July 23, 2012
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 progenitor cells. At birth, cord blood can be collected (or "recovered") from the umbilical cord.
What are hematopoietic progenitor cells?
Hematopoietic progenitor cells (HPCs) are blood-forming stem cells. HPCs are found in bone marrow, peripheral blood, and cord blood. These types of stem cells are routinely used to treat patients with cancers such as leukemia or lymphoma, and other disorders of the blood and immune systems.
How are patients and donated cord blood units “matched” so that a unit of cord blood can be used for a patient’s transplant?
Human leukocyte antigen (HLA) typing is used to match patients and donors for cord blood transplants. HLAs are proteins found on most cells in the body. A person’s immune system uses these proteins as markers to recognize which cells belong in their body and which do not. A close match between the patient’s and the donor's HLA markers can reduce the risk that the patient’s immune cells will attack the donor's cells, or that the donor's immune cells will attack the patient’s body after the transplant.
How are HPCs from cord blood different than HPCs from other sources?
There is evidence that cord blood HPCs may not require as exact a match as HPCs from bone marrow or the bloodstream because the antigens in cord blood are less mature. This suggests that transplants involving compatible HPCs from cord blood may be less likely to cause adverse reactions because the donor’s cells are less likely to see the patient’s cells as foreign bodies and attack them.
What are the options for cord blood banking?
Cord blood can be donated to a public cord blood 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 also wish to consult your health care provider about the options.
How does FDA regulate cord blood stored for personal or family use?
Cord blood stored for personal use and for use in first- or second-degree relatives that also meets other criteria in FDA’s regulations does not require approval before use. Private cord banks must still comply with other FDA requirements, including establishment registration and listing, donor screening and testing for infectious diseases (except when used for the original donor), reporting and labeling requirements, and compliance with current good tissue practice regulations.
How does FDA regulate cord blood intended for use in patients unrelated to the donor (i.e., cord blood stored in public banks)?
Cord blood stored for potential future use by a patient unrelated to the donor meets the definition of “drug” under the Food, Drug & Cosmetic Act and “biological product” under Section 351 of the Public Health Service Act. Cord blood in this category must meet additional requirements and be licensed under a biologics license application (BLA), or subject to an investigational new drug application (IND) before use.
Are there any FDA approved uses for cord blood?
Cord blood can be used in hematopoietic stem cell transplantation procedures in patients with some disorders affecting the hematopoietic (blood forming) system. For example, cord blood transplants have been used to treat patients with certain blood cancers and some inherited metabolic and immune system disorders.
If a cord blood bank is registered with FDA, does that mean that the cord bank is FDA approved?
Establishments that perform any of the manufacturing steps for cord blood 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.
FDA’s website has a searchable database that includes information on registered cord blood banks.
Does FDA inspect facilities that store cord blood?
Yes. Registered establishments are subject to FDA inspection to ensure they are complying with the regulations. The inspections of private banks are designed to ensure prevention of infectious disease transmission.
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 human cells, tissues, and cellular and tissue based products including cord blood is available on FDA's web site.