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“This is a medical service that has to be done when your baby’s cells arrive and you certainly want them to be handled by good equipment and good technicians,” says Frances Verter, Ph.D., founder and director of Parent’s Guide to Cord Blood Foundation, a nonprofit dedicated to educating parents about cord blood donation and cord blood therapists. “It’s just not going to be cheap.” 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 reduce costs.
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.
We chose the site of our lab for one reason in particular: safety. As one of the safest cities in the US, Tucson ensures our families’ samples will be protected from natural disaster. Natural disasters, such as hurricanes, tornadoes, and earthquakes, could interrupt consistent long-term storage of stem cells.
Because there are no scientific data at the present time to support autologous cord blood banking and given the difficulty of making an accurate estimate of the need for autologous transplantation and the ready availability of allogeneic transplantation, private storage of cord blood as “biological insurance” should be discouraged. Cord blood banks should comply with national accreditation standards developed by the Foundation for the Accreditation of Cellular Therapy (FACT), the US Food and Drug Administration (FDA), the Federal Trade Commission, and similar state agencies. At a minimum, physicians involved in procurement of cord blood should be aware of cord blood collection, processing, and storage procedures as shown in Table 2.
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.
Clinical experience with leading institutions: Many reputed hospitals have depended on the company for cord blood, including Duke University, Children’s Healthcare of Atlanta and the University of Minnesota Medical Center.
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).
Korthof ET, Snijder PP, de Graaff AA, et al. Allogeneic bone marrow transplantation for juvenile myelomonocytic leukemia: a single center experience of 23 patients. Bone Marrow Transplant.2005;35 :455– 461
Using their banked cord blood stem cells, ViaCord families participate in ongoing IND approved research including autism, cerebral palsy, & brain injury. Over 150 families have participated in ongoing research.
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Another advantage of using umbilical cord blood stem cells is the decreased risk of the transmission of infectious disease. This particular advantage is partly because umbilical cord blood is almost never contaminated by Epstein-Barr virus or cytomegalovirus (Drew, 2005; Gonzalez-Ryan et al., 2000). Additionally, the processing of cord blood includes collecting data on the history of infection during the mother’s pregnancy. For example, if the pregnant woman has a history of group B streptococcus, active genital herpes, or prolonged rupture of membranes and chorioamnionitis, umbilical cord blood is not saved. Generally, samples of the mother’s blood are also drawn to test for infectious diseases, such as hepatitis, human immunodeficiency virus, and syphilis (Moise, 2005). Furthermore, after the cord blood units are collected, they are screened for disease, and any units that are deemed contaminated or infected are thrown away (Gunning, 2007).
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.
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.
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
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.
Researchers continue to investigate new applications of stem cells. Ballen (2006) reported on studies examining the use of stem cells for treating autoimmune diseases, such as lupus, systemic sclerosis, and multiple sclerosis. Gunning (2007) reported on stem cell research for regenerative uses for heart attacks, stroke, spinal cord injury, diabetes, liver injury, and even traumatic brain injury. However, Gunning also noted that these regenerative uses for stem cells are purely in the research stage and, so far, no tangible evidence supports any clinical uses beyond the diseases that are currently being treated.
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.
Cord blood–banking recruitment practices should be developed with an awareness of the possible emotional vulnerability of pregnant women and their families and friends. Efforts should be made to minimize the effect of this vulnerability on cord blood–banking decisions.
The main purpose of a cord blood company is to store umbilical cord blood for families in case they need to access it for future use. Cord blood from a baby is stored because it has the potential to help treat blood or immune system diseases. There are both private and public cord blood companies, sometimes referred to as cord blood banks.
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.
10. Organ failure. What better way to ease the shortage of organs for transplantation than to grow new ones? That’s what some scientists think, and with stem cells, that vision may become more than a pipe dream. Last year, researchers grew a beating rat heart in the lab with the help of heart cells from newborn rats, preliminary proof of the concept.
There are two main types of cord blood banks: public and private. Public cord blood banks are usually nonprofit companies that store your donated cord blood for free, to be used for any sick child in another family or for research purposes, so accessing and using your own cord blood is not guaranteed. Private cord blood banks are companies that require a registration fee (plus annual storage fees) for your cord blood, but it is saved specifically for your own family, so you’ll have ready access to it.
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.
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
So what are your options? You have three choices. One is to store the cord blood with a private company at a cost to you ranging from $1,500 to $2,500 and an annual storage fee in the ballpark of $125. Secondly, you can donate the cord blood to a public bank, if there is one working with your hospital, and your doctor is on board with the idea. There are also public banks that accept mail-in donations, if you register during your second trimester and your doctor is willing to take a short training class on-line. Zero cost to you. The third option is to do nothing and have the cord blood, umbilical cord, and placenta destroyed as medical waste.
Cord blood donation should be discouraged when cord blood stored in a bank is to be directed for later personal or family use, because most conditions that might be helped by cord blood stem cells already exist in the infant’s cord blood (ie, premalignant changes in stem cells). Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in cord blood. Although not standard of care, directed cord blood banking should be encouraged when there is knowledge of a full sibling in the family with a medical condition (malignant or genetic) that could potentially benefit from cord blood transplantation.
Stay up on the latest stem cell developments with our stem cell news blog. Read about the newest trials that are underway, how current trials are faring and new ways that cord blood and tissue stem cells are being used in regenerative therapies. For doctors and researches, the Stem Cell Insider provides a more detailed look at the latest stem cell news and showcases the latest advancements in our products to help ensure stem cells preserved with us are viable and pure.
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.
A person will always be a 100% match to his or her cord blood, which is the best fit as there are some conditions that can only be treated with one’s own cord blood stem cells (or a perfect match). However, other conditions can be treated using donor stem cells that are partial genetic matches.
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).
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.
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.
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.