The Challenges Among Public Cord Blood Banks
You may (hopefully) be aware of the benefits of cord blood and cord tissue banking. However, many parents are still unsure as to what they should do with their child’s umbilical cord stem cells. You’ve made the informed decision not to let these precious stem cells go to waste after the birth of your little one, but should you donate these cells to a public bank, or store them privately for your family’s future use?
There are several benefits that both the public and private banks provide for families in need. However, banking privately with a family cord blood bank, such as Cryo-Cell International, provides parents with greater assurance, and more control over the future outcomes of procedures. Public cord blood banks are facing several universal challenges with sustainability, donor diversity, and financial setbacks, which have forced many public banks to close down their facilities. In turn, this leaves patients in potential serious need, with looming questions about the future of cord blood banking in the public sector. To provide some clarity on the subject, let’s delve into some of the issues that plague the public banking system, and outline the unique advantages of private cord blood banking.
Brief Overview of Umbilical Stem Cells
Since the first successful umbilical cord stem cell transplant performed in 1988, there have been over 40,000 transplantations performed worldwide. Cord blood and cord tissue continue to be used in various clinical trials for the treatment of several conditions and diseases. The FDA has standardized the treatment of cord blood in nearly 80 diseases. However, science is uncovering more exciting findings revealing just how special umbilical stem cells are.
An article from the Stem Cells Translational journal states, “HSCs [human stem cells] from UCB [umbilical cord blood] offer the advantage of requiring less stringent HLA‐matching criteria (six loci, rather than ten as is the case for BM [bone marrow] ‐HSCs). Also, since these cells can be cryopreserved, this provides an off‐the‐shelf solution to patients in urgent need of transplantation.” Umbilical cord blood stem cells are becoming more preferential than bone marrow because of these characteristics. Furthermore, studies show that graft-versus-host disease (GVHD), a leading cause of morbidity after stem cell transplantation, occurs much less frequently after umbilical cord blood transplantations.
The success of such transplantations has opened the door to discovering new ways for how these cells can be used. Umbilical stem cells are currently used in clinical trials for the treatment of autism, cerebral palsy, multiple sclerosis, stroke, alzheimer's, brain injury, cartilage repair, diabetes, and a wide host of other conditions.
Lack of Donor Diversity
With the explosion of stem cell therapy, we will likely see an increase in demand for donor cells. Studies indicate when donor cells closely match a patient, the chances of transplant success improve. Since the matching criteria of cord blood specimens are less strict than that of bone marrow, it has a considerable advantage over marrow and is a vital aspect of transplant success. This fact becomes more important for couples of mixed ethnic backgrounds in which the chances of finding a match in the public inventory are slim. Even for couples of Caucasian descent that may find suitable HLA match donors in the registry, using related family units significantly reduces the chance of life-threatening complications after a transplant. There is a wide array of differences in human HLA types, even more so for certain populations, such as African Americans, and people of mixed ethnic origins. Research given by the most recent RAND report on the topic of public banking highlights the critical demand for cord blood donors from the following communities:
- Black and African-American
- American Indian and Alaska Native
- Hispanic and Latino
- Native Hawaiian and Other Pacific Islander
notes this problem among other forms of donor specimens stating, “In some ethnic groups, the incidence of heritable blood-related hemoglobinopathies is particularly high. There is a substantial proportion of patients for whom neither a sibling donor nor an unrelated bone marrow donor can be found, which was one of the reasons public UCB [umbilical cord blood] banks were established.”
However, even public cord blood banks are facing the same dilemma. Another study
reported that only about one-third of patients who need a stem cell transplant using someone else’s stem cells (allogeneic) will have a suitable related donor. Another third of patients will find a suitable unrelated donor, but could be limited depending on their ethnic background. Caucasians without a matched, related donor have a 70% chance of finding a matching donor, and only a 10% chance for other or mixed ethnicities.
To further complicate this issue, the same study also highlights a flaw within the nature of public cord blood donations. Cord blood donations only provide a one-time source of stem cells—once the cells have been collected from a given donor, it is not possible to return to the same source to collect additional cells. In cases where more cord blood would be needed past the initial transplantation, this can prove to be an insurmountable challenge. Some private banks understand this critical necessity. Cryo-Cell International allows families to access their stored cord blood for multiple uses through the design of our five-compartment storage bag.
Inadequacies in Donation Collections
According to Be The Match, operated by the National Marrow Donor Program, the world’s largest marrow registry, there are specific guidelines that donors must abide by. Donor guidelines include a minimum cell count in order for a cord blood specimen to be listed in the registry. If the cell count is below the limit, the cord blood unit is not listed in the registry and, instead, is sometimes used for research purposes. Reports from the U.S. Government Accountability Office indicate that units collected from some racial groups have lower volume and cell counts compared to other groups, dismissing these specimens for inclusion in the National Cord Blood Inventory. Nearly 70% of cord blood donations are discarded for not meeting processing and storage requirements.
In addition, the mother must also meet certain health criteria taking into account exposure to or viral infections of hepatitis B, or C, AIDS, West Nile, TB, leukemia, and other cancer types. Such circumstances can leave these specimens unable to be donated for public use. However, banking cord blood privately allows the family to have more leeway in storing for their use. For example, just because a woman has been exposed, does not mean she has been infected. In these cases, she would be able to store her child’s umbilical cord stem cells in a private cord blood bank for potential use.
Another drawback of public cord blood banking is the exclusion of donations from multiple births. Women who give birth to twins, triplets, etc. are ineligible for public cord blood donation for fear of mix-ups during collection. Worldwide, there are more than 125 million multiples. This places children of multiple births at a disadvantage when it comes to finding a suitable public HLA match.
Inequality Among Standards and Participation
As we know, the best cord blood matches are those of related family members; a leading reason why families choose to store privately. However, when this is not an option for a family in need, the next best specimen, selected by cell dose and HLA type, may be located in another country. Because of this, there was a recognized need to establish international compliance regulations. The AABB and the Foundation for the Accreditation of Cellular Therapy together with NetCord (NetCord-FACT) have developed international standards for cord blood banking quality management systems, and requirements that both private and public banks can choose to follow for all collected specimens.
As of 2009, public cord blood banks are required to have approval from the FDA biologics license application (BLA), or subject to an investigational new drug (IND). As one article points out, achieving licensure is a costly and timely process, which, in turn, is having a negative impact on the cost of collecting, storing, and dispersing cord blood specimens. Some public banks have been very slow to obtaining licensure and can still operate while in the process of actually being granted licensure. The idea that public cord blood banks are not all functioning on the same terms has created some concern among the general public as to how these banks are being regulated.
Beyond the variances of licenses and accreditations, aspects of handling and processing vary from bank to bank, which can cause worry for some. Reports have shown vast disparities among public banks with factors like transit time, storage temperature, and the quality of units collected, which can result in viability issues. The lack of uniform quality management systems among domestic and international public banks can be a point of concern among many families.
Banking with a private bank such as Cryo-Cell International provides families with the added benefit of such assurances. Private banks do not need FACT accreditation. However, Cryo-Cell International voluntarily adheres to the high-quality standards necessary for accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) and was awarded accreditation in 2014. Cryo-Cell is among the most highly accredited private cord blood banks; also earning ISO 13485 and AABB accreditation.
Cryo-Cell International offers exclusive processing technology to increase stem cell viability, offers an advanced collection kit to increase stem cell yield and to deliver optimal transit conditions, as well as processes and stores specimens at one location. Families are provided with a post-processing notification once a specimen has been tested and they have the security of knowing exactly where and how their specimen is stored. Whereas private banks do not need to disclose the viability rate of their specimens, Cryo-Cell International has a 100% viability rate for specimens in therapeutic use. Read more about the many other benefits of banking privately with Cryo-Cell.
The United States, as is the case with many countries, does not have a comprehensive, organized public cord blood banking system in place; public donation is not even possible in most of the country. There are only a small number of public donation sites across the U.S. In fact, less than 200 U.S. hospitals participate in public cord blood banking.
More than 80% of umbilical cord stem cells are not even collected. In these terms, the choice between public and private banking is non-existent. Families can choose to bank privately, or sadly, allow those potentially life-saving stem cells to be discarded. When a family stores with a private family bank, they can collect at any hospital around the world through the use of a collection kit.
Neglect of Cord Tissue Collection
Most private banks offer families the option to collect and store both their child’s cord blood and cord tissue. Currently, public banks do not have the means to process and store cord tissue. The mesenchymal stem cells (MSC) found in cord tissue have been used in the successful treatment of several conditions in clinical trial phases.
Cord tissue-derived stem cells are used because of their tissue-regenerating, anti-inflammatory, and immune-modulatory properties. These particular stem cells have safely been used in the treatment of many neurological and autoimmune conditions. One study revealed that children with autism treated with umbilical cord blood, in combination with MSCs, showed significant improvement with their emotional, visual, and intellectual responses, and in their nonverbal communication skills.
In addition to neurological disorders like autism and cerebral palsy, cord tissue stem cells are also being used in clinical trials involving diabetes, cardiovascular disorders, orthopedic conditions, genetic and metabolic disorders, as well as several other conditions such as eye diseases and kidney failure. Medical science is continually evolving, and as it does, the use of cord tissue will be more commonplace. Learn more about recent clinical trials involving cord blood and cord tissue. As it stands now, public cord blood banks cannot keep pace with the speed at which medical science is growing.
Depletion of Funding and Resources
Umbilical cord blood has been a viable stem cell source for over twenty years in the use of transplantation in children. This fact, combined with the growing interest in double UCBT in adults, will increase the demand for units, particularly those with large cell numbers. Considering that a large number of units are discarded because of the limited number of participating public banking hospitals, inadequate blood volume or cell counts among collections, faulty handling of retrieved specimens, and more stringent regulations, it is becoming increasingly difficult to establish an inventory of quality cord blood units.
Add to this the overall lack of funding for public banking efforts, and we see an emerging problem within the public banking system. A survey conducted by the World Marrow Donor Association (WMDA) in 2013 revealed that only 16 of 139 public cord blood banks in operation were financially sustainable. Only two years later, in 2015, the WMDA found that only 11% of public cord blood banks worldwide were merely breaking even financially.
RAND researchers reported that public banks collect an average of 8,500 units each year, but ultimately only store anywhere from 5-40% of those collections. There is a push among public banks to stay competitive among each other since these banks profit from each unit used. In an effort to get more money, public banking is seeing a trend of favoring the quantity of cord blood units collected over the quality of units collected. The fee that a bank charges a transplant center for a cord blood unit tends to be around $36,000 regardless of the unit's TNC count or genetic makeup. In turn, families in need of these cord blood specimens are being charged a hefty amount for a unit that is not as suitable as a match they could have had, had they privately banked their baby’s cord blood; at a significantly lower cost.
Due to high operational costs, the majority of public banks need external funding. As the demand for cord blood continues to rise with future medical breakthroughs, the pressure to supply a growing market will place many public banks at a breaking point. Lack of expenses for more trained medical professionals to complete cord blood collection and the expansion of more collection sites, coupled with the general scarcity of funding needed to maintain operations, will continue to place public cord blood banks in a difficult position.
Answers in Private & Hybrid Cord Blood Banking
The economic and regulatory pressures will continue to drive many public cord blood banks to near extinction. While the benefit of having an international inventory of cord blood units that is accessible to everyone is, unquestionably, a novel and necessary requirement, executing this goal presents several challenges. The overall lack of diversity among cord blood specimens leaves many at a severe disadvantage- in addition to the gaps of what is made possible through funding and logistics. It is not only costly for sole public banks to store cord blood units, but it’s also a financial burden for the families of donor recipients to pay an average of $40,000 for the use of a cord blood unit.
Several organizations see the glaring issues within the public cord blood banking system. However, the rate at which these issues will be, or even can be solved, remains unforeseen. Families continue to see answers and promise within private cord blood banking. Banking privately ensures that your little one’s cord blood and cord tissue is always accessible and is a perfect match for them, and a suitable match for their siblings, you, or someone in your family should you need it.
Many public banks are now adopting a hybrid model to join forces with private cord blood banks. Cryo-Cell operates as one such cord blood bank in partnership with Duke University Medical Center. Cryo-Cell's public bank has been chosen by the HRSA of the U.S. Department of Health, along with other leading banks such as those operated by M.D. Anderson and Duke University, as one of the nation's highest quality cord blood banks to help build the National Cord Blood Inventory.
There is no doubt that umbilical stem cells play a key role in regenerative therapies. The future of umbilical stem cell research looks promising, and we are on the brink of new medical treatment discovery. One thing remains certain: the need for umbilical stem cells will continue to exist. What is not certain is whether or not public cord blood banks will be able to sustain themselves, solely, through this need. Please visit our private vs. public banking section to learn more.