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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.
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).
Umbilical cord blood stem cells are different from embryonic stem cells. Umbilical cord blood stem cells are collected by your ob-gyn or a nurse from the umbilical cord after you give birth (but before your placenta is delivered). Embryonic stem cells are collected when a human embryo is destroyed.
Maschan AA, Trakhtman PE, Balashov DN, et al. Fludarabine, low-dose busulfan and antithymocyte globulin as conditioning for Fanconi anemia patients receiving bone marrow transplantation from HLA-compatible related donors. Bone Marrow Transplant.2004;34 :305– 307
Cord blood has been shown to contain pluripotent stem cells that have the potential to differentiate into nonhematopoietic tissue, such as cardiac, neurologic, pancreatic, and skin tissue, in vitro.53,54 Extensive laboratory research is taking place to explore the potential therapeutic benefit of cord blood under these circumstances. The results of this research will be necessary to formulate future recommendations regarding autologous cord blood banking.
The American Academy of Pediatrics is an organization of 55,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety, and well-being of infants, children, adolescents and young adults Read the full article on the AAP website.
The collection of your baby’s cord blood happens the day your baby is born. After delivery it’s standard procedure for your doctor or midwife to clamp and cut the umbilical cord. Using ViaCord’s collection kit, they will then insert a needle into the cord to collect the remaining blood. Once the collection is complete, they will seal the bag, attach the pre-printed label with your family’s information, and place it in the collection kit. A medical courier will pick up the kit from your hospital room and transport it to ViaCord’s state-of-the-art lab and storage facility, where lab specialists will process the cord blood in preparation for long-term storage.
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.
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.
The evolution from pluripotent stem cells down to blood stem cells is currently poorly understood. The latest indication is that, under the right conditions, stem cells in cord blood can be teased to grow into other types of tissue besides blood. This would open up an entirely new realm of potential treatment through the use of stem cells.
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).
Marketing materials by Viacord and Cord Blood Registry, the two largest companies, do not mention that cord blood stem cells cannot be used by the child for genetic diseases, although the fine print does state that cord blood may not be effective for all of the listed conditions.
To most people, the issue comes down to money. If you had unlimited money, you would spend a few thousand to even miniscually increase the chance of your child enjoying good health. However, since you probably don’t have unlimited money, you will have to decide how to best spend and save for your children’s future. If you invested the Viacord fee of $1550 plus $150 for the courier at your child’s birth in the stock market, you would have $12,210 by the time he turned 21. That would certainly help pay for college or even his medical insurance after he graduated from college. The odds are that your child will need a college education more than an autologous bone marrow transplant. So if you have to choose between one or the other, make the right choice by saving the money for his future.
Most of the diseases for which HSCT is a standard treatment are disorders of blood cell lineage. The proliferation by which blood cells are formed from stem cells is illustrated in the side graphic (click on the image to expand it); you can also read about specific cell types in the immune system in more detail. In the United States, most health insurance providers will pay for a stem cell transplant if it is a “standard therapy” for the patient’s diagnosis.
Blood naturally starts to clot when its outside the body. An anticoagulant is used to help prevent the cord blood from clotting while it is in transit to the laboratory for processing. CBR deliberately chose to use lyophilized (dry) heparin as the anticoagulant because of some potential advantages, including:
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.
When researching cord blood banks, make sure they’re registered with the Food and Drug Administration (FDA), and comply with FDA regulations including current good tissue practice regulations, donor screening and testing for infectious diseases. Check for accreditations with American Association of Blood Banks or the Foundation for the Accreditation of Cellular Therapy. Other factors to consider are the bank’s shipping and delivery methods, clinical experience, processing options, payments and costs.
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The potential powers of these cells have researchers excited. But what that scientific hope means for expectant parents facing decisions about cord blood banking is far from clear. For all of the promise, there are lots of reasons why umbilical cord cells may turn out to be less useful than thought. Read my next post for more about these potential drawbacks.
Let’s look back at the expectant couple in my childbirth class who asked about banking their infant’s umbilical cord blood. They should not base their decision to bank the umbilical cord blood on the type of anticoagulant used to preserve the sample; likewise, they should not obtain all of their information on cord blood banking from the private cord blood bank, whose major agenda is to gain another client. Instead, they must be encouraged to research various resources for reliable information (see Table 4). If they have evidence that stem cells are used currently to treat a specific disease process that is affecting a family member, and is not simply a proposed idea, then it might be in their best interest to privately bank the umbilical cord blood. However, they should be aware that simply banking the cord blood does not ensure a cure, and they would most likely be banking the blood not for the current baby, but for some other family member. They must also be aware of the cost involved in the banking process. Finally, if they do not have a relative with a disease process treated with stem cells or there is no evidence that stem cells are used to treat the diseases that are known to be in their family, then they should consider public banking of the umbilical cord blood (if they have access to a public cord blood bank).
Anthony’s doctors found a match for him through the New York Blood Center’s National Cord Blood Program, a public cord blood bank. Unlike private banks, public banks do not charge to collect cord blood, they charge a patients insurance company when cells are used. And once it is entered in the public system, the blood is available to anyone who needs it.
Allows you to bank the unique stem cells in placental blood that have shown promise in the growing field of regenerative medicine,6,7,8 placing you and your family in the best position to benefit from ongoing developments in this field.
Myers LA, Hershfield MS, Neale WT, Escolar M, Kurtzberg J. Purine nucleoside phosphorylase deficiency (PNP-def) presenting with lymphopenia and developmental delay: successful correction with umbilical cord blood transplantation. J Pediatr.2004;145 :710– 712
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.
‡ Payment Plan Disclosures for in-house CBR 6-Month Plan (interest free) – No credit check required. The 6-month plan requires a $10/month administrative fee. The plans may be prepaid in full at any time.
Direct-donation umbilical cord blood banks function as an amalgamation of public and private banks. Direct-donation banks collect cord blood without charging fees. In addition, they accept autogenous donations and reserve them only for the family, especially for a family whose infant has a sibling with a disorder that may be treated with umbilical cord blood stem cells (Moise, 2005).
Cancellations prior to CBR’s storage of the samples(s) are subject to an administrative fee of $150. If you terminate your agreement with CBR after storage of the sample(s), you will not receive a refund.
Transplant science is constantly improving. Several companies are bringing to market methods of “expanding” the stem cell population in the laboratory, and these methods are starting to be applied in clinical trials.
CBR presented data, in the form of a poster, at the 2008 joint annual meeting of the Center for International Blood and Marrow Transplant Research (CIBMTR) and the American Society of Blood and Marrow Transplants (ASMBT). In the poster, CBR showed results obtained during implementation of the AXP System. The published abstract reported that, under the controlled conditions of the study, the average recovery rate of the mononucleated cell (MNC) population was approximately 99% (specifically 98.7%). The results presented at this meeting are consistent with some of the high MNC recovery rates reported by other groups that have adopted AXP System (Rubinstein P. Cord blood banking for clinical transplantation. Bone Marrow Transplantation. 2009;44:635-642).
Kasamon YL, Jones RJ, Piantadosi S, et al. High-dose therapy and blood or marrow transplantation for non-Hodgkin lymphoma with central nervous system involvement. Biol Blood Marrow Transplant.2005;11 :93– 100
Over 95% of newborns’ cord blood stem cells fall into this category. It is unfortunate that public banking is not readably available and private banking is so expensive. Some industry leaders believe that as the industry grows, banking or donating cord blood will be as common as it is uncommon today.
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.
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.
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Physicians or other professionals who recruit pregnant women and their families for for-profit placental cord blood stem cell banking should disclose any financial interest or other potential conflict of interest they have in the procedure to their patients.
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That may sound expensive, but the cost of processing cord blood and storing it in medical freezers for years on end is considerable. Even public cord blood banks say the initial collection, processing, and storage cost them about $1,500 per unit of cord blood.
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.
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.
Make no mistake, cord banks are businesses to the core. And just like any other business, there’s always the possibility of a cord bank failing. Which is why we suggest begining your search by checking the company’s experience, the number cord blood units stored, and how many of these cord blood units have been used for transplants.
Accreditation agencies and registries have recognized StemCyte™ for its dedication to higher standards and patient care. StemCyte™ is the only private cord blood bank that is both FACT- and AABB-accredited.
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.
Donating to research is another alternative. In some areas, you may be able to donate your newborn’s cord blood stem cells to a university or biotech firm. There are also now several private banks who offer to bank your baby’s cord blood as a donation, but they will typically sell it to a research facility. Cord Blood Options will be compiling additional data for this section in the near future.