In Phase II of this project, we are proposing to complete the development of a device for collecting umbilical cord blood safely and efficiently immediately after birth of the newborn. Cord blood is an increasingly popular source of hematopoietic progenitor cells, and a device for collecting cord blood without exposure to sharps is widely desired. The objectives of this phase of the project are to combine the individual elements already developed into a unified design, to add the property of inhibition of coagulation to the device surface, and to test the device in a clinical setting. Continuing the collaboration of Phase I, Fallbrook Engineering and Children's Hospital, Oakland Research Institute (CHORI) will join in an Advisory Committee with the American Red Cross and representatives from industry and regional cord blood banks. Successful completion of Phase II will provide sufficient data for FDA approval of multisite clinical trials. Evaluation of collected cord blood will be performed by the NIH-funded Sibling Donor Cord Blood Bank at CHORI.
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