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. ? ? ?
