Umbilical Cord Blood Donation FAQs

Cord blood is the blood left over in the umbilical cord and placenta. It can only be collected after a baby is born and the umbilical cord has been cut. This blood is unique because it contains cells that can support medical treatment through transplantation.

Umbilical cord blood (UCB), once regarded as biological waste, is now an accepted source of hematopoietic stem cells/hematopoietic progenitor cells (HSCs/HPCs), similar to those found in bone marrow and peripheral blood. These cells can be used to restore a patient's immune system by providing stem cells for transplantation, similar to bone marrow or peripheral blood stem cells, and can be used to treat malignant diseases such as leukemia and non-malignant diseases such as immune deficiencies and severe aplastic anemia, and congenital disorders such as sickle cell anemia and thalassemia.

UCB contains many types of blood cells but only the HSCs are routinely used in transplant today. Other uses of UCB stem cells are currently undergoing study. Each source of HPCs (bone marrow, peripheral blood or cord blood) has advantages and limitations. Decisions about the most appropriate source of stem cells - which must be matched by tissue type to some degree with the recipient - must be made by each patient in consultation with his or her physician based on available options.

Cord blood stem cells when used in a procedure called a stem cell transplant, can rebuild the bone marrow and immune system. These transplants may treat patients with serious blood disorder such as leukemia, lymphoma or sickle cell disease, inherited genetic disorders, bone marrow failure and immune deficiency diseases.

Cord blood is one of the three sources of blood-forming stem cells alongside bone marrow and peripheral blood. Expectant parents should talk with their health care provider about options that may be available to them to donate cord blood for public use or store it for family exclusively.

After the delivery of a newborn, the umbilical cord is clamped and then cut. A needle is then used to draw the blood from the umbilical cord vein into a collection bag. Since this happens after delivery, there is no pain or risk to mother or infant. The collection may take place either before or after delivery of the placenta, and techniques vary slightly among physicians. The UCB product is labeled and shipped to the processing facility for processing, freezing and storage. The volume collected varies but usually ranges from 50 to 200 mL (about one-half to one cup).

In some cases, such as when there are serious medical complications - collection may not be possible. Parents may also discuss delayed cord clamping with their provider. A delay of 30-60 seconds can benefit newborns, particularly pre-term infants, but may reduce the amount of cord blood collected. If the cord blood is intended for a known transplant (for example, for a sibling with leukemia), delayed clamping may not be advised.

No. Each mother must be informed about cord blood collection and give consent for collection and testing. This ideally happens after reviewing information with her obstetrician during the last trimester. For private storage, the mother may enter into an agreement at any point during the pregnancy. This would include consent for storage and infectious disease testing. In public donation, consent should begin before the onset of labor when the donating mother is able to fully understand what is involved and is not distracted or under anesthesia. If this is not possible partial consent before delivery and follow-up after delivery may be utilized for public banking.

Cord blood banks use a variety of processing and storage techniques, with each option offering advantages and disadvantages.

When UCB is received at a processing facility, the unit and accompanying paperwork are inspected and reviewed. The product is then reduced of the red cell and/or plasma components in preparation for cryopreservation (freezing). Procedures and methods for this part of the process vary.

Three common processing approaches are:

• Density gradient separation: Uses gravity to isolate stem cell-rich white cells. This method yields a purer product but with more overall cell loss.
• Starch solution: Removes red blood cells, which have no transplant benefit and rupture on thawing.
• Plasma depletion: Reduces liquid volume while keeping most stem cells but leaves more red cells in the product.

A freezing solution, usually containing dimethyl sulfoxide (DMSO), is added to the product, which is then frozen at a controlled rate to slowly freeze the cells without damaging them. DMSO is a cryoprotectant that helps protect the cells during this process and when stored at cold temperatures. Cooling at a controlled rate had been shown to result in better viability (more live cells) when thawed. Controlled rate freezing involves the use of equipment, including a computer, to freeze cells at an ideal, set rate for the cooling process. Alternative methods may be used for freezing that do not include a controlled rate freezer. In these cases, facilities should have validated their procedure to demonstrate the procedure results in a viable product upon thawing. In general, methods used in clinical laboratories involve bringing the cells to -80 C or colder prior to transfer into a storage tank. The storage tank contains racks or boxes into which the labeled, frozen product is placed. Nitrogen in its liquid state is at -196 C (-320 F) and is used to keep the product frozen. The cord blood storage facility should have a system to monitor the temperature and to alert staff in the event of a failure so that products may be transferred to another tank if necessary.

When a unit is identified for transplant, the selected product is shipped to the transplant facility and eventually thawed for infusion into the patient. Some centers wash the product to remove lysed red cells, though this can also cause stem cell loss. The decision depends on center practices, patient condition, and physician judgment.

No. There are private and public cord blood banks. Some facilities may offer both services, but the products are specifically dedicated for one use or another. In both cases, the mother gives consent, but the screening and testing of the mother and product will differ. The Food and Drug Administration, which regulates this industry in the United States, requires registration for both public and private cord blood banks.

Public cord blood banks process and store UCB products for public use. The facility has a minimum volume (and cell number) it will accept. These minimums are based on what will likely be adequate for a transplant patient. Products that do not meet these or other requirements are discarded or used for research (according to the consent that was signed).

Since it will most likely be many years before the product is used, a very thorough medical history and screening is performed on the mother. A family history must also be included to reduce the risk of conferring a genetic disorder through the transplant. Blood samples from the mother and product are required for a variety of tests, including infectious disease testing and tests for the detection of contamination by bacteria. All information regarding the donating family is maintained in strict confidentiality.

Because not all hospitals are linked to public banks, participation is limited. To increase access and diversity, the United States Congress has funded a national cord blood inventory program, with a focus on improving representation from underrepresented populations.

Private banks process and store the UCB product specifically for the donor and/or family. Since the bank may not be associated with a particular hospital, the mother is sent a collection kit to give the health care provider on the day of delivery. The kit contains the collection bag, labels and other materials needed for collection and shipping to the processing facility. The parent(s) pay an initial processing fee and then typically an annual storage fee.

The details of this arrangement, including transport, shipping responsibilities, ownership and liability issues, should be described in the contract between the donor and bank. Since the product is intended only for use within the family, donor screening, tissue typing and other tests may or may not be performed on the unit. These policies vary among private banks. It is important to note that units stored in a private bank cannot be "crossed over" for public use unless all of the consent process, screening, infectious disease testing, and tissue typing are complete and acceptable. The cord blood bank should be able to provide a report with laboratory data for any test results as well as consultation on interpretation of these results.

No one knows for sure the shelf life of cryopreserved cord blood. Successful cord blood transplants have been reported with products stored for more than 20 years, though the final expiration date for such products has not been established. Published studies indicate that UCB stem cells cryopreserved for 21-23.5 years have manifested biologic qualities equal to those at the time they were frozen.¹

Most transplant physicians discourage using an autologous cord blood unit in the cases of childhood leukemia and other disorders as the stem cells in the unit may also have a genetic defect or predisposition to disease. Also, cells from another person might better fight leukemia than the child's own when used for a transplant. Some of the products collected for private storage are used for allogeneic sibling transplants. Cord blood transplants in children with malignant or non-malignant disease from an HLA-matched or one antigen disparate donor demonstrate a 10-fold lower incidence of graft-versus-host disease than that seen after transplantation with an HLA-matched bone marrow obtained from a sibling.² Calculations vary among statisticians and organizations regarding the chances of using a stored cord blood product. The Center for International Blood and Marrow Transplant Research (CIBMTR) has published data on the likelihood a single individual would qualify for an autologous or allogeneic HCT according to current indicators. This statistic is 1/200 by the time an adult reaches 70 years of age (www.CIBMTR.org). Others report a likelihood of one in 2,700.³

It remains to be seen if new technology derived from stem cell transplantation will lead to the treatment of disorders such as multiple sclerosis (MS) and Parkinson's disease as well as spinal cord injuries. So far, these efforts have primarily been limited to the research laboratory and have not produced benefits in patients.

While several organizations including the American Academy of Pediatrics and the Royal College of Obstetricians and Gynaecologists recommend public banking over private, exceptions are made for cases in which a sibling has a disease that can be treated with a stem cell transplant as in the case of some genetic diseases. This could include diagnoses such as pediatric malignancies, congenital immunodeficiency syndrome, a hemoglobinopathy or lysosomal storage disease. Each family should discuss these issues with a health care provider familiar with their family situation.

Cord blood is a biological product regulated by the Food and Drug Administration. It is approved as a source of HSCs for transplantation to treat both malignant (e.g., blood cancers) and non-malignant (e.g., inherited blood or immune disorders) diseases. Research is ongoing into additional therapeutic uses for use in other advanced biotherapies.

AABB publishes voluntary standards for cellular therapy product services, including cord blood banking. These standards augment, rather than replace, any federal or state requirements. The standards describe the minimum acceptable requirements for facilities providing these services. These stringent standards cover all aspects of operation, including:

• A process for approval of vendors providing supplies.
• The consenting, donor screening and collection process.
• Product qualification, testing, processing, storage and release.
• Equipment and facility maintenance.
• A process for personnel selection and training.
• A process to monitor and improve quality of services.

While the AABB standards cover these items, it should be noted that the standards require a framework, plan and system for each item. The system includes written policies, processes and procedures. Except in a few cases such as testing for infectious diseases, the standards do not specifically prescribe how each of these may be done.

When a facility believes it complies with these standards, it applies for accreditation by AABB. This involves a detailed and lengthy application process. The facility is then assessed by an objective team with experience in the cord blood field. Any evidence the team finds of non-compliance with the standards is brought to the attention of the bank, and corrective action must be taken before accreditation is granted. Accreditation is then granted for two years. AABB tracks customer complaints and follows up on any reported deficiencies. Only cord blood banks with a current accreditation have permission to use the AABB logo, and AABB investigates reports of misrepresentation or fraudulent use once the misuse is brought to its attention.