- Cord blood bank
A cord blood bank is a facility which stores umbilical cord blood for future use. Both private and public cord blood banks have developed since the mid- to late-1990s in response to the potential for cord blood transplants in treating diseases of the blood and immune systems.
Public banks accept donations to be used for anyone in need. Unlike private cord blood banking, public cord blood banking is supported by the medical community. However, there are very strict regulations which public banks need to follow in order to enable the donated units to be added to a registry. Generally, an expectant mother interested in donation should contact the bank before the 34th week of pregnancy. The National Marrow Donor Program has a list of public cord blood banks on their website. Once the blood is donated, it loses all identifying information after a short period of initial testing. Families are not able to retrieve their own blood after it has been donated, but, as discussed below, it is very unlikely that they would be able to use the sample themselves.
Banking a cord blood in private banks is a personal choice made by both parents. Private banks store cord blood with a link to the identity of the donor, so that the family may retrieve it later if it is needed. The parents have custody of the cord blood until the child is an adult. The cord blood might someday be needed by the donor baby, or it could be used by a relative who is a close enough match to receive a transplant from the donor (typically a sibling). Private banks charge a fee of around $1000–$2000 to preserve the harvested cord blood for family biological insurance. Private banks have been criticized for aggressive marketing campaigns to expectant parents.
In the United States, the Food and Drug Administration regulates cord blood under the category of “Human Cells, Tissues, and Cellular and Tissue Based-Products.” The Code of Federal Regulations under which the FDA regulates public and private cord blood banks is Title 21 Section 1271. When choosing a cord blood bank, make sure it is eligible for voluntary accreditation with either the American Association of Blood Banks AABB or the Foundation for the Accreditation of Cellular Therapy FACT. Potential clients can check the current accreditation status of banks from the AABB list of accredited cord blood banks or the FACT search engine of accredited cord blood banks. Other countries also have regulations pertaining to cord blood.
Cord blood contains hematopoietic stem cells, progenitor cells which can form red blood cells, white blood cells and platelets. Cord blood cells are currently used to treat blood and immune system related genetic diseases, cancers, and blood disorders. Medical critics of routine cord blood collection emphasize that, if neonatal cord blood is so physiologically valuable, it is of great benefit for the neonate to receive upon birth.
The collection process
Cord blood collection happens after the umbilical cord has been cut and is extracted from the fetal end of the cord, diverting up to 75 +/- 23 mL from the neonate. It is usually done within 10 minutes of giving birth.
Additional stem cells may be collected from the placenta via Placenta Cord Banking. After the health care provider draws the cord blood from the placental end of the umbilical cord, the placenta is couriered to the stem cell laboratory, where it is processed for additional stem cells.
An adequate cord blood collection requires at least 75 mL in order to ensure that there will be enough cells to be used for a transplantation.
Before the cord blood is stored for later use, it undergoes viral testing, including tests for HIV and Hepatitis B and C, and tissue typing (to determine HLA type). It will also be examined for nucleated cell count, cell viability, blood group antigen (ABO & Rh), molecule cluster (CD34), and bacterial & fungal growth.
After the collection, the cord blood unit is shipped to the lab and processed, and then cryopreserved. There are many ways to process a cord blood unit, and there are differing opinions on what is the best way. Some processing methods separate out the red blood cells and remove them, while others keep the red blood cells. However the unit is processed, a cryopreservant is added to the cord blood to allow the cells to survive the cyrogenic process. After the unit is slowly cooled to -90 Celsius, it can then be added to a liquid nitrogen tank which will keep the cord blood unit frozen at -196 Celsius. The slow freezing process is important to keep the cells alive during the freezing process. The protocols used for the cryopreservation have largely been adapted from those originally designed for the bone marrow haematopoietic stem/progenitor cells. There is no consensus yet on optimal procedures for these cord blood cells, although many cryopreservation strategies suggest using dimethyl sulfoxide (DMSO), slow or controlled rate cooling, and rapid thawing.
Benefits of banking cord blood
Cord blood stem cells are currently used in the treatment of several life-threatening diseases, and play an important role in the treatment of blood and immune system related genetic diseases, cancers, and blood disorders.
The first clinically documented use of cord blood stem cells was in the successful treatment of a six-year-old boy afflicted by Fanconi anemia in 1988. Since then, cord blood has become increasingly recognized as a source of stem cells that can be used in stem cell therapy.
Recent studies have shown that cord blood has unique advantages over traditional bone marrow transplantation, particularly in children, and can be life-saving in rare cases where a suitable bone-marrow donor cannot be found. Approximately 50% of patients requiring a bone marrow transplant will not find a suitable donor within a critical period. In certain instances, there may be some medical issues around using one's own cord blood cells, as well as availability of cells, which will require treatments done using cells from another donor, with the vast majority being unrelated donors. However, studies have shown that cord blood stem cells can also be used for siblings and other members of your family who have a matching tissue type. Siblings have up to a 75% chance of compatibility, and the cord blood may even be a match for parents (50%) and grandparents.
Cord blood and regenerative medicine
Regenerative medicine is a field of medical research developing treatments to repair or re-grow specific tissue in the body. Because a person’s own (autologous) cord blood stem cells can be safely infused back into that individual without being rejected by the body’s immune system - and because they have unique characteristics compared to other sources of stem cells - they are an increasing focus of regenerative medicine research.
Research in this area that has the potential to revolutionize medicine is advancing rapidly, and it is difficult for professional medical societies, and other resources that expectant parents turn to for information, to keep pace.
Physicians and researchers are making significant progress evaluating the safety and efficacy of umbilical cord blood stem cells for therapeutic uses far beyond their uses for cancers and blood disorders.
The use of cord blood stem cells in treating conditions such as brain injury and Type 1 Diabetes is already being studied in humans, and earlier stage research is being conducted for treatments of stroke, and hearing loss.
Current estimates indicate that approximately 1 in 3 Americans could benefit from regenerative medicine, and children whose cord blood stem cells are available for their own potential use could be among the first to benefit from new therapies as they become available. With autologous (the person’s own) cells, there is no risk of the immune system rejecting the cells, so physicians and researchers are only performing these potential cord blood therapies on children who have their own stem cells available.
Researchers are exploring the use of cord blood stem cells in the following regenerative medicine applications:
Type 1 diabetes
A clinical trial underway at the University of Florida is examining how an infusion of autologous cord blood stem cells into children with Type 1 diabetes will impact metabolic control over time, as compared to standard insulin treatments. Preliminary results demonstrate that an infusion of cord blood stem cells is safe and may provide some slowing of the loss of insulin production in children with type 1 diabetes.
The stem cells found in a newborn’s umbilical cord blood are holding great promise in cardiovascular repair. Researchers are noting several positive observations in pre-clinical animal studies. Thus far, in animal models of myocardial infarction, cord blood stem cells have shown the ability to selectively migrate to injured cardiac tissue, improve vascular function and blood flow at the site of injury, and improve overall heart function.
Central nervous system
Research has demonstrated convincing evidence in animal models that cord blood stem cells injected intravenously have the ability to migrate to the area of brain injury, alleviating mobility related symptoms. Also, administration of human cord blood stem cells into animals with stroke was shown to significantly improve behavior by stimulating the creation of new blood vessels and neurons in the brain.
This research also lends support for the pioneering clinical work at Duke University, focused on evaluating the impact of autologous cord blood infusions in children diagnosed with cerebral palsy and other forms of brain injury. This study is examining if an infusion of the child’s own cord blood stem cells facilitates repair of damaged brain tissue, including many with cerebral palsy. To date, more than 100 children have participated in the experimental treatment – many whose parents are reporting good progress.
As these clinical and pre-clinical studies demonstrate, cord blood stem cells will likely be an important resource as medicine advances toward harnessing the body’s own cells for treatment. The field of regenerative medicine can be expected to benefit greatly as additional cord blood stem cell applications are researched and more people have access to their own preserved cord blood.
Banking umbilical cord tissue
Expectant parents can now also collect and preserve stem cells from the tissue of the umbilical cord, whose medical name is Wharton’s Jelly. Whereas cord blood is a rich source of Hematopoietic stem cells (HSC) that differentiate to form the lineage of blood cells, cord tissue is a rich source of Mesenchymal stem cells (MSC). The International Society of Cellular Therapy. ISCT, has established criteria for defining MSC.  Mesenchymal stem cells differentiate to build bone, cartilage and connective tissue, and they are also very effective at mediating the body’s inflammatory response to damaged or injured cells.  Harvesting the tissue of the umbilical cord can yield between 21 and 500 million MSC.  By comparison, a typical cord blood collection in a private bank has a median total nucleated cell count of 470 million.  For parents, private storage at birth of stem cells from both cord blood and cord tissue offer more options for future medical use.
Numerous clinical trials are using MSC derived from the bone marrow of adult volunteers to treat heart disease, stroke, bone disease and injury, and autoimmune diseases such as Type 1 Diabetes, Multiple Sclerosis, and Crohn’s Disease.  As yet, there are no clinical trials in humans using MSCs derived from cord tissue. However, over 50 studies have used MSC derived from cord tissue to treat animal models of human diseases, including: Lung Cancer,  Parkinson's Disease,  Rheumatoid Arthritis,  Sports injuries to cartilage,  and Type 1 Diabetes. 
Currently there is no standard procedure or accrediting criteria for storage of MSC from umbilical cord tissue. Many cord blood banks are storing the cord tissue by freezing an intact segment of the umbilical cord. This procedure has the advantage of waiting for the technology of cell separation to mature, but has the disadvantage that there is no guarantee it will be possible to efficiently retrieve viable stem cells from a previously frozen cord. A few cord blood banks are extracting stem cells from the cord tissue before cryogenic storage. This procedure has the disadvantage that it uses the current separation method, but the advantage that it yields minimally manipulated cells that are treatment ready and comply with FDA regulations on cell therapy products.
Issues common to all cord blood banks
The main concern of cord blood banking, private or public, is the long-term viability of cryogenically frozen cord blood, although studies have shown that the cord blood can be cryogenically frozen indefinitely.
Other established treatments may be more suitable for the patient, rather than cord blood transplants, and it may become possible to obtain the needed blood or more generalized stem cells by other means, such as from the bloodstream of an adult or from tissue culture.
The FDA governs the collection, processing, storage, labeling, packaging, and distribution of cord blood stem cells. There are two different standards which can apply: cGTP (current Good Tissue Practices) and cGMP (current Good Manufacturing Practices). cGTP standards apply to the collection, processing and storage of human cells, tissues, and cellular/tissue-based products (HCT/Ps) and are regulated by the Center for Biologics Evaluation and Research. All US cord blood banks must be compliant with cGTP standards. cGMP standards apply to the manufacture of a product that is considered a drug. How one determines whether a bank must be compliant with cGMP standards is based upon the product that they manufacture. If a cord blood bank manufactures cord blood stem cells that are overly manipulated or the cells are used in a different basic biologic function, that product is regulated as a drug, and both cGTP and cGMP standards would apply. If a cord blood bank manufactures cord blood stem cells that are minimally manipulated and the cells are used for the same basic biologic function and/or for use in people that are 1st or 2nd degree blood relatives, that product is regulated solely under cGTPs.
cGTP standards are based upon cGMP standards, and thus there are many similarities.
A primary concern with public banking is how to ensure the safety of the cord blood. Because of privacy concerns, it is agreed by most ethical review boards that blood donated to a public bank cannot be permanently linked to the donor. Although cord blood which is donated goes through a series of tests for potentially harmful genetic disorders and viruses, some genetic disorders such as congenital anemias or immunodeficiencies might not become apparent in the donor for months or years, by which time all identifying information has long been removed. Because the recipient of the blood could also develop these disorders, this is an important concern.
The larger obstacle facing public banks is that the high costs required to maintain them has prevented more than a handful from opening. Because public banks do not charge storage fees, many medical centers do not have the funds required to establish and maintain them.
Because of donation patterns, differing racial groups have different likelihood of finding a match through a public cord blood bank. Caucasians find a match 88% of the time, while other races match just 58% of the time. Public bank advocacy groups are particularly trying to encourage donations by members of non-Caucasian racial groups.
It is also important to note that families who donate their child's cord blood to public banks are not assured their samples will be banked or would be available to them if required at a later date.
Private banking is costly to insurers and private parties, averaging $2500. The ability to use the cord blood may also depend on the long-term commercial viability of the enterprise. Accordingly, whether cord blood banking is a worthwhile expenditure for the expectant parent depends in part upon whether the expenditure is offset by the likelihood of ultimately using the cord blood and by the benefits of such use.
Some cord blood banks are publicly traded on a stock exchange and perform research, claiming that this makes them more trustworthy; however, such activities may not directly benefit their clients.
It is important to ensure the credentials of any potential private bank. In the United States, the Food and Drug Administration regulates cord blood under the category of “Human Cells, Tissues, and Cellular and Tissue Based-Products.” The Code of Federal Regulations under which the FDA regulates public and private cord blood banks is Title 21 Section 1271. In addition, private cord blood banks can apply for voluntary accreditation with either the American Association of Blood Banks AABB or the Foundation for the Accreditation of Cellular Therapy FACT. Other countries also have regulations pertaining to cord blood. Cord Blood Banks in Canada must satisfy Health Canada Standards and may be accredited by AABB. Cord blood banks in the UK, both public and private, must be licensed by the Human Tissue Authority in order to release transplants to hospitals in the National Health Service. Only one bank is licensed and headquartered in New York City, Americord Registry.
So far, cord blood banking is not considered a deductible medical expense on US income taxes. To be exact, the IRS guidelines do not explicitly mention cord blood banking one way or the other. IRS policy is that health insurance is deductible but life insurance is not, and most interpretations of the guidelines have treated cord blood banking as a form of life insurance. Bills have been introduced into the House of Representatives that would amend the IRS code to explicitly allow the cost of cord blood banking to be a tax deductible medical expense. In the 111th Congress of 2009-2010, H.R.1718 garnered 20 co-sponsored but did not pass due to other urgent national issues. In the 112th Congress, the bill was re-introduced in April 2011 as H.R.1614.
Likelihood of use
The likelihood of using cord blood in private banks has rested mostly on the odds that the donor child or a family member will require a stem cell transplant. In the United States, the lifetime probability (up to age 70) that an individual will undergo an autologous transplant of their own stem cells is 1 in 435, the lifetime probability to undergo an allogeneic transplant of stem cells from a donor (such as a sibling) is 1 in 400, and the overall odds of undergoing any stem cell transplant is 1 in 217. These figures are based on actual transplant rates in 2001-2003.
Cord blood transplants require less stringent matching between the tissue types of the donor and patient, known as their HLA types Human leukocyte antigen. Bone marrow transplants require a complete match on six key antigens, which are measures of graft-versus-host reaction, known as a 6/6 match. Cord blood transplants achieve the same medical success with only a 4/6 match. HLA type is inherited from both parents, so siblings are particularly likely to be a match, and people from the same ethnic heritage are more likely to match. Minority ethnic groups have difficulty finding a perfectly matched transplant donor; for them, the ability to transplant partially-mismatched cord blood opens access to transplant therapy. The Stem Cell Act of 2005 mandated HRSA to fund public cord blood banks to recruit more cord blood donations from ethnic minorities .
Studies have found that allogeneic transplants have better outcome when the donor and patient are related (because, in addition to those six key antigens, so many other antigens match). The odds that two siblings will have the 6/6 match required for a bone marrow transplant are 25%. The odds that two siblings will have the 4/6 match required for a cord blood transplant are 39%.
Legality and ethics
In the United States, cord blood education is supported by legislators at the federal and state levels. In 2005, the National Academy of Sciences issued an Institute of Medicine (IoM) report, which recommended that expectant parents be given a balanced perspective on their options for cord blood banking. In response to their constituents, state legislators across the United States are introducing legislation intended to help inform physicians and expectant parents on the options for donating, discarding, or banking lifesaving newborn stem cells. Currently, 17 states, covering two-thirds of U.S. births, have enacted legislation recommended by the IoM guidelines.
In 2004, the European Group on Ethics in Science and New Technologies advised the European Commission that "The legitimacy of commercial cord blood banks for autologous [self] use should be questioned as they sell a service, which has presently, no real use regarding therapeutic options. Thus, they promise more than they can deliver. The activities of such banks raise serious ethical criticisms." For those at low risk, private storage of one's own cord blood is unlawful in Italy and France, and discouraged in some other European states.
Controversy among medical societies
The Royal College of Obstetricians and Gynaecologists 2006 opinion states, "There is still insufficient evidence to recommend directed commercial cord blood collection and stem-cell storage in low-risk families."
The policy of the Society of Obstetricians and Gynaecologists of Canada (SOGC) supports public cord blood banking (similar to collection and banking of other blood products, i.e. altruistic, anyone can use it), as well as stating it should be considered under certain circumstances. SOGC Clinical Practice Guidelines, No. 156, March 2005. Umbilical Cord Blood Banking: Implications for Perinatal Care Providers
The policy of the American Academy of Pediatrics policy states that "private storage of cord blood as 'biological insurance' is unwise" unless there is a family member with a current or potential need to undergo a stem cell transplantation.
Similarly, the American College of Obstetricians and Gynecologists does not recommend private cord blood banking.
Private storage of one's own cord blood is unlawful in Italy and France, and it is discouraged in some other European states. the American Academy of Pediatrics states that private cord blood banking is generally not recommended unless there is a family history of specific genetic diseases.
The American Society for Blood and Marrow Transplantation states that public donation of cord blood is encouraged where possible, the probability of using one's own cord blood is very small, and therefore storage of cord blood for personal use is not recommended, and family member banking (collecting and storing cord blood for a family member) is recommended when there is a sibling with a disease that may be treated successfully with allogeneic transplant.
Safety and effectiveness of using one's own cells unclear
Using one's own cord blood cells might not be wise or effective, especially in cases of childhood cancers and leukemia. Children who develop an immunological disorder often are unable to use their own cord blood for transplant because the blood also contains the same genetic defect. Nearly all of the transplants using privately banked cord blood have gone to relatives with pre-existing conditions, not to the donors.
Additional issues include the possible contamination of the cord blood unit with the same cancer diagnosed later in life; for example, abnormal cells have been detected in filters containing newborn blood of children who were not diagnosed with acute leukemia until the age of 2 to 6 years. The high relapse rates after autologous or syngeneic tranplant and the benefit of a graft-vs.-leukemia effect of an allogeneic transplant suggest that autologous cord blood would not be the ideal source of stem cells for patients with leukemia needing a transplant.
Usability of one's own sample unknown
Most cord blood samples - up to 75% - may be too small to be used for transplantation because they don't contain enough stem cells. While a private bank will store a sample, the sample may be too small to be usable, even by a child. Larger numbers of blood cells are required for adults because of their typically larger body mass.
Ownership of cord blood
As of 2007, contracts of the largest cord blood banks do not explicitly state that the cord blood belongs to the donors and child with all the rights and privileges one would reasonably expect from ownership. The ambiguity leaves open future uses not approved by the donors and child. Some contracts fail to spell out the rights of the donors requesting termination of storage: e.g. the right to request and verify destruction of the samples (as when a period of likely need has passed, or their minds have changed).
Concerns have been raised that the current interest in cord blood could cause a perception that cord blood is 'unused' by the birth process, thus decreasing the amount of blood which is infused into the child as part of the birth process. The pulsation of the cord pushes blood into the child, and it has been recommended that the cord cease pulsation prior to clamping. With the demand for cord blood increasing, there is a possibility that the cord could be clamped prematurely to preserve even more 'extra' cord blood. This action could have detrimental effects on the child's future development.
The American Academy of Pediatricians notes: "if cord clamping is done too soon after birth, the infant may be deprived of a placental blood transfusion, resulting in lower blood volume and increased risk for anemia."
Confusion with embryonic stem cells
Much of the general public in the United States is somewhat aware of embryonic stem cells because of the controversy associated with them. However, cord blood stem cells (hematopoietic stem cells) are not embryonic stem cells (pluripotent stem cells).
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