Developed by the Cord Blood Association (CBA) to give health practitioners and families clarity and assurance
How can we expect parents to trust cord blood banking if banks care for stem cells so poorly that they cannot be used for treatment?
Earlier this year, Joanne Kurtzberg, a pioneer of cord blood banking and one of the world’s most respected specialists in umbilical stem cell therapy, made a statement to the directors of the Cord Blood Association that put this question into sharp focus:
“I have experienced many situations in which a family-banked unit could not be used because it lacked a critical piece of data or because it was not stored or shipped properly.”
Somehow, despite the impressive and competing claims of cord blood banks, transplant nurses and doctors are finding that the stem cells that could save or enhance their patients’ lives are sometimes useless.
The Top 10 Essential Requirements for Cord Blood Banking were developed by the Cord Blood Association (CBA) in response to Kurtzberg’s report and promise to give families clarity and assurance as they make this critical decision.
Accreditations are not all equal
Awareness of cord blood banking is growing, and as more parents choose to preserve their children’s umbilical stem cells more lives are being saved and enhanced. Amidst the competing claims of cord blood banks, however, it can be difficult for parents to be sure which bank will provide them with the high quality, dependable service they need. Lots of cord blood banks compare their accreditations with those of other banks to demonstrate to parents their competence and proficiency. This is a useful starting point but it is worth spending a little time looking at each accrediting body and its requirements. Quality in this area is certainly more important than quantity.
Essential Requirements for Cord Blood Banking
These “Essentials” are high-level requirements that should be followed without exception when banking cord blood. The CBA notes that government regulations and voluntary accreditations may have additional requirements but hope that their policy is another step “toward harmonization of banking standards and practices around the world.”
As members of the CBA, Biovault Family have long adhered to all 10 of these requirements and welcome any policy that will help families and their cells to receive the care and respect that they deserve, both financially and ethically.
“We go above and beyond the demands of accreditations and actively seek out higher standards. We want the cells to be usable.” (Quality Manager, Ben Charles)
Top 10 Essential Requirements
- Collection into a validated sterile container with anticoagulant
- Enumeration of a total nucleated cell count prior to cryopreservation
- Measurement of total nucleated cell or CD34 cell viability prior to cryopreservation
- ABO, Rh typing
- Testing for sterility(If positive, identification of the organisms and antibiotic sensitivities)
- Donor screening tests on the maternal donor, including but not limited to:Hepatitis B surface antigenHepatitis B NAT or PCRHepatitis C antibodyHepatitis C NAT or PCRHIV 1 and 2 +/- O antibody and PCRSyphilis antibodyCMV antibody
- Validated cryopreservation procedure, storing product in a cryobag or other similarly validated container with a minimum of two attached segments
- Labeling and chain of custody
- Storage in the vapor or liquid phase of liquid nitrogen
- Shipment to the treatment center in a validated dry shipper