June 24, 2015

The FDA is very involved with the umbilical cord blood banking process, to ensure that children and families received a high level of care. The FDA has approved cord blood for use in hematopoietic stem cell transplants for treatments that relate to the hematopoietic system. These include certain types of cancers and immune system disorders. Cord blood can also be used for anemia treatment. Cord blood is currently used to treat more than 80 diseases, and stem cell research is widely engaged and constantly developing more treatments.

Private cord blood banks such as CariCord, which store a child’s cord blood after a mother’s pregnancy stages, must abide by regulations set forth by the FDA. These include facility registration, infectious disease testing, donor screening, reporting and labeling, and other standard practices pertaining to umbilical cord blood banking. The FDA does not require approval for cord blood use when it is being donated to a first or second-degree relative of the original donor.

The FDA performs routine inspections of all public and private cord blood banks that collect cord blood after a mother’s pregnancy stages. This is to ensure that the umbilical cord blood banking service is following all of the regulations and guidelines that the FDA has established to protect both the donors and recipients of cord blood banking, which can be used for anemia treatment.

All cord blood banks are required to register with the FDA, but that does not necessarily mean they are FDA-approved. Registration means that an umbilical cord blood banking provider lists their products and methods, among other requirements. However, there are FDA-approved cord blood processing methods (known as a Biologics License Application or BLA) that are used by CariCord’s laboratory, to manufacture cord blood as a pharmaceutical drug for our Public Bank (University of Colorado Cord Blood Bank). CariCord, the private family bank has taken things a step further than other private banks, because we use the identical methods and the same lab to process private cord blood units. Expectant mothers in their stages of pregnancy can be confident, because an FDA-approved process is employed to insure the best quality possible for our Private banking clients.

CariCord is the only private bank using FDA BLA approved processing methodology. No other private bank can make this claim.

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