“The Family Cord Blood Banking Act” was recently introduced in the United States House of Representatives. The act, if passed, would change the IRS Code to permit use of tax-free dollars to pay for private cord blood banking, thus allowing individuals to use flexible spending accounts (FSA), health savings accounts (HSA), health reimbursement arrangements (HRA), or the medical expenses tax deduction. This change would make cord blood banking more affordable and provide more options for parents interested in this service.
Several parents have already opted to preserve cord blood extracted from the umbilical cord after birth. Cord blood is a rich source of stem cells that can be saved and used for future treatments. However, there has been a great deal of debate over the usefulness of private cord blood banking, which reserves these cells for the donor or their family, versus public banking, where cord blood is donated and used by anyone that is a match. There is wide support for public banking and donation, but private banking is more controversial and is not supported by the American Academy of Pediatrics or the American College of Obstetricians and Gynecologists. Some feel that private banking is expensive, unnecessary, and unproven because children in need can find good matches using public sources. In some instances, like genetic disease, the donor could not use their own cells because the genetic trait would still exist in the cord blood.
Currently, cord blood is most commonly used in the treatment of childhood leukemia. Cord blood shows an advantage in treating the disease over bone marrow transplants, and supporters of private cord blood banking argue that around 25% of people looking for public donations do not find a match. In addition, 10-30% of those who receive treatment with public matches have adverse reactions. Another plus for private cord banking is that it can also be used by the donor’s relatives; siblings have a 75% chance of being a match and parents a 50% chance. Currently, cord blood from private banks is being used in clinical trials to treat cerebral palsy, type 1 diabetes, and traumatic brain injury. New stem cell treatments are discovered regularly and having one’s own cord blood stored would provide a source of cells for future treatment.
The process for collecting and preserving cord blood begins when the umbilical cord is collected after birth and then sent to a lab for processing. The cord blood is extracted and separated into three layers; red cells, plasma, and the “buffy coat,” which contains white blood cells and stem cells. Most private stem cell banks store only the buffy coat. The cells are put into cryopreservation media that contains DiMethylSulfOxide (DMSO), which penetrates the cells and replaces the water. The water needs to be replaced because it expands during freezing and would cause the cells to burst. In addition to DMSO, the cryopreservation media also contains a base media, such as DMEM or RPMI plus either human albumin, the donor serum, or a combination of both. The cells are then slowly cooled until they reach the storage temperature of -196° C. When cells are thawed for therapeutic use, they are washed, which removes the media and returns water to the cells.
The Food and Drug Administration (FDA) regulates cord blood under “Human Cells, Tissues, and Cellular and Tissue Based-Products,” which makes the use of human albumin a challenge in the preservation process. Using human albumin is problematic since the FDA has made their position clear regarding the safety concerns associated with using human or animal derived products in regenerative medicine. The use of human or animal components has been discouraged in production of therapeutic stem cell treatments and biotherapeutics due to the concern of viral or prion contaminants. If this legislation is successful and the banking of cord blood becomes more widespread, it seems logical that the FDA will turn its attention to the method in which these cells are banked and what constitutes safe handling of these cells between collection and therapeutic use. If history is any indication, documentation of safety and removal of all animal and human components will become a necessity and recombinant human albumin will be a vital replacement for blood-derived albumin.