Texas has state legislation around cord blood education that follows the Institute of Medicine guidelines and mandates/encourages physicians to educate expectant parents about ALL forms of cord blood banking. The Texas Dept. of Health is also tasked to to educate the public about programs that offer free family cord blood storage when the family has an existing medical need. The Texas bill was enacted 18 May 2007 and became effective 1 Jan. 2008.
- Why is it important to choose a Family Bank that is accredited?
The Parent's Guide to Cord Blood Foundation recommends that parents select a Family Bank whose laboratory has been inspected and accredited by an accreditation agency specific to cord blood banking, as this provides a degree of quality assurance.
In some countries, national regulations hold Family Banks to the same standards as Public Banks, so an independent accreditation is not necessary (Examples: Germany, Israel). But in most countries the federal requirements for Family Banks are not as strict as Public Banks, and then a voluntary accreditation is desirable. For example, in the United States the FDA registers and inspects Family banks, but does not require them to have a BLA License like Public Banks.
Caveat: The process of registering with an accreditation agency and getting inspected can take a year, so it is understandable if a brand new lab does not have an accreditation yet.
- 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?
- 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.
Reed, W et al., Blood 2003;101(1):351
Barker, JN et al., Blood 2005;105:1343-1347
Eapen, M et al. Lancet 2007;369:1947-54
Rocha & Gluckman Brit. J. Haematology 2008;147:262-274
Delaney, C et al., Brit. J. Haematology 2009;147:207-216
Michallet et al. 2010 Blood 2010;116:Abstract#361