CORD BLOOD COLLECTION DEVICE

描述（由申请人提供）：尽管每年有3万例骨髓移植用于治疗白血病、地中海贫血和镰状细胞病等疾病，但每年约有6万例符合移植条件的患者因找不到成功移植所需的几乎完全相同的供体而死亡。作为移植用造血祖细胞的来源，对高质量脐带血的需求日益增长。然而，目前还没有专门的设备可以安全、快速、方便地采集脐带血。此前，NHLBI将SBIR一期和二期拨款授予了Fallbrook Engineering， Inc.和CHORI (Children Hospital, Oakland Research Institute)，以开发一种独立的装置，该装置可以在脐带周围闭合，以安全的方式切断脐带，并在含有抗凝血剂的血管中收集脐带血。该申请寻求额外的资金，以继续评估和改进脐带血采集装置的过程，并进行FDA要求的临床前研究，作为销售该装置的510(k)申请的一部分。我们的假设是，我们的新设备将收集与传统系统相同或更大容量的脐带血，而不会使医护人员暴露于针头伤害。我们的建议包括四个具体目标：1)。脐带血采集装置样机的初步设计2)在三个地点进行临床前试验；3)申请FDA批准我们的设备（UCB 1000）；4)组建Cord Cell Technologies， Inc，并获得用于生产和销售UCB设备的融资。临床前测试和产品评估将在三个试验点进行，这些试验点将遵循相同的程序和协议：北卡罗来纳州达勒姆杜克大学的卡罗莱纳脐带血银行；MD安德森癌症中心，休斯顿，德克萨斯州；我们将在每个地点收集50份脐带血样本，并将其运送到CHORI实验室。除了测量采集的总血容量和评估每个单位的无菌性外，我们还将在血液收集、处理、冷冻和解冻后进行细胞计数（diff）、NRBC、活力（台色蓝）、CD3和CD34的流式细胞术和CFU检测。将收集定性和主观数据，以评估卫生保健专业人员使用ucb1000的便利性。我们在这些试验中成功的五个标准是：1)与传统方法相比，脐带血的采集量相等或更好；2)同等或更高水平的细胞活力；3)同等或更好的不育水平；4)操作安全，不让人员接触穿透皮肤的锋利边缘；5)快速方便的收集，不明显干扰产科实践。UCB 1000脐带血采集装置将大大降低采集脐带血所需的专业知识水平，消除溅血和针扎的风险，同时增加所采集的无污染和足够容量的脐带血单位的百分比。我们相信这款设备将成为行业标准。由于没有足够的脐带血干细胞库存来确保所有移植患者及时获得高质量的匹配，今天许多患者在等待匹配时死亡。需要改进安全有效地收集脐带血的方法，以确保有足够的干细胞库存用于儿童和成人的移植。本资助申请中描述的产品易于使用，既可以增加采集的单位数量，又可以最大限度地提高每次采集的脐带血容量，同时保护医护人员在采集过程中不接触针头和任何受污染的血液。

DESCRIPTION (provided by applicant): Although 30,000 bone marrow transplants occur each year in attempts to cure diseases such as leukemia, thalassemia and sickle cell disease, approximately 60,000 patients eligible for transplant die every year without finding the nearly identical donor match required for a successful transplant. There is growing demand for high quality umbilical cord blood as a source of hematopoietic progenitor cells for transplantation. No dedicated device, however, exists to safely, quickly, and conveniently collect cord blood. NHLBI previously awarded SBIR phase I and II grants to Fallbrook Engineering, Inc. and CHORI (Children's Hospital, Oakland Research Institute) to develop a self-contained unit that closes around the umbilical cord, cuts the cord in a safe manner, and collects the cord blood in an anticoagulant-containing vessel. This application seeks additional funding to continue the process of assessing and improving the cord blood collection device and to conduct preclinical studies required by the FDA as part of a 510(k) application for marketing clearance to sell the device. Our hypothesis is that our new device will collect the same or greater volume of cord blood than the conventional systems without exposing the healthcare workers to needle-stick injuries. Our proposal consists of four specific aims: 1). Finalize Design of the Prototype Cord Blood Collection Device; 2) Conduct Pre- Clinical testing at three sites; 3) Request FDA Regulatory Approval for our device (the UCB 1000); and 4) Form Cord Cell Technologies, Inc, and obtain financing for production and marketing of the UCB devices. Pre-clinical testing and product evaluations will be conducted at three test sites that will follow the same procedures and protocols: Carolinas Cord Blood Bank, Duke University, Durham, NC; MD Anderson Cancer Center, Houston, TX; and Alta Bates Summit Medical Center, Berkeley, CA. We will collect 50 samples of cord blood at each site and ship to the CHORI laboratory. In addition to measuring total collected blood volume and evaluating sterility for each unit, we will perform cell counts, diff, with NRBC, Viability (Trypan blue), Flow cytometry for CD3 and CD34 and CFU assays following the collection, processing, freezing and thawing of the blood. Qualitative and subjective data will be collected to evaluate the ease of use of UCB 1000 by health care professionals. Our five criteria of success in these trials are 1) equivalent or better collection of cord blood volume compared to conventional methods; 2) equivalent or better level of cell viability; 3) equivalent or better level of sterility; 4) safe operation without exposure of personnel to sharp edges that penetrate the skin; and 5) rapid and easy collection without significant interference with obstetric practice. The UCB 1000 Cord Blood Collection Device will substantially reduce the level of expertise required to collect cord blood, eliminate the risk of blood splashing and needle sticks while increasing the percentage of cord blood units collected that are free of contamination and sufficient in volume. We believe this device will become the industry standard. Because there are not sufficient inventories of cord blood stem cells to assure a quality match for all transplant patients in a timely manner, many patients today die while waiting for a match. Improved methods for the safe and effective collection of cord blood are needed to ensure that adequate inventories of stem cells are available for transplantation in children and adults. The product described in this grant application is easy to use and will both increase the number of units collected and maximize the cord blood volume per collection while protecting healthcare workers from exposure to needle sticks and any contaminated blood during the collection process.