Cord blood bank: Difference between revisions - Wikipedia
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A '''cord blood bank''' is a facility which stores [[Umbilical cord|umbilical]] [[cord blood]] for future use. Both private and public cord blood banks have developed in response to the potential for cord blood in treating diseases of the blood and immune systems. Public cord blood banks accept donations to be used for anyone in need, and as such function like public blood banks. Traditionally, public cord blood banking has been more widely accepted by the medical community.<ref name="ama-assn1">{{cite web|url=http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion2165.page |title=Opinion 2.165 -— Umbilical Cord Blood Banking |publisher=Ama-assn.org |date= |accessdate=2015-03-09}}</ref> Private cord blood banks store cord blood solely for potential use by the donor or donor's family. Private banks typically charge around $2,000 for the collection and around $200 a year for storage.<ref name="abcnews1">{{cite web|url=https://abcnews.go.com/WN/WorldNews/cord-blood-banking-marketing-medicine/story?id=10577020 |title=Cord Blood Banking: Marketing Before Medicine? -— ABC News |publisher=Abcnews.go.com |date=2010-05-06 |accessdate=2015-03-09}}</ref>▼
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▲A '''cord blood bank''' is a facility which stores [[Umbilical cord|umbilical]] [[cord blood]] for future use. Both private and public cord blood banks have developed in response to the potential for cord blood in treating diseases of the blood and immune systems. Public cord blood banks accept donations to be used for anyone in need, and as such function like public blood banks. Traditionally, public cord blood banking has been more widely accepted by the medical community.<ref name="ama-assn1">{{cite web|url=http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion2165.page |title=Opinion 2.165 - Umbilical Cord Blood Banking |publisher=Ama-assn.org |date= |accessdate=2015-03-09}}</ref> Private cord blood banks store cord blood solely for potential use by the donor or donor's family. Private banks typically charge around $2,000 for the collection and around $200 a year for storage.<ref name="abcnews1">{{cite web|url=https://abcnews.go.com/WN/WorldNews/cord-blood-banking-marketing-medicine/story?id=10577020 |title=Cord Blood Banking: Marketing Before Medicine? - ABC News |publisher=Abcnews.go.com |date=2010-05-06 |accessdate=2015-03-09}}</ref>
The policy of the [[American Academy of Pediatrics]] 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="aappublications1" /><ref>{{cite web |url=http://www.nationalcordbloodprogram.org/AAP%20News%20Release%20-%20AAP%20CORD%20BLOOD%20BANKING%20FOR%20FUTURE%20TRANSPLANTATION%20NOT%20RECOMMENDED.htm |archive-url=https://web.archive.org/web/20060105213209/http://www.nationalcordbloodprogram.org/AAP%20News%20Release%20-%20AAP%20CORD%20BLOOD%20BANKING%20FOR%20FUTURE%20TRANSPLANTATION%20NOT%20RECOMMENDED.htm |url-status=dead |archive-date=2006-01-05 |title=Aap News Release -— Aap: Cord Blood Banking For Future Transplantation Not Recommended |publisher=Nationalcordbloodprogram.org |date=1999-07-06 |accessdate=2015-03-09 }}</ref><ref name="Pediatrics.aappublications.org">{{cite journal|url=http://pediatrics.aappublications.org/content/123/3/1011.abstract |title=Private Cord Blood Banking: Experiences and Views of Pediatric Hematopoietic Cell Transplantation Physicians |year=2009 |publisher=Pediatrics.aappublications.org |doi=10.1542/peds.2008-0436 |accessdate=2015-03-09|last1=Thornley |first1=I. |last2=Eapen |first2=M. |last3=Sung |first3=L. |last4=Lee |first4=S. J. |last5=Davies |first5=S. M. |last6=Joffe |first6=S. |journal=Pediatrics |volume=123 |issue=3 |pages=1011–10171011–7 |pmid=19255033 |pmc=3120215 }}</ref> The American Academy of Pediatrics also notes that the odds of using one's own cord blood is 1 in 200,000<ref name="webmd2">{{cite web|url=http://www.webmd.com/parenting/baby/features/banking-your-babys-cord-blood?page=2 |title=Umbilical cord blood banking: Pros & cons, costs, banking basics |publisher=Webmd.com |date= |accessdate=2015-03-09}}</ref> while the [[National Academy of Medicine]] says that only 14 such procedures have ever been performed.<ref name="webmd2" /> Private storage of one's own cord blood is unlawful in Italy and France, and it is also discouraged in some other European countries. The [[American Medical Association]] states "Private banking should be considered in the unusual circumstance when there exists a family predisposition to a condition in which umbilical cord stem cells are therapeutically indicated. However, because of its cost, limited likelihood of use, and inaccessibility to others, private banking should not be recommended to low-risk families."<ref name="ama-assn1" /> The American Society for Blood and Marrow Transplantation and the [[American Congress of Obstetricians and Gynecologists]] also encourage public cord banking and discourage private cord blood banking. Nearly all cord blood transfusions come from public banks, rather than private banks,<ref name="abcnews1" /><ref name="Pediatrics.aappublications.org" /> partly because most treatable conditions can't use one's own cord blood.<ref name="aappublications1">{{cite journal|url=http://pediatrics.aappublications.org/content/119/1/165.full |title=Cord Blood Banking for Potential Future Transplantation |journal=Pediatrics |year=2007 |volume=119 |pages=165–170 |publisher=Pediatrics.aappublications.org |doi=10.1542/peds.2006-2901 |pmid=17200285 |accessdate=2015-03-09|author1=American Academy of Pediatrics Section on Hematology/Oncology |author2=American Academy of Pediatrics Section on Allergy/Immunology |last3=Lubin |first3=B. H. |last4=Shearer |first4=W. T. |issue=1 |pmc=6091883 |s2cid=73370999 }}</ref><ref name="autogenerated1">{{cite web|last=Searcey |first=Dionne |url=https://www.wsj.com/articles/SB10001424052702303887804579501500366071342 |title=Inside the Private Umbilical Cord Blood Banking Business |publisher=WSJ |date=2014-04-25 |accessdate=2015-03-09}}</ref>
Cord blood contains [[hematopoietic]] stem cells (which can differentiate only into blood cells), and should not be confused with [[embryonic stem cell]]s or [[pluripotent stem cell]]s, which can differentiate into any cell in the body.<ref name="abcnews1" /><ref name="aappublications1" /> Cord blood stem cells are blood cell progenitors which can form red blood cells, white blood cells, and platelets. This is why cord blood cells are currently used to treat blood and immune system related genetic diseases, cancers, and blood disorders. Cord blood is also a source of mesenchymal stem cells, which can further be differentiated to form connective tissues, bones and cartilage.<ref>{{Cite web|url=http://www.stemcellsaustralia.edu.au/About-Stem-Cells/FAQ/What-are-umbilical-cord-stem-cells-.aspx|title=What are umbilical cord stem cells? -— Stem Cells Australia|last=zainab|first=khursheed|date=|website=www.stemcellsaustralia.edu.au|access-date=2019-11-10|archive-date=2019-10-21|archive-url=https://web.archive.org/web/20191021194314/http://www.stemcellsaustralia.edu.au/About-Stem-Cells/FAQ/What-are-umbilical-cord-stem-cells-.aspx|url-status=dead}}</ref> On the possibility that cord blood stem cells could be used for other purposes, the World Marrow Donor Association and European Group on Ethics in Science and New Technologies states "The possibility of using one’s own cord blood stem cells for regenerative medicine is currently purely hypothetical....It is therefore highly hypothetical that cord blood cells kept for autologous use will be of any value in the future” and “the legitimacy of commercial cord blood banks for autologous use should be questioned as they sell a service which has presently no real use regarding therapeutic options.”<ref name="autogenerated2">{{cite web|url=http://bloodcell.transplant.hrsa.gov/cord/files/wmdapolicystatement.pdf|title=WMDA Policy Statement on the Utility of Autologous or Family Cord Blood Unit Storage|publisher=Bloodcell.transplant.hrsa.gov|accessdate=2015-03-09|archive-url=https://web.archive.org/web/20171010155416/https://bloodcell.transplant.hrsa.gov/cord/files/wmdapolicystatement.pdf|archive-date=2017-10-10|url-status=dead}}</ref><ref>{{cite web|url=http://www.nationalcordbloodprogram.org/donation/public_vs_private_donation.html |title=Public Cord Blood Donation |publisher=National Cord Blood Program |date= |accessdate=2015-03-09}}</ref>
==Regulation==
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.<ref>{{cite web|url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271|title=CFR -— Code of Federal Regulations Title 21|publisher=[[Food and Drug Administration]]|accessdate=2014-03-18}}</ref> Several states also require accreditation, including New York, New Jersey, and California. Any company not accredited within those states are not legally permitted to collect cord blood from those states, even if the company is based out of state. Potential clients can check the New York accreditation status from the New York Umbilical Cord Blood Banks Licensed to Collect in New York.<ref>{{cite web|url=http://www.health.ny.gov/professionals/patients/donation/umbilical_cord_blood/licensed_banks.htm |title=Umbilical Cord Blood Banks Licensed to Collect in New York |publisher=Health.ny.gov |date= |accessdate=2015-03-09}}</ref> Both public and private cord blood banks are also eligible for voluntary accreditation with either the Association for the Advancement of Blood & Biotherapies (AABB) or the Foundation for the Accreditation of Cellular Therapy (FACT). Potential clients can check the current accreditation status of laboratories from the AABB list of accredited cord blood laboratories or the FACT search engine of accredited cord blood banks (on their home page).<ref>{{cite web|url=http://www.aabb.org/sa/facilities/celltherapy/Pages/CordBloodAccrFac.aspx |title=AABB Accredited Cord Blood (CB) Facilities |publisher=Aabb.org |date= |accessdate=2015-03-09}}</ref> Other countries also have regulations pertaining to cord blood.<ref name="parents1">{{cite web|last=Moninger |first=Jeannette |url=http://www.parents.com/pregnancy/my-baby/cord-blood-banking/the-cord-blood-controversy/ |title=The Cord Blood Banking Controversy |publisher=Parents.com |date= |accessdate=2015-03-09}}</ref>
==Collection and cryopreservation==
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 ten minutes of giving birth. Additional stem cells may be collected from the placenta. 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 75mL 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 Human Leukocyte Antigen type. It will also be examined for nucleated cell count, cell viability, blood group antigen ABO & Rh blood group system, molecule cluster ([[CD34]]), and bacterial and fungal growth.{{cn|date=December 2021}}
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 the best way is. 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 cryogenic process. After the unit is slowly cooled to −90 °C, it can then be added to a liquid nitrogen tank which will keep the cord blood unit frozen at −196 °C. The slow freezing process is important to keep the cells alive during the freezing process. 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.<ref>{{cncite journal |vauthors=Jahan S, Kaushal R, Pasha R, Pineault N |title=Current and Future Perspectives for the Cryopreservation of Cord Blood Stem Cells |journal=Transfus Med Rev |volume=35 |issue=2 |pages=95–102 |date=DecemberApril 2021 |pmid=33640254 |doi=10.1016/j.tmrv.2021.01.003 }}</ref>
Cord blood stem cells (though usually from donors) are currently used in the treatment of several life-threatening conditions, mainly 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.<ref name="aappublications1" /> 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. Cord blood stem cells can also be used for siblings and other members of your family who have a matching tissue type. Siblings have a 25% chance of compatibility, and the cord blood may even be a match for parents (50%) and grandparents.<ref name="aappublications1" />▼
▲Cord blood stem cells (though usually from donors) are currently used in the treatment of several life-threatening conditions, mainly 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. SinceFor thentwo decades after that, cord blood has becomebecame increasingly recognized as a source of stem cells that can be used in stem cell therapy.<ref name="aappublications1" /> RecentSubsequently, studieswith havethe shownarrival thatof cordnewer bloodtechniques hassuch uniqueas advantages over traditional bone marrowhaploidentical transplantation, particularlythere in children, and can be life-saving in rare caseshas wherebeen a suitabletrend bone-marrowaway donorfrom cannotcord beblood found.as Cord bloodthe stem cellscell cansource.<ref alsoname="NYT be2024">{{cite usednews for|last1=Kliff siblings|first1=Sarah and|title=What otherParents membersShould ofKnow yourAbout familyCord whoBlood haveBanking a matching tissue type|url=https://www.nytimes. Siblings have a 25% chance of compatibility, and the com/2024/07/15/health/cord -blood-banking.html may|access-date=23 evenAugust be2024 a|publisher=The matchNew forYork parentsTimes (50%)|date=July and15, grandparents.2024}}</ref name="aappublications1" />
==Public banks==
Public cord blood banks function like public blood banks, in that they accept donations from anyone, discard donations that fail to meet various quality control standards, and use national registries to find recipients for their samples. Since patients who need cord blood frequently need more cells than a single collection would have provided, public banks frequently combined multiple samples together when preparing the treatment for a single patient. UnlikeBefore the advent of haploidentical bone marrow transplantation, cord blood's transplantationlack doesn'tof requirerequirement for an exact genetic match, which makesmade it easier to provide patients samples from unrelated donors.<ref name="aappublications1" /> The percentage of public bank donations discarded as medical waste is often cited to be between 60 and 80%. Some of this is due to contamination that occasionally occurs during collection or complications arising from shipping, though this is mostly due to the fact that most cord blood collections fail to collect enough usable cells.<ref name="parents1" /> Because matches are almost always likely to be better in a public than a private bank, and cord blood from public banks doesn't suffer from the problems it commonly suffers from at private banks (such as potential lower quality control and lower medical usefulness of using a patient's own potentially diseased cord blood), public cord blood banking has been more widely accepted by the medical community.<ref name="ama-assn1" /> One important obstacle facing public banks is the high cost required to maintain them, which has prevented more than a handful from opening. Because public banks do not charge storage fees, medical centers do not always have the funds required to establish and maintain them.<ref>"[https://www.babiesonline.com/articles/pregnancy/cord-blood/public-vs-private-cord-blood-banks.asp Public vs Private Cord Blood Banks]", Babies Online, Retrieved September 6, 2016</ref>
A recent large study by the journal Pediatrics concluded that almost all cord blood transplants come from public banks:<ref>{{cite web|url=https://www.washingtonpost.com/wp-dyn/content/article/2009/04/13/AR2009041301860.html |title=Study Questions Value of Private Cord-Blood Banks |work=Washingtonpost.com |date= |accessdate=2015-03-09}}</ref>
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Private banking is typically costly to parents and not covered by insurance. The ability to use the cord blood may also depend on the long-term commercial viability of the enterprise.<ref name="autogenerated1" /> 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.<ref name="autogenerated1" /> 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”. Since the FDA considers cord blood stored at public banks to be "drugs", but doesn't consider cord blood stored at private banks for use by the donor to be drugs, private banks are held to a less stringent regulatory standard.<ref name="parents1" />
CordHistorically, cord blood transplants requirerequired less stringent matching between the tissue types of the donor and patient, known as their [[human leukocyte antigen]] (HLA) types. Bone marrow transplants requirerequired a complete match on six key antigens, whichto aredecrease the measureschance of graft-versus-host reactiondisease, known as a 6/6 match. Cord blood transplants achieveachieved the same medical success with only a 4/6 match.<ref name="parents1" /> 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. Studies have found that allogeneicAllogeneic transplants have traditionally had a better outcome when the donor and patient are related, because then the minor antigens also match.<ref>{{cite journal |vauthors=Vittayawacharin P, Kongtim P, Ciurea SO |title=Future directions in haploidentical hematopoietic stem cell transplantation |journal=Hematology |volume=29 |issue=1 |pages=2366718 |date=December 2024 |pmid=38889342 |doi=10.1080/16078454.2024.2366718 |doi-access=free }}</ref> The odds that two siblings will have thea 6/6 match required, for a matched related bone marrow transplant, are 25%.<ref name="autogenerated1" /> The oddsNow that twonew siblingstechniques willfor haploidentical [[stem cell transplantation]] have thegreatly 4/6improved matchsuccess requiredrates, the requirement for a cordmatched blooddonor is much less of a barrier to transplant. are 39%Most families can provide a haploidentical donor.<ref>{{cncite journal |vauthors=Graham C, Litzow M |title=The use of haploidentical stem cell transplant as an alternative donor source in patients with decreased access to matched unrelated donors |journal=Hematology |volume=29 |issue=1 |pages=2338300 |date=December 20212024 |pmid=38753458 |doi=10.1080/16078454.2024.2338300 |doi-access=free }}</ref>
The policy of the [[Society of Obstetricians and Gynaecologists of Canada]] (SOGC) supports public cord blood banking (similar to the collection and banking of other blood products, i.e. altruistic, anyone can use it), as well as stating that it should only be considered under certain circumstances. The policy of the [[American Academy of Pediatrics]] 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. Private storage of one's own cord blood is unlawful in Italy and France, and it is also discouraged in some other European countries.<ref name="ama-assn1" />
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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.<ref name="autogenerated2"/>
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 transplant 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>{{citationcite journal |vauthors=Mosna F |title=The Immunotherapy of Acute Myeloid Leukemia: A Clinical Point of View |journal=Cancers (Basel) |volume=16 |issue=13 |pages= needed|date=JanuaryJune 20192024 |pmid=39001421 |pmc=11240611 |doi=10.3390/cancers16132359 |doi-access=free}}</ref>
In 2024, the ''New York Times'' described problems with microbial contamination as well as low-volume samples that did not have adequate stem cell counts.<ref name="NYT 2024" />
==Confusion with embryonic stem cells==