Cord blood banked at the Cord Blood Bank of Canada can be used only by the donor

Following recent complaints, Health Canada initiated a review to verify whether the Cord Blood Bank of Canada, a private cord blood bank, was in compliance with the acts and regulations that apply to cord blood in Canada. Health Canada’s review revealed that the Client Service Agreement published on the company’s website suggested that cord blood banked on behalf of clients could be donated to another individual upon termination of the agreement. This is known as allogeneic use. The document also contained statements that could lead clients to believe that the company is a registered establishment and therefore subject to Health Canada oversight under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations). As of January 1, 2016, the Cord Blood Bank of Canada is no longer a registered establishment under the CTO Regulations and as such, cannot bank cord blood for allogeneic use. It can bank cord blood for use only by the donor; known as autologous use. At Health Canada’s request, the company has clarified on its website that only autologous use is permitted. Health Canada also requested that the Cord Blood Bank of Canada notify its clients that only autologous use is permitted. Through its correspondence with the company, Health Canada has not been able to verify that clients have been adequately informed. Therefore, Health Canada is advising Canadians that the Cord Blood Bank of Canada can store cord blood for use only by the donor.

If you are a client of the Cord Blood Bank of Canada and have questions on the specific use of your banked cord blood, contact the company to review your agreement. Be aware that, upon termination of your agreement with the Cord Blood Bank of Canada, the cord blood may only be disposed of or used for research purposes and may not be used by an individual, including the donor, at a later time. When deciding whether or not to bank cord blood, you should seek detailed information about the cord blood bank you are considering. Facilities that store cord blood for autologous use only are not regulated under the CTO Regulations. These facilities can attain accreditation from reputable organizations such as the Foundation for Accreditation of Cell Therapies and the American Association of Blood Banks. If a Canadian cord blood bank stores cord blood for allogeneic use, it must be registered with Health Canada. If you would like to find out whether an establishment is registered, contact Health Canada by emailing CTO_Registration@hc-sc.gc.ca . If you have concerns or complaints about cord blood or any health product, file a report with Health Canada by calling toll-free at 1‑800‑267‑9675, or complete an online complaint form.