Cord Blood Collection Device

描述(申请人提供)：在本项目的第二阶段，我们是 建议完成脐带收集装置的研制 新生儿出生后立即安全有效地采血。脐带血 是越来越受欢迎的造血祖细胞来源，而且 采集脐带血而不暴露于锐器的装置是人们普遍希望的。 该项目这一阶段的目标是将个人 已经开发成统一设计的元素，以添加属性 对装置表面的凝结抑制，并在 临床环境。继续Fallbrook第一阶段的合作 奥克兰研究所工程和儿童医院(CHORI)将 与美国红十字会和代表一起加入咨询委员会 来自工业和地区脐带血库。顺利完成第二期工程 将为FDA批准多点临床试验提供足够的数据。 对采集的脐带血的评估将由NIH资助的兄弟姐妹进行 CHORI的捐献者脐带血库。 建议的商业应用：不可用

DESCRIPTION (provided by applicant): 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. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE