UMBILICAL CORD BLOOD COLLECTION by Frances Verter, PhD Founder & Director, Parent's Guide to Cord Blood Foundation info@parentsguidecordblood.org and Kim Petrella, RN Department of Obstetrics and Gynecology Christiana Hospital, Newark, Delaware kpetrella815@yahoo.com
ABSTRACT Nursing staff in Labor and Delivery units are on the front lines of the effort to collect umbilical cord blood at the time of childbirth. In hospitals across the nation, expectant parents may arrive at the time of delivery carrying a cord blood collection kit, with the anticipation that someone on their delivery team will perform this service for them. Some hospitals have partnerships with cord blood banks in which designated staff are assigned and trained to perform cord blood collections. Other hospitals expect that delivery personnel will maintain annual certification training for collection and storage of cord blood. This is an emerging medical service where practices have not been standardized. 2
Medical Value of Cord Blood The blood that remains in the umbilical cord after childbirth has great medical value because it is a rich source of stem cells. The stem cells in cord blood are not embryonic and do not carry any ethical, religious, or political controversies. The main challenge here is to raise more awareness of the value of cord blood stem cells and prevent them from being discarded as medical waste. Just two to three ounces of cord blood can hold about a hundred million blood-forming stem cells. Cord blood transplants are an alternative to bone marrow transplants as a way to cure patients who have blood cancers such as leukemia and lymphoma, or blood disorders such as sickle cell anemia and thalassemia. Over the past 25 years, since the first cord blood transplant in 1988, more than 30,000 cord blood transplants have been performed worldwide, and networks of banks have been established to collect donated cord blood for the public good. In the US, about two dozen public cord blood banks have collection sites at almost 200 hospitals with high birth rates. When parents donate their baby s cord blood to one of these public banks, it is much like giving a blood donation. Like donating blood, there is no cost to the parents, and they give up their rights to the donated blood. Those donations that pass testing are typed and listed on a registry that can be searched by patients seeking a match. But whereas regular blood donations are only typed by ABO type and Rh factor, and are only viable for 35 days, in contrast the stem cells from cord blood are typed by 10-12 Human Leukocyte Antigens (HLA types). Once stem cells are cryogenically frozen they stay viable for decades. Stem cells from infant cord blood have an advantage over adult bone marrow donations, because in cord blood transplants the donor and patient do not have to be an exact match on all the HLA types. That flexibility has made cord blood extremely valuable for patients who come from minority or mixed racial 3
groups where matching donors are hard to find. As the public inventory continues to grow and become more diverse, the probability of patients finding a suitable unit of cord blood for transplant increases. Within the past decade, new therapies are emerging in which children have benefited from infusions of their own cord blood. These therapies are still in clinical trials to measure their efficacy, but the most common indications for treatment are acquired neurologic disorders such as Hypoxic Ischemic Encephalopathy and Cerebral Palsy. There are also clinical trials in which children are receiving their own cord blood to treat autism, congenital heart defects, traumatic brain injury, or type 1 diabetes and other auto-immune disorders. Parents who want to privately bank their child s cord blood as a form of health insurance can contract with a family cord blood bank for this service. There are about two dozen family cord blood banks in the US, with first year processing fees that are currently between $1300 and $2200, followed by annual storage fees that are typically $125 per year. Cord Blood Collection Procedures There are two scenarios that might cause expectant parents to arrive at the delivery unit carrying a cord blood collection kit. One is that the parents have contracted with a family cord blood bank to privately store their child s cord blood, and have notified their OB/GYN practice of this decision. The other is that the parents have signed up for a mail-in donation program outside of a hospital based program. A few public banks allow mothers who have been registered and screened well in advance, ideally before 34 weeks of pregnancy, to ship their child s cord blood donation to the bank. In this case the healthcare provider who is designated to collect the cord blood is required to take an on-line training class. This training takes less than 20 minutes but maintains certification for both public and private collections. All cord blood collection kits basically contain the same equipment, although there can be many differences in packaging and implementation. The three key components of the kit are: vials to hold 4
maternal blood samples for infectious disease testing, disinfection supplies for the umbilical cord, and a blood bag with a needle attached to the tubing that is used to collect and hold the cord blood. It is always advisable to find and read the instructions that come with the kit, as banks are constantly developing innovations. One important check is whether the collection bag is sterile on the outside so that it may be used in the sterile field during a c-section. Most banks provide a sterile bag, but a few family banks pack a less expensive bag that is not sterile and provide an additional extension tube that allows the bag to be used from outside the sterile field. The actual collection process takes less than five minutes. After the cord is clamped and cut, the person who is performing the collection sterilizes the cord and inserts the needle of the collection bag into the umbilical vein. The bag is usually hung below the mother so that cord blood will drain into it by gravity. The top priority of cord blood collection is to obtain as much blood volume as possible. Ideally the collection volume should be near 100 ml of cord blood in order to hold enough stem cells for a cord blood transplant of an adult. If the blood vessel clots during collection, the collector can pinch the cord above the needle to create a stronger flow which could dislodge a clot and allow the blood to flow again. If necessary, with aseptic technique, the collector can move the needle insertion site further up the cord and closer to the placenta, while remembering to thoroughly disinfect the new puncture site first. It has to be emphasized that there is no value in collecting a large blood volume if it is contaminated. Since the blood bags already contain an anti-coagulant, it is difficult to properly assess the actual volume in a bag by holding it up. One should just try to collect as much blood as possible, allowing the cord to completely stop flowing before the needle is removed, to optimize volume. Parents who prefer delayed clamping can also collect cord blood with a skilled collector and optimal conditions. If a sterile workspace is available, another option is to collect cord blood after the delivery of the placenta, although this may not allow for as large a collection. 5
The typical cord blood collection volume is only about 60 ml. Many factors may make it impossible to obtain the ideal collection volume of 100 ml or more, including the size of the placenta, the gestational age of the baby, and complications at the time of delivery. Maternal diet and prenatal vitamin administration have been found to correlate with the stem cell concentration in cord blood. It is important to keep sight of the intended purpose of the cord blood collection. If the parents intend to store it privately in a family bank, then small volumes are acceptable. Parents may use privately stored cord blood to participate in clinical trials of emerging therapies where the cell doses are much lower than the requirements for a stem cell transplant. However, if the intended purpose is to send the cord blood to a public bank that archives donations for transplants, then it will be rejected if it does not meet their threshold for total nucleated cell (TNC) count. One cannot judge the stem cell content of a cord blood unit purely from its size. Research has found that some small cord blood collections from premature babies have a higher concentration of stem cells than large collections from full term babies. If the parents intend to privately bank, even small amounts should be sent to the bank for analysis. This is particularly important because premature babies are at higher risk for the neurological conditions that may be treated with cord blood. Send whatever collection can be obtained to the bank and let them notify the parents of the cell counts and the advisability of storage. Delivery personnel are able to offer patients advice and counseling as to the collected amount, but the final decision should be made by the parents. The next step is to ship the cord blood to the lab where it will be processed to separate and cryogenically preserve the component that holds the stem cells. The standard procedure is to ship cord blood at room temperature, and maintaining the temperature stability of the blood during shipping is crucial to maximize the survival of stem cells. The cord blood collection kits that are currently on the market contain a wide variety of insulation materials and packaging configurations. It is preferable to ship the kit with a medical 6
courier, to both expedite its arrival and to further guarantee temperature stability. A well-insulated kit can be successfully shipped via FedEx. Agencies that inspect the quality control at cord blood banks require that public banks must process and freeze the stem cells within 48 hours of birth, whereas family banks are given a 72 hour window. Hospital Policies Around Cord Blood Collection There are numerous benefits to setting up a cord blood training program for hospital staff. Given the variations among cord blood collection kits from both private and public banks, coupled with the training requirements of public banks that accept cord blood donations by mail, it is helpful for all staff to have a periodic refresher class on best practices in cord blood collection. The training can be scheduled to coincide with a regular event like a business meeting, staff meeting, or critical skills assessment. Sales representatives from family banks are usually eager to provide demonstrations of their kits. Some hospitals have formed business relationships with specific cord blood banks. These partnerships reduce the variety of kits that their staff may encounter, enable the hospital to keep kits in stock, and may carry financial benefits. By training staff on a limited variety of kits, the staff will become more proficient with the use of those kits and their associated paperwork. The ability to advertise that the hospital has an expertise in cord blood collection can be a discriminator for marketing the Labor and Delivery program. Parent education about cord blood options is another area where hospitals can discriminate themselves. There are 27 US states, covering 81% of US births, who have passed laws encouraging healthcare providers to educate expectant parents about the options to bank cord blood. In five of those states (FL, OH, MO, ND, VA), the Dept. of Health has adopted educational materials from the Parent's Guide to Cord Blood Foundation. The free brochures from Parent's Guide to Cord Blood cover both public donation and family storage in a balanced manner. The brochures can be distributed during routine childbirth education programs or as part of the pre-natal package that physicians give to expectant mothers. 7
Cord Blood Education and Public Health Policy Ideally cord blood education should take place during the second trimester, so that mothers have enough time to go through the maternal health screening required for cord blood donation. If parents learn about cord blood banking too late in the pregnancy, then they are deprived of the option to donate. The US Dept. of Health and Human Services has allocated federal funding towards banking cord blood donations from minority or mixed race births, in order to meet the transplant needs of patients with hard to match tissue types. The national Institute of Medicine has issued guidelines calling for expectant parents to be educated about all options for their baby s cord blood. Presently, less than 5% of parents arrange to store their cord blood privately or donate it, leaving over 95% of delivered cord blood to be discarded as medical waste. Given the current need to archive cord blood donations for patients seeking transplants, plus the growing medical possibilities from new therapies being developed with cord blood, it is important for all healthcare practitioners to provide expectant parents with educational material about cord blood banking. Birth is the only opportunity to save the stem cells in umbilical cord blood, thus expectant parents should be made aware and educated about their options, and birthing centers should be a partner in the process. 8
Photo of collection kit for mail-in cord blood donation, courtesy of Carolinas Cord Blood Bank at Duke University. 9