SBIR-STTR Award

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

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.

Thesaurus Terms:
biomedical equipment development, blood preservation, clinical biomedical equipment, cord blood, sample collection antisepsis, blood donor