CORD BLOOD COLLECTION DEVICE

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We propose to develop a cord blood collection device to better support the wide spread use of cord blood hematopoeitic stem and progenitor cells in transplantation. The proposed device will isolate the umbilical cord from contaminants in the environment and will protect medical staff from exposure to sharp needles and blades. The device is designed to collect the maximal amount of cord blood in as fresh a state as procedures permit. It will opemte either preor post-placental delivery. The specific aims of this Phase I proposal are to optimize the design of the aseptic seal around the cord, to optimize the design of the cutting mechanism, and to test and validate the device on a sampling of umbilical cords post-placenta delivery. The aims of Phase II will be to provide a prototype device for testing in the delivery suite. Success in this project will result in the availability of a device ready for commercial evaluation and testing. Once commercialized the device will offer to the medical community a means to collect with high reliability and safety a valuable source of fetal blood cells capable of supporting restoration of the hematopoietic system in individuals with cancer and inherited fatal blood conditions. Collection of these cells at birth and subsequent cryopreservation will allow autologous transplantation at any time in an individuals lifetime. In addition, future advances may allow the use of these same cells in gene transfer therapies. PROPOSED COMMERCIAL APPLICATION: There are no devices currently available which provide for the safe, efficient, and effective collection of cord blood in the delivery suite or outside. This device will offer significant benefits to operators of cord blood banks, obstetricians, and recipients of cord blood transplants. Companies currently distributing blood banking supplies and equipment or obstetrical supplies and equipment will be interested in the commemialization of this device.