatment, and not for potential future uses.
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
An additional cost that is borne only by public banks is the “HLA typing” that is used to match donors and patients for transplants. This is an expensive test, running about $75 to $125 per unit. Family banks always defer this test until it is known whether a family member might use the cord blood for therapy.
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.
Today, many conditions may be treatable with cord blood as part of a stem cell transplant, including various cancers and blood, immune, and metabolic disorders. Preserving these cells now may provide your family potential treatment options in the future.
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.
Another important consideration for autologous use is that, currently, it is unknown how long umbilical cord blood will maintain its usefulness while frozen. Research indicates that cord blood stem cells can be maintained up to 15 years, but it is unknown if the cells would be preserved over the entire lifetime of a person (Ballen et al., 2001; Hess, 1997). Furthermore, financial costs are associated with maintaining the cord blood over time. Kaimal, Smith, Laros, Caughey, and Cheng (2009) studied the cost-effectiveness of private umbilical cord blood banking for autologous use and concluded that it was not cost-effective in most instances because the chances that it would be used are extremely small.
New England Cord Blood Bank was founded in 1971 and is one of the pioneers in processing and cryopreservation of human cells and tissue. The company is continuing to expand its research and development center.
Initially, cord blood stem cell transplantation using allogeneic umbilical cord blood was performed in relatively small children, because the cell dose per weight of recipient was shown to be important.19,20 However, older children, adolescents, and adults have benefited from unrelated allogeneic umbilical cord blood transplantation.34,55–61 Because of the relationship between cell dose per recipient weight and transplant outcome, the number of cord blood cells needed for marrow reconstitution in older children or young adults is much larger than that needed when cord blood is used for transplantation in small children. Cord blood transplants using multiple cryopreserved units from separate donors have been performed successfully in adults, and the approach is currently under investigation as a strategy to increase the dose of cells for transplantation in a single recipient.62 Cord blood is collected in observance of good obstetric and pediatric practice.45
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.
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.
Rocha V, Wagner JE Jr, Sobocinski KA, et al. Graft-versus-host disease in children who have received a cord-blood or bone marrow transplant from an HLA-identical sibling. Eurocord and International Bone Marrow Transplant Registry Working Committee on Alternative Donor and Stem Cell Sources. N Engl J Med.2000;342 :1846– 1854
Donating your baby’s cord blood is a wonderful gift. The cells may be the perfect match for someone in desperate need of a stem cell transplant. Unfortunately, cord blood banking is still an extremely new industry; there are only a small handful of public banks in certain regions, and those banks are primarily focused on collecting cord blood stem cells from Hispanic and African American families due to the genetic diversity associated with those families. Please visit http://www.marrow.org/ for a list of public banks with their contact information. One other note: It is also a wonderful gift to be a bone marrow donor, and becoming one is much more available to the public, unlike cord blood banking. Please call your local blood bank or the American Red Cross for additional information on how to become a bone marrow donor.
§ 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.
Insurance assisted payments: Some cord blood companies work with insurance companies that can help parents pay for cord blood processing and storage, particularly if one child in the family has an illness and might be able to benefit from cord blood use.
Most stored cord blood is discarded. At public cord blood banks, a unit of stored cord blood has a greater chance of being used to help a sick child or used toward stem cell research. Private cord blood banks, on the other hand, eventually throw away blood that a family no longer wants to store or use.