The FDA has given clearance to.PrepaCyte-CB umbilical cord blood processing system from BioE Inc. out of St. Paul, Minnesota. The device, already approved in the EU, filters blood for progenitor stem cells, total nucleated cells, and mononucleated cells for a possible use in therapeutic applications.
Features from the product page:
PrepaCyte-CB provides public and private cord blood banks a simple and cost-effective method for processing umbilical cord blood to obtain potentially therapeutic cells ¾ total nucleated cells (TNCs) and CD34+ hematopoietic stem/progenitor cells ¾ for eventual transplantation in humans. Available immediately, PrepaCyte-CB is the only cord blood processing system of its kind cleared by the FDA.
PrepaCyte-CB recovers high yields of TNCs, mononucleated cells (MNCs) and CD34+ hematopoietic stem/progenitor cells from human umbilical cord blood, according to the results of BioE’s multi-site, in-vitro clinical study. PrepaCyte-CB consistently removes approximately 99 percent of red blood cells (RBCs) from the final processed cord blood unit, according to BioE’s clinical study. This benefit maximizes available cryopreservation space and reduces potential ABO incompatibility issues. PrepaCyte-CB leaves desired TNCs and stem cells unmodified and unaffected during cord blood processing. PrepaCyte-CB is intuitive and easy-to-use, permitting quick implementation within new and existing cord blood banks. PrepaCyte-CB allows batch processing and reduces “hands on” staff time. Cryobanks realized a time-savings of 50 minutes per cord blood unit using PrepaCyte-CB compared to its previous hetastarch processing method. PrepaCyte-CB requires no costly capital equipment or maintenance fees. Only a standard laboratory centrifuge is required to concentrate desired cells after separation. PrepaCyte-CB integrates with STEMSOFT Software Inc.’s StemLab to efficiently record, track and manage all associated cell processing and storage data.
Press release: BioE Recieves FDA 510(K) Clearance For Cord Blood Processing System
Product page: PrepaCyte®-CB
