Umbilical Cord Blood Banking: An Update For Childbirth Educators (2024)

History of Cord Blood Transplantation and Banking

Umbilical cord blood was first described as a resource to obtain hematopoietic stem cells in the mid-1970s (Arutyunyan et al., 2018). Hematopoietic stem cells are immature cells that can differentiate into mature cells of diverse types within the body (Devi, 2016). These immature cells are most desirable because these stem cells are immunologically immature, leading to less infections, and require less stringent matching (Waller-Wise, 2011). The first umbilical cord blood stem cell transplant took place in 1988. The recipient was a 6-year-old boy, Matthew Farrow, who had Fanconi anemia, a genetic bone marrow disease. The donor stem cells came from his younger sister’s umbilical cord blood that had been frozen. While Matthew was from North Carolina in the United States, he and his family traveled to Paris, France where the transplant was performed. Prior to the stem cell transplant, Matthew’s prognosis was bleak; however, now he is currently healthy some thirty-plus years after this historic umbilical cord blood stem cell transplant (Arutyunyan et al., 2018; Kurtzberg, 2017; Waller-Wise, 2011).

Currently, hematopoietic stem cell transplants are used for four broad categories of diseases, namely, cancers, blood diseases, genetic disorders, and immunodeficiencies.

In 1990 the first unrelated donor cord blood stem cell transplant was accomplished in the United States on a 4-year-old boy with leukemia. The first public cord blood bank followed in the early 1990s (Kurtzberg, 2017). At this point cord blood stem cells have been preserved for over 25 years (Huang et al., 2019; Roura et al., 2015). Worldwide, it is thought that there are approximately 800,000 units of umbilical cord blood currently stored in public banks while as many as 4 million units are stored in private cord blood banks (Guerra-Marquez et al., 2020).

Current State of Cord Blood Stem Cells

Collection of umbilical cord blood can be accomplished with either a vagin*l or surgical birth, and with spontaneous labor or induced labor (Roura et al., 2015). Often between 60 to 300 milliliters (mL) of cord blood can be collected (Devi, 2016). According to the American College of Obstetrics and Gynecologists (ACOG) at least 40 mL must be collected to ensure an adequate cell size (ACOG, 2019). Prior to collection the birthing person is screened for any communicable diseases (Adams et al., 2018). Retrieval of the cord blood can take place prior to the release of the placenta, or after its expulsion (Devi, 2016). Collection of the cord blood can be completed quickly, usually in under five minutes. Cord blood is placed in a medium of an anticoagulant and transported to a laboratory for processing in a regulated environment (Roura et al., 2015).

Once at the storage laboratory, the sample is tested for infectious diseases (Matsumoto et al., 2015). Often tests for total nucleated cell (TNC) count, viable CD 34 content, and the presence of granulocyte-macrophage progenitor cells are performed. These are often considered the minimum requirements for pureness and effectiveness of the stem cell sample (Rich, 2015). Outcome measures associate a higher cell count with better after-effects of stem cell transplantation (Sacchi, 2018). The sample is then labeled for identification and frozen, a process called cryopreservation (Devi, 2016). If the sample is deemed to be less than an adequate sample, it may be discarded (Roura et al., 2016).

For the stem cells to be transplanted, the donor cells and the recipient must be matched for human leukocyte antigen (HLA) differences (Armitage, 2016; Dessels et al.,2018). An advantage of using umbilical stem cells is that more of a mismatch can be tolerated with these immature stem cells than with use of bone marrow stem cells, for example (Armitage, 2016). Additionally, there is much less risk of rejection of the stem cell transplant when the source of the hematopoietic stem cells is from umbilical cord blood (Dessels et al., 2018). Typical HLA matching for transplants is for six total antigens (Waller-Wise, 2011). However, with umbilical cord blood samples the aim is for a four out of six match, and in some cases a match of three out of six is permitted (Guerra-Marquez et al., 2020). See Table 1 for advantages of umbilical cord stem cell transplants.

One disadvantage of using umbilical cord blood hematopoietic stem cells is that it takes longer for these cells to produce the therapeutic effect needed. Thus, prolonging improvement and potentially increasing costs associated with extended hospitalization for illness. Another constraint is the limited TNC counts within a single unit of umbilical cord blood. To overcome this deficit often two units of cord blood is used for a treatment dose (Dessels et al., 2018). See Table 2 for disadvantages of umbilical cord stem cell transplants.

Efforts are underway to improve the efficiency of the umbilical cord blood stem cells. One of these ways is through improvements in the collection of cord blood. Studies have shown that collection of cord blood in a way in which the blood never encounters oxygen in ambient room air improves the resulting collected cells. Likewise, attempts are being made to improve the homing capability of the stem cells obtained from cord blood (Huang et al., 2019). Homing refers to the ability of the cells to target or “home in on” the exact locations where the damaged tissue or cells exist in the recipient (Liesveld et al., 2020).

Currently, hematopoietic stem cell transplants are used for four broad categories of diseases, namely, cancers, blood diseases, genetic disorders, and immunodeficiencies (Roura et al., 2015; Waller-Wise, 2011). The highest percentage of umbilical cord stem cell transplants in both adults and children tends to be for some form of leukemia (Guerra-Marquez et al., 2020; Roura et al., 2015). For sickle cell anemia, a genetic blood disorder, hematopoietic stem cells transplants are the only known therapy to cure this disease, having a greater than 90% success rate (Rafii et al., 2017). Umbilical cord blood transplants are now considered an accepted treatment for over 80 different disorders (Peberdy et al., 2016). See Table 3 for examples of disorders treated with umbilical cord stem cell transplants.

Research on hematopoietic stem cell transplants has broadened for use in neurological and regenerative medicine applications (Dessels et al., 2018). Experimental therapies include cerebral palsy, types 1 and 2 diabetes, autism, Alzheimer’s disease, neonatal hypoxic-ischemic encephalopathy, spinal cord injury, and others (Dessels et al., 2018; Roura et al., 2015). Of importance, many of the neurological and all the regenerative uses of umbilical stem cells remain in clinical research only. However, short term reports of these research studies show favorable results. As the clinical research concludes, medicine will gain a deeper understanding for these potential uses of umbilical cord blood stem cells (Dessels et al., 2018).

Types of Banks

There are three types of umbilical cord blood banks. These are public banks, private banks, and hybrid banks (Dessels et al., 2018; Matsumoto et al., 2015). Public cord blood banks, like venous banks, are based on altruistic motives. They tend to be not-for-profit entities (Roura et al., 2015). Public banks collect cord blood and keep it for an indefinite period for whenever and whoever needs it for a medical use. Donations are made to public banks without financial obligation (Armitage, 2016). This process is different from bone marrow stem cell processes, where bone marrow stem cells are only gathered when a need and donor are preidentified (Strong et al., 2018). The units available in a public bank are cataloged and registries can be searched both nationally and internationally. Processing fees are charged to cover some of the costs of storage and administration. Public banks receive other funding from philanthropic donations, government funding, and grants (Armitage, 2016).

Private banks are often called family banks. With these banks the donors pay the bank for storage of the cord blood, which is held until the donors release the cells for use. Typically, these cells units are used by the donor family or a matched relative (Dessels et al., 2018). Private banks charge an upfront fee for initial collection, then an annual charge to manage the cells units. Therefore, these are for-profit banks. Private banks are typically less regulated than public banks; therefore, quality may suffer (Armitage, 2016).

In this latest statement the AAP reaffirms its endorsem*nt of storage of cord blood in public banks, as the evidence shows positive outcomes for hematologic cancers, abnormal hemoglobin disorders, immunologic disorders, and inherited metabolic disorders.

Hybrid banks are a combination of public and private banks. Often, these are listed as either a public or private bank but offer the services of the other alternative. For example, a public bank that offers a private option for a designated fee (Dessels et al., 2018). Another type of hybrid bank allows for the donation of cord blood for a designated pre-matched relative of the donor. These programs are often called a directed donor bank (Armitage, 2016).

Quality and Regulation

In 2005, in the United States (U.S.) the Stem Cell Therapeutic and Research Act was authorized to, among other things, establish the formation of a National Cord Blood Registry and authorized the National Marrow Donor Program to oversee it. This law also established an Advisory Council for Blood Stem Cell Transplantation and funded public cord blood banks within the U.S. (Rich, 2015). The aim of this regulation was in part to maintain high-quality umbilical cord blood units, so that they would be available for transplantation. Specifically, the law provided for the original gathering and preservation of 150,000 units, so that these units would be available as needed. Funds were also designated to increase the genetic diversity of the stem cells, so that a wide variety of individuals of various genetic backgrounds would benefit. This act was reauthorized in 2010 and 2015 (Strong et al., 2018).

In 2009, the U.S. Federal Drug Administration (FDA) designated the use of umbilical cord blood cells as a drug, due to the systemic nature of their effect. This regulation mandated that cord blood banks apply for a Biologics License. These guidelines were updated in 2014 (Rich, 2015). United States cord blood banks, both private and public, are episodically inspected for adherence to these standards (Armitage, 2016).

There are similar regulations designated by the European Union (E. U.) with respect to cord blood donation, collection, screening, testing, processing, cryopreservation, and administration of units for transplantation. In 2004, these guidelines detailed private banks were not supported, while altruistic donation, matched transplantation, and clinical research were to be the norm. The E. U. required that educational information be truthful, and that informed consent be obtained prior to the procedure of cord blood collection. Finally, the E. U. set out that cord blood banks should adhere to specific quality standards (Armitage, 2016).

Cord blood from private banks are underutilized, have less quality control, and are more costly for individual families.

In Canada, the regulation of cord blood banks falls under the purview of Health Canada, under the Safety of Human Cells, Tissues and Organs Transplantation Regulation of 2007. Likewise, in Australia, the Therapeutic Goods Act of 1989 oversees the licensure of cord blood banks. This law requires a “risk management” methodology to assure the “quality, safety, and efficacy” of hematopoietic cord blood stem cells for transplantation (Armitage, 2016, p. 3).

In 2019, the board of directors of the Cord Blood Association, a multinational organization, adopted the first ever “Model Criteria for Regulation of Cord Blood Banks and Cord Blood Banking.” These guidelines outline specific criteria for quality management, informed consent from donors, prescreening and testing, collection, processing, potency, shipping and transportation, outcome measures of quality, and data sharing (Cord Blood Association, 2019). Many believe that these guidelines were past due but are an excellent first step for ensuring international quality and consistency (Broxmeyer, 2019).

Policy Statements

The American Academy of Pediatrics (AAP) updated their policy on cord blood banking in 2017. In this latest statement the AAP reaffirms its endorsem*nt of storage of cord blood in public banks, as the evidence shows positive outcomes for hematologic cancers, abnormal hemoglobin disorders, immunologic disorders, and inherited metabolic disorders. The AAP makes the case that cord blood from private banks are underutilized, have less quality control, and are more costly for individual families. The only time that the AAP would recommend private cord blood banking is when there is a disease or disorder in a family member that is usually treated with hematopoietic stem cells which is known prior to the birth of a child (Shearer et al., 2017).

In 2019, the American College of Obstetricians and Gynecologists (ACOG) revised its previous policy statement on cord blood banking. ACOG upheld the view of the AAP to endorse the storage of hematopoietic stem cells in public rather than private cord blood banks. ACOG endorses the dissemination of knowledge about cord blood banking in a fair, ethical, and comprehensive manner. They continue to state that families of all ethnicities should consider donation to a public bank to enlarge the accessibility of stem cells for all possible matches. ACOG further states that in an emergency, care of either mother or newborn should not be delayed collecting cord blood (ACOG, 2019).

Lamaze International (2019) does not have a policy statement directly related to umbilical cord blood banking. There is a statement related to advertising, which maintains that there is to be no advertising of private cord blood banks on any Lamaze mass media instrument. This is in essence disapproval of private cord blood banks. In their book, Giving Birth with Confidence: The Official Lamaze Guide, Lothian and DeVries discuss cord blood banking; however, the context is generally limited to private banking with little mention of public banking (). It is of interest that in the World Health Organization’s (WHO) WHO recommendations: Intrapartum Care for a Positive Childbirth Experience, umbilical cord blood collection and banking are not mentioned at all (WHO, 2018).

Ethical Considerations

Discussions of umbilical cord blood banking brings up ethical issues that should be addressed. The first is the marketing practices of private cord blood banks or the issue of “truth in advertising.” Many times, the medical advertised reasons for why a family should bank the umbilical cord blood are distorted. The advertisem*nts are laced with promises of cures for diseases for which current therapies do not exist. In fact, as previously reported the diseases may be in clinical trials but not actual treatment phase of care. The private banks can utilize this tactic because “the actual product or service offered is the banking of blood, not the predicted or hypothesized future treatments that may be mentioned in marketing” (Murdoch et al., 2020, p. 3).

Similarly, the private banks do not advertise that there is a very low probability of a family using the cord blood that they have stored (Murdoch et al., 2020). In fact, one study of private cord blood banking for treatment of sickle cell disease, a known use of hematopoietic stem cells, over a 20-year period found only an 8% utilization rate (Rafii et al., 2017). Studies show that less than 50% of parents can correctly identify uses of stored umbilical cord blood (Peberdy et al., 2018). Likewise, parents are not always aware that saved cord blood cells cannot be used to treat leukemia in the same child from where the cord blood came, as those stem cells already have a marker for precancerous cells (Shearer et al., 2017). Families are often not able to make truly informed decisions as they are in an emotionally charged time and see the promises of the private cord blood banks as “biologic insurance” (Matsumoto et al., 2015). Overall, this can lead to alterations in public health and financial harm to individual families (Murdoch et al., 2020).

Discussions of umbilical cord blood banking brings up ethical issues that should be addressed.

Another ethical issue involves kickbacks to or ownership of private cord blood banks by physicians. When there is a vested interest in the profits of the bank, it leads to ethical dilemmas with physicians marketing and/or obtaining informed consent for collection (Murdoch et al., 2020). Similarly, healthcare professionals often report that their prime source of information on cord blood banking comes from the literature of private cord blood banks themselves (Peberdy et al., 2016).

A final ethical consideration is that of timing of umbilical cord clamping. In a study by Peberdy et al. (2020) findings showed that healthcare providers did not use evidence-based guidelines for when to clamp the umbilical cord. While they reportedly used delayed cord clamping, each clinician defined delayed cord clamping differently. In addition, timing of cord clamping varied if there was collection of cord blood for banking (Peberdy et al., 2020). The guidelines are also varied among organizations. WHO states that cord clamping should be delayed at least one minute (WHO, 2018). ACOG varies from that with their guidelines by stating at least 30–60 seconds of delay after birth before clamping the umbilical cord (ACOG, 2020). ACOG describes a lower total cell count when cord clamping is delayed (ACOG, 2020); however, international cord blood banks report that delayed clamping does not decrease the competence of the unit of cord blood when performed by a skilled obstetrician (Sacchi, 2018).

•

RENECE WALLER-WISE is licensed in Alabama as a women’s health clinical nurse specialist. She is the program director and principal educator for Teach You! Childbirth in Spring, TX, and she is a lecturer for Sam Houston State University School of Nursing. She has been teaching childbirth education classes for almost 40 years, and has been a Lamaze Certified Childbirth Educator for 20 years.

• Adams, Z., Morris, G., Campbell, T., Mostert, K., Dibdin, N., Fearon, M., Elmoazzen, H., Mercer, D., Young, K., & Allan, D. (2018). Risk of exposure to Zika virus and impact on cord blood banking and adult unrelated donors in hematopoietic cell transplantation: The Canadian blood services experience. Biology of Blood and Marrow Transplantation, 24, 861–865. 10.1016/j.bbmt.2017.11.032 [PubMed] [CrossRef] [Google Scholar]
• American College of Obstetricians and Gynecologists. (2019). Umbilical cord blood banking. Obstetrics and Gynecology, 133, e249–e253. 10.1097/aog.0000000000003128 [PubMed] [CrossRef] [Google Scholar]
• American College of Obstetricians and Gynecologists. (2020). Delayed umbilical cord clamping after birth. Obstetrics and Gynecology, 136, e100–106. 10.1097/aog.0000000000004167 [PubMed] [CrossRef] [Google Scholar]
• Armitage, S. (2016). Cord blood banking standards: Autologous versus altruistic. Frontiers in Medicine, 2, 94. 10.3389/fmed.2015.00094 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Arutyunyan, I., Fatkhudinov, T., & Sukhikh, G. (2018). Umbilical cord tissue cryopreservation: A short review. Stem Cell Research and Therapy, 9, 236. 10.1186/s13287-018-0992-0 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Broxmeyer, H. E. (2019). Long-overdue guidelines for the cord blood banking community. Stem Cells Translational Medicine, 8, 320–322. 10.1002/sctm.19-0056 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Cord Blood Association. (2019). Model criteria for regulation of cord blood banks and cord blood banking. Stem Cells Translational Medicine, 8, 340–343. 10.1002/sctm.cbmc [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Dessels, C., Alessandrini, M., & Pepper, M. S. (2018). Factors influencing the umbilical cord blood stem cell industry: An evolving treatment landscape. Stem Cells Translational Medicine, 7, 643–650. 10.1002/sctm.17-0244 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Devi, K. N. (2016). Cord blood banking. International Journal of Nursing Education, 8, 16–18. 10.5958/0974-9357.2016.00083.0 [CrossRef] [Google Scholar]
• Guerra-Marquez, A., Penaflor, K., & Mayani, H. (2020). Cord blood banking and transplantation in a national program: Thirteen years of experience. Archives of Medical Research, 51, 54–62. 10.1016/j.arcmed.2019.12.006 [PubMed] [CrossRef] [Google Scholar]
• Huang, X., Guo, B., Capitano, M., & Broxmeyer, H. E. (2019). Past, present, and future efforts to enhance the efficacy of cord blood hematopoietic cell transplantation. F1000Research, 8, 1833. 10.12688/f1000research.20002.1 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Kurtzberg, J. (2017). A history of cord blood banking and transplantation. Stem Cells Translational Medicine, 6, 1309–1311. 10.1002/sctm.17-0075 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Lamaze International. (2019). Policies: Advertising policy. https://www.lamaze.org/About-Us/Policies/Administration
• Liesveld, J. L., Sharma, N., & Aljitawi, O. S. (2020). Stem cell homing: From physiology to therapeutics. Stem Cells, 38, 1241–1253. 10.1002/stem.3242 [PubMed] [CrossRef] [Google Scholar]
• Lothian, J., & DeVries, C. (2017). Giving Birth with Confidence (3rd ed.). Meadowbrook Press. [Google Scholar]
• Matsumoto, M. M., Dajani, R., & Matthews, K. R. W. (2015). Cord blood banking in the Arab world: Current status and future developments. Biology of Blood and Marrow Transplantation, 21, 1188–1194. 10.1016/j.bbmt.2015.01.012 [PubMed] [CrossRef] [Google Scholar]
• Murdoch, B., Marcon, A. R., & Caulfield, T. (2020). The law and problematic marketing by private umbilical cord blood banks. BMC Medical Ethics, 21, 52. 10.1186/s12910-020-00494-2 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Peberdy, L., Young, J., & Kearney, L. (2016). Health care professionals’, knowledge, attitudes, and practices relating to umbilical cord blood banking and donation: An integrative review. BMC Pregnancy and Childbirth, 16, 81. 10.1186/s12884-016-0863-6 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Peberdy, L., Young, J., Massey, D. L., & Kearney, L. (2018). Parents’ knowledge, awareness and attitudes of cord blood donation and banking options: An integrative review. BMC Pregnancy and Childbirth, 18, 395. 10.1186/s12884-018-2024-6 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Peberdy, L., Young, J., Massey, D., & Kearney, L. (2020). Maternity health professionals’ perspectives on cord clamp timing, cord blood banking and cord blood donation: A qualitative study. BMC Pregnancy and Childbirth, 20, 410. 10.1186/s12884-020-03102-8 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Rafii, H., Bernaudin, R., Rouard, H., Vanneaux, V., Ruggeri, A., Cavazzana, M., Gauthereau, V., Stanislas, A., Benkerrou, M., DeMontalembert, M., Ferry, C., Girot, R., Arnaud, C., Kamdem, A., Gour, J., Touboul, C., Cras, A., Kuentz, M., Rieux, C., Volt, F., et al. (2017). Family cord blood banking for sickle cell disease: A 20-year experience in two dedicated public cord blood banks. Haematologica, 102, 976–983. 10.3324/haematol.2016.163055 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Rich, I. N. (2015). Improving quality and potency testing for umbilical cord blood: A new perspective. Stem Cells Translational Medicine, 4, 967–973. 10.5966/sctm.2015-0036 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Roura, S., Pujal, J. M., Galvez-Monton, C., & Bayes-Genis, A. (2015). The role and potential of umbilical cord blood in an era of new therapies: A review. Stem Cell Research and Therapy, 6, 123. 10.1186/s13287-015-0113-2 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Roura, S., Pujal, J. M., Galvez-Monton, C., & Bayes-Genis, A. (2016). Quality and exploitation of umbilical cord blood for cell therapy: Are we beyond our capabilities?Developmental Dynamics, 245, 710–717. 10.1002/dvdy.24408 [PubMed] [CrossRef] [Google Scholar]
• Sacchi, N. (2018). Is it time to re-think a sustainable banking model for the Italian blood network?Blood Transfusion, 16, 221–223. 10.2450/2017.0040-17 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Shearer, W. T., Lubin, B. H., Cairo, M. S., & Notarangelo, L. D. (2017). Cord blood banking for potential future transplantation. Pediatrics, 140, e20172695. 10.1542/peds.2017-2695 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Strong, A., Gracner, T., Chen, P., & Kapinos, K. (2018). On the value of the umbilical cord blood supply. Value in Health, 21, 1077–1082. 10.1016/j.jval.2018.03.003 [PubMed] [CrossRef] [Google Scholar]
• Thomas, T. (2017). Assessing the knowledge regarding cord blood banking among nurse educators, staff nurses, and nursing students. International Journal of Nursing Education, 9, 149–154. 10.5958/0974-9357.2017.00053.8 [CrossRef] [Google Scholar]
• Valle, V., Screnci, M., Murgi, E., Capozi, M., & Girelli, G. (2017). Collection of umbilical cord blood for banking: Collection rate and factors influencing collection. Blood Transfusion, 15, 587–588. 10.2450/2016.0262-16 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• Waller-Wise, R. (2011). Umbilical cord blood: Information for childbirth educators. The Journal of Perinatal Education, 20, 54–60. 10.1891/1058-1243.20.1.54 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
• World Health Organization. (2018). WHO recommendations: Intrapartum care for a positive childbirth experience. World Health Organization. License CC BY-NC-SA 3.0 IGO. [PubMed] [Google Scholar]