Massachusetts has state legislation around cord blood education that is two-tiered. Hospitals are required to inform all pregnant women in the 3rd trimester of the opportunity to donate cord blood. There is also a public education program run by the Dept. of Health that follows the Institute of Medicine guidelines and asks (but does not mandate) physicians to educate expectant parents about ALL forms of cord blood banking. The Massachusetts bill was enacted 30 May 2005 and became effective immediately.
- What questions should parents ask a Family Bank about Laboratory Standards?
- Is the cord blood laboratory accredited by an agency that has specific standards for cord blood banks and conducts inspections? (ex: AABB, FACT, ISO)
- Some US states license cord blood banks (CA, MD, NJ, NY): Do they operate in those states? Note that the California Biologics License is based on AABB accreditation, but lags behind the latest AABB updates.
- Does the lab process cord blood around the clock, or only on selected shifts?
- What tests does the lab perform on maternal blood?
- What tests does the lab perform for infectious disease markers?
- What tests does the lab perform for contamination?
- Does the lab ever reject cord blood collections on the basis of the tests of maternal blood, infectious diseases, or contamination?
- Does the lab maintain a "quarantine tank" for the storage of blood that might be able to transmit an infection?
- What tests does the lab perform to measure the stem cell count of the processed cord blood and the stem cell viability?
- Does the lab/bank inform parents, prior to storage, if the collection is too small for a transplant, and give them the option not to save it?
- Does the lab/bank offer parents a refund if the cord blood collection has certain problems (contamination, low volume)? These refunds are typically only offered if the bank performed the collection as part of their service.
- What information will parents receive in the final report about their stored cord blood?
- What questions should parents ask a Family Bank about the Storage Facility?
- What type of records do parents receive after storage?
- Does your contract state that the storage fee is fixed, or may it increase later?
- Does the bank reserve the right, in your contract, to change storage facilities?
- Does the bank operate their own storage facility, or is it provided by another laboratory?
- What type of accreditation or other certifications does the storage facility carry? In most banks the cord blood is stored in the lab where it was processed, and the accreditation of the lab covers the storage conditions.
- What is the geographic location of the storage facility: Is it at risk for hurricanes, earthquakes, or other natural disasters?
- What type of back-up systems does the storage facility have in case of power failure?
- What type of security systems does the storage facility have?
- How much cord blood is needed for a transplant?
The crucial thing is not the volume of the cord blood collection, but the number of stem cells it contains. Transplant doctors develop recommendations based on the Total Nucleated Cell count, or TNC, because it is the easiest measure to reproduce between different labs. For treating cancer, the transplant dose should be at least 25 million TNC per kilogram of patient body weight (1 kilogram equals 2.2 pounds). The average cord blood collection holds 8.6 million TNC per mL. Thus, the optimal transplant dose requires harvesting:
1.3 mL of cord blood for every pound of patient weight, -or-
2.9 mL of cord blood for every kg of patient weight
However, as more transplant centers are adopting the practice of giving adult patients "double cord blood transplants" with two cord blood units, it is less critical for both units to have adequate cell dose.
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