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Article:Cord blood bank
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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 [[Organ transplant|transplant]]s in treating diseases of the blood and immune systems.
Expecting parents are faced with a lot of important decisions before their baby is born. These include the basics, such as what to name the baby, which Pediatrician to go to, breastfeeding vs. formula feeding, etc. And more and more, they are having to consider the issue of whether or not to bank their baby's umbilical cord blood.
From ads in parenting magazines, direct mailings, and flyers in their obstetrician's office, expecting parents are repeatedly told of their 'once-in-a-lifetime chance' to save their baby's umbilical cord blood for possible use later to save his life.
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.<ref name="opinion2006">[ Parents Guide] (PDF)</ref><ref name="pressrelease">[ AAP: CORD BLOOD BANKING FOR FUTURE TRANSPLANTATION NOT RECOMMENDED] Press Release</ref><ref name="canroutine">[ Can Routine Commercial Cord Blood Banking Be Scientifically and Ethically Justified?]</ref> 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.
Since it doesn't hurt to take a baby's umbilical cord blood and it would in fact be discarded anyway, you wouldn't think that there would be much of an issue with cord blood banking. What parent wouldn't want to do everything that they could to make sure that their baby grows up to be healthy?
Banking a cord blood in private banks is a personal choice made by both parents.<ref name=CB>{{cite web|url=|title=Banking Cord Blood: More Than A Parent's Responsibility|accessdate=September 29, 2011}}</ref> 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.
But the issue isn't really with cord blood banking, which every parent should likely try to do. The issue is more about banking blood in a for-profit private cord blood bank for a family's own use. As an alternative, parents can donate their baby's umbilical cord blood in a public bank for free.
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]. Other countries also have regulations pertaining to cord blood.
Cord blood contains [[Haematopoiesis|hematopoietic]] [[stem cell]]s, progenitor cells which can form [[red blood cell]]s, [[white blood cell]]s and [[platelet]]s. 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.{{clarify|date=November 2011}}
Latest Developments
==The collection process==
Umbilical cord blood stem cells can be used in transplants to treat a variety of pediatric disorders including leukemia, sickle cell disease, and metabolic disorders. Patients who need a cord blood transplant can currently try to find a match with a sibling or from an unrelated person. An autologous (self) transplant can also be done if a child's umbilical cord blood has been stored in a private cord blood bank, although you wouldn't do that for conditions like leukemia because of the genetic risk of the leukemia being in the cord blood too.
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]]'''<ref name=Health>{{cite web|url=|title=Banking Cord Blood is Health Investment|accessdate=August 19, 2011}}</ref> is stored for later use, it undergoes viral testing, including tests for [[HIV]] and [[Hepatitis]] B and C, and [[tissue typing]] (to determine [[Human Leukocyte Antigen|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 [[Cryopreservation|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 disease]]s, [[cancer]]s, and blood disorders.<ref>See [[cord blood]] for a list of treated diseases, or visit the [ National Donor Marrow Program website]</ref>
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<ref>[ Cord Blood for Neonatal Hypoxic-Ischemic Encephalopathy], Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety</ref> and Type 1 Diabetes<ref>{{cite journal
|author=Haller MJ, etal.
|title=Autologous Umbilical Cord Blood Infusion for Type 1 Diabetes
|journal=Exp. Hematol.
}}</ref> is already being studied in humans, and earlier stage research is being conducted for treatments of stroke,<ref>{{cite journal
|author=Vendrame M, et al.
|title=Cord blood rescues stroke-induced changes in splenocyte phenotype and function
|journal=Exp. Neurol.
}}</ref><ref>{{cite journal
|author=Vendrame M, et al.
|title=Anti-inflammatory effects of human cord blood cells in a rat model of stroke
|journal=Stem Cells Dev.
}}</ref> and hearing loss.<ref>{{cite journal
|author=Revoltella RP, et al.
|title=Cochlear repair by transplantation of human cord blood CD133+ cells to nod-scid mice made deaf with kanamycin and noise
|journal=Cell Transplant.
Current estimates indicate that approximately 1 in 3 Americans could benefit from regenerative medicine,<ref name="Harris DT, et al. 2007 1311–1322">{{cite journal
|author=Harris DT, et al.
|title=The potential of cord blood stem cells for use in regenerative medicine
|journal=Expert Opin. Biol. Ther.
}}</ref> 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.<ref>{{cite journal
|author=Haller MJ, et al.
|title=Autologous Umbilical Cord Blood Infusion for Type 1 Diabetes
|journal=Exp. Hematol.
=== Cardiovascular ===
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.<ref name="Harris DT, et al. 2007 1311–1322"/>
=== 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.<ref>{{cite journal
|author=Lu D, et al.
|title=Intravenous administration of human umbilical cord blood reduces neurological deficit in the rat after traumatic brain injury
|journal=Cell Transplant.
}}</ref><ref>{{cite journal
|author=Meier C, etal.
|first7=Hubert R.
|title=Spastic paresis after perinatal brain damage in rats is reduced by human cord blood mononuclear cells
|journal=Pediatr. Res.
}}</ref> 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.<ref>{{cite journal
|author=Taguchi A, et al.
|title=Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesisin a mouse model
|journal=J. Clin. Invest.
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.{{citation needed|date=October 2011}}
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.{{citation needed|date=October 2011}}
== 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.<ref>{{cite journal
|author=Dominici M, etal.
|title=Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement
|last2=Le Blanc
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.<ref>{{cite journal
|author=Uccelli A, etal.
|title=Mesenchymal stem cells in health and disease
|journal=Nature Reviews Immunology.
Harvesting the tissue of the umbilical cord can yield between 21 and 500 million MSC.<ref>{{cite journal
|author=Schugar, Rebecca C., etal.
|title=High Harvest Yield, High Expansion, and Phenotype Stability of CD146 Mesenchymal Stromal Cells from Whole Primitive Human Umbilical Cord Tissue
|journal=Journal of Biomedicine and Biotechnology
By comparison, a typical cord blood collection in a private bank has a median total nucleated cell count of 470 million.<ref>{{cite journal
|author=Sun, Jessica J, etal.
|title=Differences in quality between privately and publicly banked umbilical cord blood units: a pilot study of autologous cord blood infusion in children with acquired neurological disorders
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.<ref>{{cite journal
|author=Giordano A, etal.
|title=From the laboratory bench to the patient's bedside: An update on clinical trials with mesenchymal stem cells
|journal=Exp. Hematol.
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,<ref>{{cite journal
|author=Maurya DK, etal.
|title=Therapy with un-engineered naïve rat umbilical cord matrix stem cells markedly inhibits growth of murine lung adenocarcinoma
|journal=BMC Cancer.
|first4=Marla M
Parkinson's Disease,<ref>{{cite journal
|author=Fu, YS,
|title=Conversion of human umbilical cord mesenchymal stem cells in Wharton's jelly to dopaminergic neurons in vitro: potential therapeutic application for Parkinsonism
|journal=Stem Cells.
Rheumatoid Arthritis,<ref>{{cite journal
|author=Liu, Y, etal.
|title=Therapeutic potential of human umbilical cord mesenchymal stem cells in the treatment of rheumatoid arthritis
|journal=Arthritis Research & Therapy
Sports injuries to cartilage,<ref>{{cite journal
|author=Limin Wang, etal.
|title=A Comparison of Human Bone Marrow–Derived Mesenchymal Stem Cells and Human Umbilical Cord–Derived Mesenchymal Stromal Cells for Cartilage Tissue Engineering
|journal=Tissue Engineering Part A.
and Type 1 Diabetes.<ref>{{cite journal
|author=Rita Anzalone, etal.
|title=Wharton's Jelly Mesenchymal Stem Cells as Candidates for Beta Cells Regeneration: Extending the Differentiative and Immunomodulatory Benefits of Adult Mesenchymal Stem Cells for the Treatment of Type 1 Diabetes
|journal=Stem Cell Reviews and Reports.
|last2=Lo Iacono
|last4=Di Stefano
|last7=La Rocca
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.<ref>{{cite journal
|author=Mazur P
|title=Stopping biological time. The freezing of living cells
|journal=Ann N Y Acad Sci.
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<ref>[ Serendipity in lab turns blood into stem cells]</ref> or from tissue culture.
==Banking methods==
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.<ref></ref> 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.
==Public banks==
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 [[Ethics|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.{{Citation needed|date=July 2010}}
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.{{Citation needed|date=July 2011}} 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 banks==
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.<ref name="canroutine"/> 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.
=== Tax deductibility ===
Currently cord blood banking is not a deductible medical expense in the US tax system. The IRS guidelines do not explicitly mention cord blood banking one way or the other. The 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 votes. 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.<ref>Nietfeld JJ, Pasquini MC, Logan BR, Verter F, Horowitz MM. Lifetime probabilities of hematopoietic stem cell transplantation in the US. Biol Blood Marrow Transplant. 2008;14:316-22.</ref> 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).<ref>{{cite journal | doi = 10.1056/NEJM199708073370602 | last1 = Gluckman | first1 = E | last2 = Rocha | first2 = V | last3 = Boyer-Chammard | first3 = A | author-separator =, | last4 = Locatelli | author-name-separator= | first4 = F| year = 1997 | last5 = Arcese | first5 = W | last6 = Pasquini | first6 = R | last7 = Ortega | first7 = J | last8 = Souillet | first8 = G | last9 = Ferreira | first9 = E | title = Outcome of cord blood transplantation from related and unrelated donors | url = | journal = New England Journal of Medicine | volume = 337 | issue = 6| pages = 373–381 | pmid = 9241126 }}</ref> 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 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. {{Citation needed|date=December 2011}}
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."<ref>[] (PDF)</ref> 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.<ref name="opinion2006"/><ref name="bloodpressures" />
In South Africa, there are three active commercial cord blood banks. The South African government has published two consecutive versions of draft regulations for public comment in terms of the National Health Act: An initial version in 2007<ref>''Draft regulations relating to human stem cells'', published under Government Notice R376 in Government Gazette 29840 of 4 May 2007.</ref> and a revised version in 2011.<ref>''Draft regulations relating to stem cell institutions or organisations'', published under Government Notice R265 in Government Gazette 34159 of 1 April 2011.</ref> While the 2007-version sought an effective ban on commercial cord blood banks by a) limiting access to private stem cell banking to high-risk families, and b) instituting a comprehensive profit-ban on activities of stem cell banks, these two features were omitted from the 2011-version. It has been argued that a ban on commercial cord blood banks, whether explicit or implicit, would violate South Africa's Bill of Rights.<ref>{{cite journal |author=Jordaan DW, Woodrow C, Pepper MS |title=Banning private stem cell banks: a human rights analysis |journal=South African Journal on Human Rights |volume=25 |issue=1 |pages=126–51 |year=2009 |url=}}</ref>
Some doctors and patients have stated that the claims of some private cord blood banks are deceptive and misleading.<ref name="bloodpressures" /><ref>[ IS IT WORTH BANKING YOUR BABY'S CORD BLOOD? - Doctors say hard sell of hope is deceptive]</ref><ref>[,70091-0.html?tw=rss.index Law Annoys Private Cord Banks]</ref>
===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."<ref name="opinion2006"/>
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.<ref></ref> 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.<ref name="pressrelease" />
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.<ref name="opinion2006">
[] (PDF)</ref><ref name="pressrelease"/><ref name="canroutine"/> 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.<ref name="bloodpressures">[ Blood Pressures: The Controversy Over Cord Blood]</ref>
The American Society for Blood and Marrow Transplantation<ref>[ American Society for Blood and Marrow Transplantation (ASBMT)]</ref> 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.<ref>[ Medical References: Umbilical Cord Blood]</ref> 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.<ref name="bloodpressures" />
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.<ref>Ballen et al. ASBMT Committee Report: Collection and Preservation of Cord Blood for Personal Use BBMT 14: 356 - 363, 2008</ref>
===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.<ref name="bloodpressures" /> 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).{{Citation needed|date=August 2010}} One large private bank reverts ownership to the bank if the client cancels the ongoing contract or if maintenance (storage) fees are not paid. The bank then "...will have the right to discard or use the sample(s) at its sole discretion."<ref>{{cite web|last=Cord Blood Registry|title=Client Services Agreement|url=|work=Only available prior to submitting payment information in account creation|accessdate=3 June 2012}}</ref>
==Medical issues==
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.<ref>See the website: []</ref>
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."<ref name="pressrelease" />
The Journal of the [[American Academy of Pediatrics]] published an article in April 2006 recommending that clamping be delayed to reduce anemia and improve neonatal iron storage.<ref>[ The Effect of Timing of Cord Clamping on Neonatal Venous Hematocrit Values and Clinical Outcome at Term: A Randomized, Controlled Trial]</ref>
==Confusion with embryonic stem cells==
The public in the United States has a general awareness of [[embryonic stem cell]]s because of the [[stem cell controversy]]. However, cord blood stem cells ([[haematopoiesis|hematopoietic]] [[stem cells]]) are not embryonic stem cells ([[pluripotency|pluripotent]] stem cells).
==See also==
*[[Cord blood]]
*[[Umbilical cord]]
*[[Stem cell]]
*[[Bone marrow transplant]]
*[[Placenta cord banking]]
<references />
*Cairo, Mitchell S. and John E. Wagner, "Placental and/or Umbilical Cord Blood: An Alternative Source of Hematopoietic Stem Cells for Transplantation," ''The Journal of The American Society of Hematology'' 90:4665-4678 (1997)
*Kline, Ronald M., "Whose Blood is it, Anyway?", ''Scientific American'' 284: 42-49 (April 2001)
*Kline, Ronald M., and Salvatore Bertolone, "Umbilical Cord Blood Transplantation: Providing a Donor for Everyone Needing a Bone Marrow Transplant?", ''Southern Medical Journal'' 91: 821-827 (1999)
==External links==
'''NOTICE: Please do not add links to commercial banking sites. If the site makes a profit by banking blood, it's a commercial site, even if it also provides information. Such links will be immediately removed. Only public information sites (on either side of the debate) should be included here. Please see [[WP:SPAM]] for more information on this policy. Thank you.'''
* [ NHS UK Cord Blood Bank]&mdash; The NHS Cord Blood Bank
*[ Blood Pressures: The Controversy Over Cord Blood], Parents' magazine, April 2006
*[ SOGC Practice Guidelines]
*[ Cord Blood Banking] &mdash; A complete resource and guide to private cord blood banking
*[ Can Routine Commercial Cord Blood Banking Be Scientifically and Ethically Justified?]
*[] &mdash; Umbilical Cord Issues
*[ Cord Blood Banking UK] &mdash; UK Cord Blood Bank Association
*[ Community Blood Services] The New Jersey Cord Blood Bank (NJCBB)
*[ Hong Kong Red Cross Blood Transfusion Service - Cord Blood Bank]
*[ Gift of Life Bone Marrow Foundation - Cord Blood Program]
*[ Swiss Stem Cells Bank Salveo Biotechnology active in Europe and Russia]
*[ Cord Blood Storage - Stem Cells Bank in India]
{{DEFAULTSORT:Cord Blood Bank}}
[[Category:Blood banks]]
[[Category:Stem cells]]
[[es:Banco de cordón umbilical]]
[[fr:Banque de cellules souches issues du sang de cordon]]
[[pl:Bank komórek macierzystych]]
[[ru:Банк пуповинной крови]]
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