Cord Blood Bank Guidelines
Cord Blood Bank Guidelines: Umbilical cord blood was first used in transplant in 1988, and is a plenteous and rich source of stem cells. Stem cells are the building blocks of the immune system that can be used to treat a variety of life-threatening diseases including leukemia, cancers, and many blood and immune disorders. It is said to treat more than 50 life-threatening diseases.
Just during the last few years, hundreds of acutely ill patients have received treatment because of this tremendous medical advance. Recent research findings, early success and future promises using stem cells for heart disease, stroke, vascular disease, and brain and spinal cord injury have fueled an increased level of awareness about the power and value of saving newborn stem cells. Banking newborn stem cells is a one-time opportunity to collect and preserve a lifesaving biological resource for families.
Different countries have different legal requirements or guidelines for cord blood banks. For example, for the people who live in the US, should learn about the AABB and what this accreditation means as well as the FDA guidelines to be followed by cord blood banks in the country. Currently, there is little regulation by the Food and Drug Administration of the cord blood bank industry. While the FDA has established guidelines, they have not enforced any regulations aside from the mandatory screening for diseases including HIV.
However, in 2000, the FDA did look to implement regulations on the industry but they received strong opposition from different groups especially from the private banks. Because achieving and maintaining regulatory compliance is a significant financial investment that many banks will not be able to undertake. Instead, guidelines were established that allow inspectors to go into the companies to review their facilities. However, the FDA does not examine the company’s operating procedures. As of January 2004, all cord blood banks need to register with the FDA. This will allow the FDA to track the companies and the stem cells that the banks are storing.
Beginning in May 2005, cord blood banks must meet new federal safety standards mandated by the Food and Drug Administration (FDA). From 1997, the Cord Blood Registry (CBR), the nation’s leading newborn stem cell bank, has been preparing for these new regulations, which will set the baseline standards for all cord blood banks. In 1998, CBR was the first cord blood bank to receive accreditation from the American Association of Blood Banks (AABB) for the specialized processing of cord blood stem cells. While CBR is not “FDA approved” it follows the FDA guidelines very closely.
According to Stephen Grant, Vice President of Communications for CBR, “Unlike other companies, we have been anxious for the FDA to issue these regulations. CBR has spent a great deal of time and effort working with the FDA. Although CBR has always maintained the highest level of quality standards, these regulations provide an important legal foundation and add validation to the importance of family banking.”
First suggestion in 1997, the FDA rules require cord blood banks to take specific steps to prevent contamination throughout the collection, processing, labeling, and distribution aspects of the service. The only current industry oversight is offered by the AABB (formerly the American Association of Blood Banks), which established voluntary accreditation guidelines for cord blood banks.
Having AABB accreditation means the bank is accredited for the specialized processing of hematopoietic stem cells. This means that the bank has had their laboratory and administrative procedures reviewed, inspected and validated and were found compliant with the guidelines established by AABB for the specialized processing of stem cells. However, general accreditation is not sufficient, but if they are not accredited, forget them!
Regarding another great issue called “autologous” and “family” use, FDA guidelines require that specific types of testing be performed prior to storage to allow for use of your baby’s cord blood stem cells for other family members. If the bank you choose doesn’t perform this testing then your stem cell sample is banked “autologously” – allowing use only for the child it was collected from and excludes other family members, such as siblings.
Lastly, it is important that your baby’s blood is being stored in a bank that has a proven history and one whose specimens have been used repeatedly in successful transplant operations. It is vital that they engage in sound and ethical business practices and maintain all required regulatory licenses and certificates of accreditation. The FDA does not regulate private cord blood banking but they do regulate blood banking. By selecting a facility that is also a Blood Center, you know they are required to follow all FDA regulations and good manufacturing practices (GMP) guidelines. For immediate response capabilities, they are staffed 24 hours a day, 7 days a week to receive and process cord blood specimens.
With that being said about US, let’s put some light on the current scenario in European countries. The NHS has been banking donated haematopoietic stem cells from cord blood since 1996, through a service operated by the National Blood Service at a small number of specialized centers located at maternity hospitals. The NHS cord banks consist mainly of altruistic cord blood donations that are used to treat unrelated recipients, but arrangements can also be made for ‘directed’ cord blood collection and banking in families affected by or known to be at risk of diseases that are treatable by blood stem cell transplantation.
Cord blood banking in the public sector is currently regulated through Department of Health (DH) guidance, the Code of Practice for Tissue Banks. While the guidance has no statutory force, it is the basis for the DH’s accreditation scheme. The Code of Practice requires all tissue banks to provide safe tissue of reliable quality by adhering to good practice standards including adequate hygiene procedures, storage facilities, and measures for ensuring traceability of samples, documentation, and staff training.