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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.
M.A.Z.E. Cord Blood Laboratories is an FDA-approved and regulated storage facility that partners with Community Blood Services for processing. The company has processed over 30,000 units of cord blood since opening in 1997.
These are diseases for which transplants of blood-forming stem cells (Hematopoietic Stem Cell Transplants, HSCT) are a standard treatment. For some diseases they are the only therapy, and in other diseases they are only employed when front-line therapies have failed or the disease is very aggressive. The lists below include ALL therapies that use blood-forming stem cells, without distinction as to whether the stem cells were extracted from bone marrow, peripheral blood, or cord blood.
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Lifebank USA is another private bank, located in Cedar Knolls, New Jersey, that’s accredited by the AABB. What sets this bank apart from the others: it’s one of the few banks that store umbilical cord blood and placenta blood (this is done for free). Stem cells from placenta tissue can turn into skeletal tissue types such as bone, cartilage, fat tissue, and connective tissue, whereas cells from cord blood turn into different types of blood cells.
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.
This is only the beginning. Newborn stem cell research is advancing, and may yield discoveries that could have important benefits for families. CBR’s mission is to support the advancement of newborn stem cell research, with the hope that the investment you are making now will be valuable to your family in the future. CBR offers a high quality newborn stem cell preservation system to protect these precious resources for future possible benefits for your family.
Private cord blood banking costs $2,000 to $3,000 for the initial fee, and around another $100 per year for storage. While that may seem like a hefty price tag, many expectant parents may see it as an investment in their child’s long-term health.
When all the processing and testing is complete, the cord blood stem cells are frozen in cryogenic nitrogen freezers at -196° C until they are requested for patient therapy. Public banks are required to complete the entire laboratory processing and freeze the cord blood stem cells within 48 hours of collection. This is to insure the highest level of stem cell viability. The accreditation agencies allow family banks a window of 72 hours.
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.
This web page was researched by Frances Verter, PhD, Alexey Bersenev, MD PhD, and Pedro Silva Couto, MSc ©2016-2018. Sources of information about established therapies were publications in the medical literature found via PubMed and Google Scholar. Sources of clinical trials were searches of ClinicalTrials.gov, Chinese Clinical Trial Registry (ChiCTR), Japan University hospital Medical Information Network Clinical Trial Registry (UMIN-CTR), Japan Medical Association Clinical Trial Registry (JMA-CTR), Clinical Research Information Service from South Korea (CRiS), EU Clinical Trials Register (EudraCT), World Health Organization International Clinical Trials Registry Platform (ICTRP), Netherlands Trial Register (NTR), Australian New Zealand Clinical Trial Registry (ANZCTR), Clinical Trials Registry-India (CTRI), German Clinical Trials Register (DRKS), and Iranian Registry of Clinical Trials (IRCT).
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.
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.
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.
Cord blood can’t be used to treat everything. If your child is born with a genetic condition such as muscular dystrophy or spina bifida, then the stem cells would have that condition, says Dr. Kurtzberg. But if the cord blood donor is healthy and there is a sibling or another immediate family member who has a genetic condition, the cord blood could be a good match for them.
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.
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.
Entz-Werle N, Suciu S, van der Werff Ten Bosch J, et al. Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogeneic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group report. Leukemia.2005;19 :2072– 2081
Public cord blood companies are mostly nonprofit companies that are traded publicly, and doctors can utilize matching cord blood in these banks for treating their patients, even if the blood is not their own.
Stem cells’ role is critical for regenerative medicine. A stem cell is a special type of cell because it is the basis for all the other cells in our bodies. Stem cells have the ability to develop into one of many different types of cells. This process of a stem cell becoming a specific type of cell like a skin cell, blood cell or bone cell is known as differentiation. The other unique ability of stem cells is to replicate quickly. Combined, these abilities can quickly replenish different types of cells, making stem cells a driving factor or major enhancement in the healing process.
According to the statement, “Families may be vulnerable to emotional marketing 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 cells. The range of available estimates is from 1 in 1,000 to 1 in 200,000.” For this and other reasons, it is difficult to recommend that parents store their children’s cord blood for future use. The AAP policy states:
Of particular interest are the flexible hematopoietic stem cells important in that initial transplant. In certain cases, transplanting these cells might be able to reboot a person’s body and get rid of a disease-related defect. Cord blood transplants are similar to bone marrow transplants. A person with leukemia, for instance, might have his own cancerous blood cells wiped out with chemotherapy and radiation. Healthy, non-cancerous stem cells from a donor can then repopulate the blood.
The stored blood can’t always be used, even if the person develops a disease later on, because if the disease was caused by a genetic mutation, it would also be in the stem cells. Current research says the stored blood may only be useful for 15 years.
Cord tissue contains a special type of stem cell that has the potential to treat injuries and diseases affecting cartilage, muscle, and nerve cells.19 Since 2007 there have been about 150 clinical trials that have used cord tissue stem cells in human patients.
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.
Preserving stem cells does not guarantee that the saved stem cells will be applicable for every situation. Ultimate use will be determined by a physician. Please note: Americord Registry’s activities are limited to collection of umbilical cord tissue from autologous donors. Americord Registry’s possession of a New York State license for such collection does not indicate approval or endorsement of possible future uses or future suitability of cells derived from umbilical cord tissue.
At the end of a recent childbirth class, I found two couples engaged in a lengthy discussion. In the course of the conversation, both couples agreed that their goal was to do the best things for their pregnancy and birth. They were attending childbirth classes to learn how to support normal birth. They each were planning to attend breastfeeding classes. As their conversation continued, the first couple described their decision to bank the umbilical cord blood of their yet unborn daughter. They were adamant that their decision was the best action for them because they had a strong family history of myasthenia gravis. They stated that they had researched the issue by talking to several different cord blood banks, and they had decided on one particular bank because it processed the cord blood without the use of the anticoagulant drug, heparin. The couple went on to parrot back the information that the cord blood bank had told them. It was evident that the first couple wanted what was best for their yet unborn child.
Private cord blood banking can benefit those with a strong family history of certain diseases that harm the blood and immune system, such as leukemia and some cancers, sickle-cell anemia, and some metabolic disorders. Parents who already have a child (in a household with biological siblings) who is sick with one of these diseases have the greatest chance of finding a match with their baby’s cord blood. Parents who have a family history of autism, Alzheimer’s, and type 1 diabetes can benefit from cord blood. Although these diseases aren’t currently treated with umbilical cord steam cells, researchers are exploring ways to treat them (and many more) with cord blood.
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.
The use of cord blood is determined by the treating physician and is influenced by many factors, including the patient’s medical condition, the characteristics of the sample, and whether the cord blood should come from the patient or an appropriately matched donor. Cord blood has established uses in transplant medicine; however, its use in regenerative medicine is still being researched. There is no guarantee that treatments being studied in the laboratory, clinical trials, or other experimental treatments will be available in the future.
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.
3. Heart disease. It’s the leading cause of death in the United States, and stem cells may provide some relief. Research is underway to see if injecting the cells into the heart could help regenerate heart muscle damaged by, for example, a heart attack. Again, researchers have reported success in rodents.
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.
Americord offers parents the ability to collect stem cells from the placenta and umbilical cord soon after the child’s birth. These stem cells, obtained from cord blood, cord tissue and placenta tissue, can be used to help treat genetic diseases and other threats to the baby’s life. Placenta tissue stem cells can also be used to benefit the mother.
Banking a baby’s blood and stem cells in a cord blood bank is a type of insurance. Ideally, you would not need to access your baby’s stem cells in order to address a medical concern. However, using a cord blood bank can provide peace of mind in knowing that you have a valuable resource if you need it.
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.
Cord tissue is rich in another type of stem cell. Although there are no current uses, researchers are excited about the benefits cord tissue stem cells may offer in potential future users, such as regenerative medicine. By storing both, you’ll have potential access to more possibilities
Umbilical cord blood was once thought of as a waste product of the birthing experience, but now it is valued for its content of stem cells. Today, more than 20 years after the first successful umbilical cord blood stem cell transplant, more families are seeking information about whether or not to invest in saving their newborn’s umbilical cord blood. Saving the cord blood in public banks is a worthy undertaking for any family. It is recommended that expectant families only consider cord blood banking in private banks when they have a relative with a known disorder that is already treatable by stem cell transplants. Moreover, expectant families should not rely on commercial cord blood banks as their sole source of information about cord blood banking.
Part of the reason for the dominance of these three companies in terms of the total number of units stored is that they are three of the oldest cord blood banks within the U.S., founded in 1992, 1993, and 1989, respectively. All three of these cord blood banks also support cord blood research and clinical trials.
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 stem cells obtained from umbilical cord blood are also less likely than bone marrow stem cells to be rejected in transplants. Considered to be immunologically immature, umbilical cord blood stem cells produce significantly fewer natural killer cells, creating a substantial decrease in rejection. Consequently, cord blood stem cells require less rigorous antigen tissue matching for transplants than bone marrow stem cells (Sullivan, 2008). Research indicates that a mismatch of up to two antigen sites still provides successful clinical outcomes (Ballen, 2006; Fox et al., 2007). In fact, researchers report that the rate of rejection for cord blood stem cell transplants is half the rate of rejection for bone marrow transplants (Ballen et al., 2001). When compared directly in cases of mismatched antigens, there was clearly less rejection in transplants involving cord blood stem cells than bone marrow stem cells (Moise, 2005).