Thinking about banking your child’s cord blood?
Find information on cord blood, its use and how we regulate human cord blood banks in Canada, to help you make an informed decision about banking your child's cord blood.
On this page
- What is cord blood
- Why store cord blood
- What is cord blood used for
- Types of cord blood banks in Canada
- How cord blood banks are regulated
- Choosing a cord blood bank
- For more information
What is cord blood
Cord blood is the blood that remains in the umbilical cord connected to the placenta after childbirth. Cord blood contains all the normal elements of blood - red blood cells, white blood cells, platelets and plasma. But it is also rich in stem cells, similar to those found in the bone marrow.
Stem cells may be obtained from three main sources:
- Cord blood: After a baby is born and the umbilical cord is cut, some blood remains in the blood vessels of the placenta and the portion of the umbilical cord that remains attached to it. After birth, the baby no longer needs this extra blood which is called umbilical cord blood or "cord blood'' for short.
- Peripheral blood: To collect stem cells from the blood, the donor has to receive a drug to make the stem cells leave the bone marrow and enter the blood stream, where they can be easily collected by a procedure called "apheresis".
- Bone marrow: Normally, the stem cells are collected from the pelvic bone.
Why store cord blood
Cord blood is rich in stem cells. These stem cells are the blood cells that give rise to all other blood cells that are vital to the human body. When transplanted, these stem cells can repopulate the patient's bone marrow, cause cells to reproduce rapidly, and differentiate into healthy blood cells.
Cord blood stem cells can be used to treat certain health conditions, which is why a growing number of parents are considering storing their child's cord blood. A baby's immune system is less mature, therefore when their cord blood is used as a source for stem cells, it is more likely to be compatible than stem cells from other sources.
Cord blood can be collected and stored in advance, so it is readily available when needed. The quantity and quality of stem cells in a unit of cord blood is affected by how the cord blood is collected, transported, processed and stored by the cord blood bank. This is why it is important for cord blood banks to have well controlled procedures during all phases of cord blood banking.
Stem cells from other sources, like bone marrow, are collected from the donor only when the patient needs them.
What is cord blood used for
Stem cells from cord blood can currently be used in the treatment of patients with blood and immune system disorders such as:
- myeloproliferative syndrome, among others
Types of cord blood banks in Canada
Cord blood stem cells can be banked for use by either the original donor (known as autologous donation) or by someone else (known as allogeneic donation). In the case of cord blood stem cells, your child is the donor.
There are three types of cord blood banks in Canada:
- Public banks that store cord blood for allogeneic use
- Private, for-profit banks that store cord blood
- for autologous use only
- for autologous and allogeneic use (can be used by the donor or other family members)
- Biobanks, which store stem cells for research and potential manufacturing into a drug (otherwise known as cellular therapy or regenerative medicines)
Public cord blood banks
Public cord blood banks collect, process and store cord blood units with the intention for transplantation into patients who are not the donor. There are no fees associated with donating cord blood to a public cord blood bank.
Donation to a public cord blood bank is done mainly for the benefit of others and has the potential to save the life of any person for whom the unit is a good match. It is a source of hope for patients who have no matched bone marrow donor in their family.
Information on cord blood donations is stored in searchable registries used to match donations with patients in need. Registries do not provide information about the identity of the donor. Success in finding compatible donors depends on the amount and diversity of cord blood available. All registries worldwide are connected and share information about their stored units to help find the most suitable and compatible donor as quickly as possible.
Private cord blood banks
Privately owned cord blood banks charge a fee to process and store cord blood. Cord blood stored at private banks is not made available for public use through registries.
There are two types of private cord blood banks:
- Banks that store cord blood for autologous use only.
- The cord blood stored at these banks is only available to your child, and not to anyone else.
- Banks that store cord blood for autologous and allogeneic use.
- In this case, the cord blood stored at these banks can be used by the donor or their family members.
Grown up children and adults may need more cells to be transplanted than those contained in a single cord blood unit. Therefore, in most cases, even if parents had stored a unit for family use, it would likely not be sufficient for a successful transplantation and additional units stored in public use banks would still be needed.
Parents should be aware of the low probability of using one's own cord blood for autologous transplantation, which studies have estimated are between 1 in 20,000 and 1 in 250,000. When a patient needs cord blood transplantation, cells from a healthy donor are preferred to their own cord blood if their cells carry the same genetic or congenital disorder that caused the disease.
Biobanks store biological samples, including stem cells and tissues rich in stem cells, for research purposes and the potential to be manufactured into a drug in the future.
Parents should be aware that drugs (which may also be called cellular therapies or regenerative medicines) that are made using cord blood or other sources of stem cells from tissues would be subject to the regulatory requirements under the Food and Drug Regulations (FDR). As such, parents may wish to confirm with the company that their practices would support future compliance with the FDR.
How cord blood banks are regulated
Health Canada regulates cord blood banks that process and store cord blood that is collected from a donor for use in another individual (allogeneic use) under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations).
Both public and private cord blood banks that process and store cord blood that is for allogeneic use are required to register with Health Canada under the CTO Regulations and therefore are subject to routine inspections.
The main purpose of the CTO Regulations is to minimize the potential health risk to Canadian transplant recipients of human CTO from another donor (allogeneic use). Private cord blood blanks that store cord blood for use only by the donor (autologous use) are not subject to the CTO Regulations or routine inspections.
As part of Health Canada's (HC) commitment to regulatory transparency, information on all CTO inspections conducted under the CTO Regulations are published in Drug and Health Product Inspections.
All cord blood banks, including those private cord blood banks that store cord blood for autologous use only, are subject to the Food and Drugs Act, which governs health product safety. Cord blood products cannot be manufactured, prepared, preserved, packaged or stored under unsanitary conditions, to prevent contamination and protect safety.
Choosing a cord blood bank
Things to consider when choosing a cord blood bank include:
- Know what health conditions can be treated with stem cells. Be wary of cord blood banks that promise that your child's cord blood can be used to treat conditions that there is no scientific evidence to support the claims that are being made.
- When banking cord blood, know what type of bank you are selecting and who the cord blood can be used for:
- Private banks for autologous use only (for use in the donor only);
- Private banks for autologous or allogeneic use (for use in the donor or family members); and
- Public banks for allogeneic use (for use by anyone).
It is important to remember that only cord blood banks that store cord blood for allogeneic use are registered with Health Canada.
- Ask the cord blood bank what would happen to the cord blood unit if the bank was to close down for any reason.
- Get informed about the cord blood bank you choose. Canadian cord blood banks can attain accreditation from reputable organizations such as the Foundation for the Accreditation of Cellular Therapy and the AABB. Health Canada is not involved with these accreditation organizations but you may choose to confirm accreditation status with the organization or the potential cord blood bank.
- Find out if your cord blood bank is registered with Health Canada by contacting CTO Registration at firstname.lastname@example.org. Not all cord blood banks are required to be registered and subject to routine inspection by Health Canada.
- Read summaries of Cells, Tissues and Organs (CTO) Inspections to know how your cord blood bank is complying with regulatory requirements.
- Report concerns to Health Canada using the Health Product Complaint Form. Even if a cord blood bank is not registered with Health Canada, anyone with concerns about the safety of banked cord blood or who thinks a cord blood bank is not complying with federal requirements can report their concerns to Health Canada.
Drafted with the co-operation of the European Directorate for the Quality of Medicines & HealthCare
Additional Sources of Information
- European Directorate for the Quality of Medicines & Healthcare
- The Society of Obstetricians and Gynaecologists
- Contact Health Canada's Biologics and Genetic Therapies Directorate at email@example.com if you have questions about how stem cells are regulated
- Contact Health Canada's Biological Product Compliance Program at firstname.lastname@example.org if you have questions about cord blood bank compliance and enforcement.
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