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To explain why cord blood banking is so expensive in the United States, we wrote an article with the CEO of a public cord blood bank that lists the steps in cord blood banking and itemizes the cost of each one.
Tracey Dones of Hicksville, N.Y., paid to bank her son Anthony’s cord blood. But four months after he was born, Anthony was diagnosed with osteopetrosis, a rare disease that causes the body to produce excess bone, leads to blindness, and can be fatal if left untreated.
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.
For the 12- and 24-month payment plans, down payment is due at enrollment. In-house financing cannot be combined with other offers or discounts. *Please add $50 to the down payment for medical courier service if you’re located in Alaska, Hawai’i or Puerto Rico. **Actual monthly payment will be slightly lower than what is being shown. For the length of the term, the annual storage fee is included in the monthly payment. Upon the child’s birthday that ends the term and every birthday after that, an annual storage fee will be due. These fees are currently $150 for cord blood and $150 for cord tissue and are subject to change.
Although cord blood is currently considered discarded human material, it should only be collected for banking with an institutional review board–approved protocol and with signed informed consent from a parent.42,43 Pertinent donor information communicated to the cord blood bank should be kept confidential by the cord blood bank and used only to report important medical information obtained during the cord blood collection, processing, and screening process that is relevant to the safety of the donor and family. If cord blood was collected from a newborn who subsequently developed a genetic, immunologic, or malignant neoplastic disorder, parents should notify the cord blood bank so that the unit is not used for transplantation. All cord blood units banked for potential use should be tested for infectious diseases, similar to those tested in a blood bank, and for hereditary hematologic diseases. The informed consent must contain information pertaining to what tests are to be performed on the cord blood and how the parents will be informed if test results are abnormal. Pediatricians should be aware that legal cases relating to the duty of a physician to warn parents about the risks of inheriting a genetic disease are new and untested. Pediatricians should remain vigilant, because future cases may define who has a legal duty to notify parents about genetic abnormalities identified during cord blood testing. Informed consent should be obtained before the onset of active labor and before cord blood collection.
Currently, cord blood stem cells have been approved by the FDA in the treatment nearly 80 diseases. In addition to these approved regenerative therapies, there are close to 350 clinical trials underway investigating the use of umbilical cord blood and umbilical cord tissue for stem cell transplantation, and this number promises to steadily increase. Cord blood stem cells are approved for numerous types of malignancies, anemias, inherited metabolic disorders and deficiencies of the immune system. The majority of cord blood transplants to date have been performed in patients younger than 18 years; however, advancements in regenerative medicine show promise for all ages. See all the diseases currently being treated.
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
After a baby is born, the umbilical cord and placenta are no longer needed and are usually discarded. However, the blood remaining in the umbilical cord and placenta is rich with blood-forming cells. (These cells are not embryonic stem cells.) By collecting and freezing this blood, the healthy blood-forming cells can be stored and may later be used by a patient who needs them.
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.
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.
* Annual storage fees will be charged automatically to the credit/debit card on file, on or around your baby’s birthday, unless you’ve chosen a prepay option and are subject to change until they are paid.
Smith F, Kurtzberg J, Karson E, et al. Umbilical cord blood collection, storage and transplantation: issues and recommendations for expectant parents and patients. Cancer Res Ther Control.1999;10 :217– 226
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.
Cord blood can be used in the treatment of nearly 80 life-threatening diseases – from cancers to blood disorders. It’s also being used in regenerative medicine research to help kids with conditions like Autism and Cerebral Palsy.
In 1989, Cryo-Cell International was founded in Oldsmar, FL, making it the oldest cord blood bank in the world. By 1992, it began to store cord blood. In addition to pursuing a wide variety of accreditations (AABB, cGMP, and ISO 1345), it was the first private cord blood bank in the U.S. to be awarded FACT accreditation. In 2017, it initiated a $100,000 Engraftment Guarantee (previously $75,000), the highest quality guarantee of any U.S. cord blood bank.
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
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.
Because of their ability to regenerate, umbilical cord stem cells may provide the answers to conditions such as various forms of heart disease and diabetes. Medical researchers studying umbilical cord blood stem cells have recorded several positive observations in animal studies, including instances where cord blood stem cells have improved vascular functions in injured tissue, as well as blood flow and improved overall heart function.
Some parents-to-be are sold on the advertising that banking their child’s cord blood could potentially treat an array of diseases the child, or his siblings, could encounter in their lives. Other parents-to-be may find all the promises too good to be true.
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.
3. Families should consider is whether the odds given for the “average baby” apply to them. Some families do have a higher predisposition to cancer and immune disorders and would be far more likely to benefit from cord blood banking than the statistics indicate.
If you want the blood stored, after the birth, the doctor clamps the umbilical cord in two places, about 10 inches apart, and cuts the cord, separating mother from baby. Then she inserts a needle and collects at least 40 milliliters of blood from the cord. The blood is sealed in a bag and sent to a lab or cord blood bank for testing and storage. The process only takes a few minutes and is painless for mother and baby.
FACT accredited: Cord blood companies that are FACT accredited have been evaluated by the Foundation for the Accreditation of Cellular Therapy, and they’re found to have met the foundation’s standards of operation.
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).
Despite the benefits of using umbilical cord blood stem cells for transplant, the process also has some disadvantages (see Table 3). For stem cell transplants to be successful, measurable signs of engraftment must occur. Engraftment is the opposite of rejection and indicates that the stem cell transplant is “working.” Two measurable signs of engraftment are the recovery of both neutrophil (a type of white blood cell) and platelet (a clotting factor) production. These two clinical signs of recovery take longer to occur in umbilical cord blood stem cell transplants than in bone marrow stem cell transplants. In other words, the lab values for white blood cell production and platelet production take longer to increase after umbilical cord blood stem cell transplants than after bone marrow stem cell transplants (Hess, 1997; Moise, 2005).
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.
There are no health risks related to cord blood collection. Cord blood is retrieved from the umbilical cord after it has been cut, thus preventing any pain, discomfort, or harm. This process is completely safe.
As with all important decisions you make, the more educated you are, the better. After all, you only get one chance to bank your baby’s cord blood and you want to make sure that you choose a cord blood bank you can trust. Cord blood banking companies—especially private ones—vary widely in terms of quality, experience, and even the technology they use to collect, process, and store cord blood.
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.
Families should seriously pursue public banking, donation for research, or private banking instead of discarding their baby’s umbilical cord blood. We aim to be nonpartisan in our dissemination of information, but we believe that discarding your baby’s cord blood is a waste of a once-in-a-lifetime valuable resource.
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
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 injections with their own umbilical cord blood, 63 children with cerebral palsy improved on motor skills, on average. And a clinical trial to see whether cord blood transplants improve symptoms of children with autism spectrum disorder should wrap up in the summer of 2018, says pediatric researcher and clinician Joanne Kurtzberg of Duke University, who helped establish a not-for-profit umbilical cord bank in North Carolina. (A small but optimistic pilot study has already been completed.)
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.
Anak S, Saribeyoglu ET, Bilgen H, et al. Allogeneic versus autologous versus peripheral stem cell transplantation in CR1 pediatric AML patients: a single center experience. Pediatr Blood Cancer.2005;44 :654– 659