Cord Blood Banking Information for Consumers

December 7, 2010

Expecting a baby can be a very exciting time for soon-to-be-parents. It can also be very confusing, with many decisions to make. One choice prospective parents often face is whether to donate, bank or discard their baby's cord blood. Did you know that the Food and Drug Administration (FDA) regulates cord blood? Here is some information for expectant parents about the regulations in place designed to help ensure the safety of cord blood for transplantation.

What is cord blood?

Cord blood is the blood contained in the placental blood vessels and umbilical cord, which connects an unborn baby to the mother's womb. Cord blood contains hematopoietic (blood-forming) progenitor/stem cells. At birth, cord blood can be collected (or "recovered") from the umbilical cord.

What are the options for cord blood banking?

The cord blood can be donated to a public cord bank where it will be stored for potential future use by anyone who may need it. Alternatively, parents may arrange for the cord blood to be stored in a private cord bank, for potential use if it is later needed for treatment of the child from whom it was recovered, or for use in first- or second-degree relatives. Information on cord blood donation options may be found on the Health Resources and Services Administration (HRSA) web site.

You may wish to consult your health care provider about the options.

How does FDA regulate cord blood that is banked?

FDA has in place a risk based approach for the regulation of human cells, tissues and cellular and tissue-based products (referred to as HCT/Ps for short). HCT/Ps include cord blood, and are subject to FDA requirements regarding manufacturing steps, including the recovery, processing, storage, labeling, packaging or distribution of the products, as well as the screening and testing of the donor (also known as donor eligibility). These regulations apply to cord blood that is stored at public or private banks. Banks that provide cord blood products for use in an unrelated individual (public use) must follow these and additional FDA requirements.

Establishments that perform any of these manufacturing steps must register with FDA and list their products and each of the manufacturing steps they perform. Registration with FDA doesn't mean a firm is "endorsed" by the agency, it simply means the firm has notified FDA that it is performing one or more manufacturing steps.

Does FDA inspect facilities that store cord blood?

Yes. These registered establishments are subject to FDA inspection to ensure they are complying with the regulations designed to help ensure the safety of cord blood.

Where can I get more information about donating my baby's cord blood?

To make your baby's cord blood available for use by anyone who needs a cord blood transplant, you may donate it to a public cord blood bank. Information on donating cord blood to a public cord blood bank is also found on the HRSA web site.

Where can I get more information about banking my baby's cord blood?

To make your baby's cord blood available for use by the child from whom it was recovered, or for use in first- or second-degree relatives, you may bank it with a private cord blood bank. Information on banking cord blood with a private cord blood bank is also found on the HRSA web site.

For some diseases, such as genetically heritable diseases, in the event that your child would need treatment, it is possible that the cord blood would not be recommended for such use.

Where can I get more information about FDA's regulations?

Information about the regulation of HCT/Ps is available on FDA's web site.