Cord blood banking is the collection and storage of blood from the umbilical cord and placenta after birth, because that blood contains blood-forming stem cells. Families can donate it to a public bank or store it in a private one.
Cord blood is one source of stem cells within the field described in what is regenerative medicine. This page explains what is stored, how public and private banks differ, what the stored cells are actually used for and where the evidence is thin.
What cord blood contains
The FDA’s consumer guide on cord blood explains that cord blood is the blood contained in the placental blood vessels and umbilical cord, which connects an unborn baby to the mother’s womb. It contains hematopoietic progenitor cells, which are blood-forming stem cells, and it can be collected from the umbilical cord at birth.
The same guide states that these cells are found in bone marrow, peripheral blood and cord blood, and that they are routinely used to treat patients with cancers such as leukemia or lymphoma, and other disorders of the blood and immune systems. The transplant procedure itself is explained in the guide to hematopoietic stem cell transplant.
The FDA guide frames the parental decision as whether to donate, bank or discard the baby’s cord blood. It was written to explain the regulations in place designed to help ensure the safety of cord blood for transplantation, and it points families to the Health Resources and Services Administration for information on donation options.
Public and private cord blood banks
The FDA describes two routes. 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.
The American Academy of Pediatrics states in its policy statement that the procurement, characterization, and cryopreservation of cord blood is free for families who choose public banking, while the family cost for private banking is significant and not covered by insurance, and the unit may never be used. The same statement notes that both public and private cord blood banks worldwide hold hundreds of thousands of cord blood units designated for the treatment of fatal or debilitating illnesses. It adds that quality-assessment reviews show private cord blood banks to be underused for treatment, less regulated for quality control, and more expensive for the family than public banks.
The American College of Obstetricians and Gynecologists reached a similar position. Its committee opinion says the benefits and limitations of public versus private banking should be reviewed with the patient because they serve different purposes, and that routine use of private cord blood banking is not supported by available evidence and public banking is the recommended method of obtaining cord blood.
What stored cord blood is used for
The established use is transplantation. The ACOG opinion notes that since the first successful umbilical cord blood transplant in 1988, it has been estimated that more than 35,000 transplants have been performed in children and adults.
Matching matters. The FDA explains that human leukocyte antigen typing is used to match patients and donors for cord blood transplants. 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. The agency adds that there is evidence cord blood cells may not require as exact a match as cells from bone marrow or the bloodstream.
A child’s own cord blood is not always usable for that child. According to ACOG, cord blood collected from a neonate cannot be used to treat a genetic disease or malignancy in that same individual, because stored cord blood contains the same genetic variant or premalignant cells that led to the condition being treated.
Regenerative claims and the evidence
The ACOG opinion states that there is no current evidence to support the use of an autologous umbilical cord blood sample in regenerative medicine. The AAP statement describes the possibility of regenerating tissue systems as something that may come in the future and as an area that needs study.
Research on rebuilding tissue with cells, scaffolds and growth signals is covered in what is tissue engineering. That work is investigational and does not change what cord blood is approved for today.
In a 2020 consumer alert on regenerative medicine products, the FDA said that the only stem cell products that were FDA-approved for use in the United States consisted of blood-forming stem cells derived from umbilical cord blood, for disorders that affect the production of blood. On December 18, 2024, the FDA approved Ryoncil, a donor bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft-versus-host disease in children; the FDA’s list of approved cellular and gene therapy products is the current reference. The 2020 alert also says products derived from umbilical cord blood have not been approved for orthopedic conditions such as osteoarthritis or for neurological disorders such as multiple sclerosis.
How the FDA oversees banks
Regulation differs by type of bank. The FDA says cord blood stored for personal use and for use in first- or second-degree relatives that meets other criteria in its regulations does not require approval before use, though private banks must still comply with requirements including establishment registration and listing, donor screening and testing for infectious diseases, and current good tissue practice regulations. Cord blood stored for potential use by a patient unrelated to the donor must be licensed under a biologics license application or be subject to an investigational new drug application before use.
Registration is not an endorsement. The agency states that registration with the FDA does not mean a firm is endorsed by the agency; it only means the firm has notified the FDA that it is performing one or more manufacturing steps. Registered establishments are subject to FDA inspection.
ACOG also advises that cord blood collection should not compromise obstetric or neonatal care or alter routine practice of delayed umbilical cord clamping, except in rare medical situations. Decisions about donating or banking cord blood belong with a licensed physician who knows the family’s situation.
Frequently asked questions
What is the difference between public and private cord blood banking?
Show answer
A public bank stores donated cord blood for potential use by anyone who needs it. A private bank stores it for the child or for first- or second-degree relatives.
Is cord blood banking recommended for every family?
Show answer
ACOG states that routine use of private cord blood banking is not supported by available evidence and that public banking is the recommended method of obtaining cord blood.
Can stored cord blood treat any disease?
Show answer
No. Cord blood contains blood-forming cells used in transplants for some disorders of the blood and immune systems, and ACOG finds no current evidence for autologous cord blood in regenerative medicine.
Does FDA registration mean a cord blood bank is approved?
Show answer
No. Registration only means the firm has notified the FDA that it performs manufacturing steps; it is not an endorsement.
