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27-04-2006: ViaCell, Inc. and Pall Corporation announced the first U.S. Food and Drug Administration clearance of a cord blood collection bag suitable for use in a sterile field. Pall and ViaCell collaborated on the development and design of the new collection bag. ViaCell has exclusive rights to the new collection bag for family cord blood banking and expects to introduce it as part of its ViaCord® collection kit. The new sterile field bag will give families and their health care providers the ability to more safely and easily collect umbilical cord blood from newborns, even when born by cesarean section.
Umbilical cord blood is a valuable source of stem cells used to treat more than 40 life threatening diseases including a wide range of cancers, immune deficiencies and genetic disorders. Collection of cord blood is a critical first step in the process of preserving a baby's umbilical cord blood to meet these and other future medical needs. It is important that the collection kit simply and aseptically collect as much blood as possible since larger units for cord blood generally produce more viable stem cells.
Collecting blood from the umbilical cord of babies born by cesarean section, unlike vaginal births, must be done in a sterile surgical field. There are about 1.2 million cesarean sections performed in the U.S. each year, representing about 30 percent of all births. Since not all cesarean births are planned, ViaCell intends to include the new sterile field bag in its ViaCord collection kit provided to all expectant families who decide to preserve their baby's umbilical cord blood. Expectant parents and medical professionals will then have the optimal tools to collect their infant's cord blood, no matter the type of birthing situation.
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U. S. Food and Drug Administration (FDA)
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public hea ... more
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